MEDICINE SCIENCE AND THE LAW
Law Reform Commission of Victoria
SYMPOSIA 1986 INFORMED CONSENT Law Reform Commission of Victoria MEDICINE SCIENCE AND THE LAW INFORMED CONSENT
SYMPOSIA 1986 TABLE OF CONTENTS Preface (v) INFORMED CONSENT: AN IN1RODUCTORY OVERVIEW Margaret Somerville
STRUCTURAL CONDITIONS FOR INFORMED CONSENT 14 Neville Hicks INFORMED CONSENT: A LINGUISTIC PERSPECTIVE 23 Robert Eagleson
INFORMED CONSENT AND TRANSSEXUAL SURGERY 44 Janice Raymond INFORMED CONSENT AND THE ELDERL Y: PROFESSIONAL DEFENCE OR CONSUMER RIGHT 50 Elizabeth Ozanne MINORS AND CONSENT TO MEDICAL TREATMENT: REFLECTING ON GILLICK 68 Jenny Morgan INFORMED CONSENT TO MEDICAL CARE BY PERSONS OF DIMINISHED CAPAClTY 77 Alan Rassaby COERCION AND INDUCEMENT IN MEDICAL EXPERIMENTATION 92 Bernard Dickens CHOICE CONTROL AND ISSUES OF INFORMED CONSENT: THE NEW REPRODUCTfVE AND PRE-BIRTH TECHNOLOGIES 102 Robyn Rowland INFORMED CONSENT IN REPRODUCTION AND PRE-BIRTH TECHNOLOGY: CHOICE OR CON1ROL 121 June Factor
INFORMED CONSENT: AN OVERVIEW 127 J. Kenneth Mason
List of Contributors 144
ISBN 0 7241 6720 Y December 1987 Printed by Globe Press v
PREFACE The Law Reform Commission decided to make the subject of Informed Consent its first specific enquiry within its general reference oo Medicine, Science and The Law. In con nection with that enquiry, the Commission organised a series of Symposia throughout 1986, at which a number of people, drawn from a variety of disciplines and with a range of professional experience and connections, presented papers on particular aspects of the sub ject. At each Symposium, the audience was made up of Commissioner, research staff and guests invited, like the speakers, from various groups, - from the professions of medi cine, the law, nursing, social work, clinical psychology and teaching, and from distinct constituencies within those professions and in the community as a whole. Both the presen tations of the papers and also the lengthy and often vigorous discussions which followed them did much to refine and define the boundaries and the dire(,1ions of the Commission's enquiry. The Commission owes a distinct debt of thanks to Professor Margaret Somerville,_ McGill University; Dr. Nev ill e ~· University of Adelaide; Professor Robert Eagleson, University of Sydney; Professor Janice Raymond, University of Massachusetts at Amherst; Dr. Elizabeth Ozanne, University of Melbourne; Ms. Delys Sargea.fil, Social Biology Resources Centre, Melbourne; Ms. Jenny Morgan, Monash University; Mr. Alan Rassaby, Health Department of Victoria; Professor Bernard ~s, University of ~o; Ms. June Factor, Victorian Council for Civil Liberties; Dr. Robyn Rowland, Deakin University; and Emeritus Professor J. Kenneth Mason, University of Edinburgh. The Commission has decided to publish papers presented at the Symposia, as part of its work in developing an informed community discussion on the subject of Informed Consent. Tt hopes, and expect:;, that this collection will be of value not only in Victoria, but also in Australia, since the questions, and the issues, are clearly of national significance. Much of the organisation of the Symposia and the editing of the papers in this collection was done by Ms. Kathy Sanders, Research Officer in the Law Reform Commission. She was. assisted by Ms. Debra Bartlett. Word processing work was carried out by Ms. Chris tine Frazer, Ms Rhonda Moon, Ms. Esther Shoueka and Ms. Patricia Tickner. As the Commissioner in charge of this enquiry T would like to express my particular appreciation for the work done by Ms. Kathy Sanders in connection with the Symposia. I also thank the Chairperson, David St. L. Kelly, the fonner Deputy Chairperson, Dr. Jocelynne Scutt and my fellow Commissioner Dr. Linda Hancock, for their advice and co-operation in connection with the series.
Louis Waller 20 August, 1987 INFORMED CONSENT: AN INTRODUCTORY OVERVIEW
Margaret Somerville
INTRODUCTION The task to give an overview of the doctrine of informed consent in a limited space calls for a creative approach. I hope that what I have to say regarding infonned consent will also produce a creative response on your part. The need for empirical research It is interesting that you have chosen to study 'informed consent' at this time, because it is one of the doctrines on which we thought, until ve1y recently, that most of the work had been completed. This may not be thecase for two reasons. First, although the theoretical, legal basis of the doctrine has been thoroughly researched, the effects of applying these theories in practice have not been. The era of empirical research on the application of health law in the clinical context, in particular research in the clinical context on the effects of obtaining informed consent, is just beginning. Secondly, we are starting to recognize many previously unidentified functions of the doctrine of informed <;Qll!ieDL The image tl1at I wouldu se to describe this, is of a stone dropped in a pond of still water maybe not all that clear - and the stone has sent out multiple ripples, not all of which have yet reached the banks and been identified. Functions of informed consent These ripples represent the various pu!Poses, functions and effects of the doctrine of informed consent. Some of these are easily recognizable, suc~eeing that the basic function of infonned consent is ~ pr? tect a patient's rights, to autonomy and self determination. Such rights are worthy of protection both in themselves and because to respect tllem is to promote a person's psychological freedom. Requiring health care profes sionals to respect these rights also causes them to see the patient as a person - the subject of medical care and not an object - and as a result helps to ensure that encounters between health care professionals and patients are not de-humanized. A later insight was the percep tion that the doctrine of infonned consent can operate as a mechanism to reduce suffering. At least to the extent that people suffer because they perceive their own disintegration and a loss of control .over what happens to them, then infonncd consent can help to redress the balance towards control. The person is given back some control through being made the decision-maker. Even though \ve may not 6e -afile To avoid unwelcome outcomes, those outcomes may not be as unbearable when we feel that we have control over some features of the situations in which they occur. For example, a woman who has breast cancer may suffer less from having a mastectomy if she feels that she chose this procedure from a 2 3 range of o~ons with varying risks and benefit~, ~if she feels that she had no choice Many physicians fear the changes that applying the doctrine of informed consent and this erocedure was im_p_osed upon lier. imposes. In particular, although often in an unconscious or unarticulated form, they have ' One of the mOSt surprising questions I ever received at a symposium, was asked at a fears (which, indeed, prove to be well-founded) that their power base will be altered. But meeting to open the International Year of the Handicapped, and it is relevant in this same the interesting result in my experience, is that the large majority of physicians find the respect. The questioner said that she worked in a unit for very 'high level', spinal cord change to be for the better, once they become used to it. That is, most physicians prove to injury, quadriplegic patients. These patients are not capable of any voluntary movement have Geen more frightenea of the change described, than when they experience the changes other than to blow breath. A board had been designed to allow the patients to blow on which occur. different buttons to bring down a book, tw·n over the pages, and so on. But, these patients Finally, in terms of the relationship of informed consent to power, it is worth consider are also on life-support systems which, by definition, are necessary to the continuation of ing the concept that ~ haye shifte.f!, possibly both in theory and in fact, from the old their lives. The question was whether it was le ally an when we are formulating doctrines that are inconsistent with the origins and history of a Further lessons given concept, or extend these if this is indeed the case. Informed consent can be regarded My final general remark is tl1at 1 believe that the lessons that the doctrine of informed as such a variation on the traditional doctrine of consent. consent has to teach us are not yet complete. In the older literature. the doctrine of ~criminal la':''. consent is a n~cessary but ~_?t sufficient conditi2,!! for the legality of. an informed consent was often refe1Ted to as the 'cornerstone doctrine' of health law and intervention to wh1cfi 1t pertains. l often ask groups of surgeons how many of them thmk ethics and in truth it is. I often think that this statement came from intuition, more than that they prima facie commit a criminal offence each time they carry out surgery. Usually, from a reasoned analysis. We had no idea of the size or the depth of the foundations of the most of them are appalled by my even asking this question and are astonished to learn that building of which it would prove to be the cornerstone. In fact, we still do not know this, under English common law and man codified criminal law s stems, all surgery is prima and although we know much more, it has proven already to be much larger than we fac1e, a cnminal offence. t 1s that of intentioual infliction of bodJ.ly har112, ut surgeons are initially anticipated. not prosecuted if the surgery was justified. Traditionally, justification requires the presence of two factors. First, that there was an adeguate reason for infl.ictins' the wound.,s: that is, THE NEED FOR A DECISION-MAKING STRUCTURE that the surgery was intended to be therapeutic. and its potential benefits outweighed its Before investigating the content of the doctrine of informed consent, 1 would like to give risks. Second, that the patient gave consent. you a very brief introduction to a decision-making structure, which can be used to expose There are exceptions, however, in the modem law, to both requirements, for example, and to explore the issues raised in relation to informed c~nsent, the inter-relationship of the presence of therapeutic intent for legality is not required in relation to some cosmetic these issues, and their relationship to other issues. It is not possible within the limits surgery. The effect, from the point of view of legal theory, of being able to classify any imposed in giving an overview of the doctrine of informed consent to examine the content given sur ical wounding as therapy, is that it brings that intervention within the concept of of such a structure in det~il,3 but, a brief survey of such an approach can convey the an ac not contr to ublic lie or to public order and good morals. Consequently, general idea of what it involves. prov1 e at a therapeutic intent in inflicting the wounding is not the sole mechanism for It is important when we investigate the many individual aspects of a doctrine such as bringing such an act within the parameters of these concepts, in theory, non-therapeutic informed consent tl1at we, at the same time, see where these individual aspects fit into a surgical interventions could be justified on other bases. It would simply be a matter of more com.Qlex and global whole composed first of the entire doctrine itself and, second, of detenuining what criteria, other than therapeutic intent. are necessary and sufficient for the field of health care law and ethics. Such a structure allows for more in-depth vertical such justification. This is open to debate, but clearly male circumcision, especially for analysis of individual issues and a more comprehensive horizontal analysis of groups of religious reasons, ear-piercing, and even highly invasive aestl1etic surgery or the removal issues. Also, it is important to recognize that, in all our decision-making, including decid of some organs and tissue from living donors for transplantation, are treated as not being ing which. docuines. policies and concepts we should adopt, that ~e stru1 with initial contrary to public policy. Jn other words, consent is necessary, but not sufficient1 for the pi;.ysumptions and identify these. legality of a surgical intervention because tfie act to which consent is given must also not For instance, in the model that Tsuggest for structuring the issues in infonncd consent,4 1 contravene public policy or, in a civilian legal system, public order and good morals. start from what I have called the competent, free-living adult model and I would then Applying the above analysis to an issue which has been discussed recently in Victoria, modify this model for those persons who do not fit within it. This represents a choice of that of circumcision of young girls, is a worthwhile exercise for the insights it provides. Jt-{jv. initial presumption, which is to enshrine one situation as the status quo. But it must always This practice raises many difficult questions, including those concerning customs and reli- be recognized that other choices are available in this regard. Moreover, the choice made is gion, and the breadth of the freedom which should be allowed and respected in these not neutral in terms either of outcome or of symbolism. For instance, a person who alleges regards. It also raises the righi of parents to authorise mutilating interventiwis on their that some approach should be taken, other than that indicated by the status quo, has the children who are incompetent to consent to or to refuse such interventions. burden of proving that such an exception is justified. TI1is means that in situations of equal Among the legal issues raised are that circumcision is a 'medical act' and, therefore, the doubt, the approach indicated by the status quo will be the one which prevails. With pen;ons carrying out the circumcision could be prosecuted under statutes which restrict the respect to symbolism, there is a great difference between. on the one hand, prohibiting practice of medicine to qualified medical practitioners. certain conduct, but allowing some exceptions and, on the other hand, allowing that con Second, the persons performing the circumcision are undertaking a non-therapeutic act, duct but prohibiting it in some circumstances, even though the overall result in any given which is much more likely to attract legal liability than a therapeutic act. As explained circwnstances with respect to both the range of conduct allowed and that prohibited, might above, in many jurisdictions a surgical act is prima facie a crime and requires justification. be identical. Such j!:!,!tification will not be 12resent if f~ale circwncision is held to be contrary to public P~fl' or public order and good morals. An interesting issue in this regard is whether female circumcision would be held to be illegal pursuant to such reasoning and male cir CONSENT AND CRIMINAL LAW cumcision would not be. To examine the concept of consent within the law, one needs to consider, first, the notion Third, circumcision constitutes a non-therapeutic intervention on an incompetent child of consent within the context of c1iminal law. In a sense, there are two doctrin,t~: that of who, by definition, is unable to give his or her own consent. It may well be that parents consent and that of informed consent. Consent, in comparison to informed consent, is a have no right to authorise such an intervention. The Supreme Court of Canada has just held veryancient doctrine, the origins of whiciiC'iiilbe traced in the earliest common law in both that ~ have n2.J!lrisdiction under their _parens patriqe. power to ~uthorise a~ cnmmal and private law actions. For example, success in an action based on the old writ of t!!;rapeutic interventic_>n on an incompetent adutt.s In this case, the mother of a mentally trespass to the person, was dependent on a lack of consent to the touching. History needs to incompetent woman nad asked the court to authorise her daughter's non-therapeutic sexual be taken into accow1t when we are formulating our modem doctrines. We must be aware sterilization. It would seem almost certain that the same line of reasoning would be applied 6 7 to detennine the parameters of the powers of parents to authorise interventions on their evil cause, no cause of action can arise. That is, the courts refused to hear these cases by children. The limits of third party authorisation, that is, what we may permit to be done to reiusmg to give standing to the women plaintiffs. The reasoning behind this approach was persons in our care, custody and control, are much narrower than those for personal that each woman had been engaged in an illicit and immoral relationship and, conse informed consent which is what we permit with respect to ourselves. Use of the term 'third quentfY, she had no cause of action. Alternatively, or in aodition, a court m1gl'it hold that in party authorisation' is preferable to that of 'proxy consent' because it raises an awareness such circumstances a woman had given consent to the basic nature and quality of the act of of the difference between these two sets of parameten;. sexual intercourse and, consequently, there was no cause of action for assault and battery. To summarize, unless the act of circumcision is within the concept of public order and Let us now alter these facts. It is 1987 and a person has AfDS. Another person asks the good morals and there has been either personal consent to or a legally valid authorisation of first person whether he or she is at risk of transmitting AIDS , and the reply is no, but the the procedure, it constitutes a criminal offence. The issues surrounding drcumcision, espe first person knows that this is a lie. The two persons engage in sexual relations and the cially female cir~umcision, provide a good example of why it is very important to develop second person is infected with the AIDS virus and sues the first person, or this person is fully a doctrine of consent and to determine exactly the role that it should play in the prosecuted for an offence of causing death or bodily harm through criminal assault or protection of incompetent persons from unwarranted interventions, medical or otherwise. criminal negligence. One can only speculate what a court would hold today, whether it · The role that consent plays in protecting competent persons from unwarranted interven would find that there was consent to the basic nature and quality of that act, or whether it tions is dlfferent. This raises the issue of md1vidual rights of autonomy versus paternalism. would hold that having AIDS was simply a collateral feature of the act of sexual inter As explained, an intervention can be made illegal, usually because it is considered inher course and, consequently, consent would not be vitiated. If the fact that the person was at ently harmful, by characterising it as contrary to public policy, in which case consent risk of transmitting AIDS is held to be simply a collateral feature, there would be no becomes in-elevant. The broader the group of interventions characterised in this way, the criminal assault and probably no tortious actions available. If it is held to be part of 'the more paternalistic is the approach taken by that society; the narrower this group of inter basic nature and quality of the act', that is, the act was sexual-intercourse-with-someone-at ventions, the more that society respects autonomy. Interventions not in this category are risk-of-transmitting-AIDS, and there was no consent to this, then a criminal action would legal with consent, but illegal without it. That is, consent beromes the sole determinant of lie for either assault or sexual assault and/or the tort of battery. their legality. Whether a given feature of an act is characterized as basic or collateral, has important It is essential to keep in mind when developing doctrines of consent in the medical consequences with respect to consent and, consequent! y, with respect to liability when this context that the doctrine also operates much more widely. The general concept of consent depends upon consent. Whether an offence in criminal negligence would have been com should not be conto11ed simply to fit it into the medical context. For instance if, in general, mitted would depend in part on whether or not consent is relevant to establishing this. consent is present when a person understands the basic nature and quality of an act to Probably, it is not. Therefore, provided the conduct constituted conscious, unjustified risk which he or she agrees, then that is the rule that should be applied unifonnly in both taking by the accused (that is, a recklessness mens rea is present) and it 'showed wanton or medical and non-medical criminal assault situations, even though the person does not reckless disregard for human Jjfe or safety', an offence of causing death or bodily harm to understand the collateral features of the act, for example, a certain risk as compared with the victim would be estab lished if these outcomes resulted. an inevitable consequence. There should be an aim to have coni:iistency in the law in a Finally, to repeat my earlier warning about the necessity to try to achieve consistent and given respect or, if not, at least to be aware of inconsistencies and to deternrinc whether or coherent structures and concepts in relation to consent consent in the context of criminal not these are justified and can be tolerated. law should not be trea~ as a totall different entit from consent in the C01.!_text of private. The features or characteristics of any given act to which consent is relevant for the law and consent in the me ical context shoul not be an entirely separate entity or concept purposes of avoiding criminal liability can be further defined, and the necessity or other Irom that used i..n offier areas of law where consent is relevant. Consent needs to be seen wise for consent in relation to each of these can be explored. There are three groups of and dealt with as a global and complex whole. characteristics. First, there is consent to the basic nature and quality of the act; second, there is consent tothe inevitable consequences of the act; third, there is consent to thetlSks that the act entails. Consent can tie relevant in relation to all of these factors. The law is PRIVATE (CIVIL) LAW AND CONSENT quite technical wiih respect to the range of characteristics for which consent is required to There are two causes of action in the private Jaw which are relevant when there is an avoid criminal liability. Fundamentally, for the purposes of the criminal law there will be all~ga~on of failure to obtain consent or adequate consent. One of these is battery, which, consent to an act providing that there is consent to the basic nature and quality of that act. as 1od1cated above, is th~ ancient cause of action closely related to criminal assault. The That is, consent to the 'collateral features' of the act (whether those were inevitable conse '2!!!er one is negligence. Tlie modern doctrine of informed consent is more related to negli ~nces or risks) 1s not enma facie required for an effective consent to be present. gence than to battery. In this regard, it may be instructive to take an old example and examine its application in There is a moderate amount of confusion about when battery wjl] lie for failure to obtain a modem context. Some of the older trespass to the person, tort cases are very close to consent to medical treatment. The Supreme Court of Canada, with all due respect, has not modem criminal assault cases in the concepts and reasoning used. The plaintiffs in these eliminated this confusion and may have added to it in the landmark case of Reibl v cases were women who were not married to men with whom they had sexual relationships Hughes.6 Clearly, battery will lie where there is no consent. The difficulty is when will in which they contracted venereal disease. These women went to court seeking damages on apparent consent be totally negated, rather than rendered simply defective, with the result the grounds that there was no consent to the sexual contact. They alleged that their consent that a cause of action in battery would lie. The Supreme Court of Canada held. that this was invalid because they would never have agreed to participate in sexual intercourse with would only occur where there was 'misrepresentation or fraud' as to the act. It is arguable, these men if they had known that the men suffered from sexually transmissible diseai.e. first, what conduct would amount to such misrepresentation or fraud and, second, whether The courts almost uniformly applied a maxim ex trupae causa non ori'tur actio - out of an it is desirable to adopt this rule. In particular, should it always be the case that non- 8 9 disclosure even of very serious and probable risks, does not vitiate consent entirely and But before discussing malpractice in relation to informed consent in more detail, I would consequently, would never give rise to the possibility of a cause of action in battery? like briefly to establish where this form of medical malpractice fits into a structure com posed of all forms of medical malpractice. Battery Medical malpractice, or negligence in the medical context can occur first in relation to Fundamentally, to establish a cause of action in battery, consent must be abseJtt ,o! elimi:;; diagnosis and secondly by undertaking an intervention that is not indicated. Either that nated. This will occur if there was fraud or there was misreeresentatioQ, as to the 'nature particular procedure should never have been recommended or no intervention should have and quality' of the act. For.example,Ta man consents to a vasectomy and is told that th~s been undertaken, that is, the very act of unde11aking a given procedw·e can constitute will not affect his fertility, when the opposite result is an inevitable consequence, his unreasonable medical practice. Thirdly, negligence can occur in obtaining info1med con consent would be vitiated and battery would lie. sent to treatment. Fourthly, it can occur in carrying out a procedure. This is the form of However, the same result with respect to vitiation of consent may not ensue when a very medical malpractice that people who are not familiar with the area of medical malpractice serious undisclosed risk eventuates,. The Supreme Court of Canada seems to have said that most often identify as medical negligence. Fifthly, it can occur in follow-up care. Obliga risks are not pait of the basic nature and uality of the act. They are collateral, features and, tions of physicians in relation to patients who have been fitted with intra-uterine contracep ere ore, L..t ey are not disclosed, the appropriaJ~ cause of action is negilsence. But with tive devices (IUD) provide a good example in this respect. Imagine the case of a physician all respect, it is su oested that some risks~could be so serious and probable that tbe should who inserted an IUD into a woman and then terminated the treatment relationship. Later, be regarded as art of the basic nature and qua uy o the act. For mstance, if an ope!auon the physician had evidence that ruD's could cause pelvic inflammatory disease. Tl1e has a 90% risk o eat ut, esplle t is, t e patient wants to have it to avoid ce1tain physician would not be acting as a reasonably competent and careful gynaecologist, that is death, at a later time without the operation), the nature and degree of risk could be would be negligent, unless he or she made reasonable efforts to contact and warn the regarded as part of the basic nature and quality of the act of surgery. woman of the risks of continued use of an nm. In short, there is a complex series of Although drawing distinctions between defects of consent which give rise to a cause of internctions and events involved in a medical treatment relationship and medical malprac action in battery and those that give rise to a suit in negligence may appear to be only or tice can occur at various points in this process and can be constituted in different ways. largely a theoretical exercise, it has very non-academic ramifications in practice. The rea One reason for the development of the doctrine of informed consent was the conspiracy son is that when a plaintiff-patient goes to court and the plaintiff says 'I accuse you of of silence that unfortunately used to exist in the medical profession. This made it difficult, battery', the plaintiff need only prove that he or she was touched by the defendant. The if not impossible on occasion, to obtain the expe1t medical evidence that was necessary in total burden of proof of consent is on the physician-defendant: the burden of proving that order to establish the standard of care of the reasonably careful and competent medical there was consent, that it was adequate and voluntary and that it was informed with respect practitioner, which was essential to prove negligence. The courts responded to tl1is con to the nature and quality of the act. Moreover, more extensive damages are available in spiracy of silence on the medical side, by imposing liability for another silence, failure to battery than in negligence, because not only reasonably foreseeable damages are recover inform the patient. They stai1ed to look at what the patient had been told, instead of able as in negligence, but also, all directly flowing damages. Further, there can be some looking only at what had been done, or not done, for the patient, and held that there could situations in which it would not be possible to establish negligence, because a reasonable be negligence in not informing the patient. At first, the standard for the required scope of standard of care has not been breached, but it would be possible to establish battery, disclosure of information was set according to what the reasonable physician in the same because battery does not depend on breach of a reasonable standard of care. Battery con circumstances would have disclosed. Setting this standard also required expert medical sists simply of an unconsented to touching, regardless of whether the touching was reason evidence, but there may well have been, in practice, a greater latitude in the court's discre ably careful or not. tion whether to adopt or reject that expert evidence than in relation to expert evidence In short, a plaintiff-patient may be without a cause of action if battery is not available. I concerning medical procedures. Moreover, when the reference point for the standard would respectfully suggest that the Commission keeps such considerations in mind in became that information which would be material to the reasonable patient in the same formulating its report on consent to medical treatment. And, again, I think that it is very circumstances,s expert medical evidence was still relevant, but it was not as dominant or important not to distort your general law in introducing new doctrines relating to consent in determinant of the standard as previously. the medical context, which may have occurred in the approach taken by the Supreme Court Disclosure of information can be represented by a continuum from zero disclosure which of Canada in this respect. would be the situation with an unconscious patient needing emergency medical care, to 100% disclosure which is probably impossible as a practical reality. In between these two Negligence poles there are four standards of disclosure. The first is the subjective physician standard The law goveming liability in negligence for failure to inform patients is often regarded as where the physician discloses only the information that he or she thinks is appropriate, a the real doctrine of informed consent. The Canadian expression of this law is to be found in patemalistically based standard. The second is the reasonable physician standai·d, where the Supreme Court of Ca1iada case Reihl v Hughes.' One member of the English House of the physician must disclose the information that the reasonable physician in the same cir Lords has been reported as re-marking in relation to this case that: 'We don't want any of cumstances would disclose. This standard was used until recently in most common law. that No11h American nonsense introduced into England'. I would ask you, however, to jurisdictions which recognised the doctrine of informed consent. The third is the reason look se1iously at this 'North American nonsense'. [ believe that the Supreme Court of able patient standard where tl1e physician must disclose the information that the reasonable Canada has developed this law in a most appropriate way. The court not only held that a patient in the same circumstances would want to know. This was the standard adopted by failure to obtain informed consent is a form of medical negligence, but also, that the legally the Supreme Court of Canada in Reibl v Hughes. And the fourth is the subjective patient required scope of disclosure of info1mation is to be assessed according to the standard of standard where the information that that particular patient wishes to know must be the information that would be material to the reasonable patient in the same circumstances. disclosed. 10 ll It is worth noting here the effect of the patient's questions. When they relate to informa coercive simply because of its nature, without any intention in this regard. Care must tion outside the normally required scope of disclosure, such questions move the legally therefore be taken to avoid coercion. required standard, that is, the reasonable patient standard, to the subjective patient one. The other major component of the doctrine of informed consent, and likewise one that That is, the legally required scope of disclosure becomes that scope which would be neces has given rise to problems in the law, is that of causation. In negligence, the plaintiff must sary to answer the patient's questions. To the contrary, an 'informed waiver' of disclosure prove that the breach of vigorously in that country, we should not be surprised that there is virtually no empirical study of informed consent in Australia. STRUCTURAL CONDITIONS FOR DEFICIENCIES IN INFORMED CONSENT Sociological theories INFORMED CONSENT If the practice of informed consent is deficient, a'i the systematic review of American ~iterature s_uggests it is, and as my brief survey of some local evidence hints that it may be m Australia, what are the reasons for the deficiency? Of the two historically dominant Neville Hicks theoretical streams in the sociology of medicine, functionalism is unable to address this question effectively but conflict theory does provide a framework consistent with a number of empirical studies of professional behaviour which are relevant to the practice of inf~rmed cons~nt. Parsonian fwictionalism regards relations between doctor and patient as reciprocal: patients are temporarily in the sick role which excuses them from their normal so?ial functions. The doct?r's role is to legi~imate occupancy of the sick role and by appro INTRODUCTION AND EMPIRICAL REVIEW pnate.therapy t~ help patients return to their normal functions.2.5 Unfortunately this argu The doctrine of informed consent has received a goo 18. WILLIS E, Medical Dominance, George A\len & Unwio, Sydney 1983. . .. 19. WOLINSKY FD & MARDER W D, The Organization of Medical Practkt and the Practice of Medicine Health Administration, Univ. Michigan, Pr., 1985 20. CAMPllELL AV, Professional Care. Its Me.aning and Pra(tice, SPCK, London , 1984: 2 1. BUCKENHAM J & MCGRATH G, The Social Reality of Nursing, ADIS Hcahh Staence Press, Sydney 1983. INFORMED CONSENT: A LINGUISTIC 22. PUSEY M, Dynamics of Bureaucracy. A Case Analysis in Education, Wiley: ~ydney 19~6 . . 23. BENJAMfN M, 'Lay Obligations in Professional Relation.~·, Journal of Medicine and Pluwsnphy 10.1 1985 PERSPECTIVE pp.85-103. . . . h 10 2 24. liULL RT, 'Informed Consent: Patient's Right or Patient's Duty'!' Journal ofMedicin e and Phiwsop y, : 1985 pp.183-197. . al •. 25. BOYLE TM, 'Difference between patients' and doctors' interpretaLions of some common medic terms m Robert Eagleson Cox & Mead (eds): A Sociology of Medical Practice CH. 18, Collier McMillan, London 1975 pp.299-308. 26. SOUTH AUSTRALlA, Report of1he Migrant Health Task Force, Adelaide June 1983. 27. VEATCH RM, A Theory of Medical Ethics, Basic Books, New York 1981. 28. BERLANT J L, Profession Md Monopoly, Calif. Univ. Pr 1975. . , . 29. MCCK Set aJ , 'Physician Turnover in Eight New England Group Practices. An Analysis • Med1rnl Care, 21 1983 pp.323-7 (quoted in Wolinsky & Marder: Organisation . . . . . , . 30. HICKS N, FURLER E and WOODWARD A, 'Quality Assurance and Health Care, Comm11n1ty Healrh Sr11dies 6:2 1982 pp.160-166. INTRODUCTION 31. KASSIRER J P, 'Adding Insult to Injury. Usurping Patients' Perugatives', N ew England Journal of It would be well to begin our discussion with a record of a medical interview reported by Medicine, 308:15 1983 pp.898-901...... 32. JONSEN A R et al, Clinical Ethics. A Practical Approach to Ethical Decisions m Climcal Medmne, Shuy.I MacMlllan, New York, 1982. Doctor: Have you had a history of cardiac arrest in your family? 33. SYME LS, 'Social Determinants of Health and Disease' La~t , J. (ed). : Maxr:y-Rosena11's Public Health and Patient: We never had no trouble with the police. Preventive Mtdicine (edn. 12, 1985). Or, to take another situation, in one test, of mothers reported that they felt satisfied 34. WAITZKIN H, 'The Micropolitics of Medicine: a contextual analysis', lntemational Jo11rnal of Health 75% Services 14:3 1984 pp.339-378. with an interview with a doctor on the health of a child; 25% did not. This dissatisfied 35. FOUCAULT M, The Birth of the Clinic: An Archeology of Me.dical Perception, PanthcQn Books, New York group is a sizeable proportion, and yet presumably the doctors would not have varied much 1973...... h c . from one mother to the next. 36. ARMSTRONG, D, Political Anatomy of the Body. Medical KtWwledge in Britain m zhe Twentier entury, These two episodes illustrate that what we are involved with in infonned consent is more C.U.P. 1983. 28 9 972 37. lNGELFINOER F S , 'lnfonned (But Uneducated) Consent.' New England Journal of Medicine 7: 1 than just content. In fact there is a THE PROBLEM OF TERMINOLOGY Tenninology is the one aspect which would appear to be most obvious as a problem in communication between doctors and patients. A medical interview at Georgetown Univer sity again: 24 25 Doctor: How about varicose veins. To-day we cannot make what might appear to be commonsense assumptions because the Patient: Well, I have veins, but I don't know if they're close or not. media often make certain teclmical terms widely known. There are the articles about fad The first difficulty is the patient's total unfamiliarity with the tenns being used by doc illnesse~ and the medi~al fictions on television which spread knowledge of terms among the tors. To varicose we might add climacteric (a term used in a leaflet on oestrogen produced populauon. Add to this the efforts which patients take to pick up terms from their doctors. by the Corrunonwealth Department of Health in 1985), hypertension, psoriasis and They do not want to appear ignorant and so they try to imitate their doctors. All this can be emphysema. In a study in Glasgow2 29.5% of patients defined flatulence as an 'acid taste dangerous. It can suggest that patients know more than they actually do. Also patients may in the mouth'. A United States test tumed in the following results: 88% understood ra sh; n~t say all that th~y should to_ a doctor ?ecause they do not have the tenns. We cannot stop 50.2% allergic:; 34.4% orally (in the context 'This medicine should be taken orally') and this from happenmg but a httle learrung on the part of patients can be misleading for 30.4% respiratory (in the context 'Have you ever had any respiratory diseases'). To return doctors and may tempt them to omit information in order to avoid being patronising. to Glasgow, incubation period was defined as 'the time the patient had to stay in bed'. Generalised terms of degree There is no point in one protesting shock at these results and less point in wrongly wanting to spend energy on blaming the school system. We have to face the implication of ~any. terms of degree are more subjective than exact. While they serve in every day these facts in our present situation and for our present concern. The problem is not going to s1tua.t10ns, they can let. us down seriously in special contexts. A few is a case in point. In disappear for generations, if at all. It must be taken into account in determining any policy medical contexts we ought think of: on informed consent. As Boyle found in Glasgow, good appetite is about the only te1m on severe - 'severe pain' which doctors and patients agree. slight - 'slight ache', The matter is more complicated than just this straightforward issue of ignorance by one spasmodic - 'spasmodic coughing' party to the communication. There is, as well, a difference in the ex.tent of meaning or These terms pose problems for patients especially when the conditions which have application given to a term. Doctors are likely to use abortion for instance in a wide sense caused them to go to their doctors are new to them. They have no context in which lo to cover any loss of a baby. But some patients restrict the tenn to self·induced losses. For judge, consequently their interpretation of these terms could be quite different from that of other situations they will use 'lose a baby' or some other term. Doctors then may elicit a doctors who may have witnessed hundreds of cases. Again for some patients the fact they wrong response from these patients if they do not indicate how they are using the word have come to the doctor may heighten the seriousness of the illness. For them, their lack of abortion. knowledge and their subjective involvement blocks them from seeing their illness in !he For a time in the United States doctors talked of heart disease, but many people did not same objective way as the doctor. perceive the illness as a 'disease'. They consequently answered 'no' to enquiries from Non-native speakers doctors, becau..«c for them what they had was heart trouble. Side-effects well illustrates this difficulty. For the general public it is a largely pcrjorative tcnn. The reactions are If aU these ~aiters are causes of misunderstanding and confusion for native speakers, they unwanted. But for the ex.pert it has its more t'avourable connotations. A side-effect is often ~ust ~sult m even greater difficulty with non-native speakers. This is a problem that is an indication that a drug is doing its job, as with some of the effects of diuretics. As a mcrcasmg ~s more and more migrants come to Australia from countries where English is result of testing plain language publicity material with the public, Pfizer, a leading phar not the ma1or language. Moreover the range of difficulties could be more extensive. Not maceutical firm in the US, has found that it had to develop material to correct this mis o~ly is there the likelihood of ignorance of technical tenns but even more general words understanding. It is a widespread one, but how many in the medical. profession are aware might not be understood, for example malignant and infectious. of it. We cannot expect doctors to be skilled in every language. Nor will translation services Again, for specialist tenns there are often popular equivalents. Here are some: always be readily available. What then are we to make of informed consent? How can we Specialist Popular demand it on the one hand and be fair to doctors on the other? tuberculosis TB stroke high blood pressure SOCIAL INFLUENCES ON COMMUNICATION diabetes sugar Communication is influenced by other factors as well as words and sentences. We must analgesic painkiller or reliever take into account the social features of the situation. Doctors may have to learn to adjust to and at times use this less sophisticated terminol Status of the parties ogy. But there can be problems even here. Royal Prince Alfred Hospital in Sydney has a renal unit. Many patients are confounded by its name. Renal failure is also probably mean Th~ do~tor and the patient are hardly on an equal footing. The doctor is in control; the ingless to them. On the other hand their pain in the belly or pain in the back may be too patient is already weak and in need of help. It is the doctor who is in command even when vague to help the doctor diagnose their illness. he or she is called into the home. Moreover there is often a distinction in social' class and if There is no easy solution to this dilemma and there are pitfalls for those who do not the~e is a difference it will be the doctor woo has the prestige on most occasions. This can engage in testing. 1n the oestrogen leaflet that I have already mentioned, the expert authors be important. The less well-off and the uneducated may hold the doctor in awe and so may used loss of bone and hone loss in place of osteoporosis. On the surface this might look be less demanding of their rights. like a commonsense approach. But when we interviewed a group of women, we found that Again the doctor is used to the medical interview; for the patient it can be a rare occur they were all disconcerted by the apparently popular term. Because they all knew the term re~ce .. It is the patient who has to learn the rules, for example to being questioned and to osteoporosis, loss of bone or bone loss suggested something else; they saw it almost a~ a bemg mterrupted. The doctor can interrupt in ways which would not be permitted in nor joke. We cannot rush in then. mal exchanges between adults and these very ways can disturb easy communication. They 26 27 interest for ~omen. Our tests with women on the drug revealed that they wanted the Ieattet tend to distance the doctor from the patient . and make frank exchanges of information to tack\~ a different mat~er ~rst. Only when that is resolved are readers in a frame of mind difficult. The tendency of doctors to express in medical terms what the patients have just to take m the .otht;r details, 1f they take them in at all. Even then it is questionable if many described in loose terms can also be off-putting. The doctors may be recording what tpe could cope with the tenn diethystiboestrol. patient!. say simply to help themselves see the problem in familiar ways, but the practice can be interpreted by patients as a mark of disdain. The whole physical setting tends to iutimidate patients. Receptionists are frequently Conventions of the conversational situation poorly 1rained in handling patients and can be abrupt, even gruff. The patient enters the Jn employment in.tervie_ws some rnces are concerned to present all their certificates first. doctor's surgery only when told or ordered, and frequently the doctor is looking at a The~ expect the mte.rv1ewers to stud.y the?1 very carefully and foel cheated if they are medical history or card. The patient ca11 be left suspended as it were. Everything conspires gJos~ed over. Australian employment rnterv1ews rarely operate in this way but with certain to render him or her inarticulate. The pressure is really on the patient to adjust, not on the applicants they should, if justice is going to appear to be done. ' doctor. ""'.hat are the con~entions in medical interviews? Are there any? Do they vary from The result of this accumulation of factors is thal patients will not ask and therefore ethnic group to ethmc group? What about eye contact? It is important in some societies. cannot get all the information they want and need. There is a general nervousness on their How. !>hould the doctor react to it? What messages will the patient draw from the doctor's part and a fear to show ignorance. In turn this creates a problem for doctors. In the face of ~ract1ce ..Bo~y la~guage may also be important. It certainly is with Aborigines, for silence what are they to do? How arc they to interpret their patients' silences? Are they to mstance, ill s1gnalhng a negative response. keep on talking or should they stop for fear of stating the obvious and the known? The ~octor's concentration on tcc.hnical aspects may be regarded a.s callous. Patients may be lookmg fo~ ~ssur~nce, for calming as much as for information, for instance when the The training of doctors new mother v1s1ts w1th her baby. Doctors' training is primarily concerned with the detection and cure of disease. Very little The presentation of material can also be critical. With risks should doctors talk of an attention has been given in the past - and from what I can gather even today - to coping ~0% success rate or .a 20% failure rate? How much time should be devoted to risks: could and communicating with people, especially with the less well-educated. Non-standard tt ~et out ?f proport1?~ so that patients shrink from treatment unjustifiably. The way one speakers have been largely ignored until the last decade or so. It is very easy tiien for asks questions can eltctt erroneous responses, for example: doctors to imagine that all are as knowledgeable as they are. They find it hard to see illness Did you see a red spot on the chart? from the patients' viewpoint. Did you see the red spol on the ch.art? The constant practice with medicine and disease orients doctors to a different view of Equ~Uy important can be the way ?thers ask you questions. Here skill is being able to them from that of patients. With doctors a disease is seen in an objective, technical fash recogmse whether a deeper problem hes beneath a superficial form. ion. But for patients it is a personal, worrying, strange phenomenon. Because of their proressional involvement with disease, doctors may find it hard to be aware of this fearful The emotion of the situation aspect of illness. So it is also with risks. Doctors live with certain ones every day. The A medical int~rview is stressful for the patient. It is usually held because tbe patient is ill. anaesthetist for instance faces a similar set in every operation. But patients may meet these We all recogms~ that when we are upset we are Jess likely to concentrate and are less able only once in a lifetime. The perceptions cannot help but be different. to abso~b matenal. Yet it is in this context that the doctor has to inform the patient so that This training and professional experience creates a problem for doctors of comprehend the. patient can consent. The patient may not be in a state to hear all that the doctor is ing what the reasonable patient thinks. 1t is a real conundrum the more expert the doctor saymg. Suppose, for example, that you were told in the first couple of sentences that you becomes. Doctors arc not unique in this: all professionals have the same problem. People had ca~cer, bow much else of the conversation would you take in? The emotional state of do not produce gobbledegook deliberately - or most don't. theyatient can also colour w.hat the doctor is trying to convey. Risks may appear far more How can doctors tell what is adequate information for patients? How can they tell that penlous and may even be seized upon if the patient is afraid of an operation. they have been understood? These are not easy questions to answer. The issue of how much knowledge we can ever assume is a tricky one and a constantly varying one as we The culture of the patient move from group to group. I know of no study in the medical area in Australia to help us. How do _pa tien~s express their attitude to pain? Do they openly admit to it, even to the What all this means is that we will have to devote more time to helping doctors become e~tent of ~eepmg, or do they keep a stiff upper lip because their culture frowns upon good communicators in school and in medical school, if we are serious about informed d1spla~s of weakness. T~is show of fortitude may lead people to hide symptoms. It has consent. But training in this area is time consuming and it goes beyond good grammar and been fo11nd that wo~ke.rs m the US a~ l o~the to admit to psychol<1gical or emotional prob correct spelling. It encompasses learning how to present material in such a way that non- lems. They. complain mstead of phys1cal illness and end up getting treatment for what arc experts can grasp it. really 1magmary pains. On the other side of the coin, perhaps we should be teaching patients how to absorb Again ther~ are the cultural attitudes to health and treatment. Many orthodox Jews, for material. Since most of us come face to face with illness in our lives, either our own or that example, believe that they are bound by their duty to God to keep thei' bodies in sound of relatives and friends, this type of training might have more point than a lot of other heal~ and that consequently they are also bound to follow the advice of doctors. Il is not a topics in school curriculums. question of consent. Then there are the attitudes of groups towards various types of treat The leafiet Oestrogen Replacement Therapy previously referred to shows us something ment. Jehovah Witnesses, for instance, cannot accept blood transfusions. of the size of the problem. While it is accurale medically and while most doctors find it There arc also taboos to be considered. These may block patients from talking to doctors helpfu l, it is far too technical for the general patient. Moreover it misses the main point of 28 29 about certain matters. lt becomes difficult then for the doctor to assess the situation accu How do doctors find out about these misunderstanclings and false legends in the commu r.1tely and to give the range of details that would inform completely. nity? It is no easy task, but until they know, their central messages may not get through. The amount of material to be communicated CONSENT FORMS On top of all these considerations there is the question of how much material should and Many hospitals and research agencies in Victoria sent the Law Reform Commission copies can be reasonably presented. A medical interview might cover: of their consent forms and many added useful explanations. If some comments now seem • the part of the body affected cJitical it is in the interests of contributing usefully to this complicated subject. Identifica • the causes of the problem tion has been removed from the fonns and documents. The originals are printed with • possible remedies numbers added in the margin: these refer to the following comments. Please refer to them • risks of each remedy a.ml side-effects and at the end of this paper. • the consequences of not undergoing treatment . . This is a lot of information and the problem of information overload could easily. ans~. Sample I Our experience with disclosure in consumer credit makes us aware of the dangers m this 1) The consent form is squashed in among other matters. It hardly appears as very important. ~~- . We need to remember too, that the medical interview is a form of spoken communica- 2) Broad vague statements with no specific detail to guide the patient. The form assumes a tion. Patients have to absorb the information as the interview proceeds and they only have lot of knowledge on the part of the patient. It is more an aut11orisation than an indication their memory to rely on once it is over. A study of the effecti~ene_ss of a di_sclaimer in an of understanding. insurance booklet which was carried out by the Commumcat10ns Design Center at 3) Legalistic and difficult language. The patient is asked only whether he or she under Carnegie-Mellon University3 is instructive. Onl y 14.8% of a test ~roup took in t~e dis stands the Authorisation itself, not whether he or she has been informed about the claimer in reading the booklet even though the group had been motivated by questJ(~ ns to treatment. do so. This means that doctors have to understand the capacity of patients to absorb lllfor Sample 2 mation. The fact that they might be liStening intently is not a sure g~aran_tee that ~he message has been received completely. As well the patients have to ~e skilled m absorbmg 1) The fonn ensures that the patient receives specific details. 2) Patients are made aware explicitly that they can make restrictions. medical information. Perhaps what we need is a set of printed checkb.sts for each treatment to serve as a reminder for doctors and to be handed to patients for later reconsideration. 3) The responsibility for providing information is clearly placed on a medical practitioner. Tests show that patients forget. We all do. But this creates problems afterwards if things 4) One weak point: it is left to the doctor to judge the patient's understanding. (See com- ments on later samples e.g. [4J). go wrong. Patients may claim they have not been infom:ied b~cause they ~ave not remem bered all the information their doctors gave them. Agam pallents may signal to a doctor Sample 3 that they have had enough, that they cannot absorb any more or do not want any more. 1) The responsibility for explanation rests on the doctor. This too can cause difficulties afterwards if things go wrong. Should the doctor have 2) Patients are given some idea of the matters that the doctor should cover and on which insisted? Would it have made any difference? they might ask for information. These are not easy issues. We want patients to be independent. We want to rid medicine of paternalism, but we do not want to deprive the con:munity of cure.. . . Sample 4 As well as infonnation patients want advice, that is they are seeking mformatio~ and I ) Perhaps this is a special matter, but at least there is a clear statement from the doctors. recommendations. These recommendations may be more important for some than the mfor 2) The question of comprehension is left with the patients. They have to be asked whether mation. It could be critical if alternatives are available. This is one of the points at which they understand. (Compare sample 2 which leaves the decision to the doctor). consent seems to be too strong a term. Sample 5 Misinformation l) Patients are not given any guidance on what information they are entitled to. Also they There is one other factor to consider. Medical interviews do not take place in a vacuum, should not be expected to retum to the doctor for information. This is a weakness in nor is the discussion of illness restricted to the doctor's surgery. Instead people are continu having the forms handed out at a hospital if the doctor is not present. . ally exchanging ideas, and worse, spreading myths and old-wives tales. The public is ~ot The language is demanding. always aware of the latest advances in medical service and so may approach docro~ wtth Sample 6 outmoded beliefs. For example, the National Cancer Institute (US) launched a sencs of I) A commendable attempt at e~planation . Patients have the written words as well to television notices for a new cure for a type of cancer a couple of years ago. The program study. Coula not this approach be adopted at least with the more common operations? failed initially and had to be withdrawn temporarily as the Institute discovered that the 2) The discretion is left with the doctor again. See sample (2) and compare with sample community was taking little notice. Its reaction was explained by ~e discover~ that the (4). community on the whole imagined that cancer was incurable. The lnstltu~e had to t?trod~c.e a more basic campaign to combat this misconception before it could re-mtroduce its ong1- nal campaign. 30 31 Again I think attention to communication is needed in areas other than procedures and Sample 7 1) A brief description of the purpose of the procedure with a commendable note of operations. For instance: • inserts in medicine packages caution. • labels . 2) A comprehensjvc statement of side-effects and later risks. . . . • directions on prescriptions. (ls it good enough to have 'Take 3 times a day' or 'take as 3) The complications are not left unqualified. A wise balancmg of the s1tuanon to help directed'?). patients by inserting rare. I fear that far too much attention is being given to consent and I am not sure that the Sample 8 emphasis is valid and in the interests of patients. I am not advocating that patients should 1) This is a consent for research, hence the introduction of the witness as a double effort to have no role in decisions and no rights, but can they know whether it really is their liver - protect the rights of patients. . or whatever - that is causing them trouble? In the end we have to trust that the doctor's 2) The procedures are listed, but not the risks. The chief of these at least might well have diagnosis is correct: as patients we have no way of telling because we do not have the been, included. Compare sample 7. expertise. The stress needs to be more on the first element in the phrase - on informed - 3) The rights of patients are spelt out on the fonn. on the patients' rights to information to help them contribute to their health and to take full advantage of what medicine is offering. We need to move away from a litigious atmos Sample 9 phere to an environment of comprehensive communication where the doctor is both a 1) A general, vague list, but at least patients are given hints about what information to ask willing and able communicator. Tf this happens then the matter will remain in the realm of for. . medicine, cure and health, and not fall into the region of law and conflict. 2) The use of a witness in sample 8 seems a better procedure than allowjng the investigator If we seek informed consent and expect doctors to get it, then we are accepting that to be the judge. intricate matters of medical science can be explained to the non-expert. If this is the case and if lawyers and other professionals are prepared to demand this, then their argument Sample 10 against plain English in legal and llther matters falls to the ground. There is a need for I) This is an extract from guidelines which some hospitals issue to staff. The onus is intellectual honesty from others in this discussion and a greatei,- consciousness of what is placed on the doctor. involved when we ask for consent in any area. If it is to be proper for doctors then it must 2) A demand for specific detail. be proper for all professions. Sample 11 I) From another set of guidelines. Medical staff are helped to understand the types of NOTE matters they should cover with patients. In the discussion that followed the presentation of this paper, the role of others, such as 2) The legal aspect of consent is not far away. nurses and pharmacists, in medicine·was raised. Their role is important and it is a retlee,,1ion 3) Special emphasis on risks. of the incapacity of doctors to communicate and the fear of patients to ask, that patients so often turn to others for clarification. The paper, however, concentrated on doctors, not out Sample 12 of neglect of these other participants, but because it is with doctors that informed consent is A consent form in plain English. the issue. 1) Patients are given reasons. 2) The specific risks are listed. REFERENCES 3) General risks are spelt out. 4) Patients' rights to know about alternatives are protected. \. SHUY R, (1976) 'The Medical Interview' in Primary Care 3:3:365-386. 2. BOYLE CM, (1970) 'Difference between Patient$' and Doctors' Interpretation of Some Common Medical 5) The doctor has to accept responsibility. Tenn~', British Medical Journal Tl: 786· 789. 6) Patients can see that they are entitled to ask questions. 3. STRAT MAN J F, (1985) 'Readers' Perception of Contractual Rights in Medical Insunmce Summary', C'DC 7) The doctor as well as the patient is committed. Technical Report No. 15, Carnegie-Mellon University: Communications Design Center. 4. JANJK CJ, SWANEY J H, BONDS J, & HAYES JR, (1981) 'Tnfonned consent: rcalilty or illusion', lnforma1ion Design Journal 2:3 and 4: 197-207. Some concerns 5. BART P B, (1968) 'Social Structure' and the Vocabularies of Discomfort: What Happened to Female Most consent forms arc too much like legal contracts. The emphasis is on the legal situa Hysteria?', Journal of Health and Social Behaviour, IX: 188-193. 6. KAUFJ.:R D S, STEINBERGER, and TONEY SD, (1 983) ' Revising Medical Consent Forms: An Empirical tion and in this there is a real concern. Are we shifting the attention away from medicine Model and Tesi: ', CDC Technical Report No. 2 Carnegie-Mellon University: Commun i cati on.~ Design Centei-. and the proper relationship between doctors and patients? Doctors should and must explain, 7. MECHANIC D, (1972) 'Some Psychological factors affecting the preseotation of bodily complaints', New but it should not be to avoid litigation. Eng/1111d Journal ofMl'.dicine 286: 1132-39. 8. ZBOROWSKI M. (1952) 'Cultural Components of Response to Pain', Journal ofSodalls.me.~. VITI: 4:16-30. Studies have shown that a major factor in patients not following medical advice is the failure to receive an adequate explanation of their illness. In short, information is needed not just for operations but for all types of treatment. This is where the emphasis s_hould be: doctors should improve their quality of communication as a pat1 of sound medtcal treat ment. For instance, patients should be told why doctors want them to breathe deeply after an operation or why they should take pain killers. 32 33 l'DSONAl flttOPHTY COtlSElft TO MEDICAL IUfO SURCICAL TRUTMEJIT AHD .>.NV PERSONAi PROP£RlY BROUGHT ON TO THE H05PfTJIU PRfM!SES (WHETHER Oii NOT DEPOSITED F04l ADMUUSTR.A1'l01f SAff.l(f[l'ING) SHAU AT All TIMES SE AT THE SOU Rl5K Of THE PATIENT ANO THE H061'1T~ SI-WI. NOT Ill: OF ANA£STHETIC UA&E f()Q 115 lOSS [Jl;STRUCTION Oii DAMAG£ wtil'THER CAUSEO AS A 11£SUlT Of THf NEGUGENC£ Of TH! HOSPITAl ITS SERVANTS OR J'J3ENTS OR KOWSOEVEJI OTl-t£RWISi ~ NO ~ANT Oii AGENT Of Tl1f HO:il'l'TAL SHAU IM: AUTHORISEO TO VARY OR WANE THIS C0N0m0N INSTRUCTIONS Erwelope No.______------FOR A PATIBHT' UND£R 18 YJ!ARS OF Act.~ l'ARENT/GUARDIAH CX>MPt.BTBa sacrtOH A. Oetcube Valuobles he&d 1n 8vs.mets Off ~ce FOR A PATIEHT OVEll 18 T.EAJlSOI' AGE.THE PATIENTCOMPUn'ESSBCl'IOlf B. Ring•- ____ ------•.Watch..------..Monoy------°'""'------· SECTION A SECTION B Pot1enc 01' neore1tf'~oh"'•- _ ------___ --_____ ..__ ...... Wrtrtess .. ______..,Date_ ------I, ...... ··-················· ...... (...... af ...... t<>r9'1llnWm) ll AUTHORIZATION FOR MEtllCAl ANO/OR SURGfCAI. TfllEATMENT I. 1ha uodersogoed, o pot.en! 10 ~tot h«ebv outhotl• bliiocJ-dis 191 of II [2 Or .•.• ____ . _ ____ ------______--- ______(ondwh~verhe moydesignclleG& hia oss1sloo1$) to odm1n1S1er :wch treatment Os " nec•soary, ood IO perfol'M such operatlotl& ood H£RE.BY CONSENT to: procedure• 01 mcy be co (lJ I. tho follo...,,g operatloa(•) ....,q performed°" dwt !lflietlmt; Patient or neo (21 {a) wcll lllr!Mr pn>cedureo and .0 tn.ilmn•t, nwnR>trioN.-. TokeoHome 0 0 0 0 1bt MN19 oM tlrect ol !M e>penllOD(I) ~-·..teaed tD tboft haft ...... ,_ l!r: W ith Pat1eol Q 0 0 0 Patient 01 nearest relohve __ .... ------·--____Witness ______[late ______----- [3] t>r./Mr ... ,._ -· ...... ·-···--·-- --·-··------··· Dal*! thio ...... d.ty cl ...... - ••·.-· .. ·-····--·--·19.--···- - A RECEIPT MUST BE OBTAINED FOR ANY VA1.UA81.ES PlACB:> WITH 'TM: BUSINESS Cffla AFTI:R Signed THE INITIAL AOMISSION PROCIOURES ...... i;;;;;~·;;;;;· .. ;;.1 --···· 141 l haft n:pl.tiilod IO th• aboof ~ pme~tiMt tM natme 1184.n.:tol. dltat.o.o ~) UNAUTHORIZED Q!SOIMGI aod tNattHllt. !rt 1111 opinion, he/olM/W>dftttoQd ti*~ IOd alftud...-...... ill •J' PIWOOC S19n11d ______Oate·~ __Wuness: ______! s J (....ua.I Oftloef) HIS COMl'LETED FORM MUST BE SIGtlTED BY THE SURGEON, ANO/OR ANAESTH£TIST BEFORI ROCl:'.EDINC WITH THE ANAESTHETIC AND SPECIFIED 01'£1lATION{S) Sample .1 Sample 2 34 35 (.ONSLN r l Oll'.l f\)tt ~lLHILfl.\l !CIN .\NU n !(\\IN,\ ll()N 01' r1u:.c;NANC.:Y OR ':UNSl::NT fOR~I A SlT.RILtZATION OR TER ~llN,\ 1 ION OF PRCGNANCY COHSENT===.:...:.....:.;;.....;::..:c:.:.:.;. TO ... 11111;~n ______1 L Of'ERAT!;Jt ::...L,' __~ROCEOUPE - -~-=-.;;;.;..'--",;,;;.:;.;:.=,;:_~·:.;===.:. OR HEDICAL TllEATHEICT I ...... • ...... • • ..... • .. • .. • .. or ...... ••••.....•.•••• • O H ....._, __.... , ' ••f•oo -···--··•-•o.oo 000- o,o lfld rind 1h1t &he" agr~e to t:"le proc<-dure.'treatNnt of ...... • . • . • • • • . • . . • • • • • . . • • . • . •• , .••••••••••••••• b•ilW perror..c or1 -· l alao .aicree to the ad•!nt•tration or ana•athetica, -.diclnes, lllood transrus~ons or other tor.. or tr.. tlMl(lt 1101"9111llr ••soc:iat.cl with tnh pro<.'edure. l under.stan.i that oth•r unexpected treat•enta/procedures ar~ •o.. tl .. , ncc•aaar)' ancl I •er.. to Ul~• lll if req1.ured. or .••.••..•.•.•••.•••••. has eaplatned to• .. ti..t l n.. d to ha•• [2) ••dlcal attention for mr present condition and we have discussed .• ,,_,.., ...,, , ....., ,, ,,,,,,.,,,,,,,,,,,..__,,,_. ..,_ .. .,,,. ... ,,, .. . ,l"'I •·• ''•'''"'''' ""''''.. ways &n whLCh Lt can appropr1at•lr be trelttHI. Ve ha•• di~uaaed or the nature, eff~ts and possible risks or tfte cttoamn proceclure/treat•ent. t acree that H 1a in 111 iAt•r••t• to nave t,1..., hc;c~r Cl'rto,,('1H 10 "'>' "-\fr thl• procedure/tre1taent. r,)'lctf Signed •••••.••••.•••.••••••••• • • ••••••• • ••• Date •••• •• ••• • •• •• 19, • 1.:r1Jcrt1..•1. \. tl1\: OIY'fJh(lll of , P.atient •"' signature w1 tne•••4 Oy •• • • •••••• , • • • • •. • • • • • • • •, • • • • • • •• Wl tn~•• • • Ka• ••• • •.•• , • ••.••••••••••••••••••• • •••••••••••••• • ••• llt.OCi LEnl!llS Doc tor • s S1gn:&t.uri!' ...... ~ ...... P-attc"ot'1 S 1..,~1u.cc. .,. • Sample 3 [2J o•• c .•.• . '\'llPCH ...... _.... _,.,_,,,...... _...... _ .,,__ ,._...... Sample 4 36 37 (lj 'ff you have any queries re the pertinent details of your operation and/or treatment please consult your doctor before completion and submission Consent Form of this form. (Male) (f'u ldent.hcahcon LM>el Kerel PRIVATE HOSPD'AL -:OtJ:i'Etrr TO STEf ~iotf.?. All S•N.:t.itJn5. mus.t. be c;ompl.eted Consent to Operation, Anaesthetic, I------·------111 .. • • • • • • • • • • . • • .. • . •...••.•.•.•••.••.• hereby request. ~nd q111e "'Y con£ent to and Treatment ·: '~e..;:t~IT'I'>'. l. Tc. i:"E:!&!dQ>r r.t.o ~C'Ct:"J.l<>. :'la~ •·i.i L aol cccur i.mmcdJ.at.e-ly after the operation ..>r.d it w1 il be: rleC.e.s~~t:t tQ n.lv4! 4.n e-x.lll'1n.at1on of my sem1nal fhu.d t:o (") I, ·······-······················-·· .. patient of THIS BLOCK TO BE COMPLETED AND SIGNED BY PAR.ENT 0Jt. I A:JT\E~T: l> ! GUARDIAN IN THE CASE OF MINORS or NEXT OF KIN IN THE CASE l ~.ave reJ.d the dbove CONS!;:~'-r TO oTE:Rl ;.1ZA'UON and do hereby a9ree to t.he r OF VERY ILL PATIENTS UNABLE TO CO-OPERATE. ' ~Jfl~C.:it.ton undec t~.e tet't"ls ~heres.11 set forth as the wi.Ie of the pauent. rn ' ::...a.Lc:l th LS ...... :idy of ...... 19 ...... i S:19ned: ...... S19nat.\l.l'e of W1tnes•: ...... - 1....• ------·------.:-o:iE'!n..'V'\'l'lON: I. of 1• • ...... ••••.••...... •....••...••.•.• iw.,,. described U> the { :i~r.-ie ·>f .joc tor) , '::· .::.1e ... ~/per&-..m l~g:..li .-· rep0n51tle tc:.r tM pat\e'C'\t t..h.e n ·;i.·~r.:.tu?."e cf Oo:~to~., ...... • •...•. , ...... ;----·----- ·~------i • ~tnJc~ a ut. where t./:dppl 1cablc as. explained. Sample 6 Signed ...... ••...... •...... •..... ,...... D•t•...... Sample 5 38 39 CONSENT FORM FOil PATIENTS UNDEROOrNC RADlAL KERATOT 5. Tl~re may be early presbyopia i.e. need to use glasses ror reading ...... ~ ...... an.er the age or 40...... , ...... 31 Tbere are also possible more serious COlllplications although these are rare. • ... I 0" • •"'• • • • • • • • • I • " 0. 0 ""'I" ...... 0 .... I++ .. + t • 0 0 •• f."' .. "" ' .. 4" 4 f. ' • However, they do include:- I _..-.un4 •llat I .,. ''" to wlt!Mtr• ,,_ Ulfs it.NJ It - tf• 1. Perforation or the eye. SI ..... : ...... 0.U: ...... 2. 1nrect1ons - both superficial and deep. fOll THC llflllltSS 3. Endothelial cell loss which inay. pre dhipose t.o clouding or the cornea in the future. r...... ~ t ...... t ...... ····· ...... , 4, Abnorml wouod healing. ,,, [11 M "" 1..,..,..,t wltMn, a.fttS u..tt • •1- 941 '11n•• u ol a. It should be ren.embered that =e~ my oot ghe social or prol"esalonal ~r-. t114 ..-, rtsb hrYOhM hi,. .... Nflri.... ljj IN ,.,_ -I achievement. I... .._. Jll"IW" I wlb!Mt. la"'° epU.ta, flllll* ts ecu., ,..1.t..111 ....., ~01 ..ur111. 1 ••...... ••••...••••.••••..• hereby acknowledge that I have read and under3tooc the possible side effects and complications of Radial Keratot 1 •••.•.••••.••.••.••••••••••• hereby c~ot to undergoin& the operation of Radial ~eratotocny. r also coo.sent to such further er alternative operative P'Oll M UIWtsTlCATOI ~ieasures as 1113y be round to be necessary during the course or such operation l ...... , ...... lltft ful11 ••1•1,.... 1111 and to the administration of a general {or local) ana9sthetic for the purpo• or sarie. I also consent to such medical or nursing treatment as my be al•. rhk• lftd ,,.ocffu,..t of Ult •M...... 0 tt.NJ "- U. ...,._ 11.-1 considered necessary for recovery whilst in hoopit..l •. _...... s1,,,..., ...... •...... c.: ...... Date. • . • • • • • • • • • • • • • • • • • • • • Signed...... • •• • • • •• • • • • • • • • • • • The consentirig party states that he/she understand.s the above and has affixed his/her signature in my presence. [3) llOT£S1 2. f-• t11l"lftf Clift fo,. •re ,...... ,. Ullt 1111n1 ntMrdl .o>'Mrs h&'H • ..\!' to ··-'-'""" 'J N ...rdt. tll9 Date •.. , • • . • • • • . • • . • • • • • • • Signed ••••..••••••••••••..•••• rltl'U ltf tlle llMlhl... t fl,_ ttle ~ onr •"'9 J. 'Iha lftYMtlt1t.tr h ...... Of !Ill -" to ...... Sample 7 confl*'tt11ltt1, ....., .,,...,..101, to ,..o*t - fatoel'ffa or persons COflMntl"9. C, P•rl- COlllOllttog, - ore ....lorett of U.. IMl...-slt¥ &re 11IYIHd u.1i p1rtt~lp1tl• t10 tlllt resu"'• Ms 1111t effect I~ •111 w11 U..fr •tltl~ or rt9'1t to MtCll1" •rMI'$' _..Htf•. Sample 8 40 41 CONSENT MUST BE •INFORMED•: [l] Consent is invahd if the patient is not informed in reasonable detail of PRO'l'OCOL HUMBER •• • • • • •• • • • • • • • • • • • • • • • • • ••••••••••••••••••••••••••••• the procedure <1nd the risks involved. The onus is on the doctor to give !'IA.ME OF Pl\Tlf;N.'l'! ...... • ..... ·• .... · .. U.R. 110: ...... ••• · ...... •. this inform;1tion to the p<:1tient. The particular operation should be l'l>.ME OF HNES'UGATORS: ••••••••••••• , • ••••• . ••••• •• •• •• •• • • , • •• , , • •• , , ••• • ••• {2 ] specified in a written consent, together with .:iny foreseeable extension • ...... " ...... :a general or "blanket" consent is invalid in 1.!lw • ...... It follows tb.:at the task of giving the explanation must be undttta.Jcen by STIJDY "t"ITLE: ...... " ...... • ...... '" doctor who is <\Ware o1 the clinic~ det3iJs, in relation to the patieut ...... {1] .:ind the risl<.s of the procedure to be undertaken. 'fbe taali: can be delegated to lnterns and R.M.O's in most but not all instances• ...... ~ ...... •.• ...... EXPLANATIOH TO PATIENT OF R.e:SE:ARCH PROC£OURE: (tneludin9 possible short ' When angiogrnphic investigahons ::i..re under consideration reference js to tong term risk!S) be made to the special information sheet prep<".red by the Radiologist...... ·...... " ...... (Copies .ve 'l'tle above patlent CERTIFIES (di Tne ¢onsent must be lnfor••d •s a rule and the emus to pt d) r also understand that I am fcee to withdraw fron1 the ceseacch at any Ii Ttl• pat1ent ~ust. be acquainted wltn the risk or ~oth proposed and t \rne. alternat1ve courses of act1on (in bro.d ~ teras) fh4!'re- must be so111e 1nroraat Lon tile chances succesa or 19 or or oated the Sample 9 Sample 11 42 43 c;ly Hospit.tl Conscft( lo S<1rgery Put S I r~11ttt \l••t an.vU\111( rtftWl'ltd Di•positi91t or Tffsvu '"°'° - T...... ,,...,N..,, 0 lH Gifposed ol b1 tM hot,pit.it u •S11•l. Oii .... ,...... 0 01!.or: [lJ [5] p.,, 4 • I dect.r• that I tia.,,, ,,..,sOMlly npJ•i'""' t)w - ef tM Si~n.luru J',l (6) S. ThT doc\OI' hu uplaif)fd tllllt: I Ila•• ;i~n ti.. potirn< or the .,.,.oa """*' •.,.,.. •• Gil>POf\unit• [2) 14 Hk q ...ct;01\t ,..)lid\ 1 MW ...... AS f"1J7 U ,_;wr. • •· tt.. IC!llo ....in; ti1lcs •N '""ol"td in 0.. OJMt••tlcm:'.______[7] $ipo•-"'D.t... • TM de<:t0t hu opltintd all ol thc lftfonn.tlloot In Paris I ::t •hit S [3] b ••u tUr•ff)' i11¥fl1Yft rislll ~ at M'Htot 19110 41l &Joo4. C.""' and hat ...,,..,.., 11>7 q~ ' ' ' U>l...:tMin. •ltd Marl s14>ppa1c; J "ndtt'St.e...t t!'at .• Co;?y or this compMud 1-trill to. cl"" It> PH thar I ''I" it. c. 1i.. •.,,,.,Y ... ;u i.. .i-iii • ·~•,,_,iw. •-b,. licenHd JMlfOm.l No per•- hH bet-. M64e dia' s..r.1 .... .t ~.,,... ti.. ,.,,,.,,,. ..;u COl'llf!Uoa: (4J ;..,JI'."" '"' d. nq ~ioet:wM b. 1.taud I• I.he: f~~.,.,. ~ "'..;•-.·-='------wlllch M~ Nl wi11~ -....ton IM •l dib u-______~ ~~~~~~~T~.....::!..~~~~~~.....!·~·~,..!!!.. r •• c 2 M1 dodot hat Hpl•;Md '-,,,. \1111 •-"-dwfftla twc-1 1 ~tloH' ci~ cOftMnt °"' the ,.~.. t'• .,._"· it It dO.CeWl'rff dial edditl-1 • aihc~ ffMr.-7 it """""'4. Addit:...,.1 Suri:~'>' ci..- ••i...... If l nHd •ddition1I « ~ 1ur~'7 4inin.s 1117 opotfaU., .,s..,...... ,.... •• c ., ...... """"'Url.tft&Wfl4i...... " 0 I •uU.0.iae the dottor i.. pr«ft'd. 0 I dD not 1uOioriu tM d~ to pr-". !!!..i...!.-i..r .. "••-=------·------s~r"'W'Y., w.,,..,. _,. eonll11..ed Sample 12 44 45 surgery to conform to those measurements. The difference between transsexuals who undergo the surgical procedures I have mentioned earlier, and the non-transsexuals who undergo various forms of plastic surgery - from ear surgery to augmentation mammo plasty - is the difference in the degree of surgery and the amount of surgjcal intervention. INFORMED CONSENT AND There is also a difference in the degree of mutilation of healthy bodily organs. One of the principles that bas always been recognised in informed consent discussions is TRANSSEXUAL SURGERY the principle of beneficence. It implies a duty on the part of the physician to do good. Negatively, it is more well-known as the duty to do no harm, primum non nocere. Doctors have always interpreted beneficence as their duty to act in the best interests of their patient. Janice Raymond But who is to decide what the best interests of the patient are, particularly when the patient is desperately seeking the surgery? There is an overarching conflict here. In order to meet the requests of the transsexual patient, the physician is placed in the situation of performing dire mutilation of healthy body organs. I can think of no other situation in which surgery is done so extensively .on non This paper centres on informed consent as it relates to the topic of tran~sexual surgery and, pathological organs and, further, where the potential for pathology is created by the treat to a lesser extent, as it relates to more interventionist forms of plastic SUigery. Much of ments that attend surgery. Consider just what happens in transsexual operations. For men, what I will say concerns those aspects of informed consent that have been relegated to the the removal of the penis and castration are preceded and followed by exogenous hormone background of the debate and which, in my opinion, need to be raised to t~e foregro~nd. treatments. The treatment of male transsexual candidates is almost totally depel"\dent on For example the informed consent debate while addressing issues of available choices, oestrogen to induce hormonal castration and feminization. Such treatment is most often patient auton~my, the principle of beneficence or 'doctor do no harm,' s~ldom a.ddresses lifelong. Breast enlargement also depends on oestrogen therapy. The correlation of breast the context in which choices are made, the patients' motivation to choose m certam ways, cancer with oestrogen therapy has been documented in the medical literature. In the case of and the conditions that are necessary for a genuine autonomy to be exercised in the transsexualism, however, breast cancer is increased by the honnonal imbalance· created by informed consent process. . . excessive oestrogen therapy and orchidectomy (removal of the testes). Specifically, this paper will address the subject of informed conse~t m relat10n to trans For women who undergo surgery to become men, the surgery entails the removal of a sexual surgery and other operations, such as plastic surgery, which not .only . change healthy uterus and ovaries, as well as a bilateral marnmectomy. So once more, we are physiognomy to conform to stereotypes, but by their very e.ll istence and prohferation, are talking about a massive amount of suTgery that is not indicated by reference to any tradi trend-setting. That is , such surgery which begins as a consequence o~ se~ role stereotyp~s tional standard of pathology. often becomes a cause of those very stereotypes, or at least, a contnbutmg cause of their In the case of transsexual surgery, rhe principle of beneficence - do no hann - seems existence. For example, persons wishing to undergo transsexual surgery give as t~e to be ignored. The mutilation of healthy organs is justified by the less tangible therapeutic primary reason for wishing to convert to the opposite sex, a desi~ to Jive out the opposite goal of psychological we~l-being, that is the impTOved self-esteem and self-image of the sex role and identity. Women who wish to undergo augmentation mammoplasty, a so post-surgical transsexual. By this standard of measurement, that is the well-being of the called plastic surgery, express the feeling that their breasts are inadequate as measured by transsexual who supposedly is psychologically but not physiologically healthier after the the nonns of a gender-defined body image for women. . surgery, the principle of beneficence seems satisfied. The therapeutic purpose of the sur Let me also distinguish initially between transsexual surgery and other SUigenes call~d gery gets re-defined at another level, the psychological. plastic, because I do not think that they are of the same magnitude on the scale of drastic It can be argued that the physician in undertaking the surgery relies on a very dubious and mutilating surgery. Transsexual surgery is major surgery. For th~ male-to - fe~ale trans notion and standard of beneficence, that of the patient's psychological weJI-being. Let us sexual, primary surgery entails castration, penectomy and vulvo-vagmal construction. Most consider a hypothetical situation of a black patient \vho comes into a physician's·office and persons undergoing transsexual surgery are men who wish to become. wome~. TI1e asks for a pigmentation change. Given the fact that such a treatment is a real possibility, accepted ratio is 4: I. For the female-to-male transsexual, the surgery consists of bilateral would the physician accept the patient's own claims of psychological well-being that such a mammectomy, hysterectomy, and salpingo-oophorectomy. These procedures may be fol treatment would provide? Or would the physician see it as part of his or her role as lowed by phalloplasty and the insertion of testicular prostheses. Also, the transsex~al ~ften physician to inform this patient seeking the pigmentation change that other alternatives seeks secondary surgery, for aesthetic reasons and/or to correct real or felt complica~1ons. exist? And would it be appropriate, as part of the informed consent process, to raise the Such surgery can range from limb, eye, chin, to ear surgery, scar revision and reduction of issue that the reason the patient may be seeking such a pigmentation treatment may be the Adam's apple. because of the oppressiveness of a society that discriminates against people on the basis of Many transsexuals, especially male-to-females, go to great lengths to adapt to the skin color. culturally prescribed body type of the opposite sex. But then, of course, so do man~ non In exploring why such a patient might want a pigmentation change, the patient might say transsexuals who undergo various forms of plastic surgery for purposes of confonmng to that he has always felt like a 'white trapped in a black body' as the transsexual commonly culturally-prescribed images of masculinity or femininity. A woman, for e~ample, who says that he is a 'woman trapped in a male body. ' Since transsexualism is now accepted feels that her breast size is inadequate and therefore undergoes augmentation mammo widely in medical circles as a clinical entity - in effect as a disease or disease-like - the plasty, is measuring both her prior inadequacy and her post-surgical adequacy by. cultu.ral situation is a bit different. What has come to be defined as the syndrome of transsexualism, standards which encourage women, in particular, to submit themselves to such intrusive a syndrome often requiring surgical intervention, provides the doctor with more profession- 46 47 al support for proceeding with transsexual surgery than with pigmentation treatment, anatomy and role when the coercive power of sex role socialization is filtered thr9ugh all because the latter has not acquired the status of a medically-recognjsed entity. But here societal institutions? Not that such socialization ever determines a person's choices, but exactly is the rub. rather that it deeply conditions one's choices as well as one's motivation to choose. lf transsexualis.m is a disease, then does desire qualify as disease? As Thomas Szasz has No one, strictly speaking, forces the transsexual to start hormone therapy. No one, asked , does an old person who wants to be young suffer from the 'disease' of being a strictly speaking, forces the transsexual into 'passing' behaviour. No one, strictly speaking, 'transchronological' or does the poor person who wants to be rich suffer from the 'disease' forc.-es the transsexual to undergo surgery. But in a society where masculinity and feminin of being a 'transeconomical"? In my own example, does a black person who wants to be ity accompany a male or female body, the options are limited if one does not have a white suffer from the disease of being a 'transracial'? More importantly. can these very context of critical judgment and support to search for other alternatives. When the transsex questions, or should these kinds of questions, be raised as part of the informed consent ual experts maintain that they use transsexual treatment and surgery only with people who process that surrounds transsexual surgery? For i11 raising these kinds of questions, the ask for it, and who prove that they can 'pass', they obscure the social context in which physician is inevitably required to give information about the kind of society that generates gender dissatisfaction arises. a desire to be transsexed and why that desire comes to be interpreted as a disease in need of Transsexualism as an accepted surgical procedure raises many more expansive issues surgical treatment. . . about the medical model in general and the ways in which lranssexualism has come to be However, the physician is already giving infonnation without acknowledgmg 1t, about defined as legitimate medical territory. Within the last century, more and more areas of life the kind of society that generates a desire to be transscxed by participating in and insti have come to be defined as medical and technical problems. All sorts of behaviours, espe tutionalizing transsexual surgery. The medical frame of reference that surrounds gender cially in the mental health realm, have been categorized as diseases, and then treated by dissatisfaction has introduced more subtle yet more significant limits on choice. For it has drugs, surgery and other medical-technical means. initiated a new way of perceiving, ordering, and ultimately treating gender dissatisfaction My point here is to affinn that more and more personal, moral, and now social problems by transsexual surgery. It has transferred whole areas of behaviour from the domai~ of the are defined as medical problems when they are actually human, interpersonal and social moral, personal, and social and redefined this behaviour in medical terms. A piece of conflicts. Approaching these conflicts from a diagnostic and disease perspective prevents behaviour, such as what is stereotypically called effeminacy in men, can now be seen as the person who is dissatisfied with his sex from seeing the problem in an alternative frame sick or healthy, neither more nor less. By institutionalizing transsexual treatment and sur work. Specifically, persons who think they arc transsexuals are not encouraged presently to gery, doctors become shapers of acceptable or permissible behaviour without having to see this desire as arising from the social constraints of masculine and feminine role-defined accept the responsibility of examining the social implications of such behaviour. behaviour. Thus a man who wishes to be emotional or nurturing is encouraged to think of Presumably no one can question the person who is desperately seeking the surgery and himself as a woman instead of as a man who is trying to break out of the masculine role. feels his happiness and we11-being depend upon having access to the operation. Also, there The ultimate social effect of defining transsexualism as a rusease and as a medical problem, is a wide popular literature, and some professional literature, which reports th_at ~ost tran~ is to encourage persons to view other persons (especially children) who do not live out sexuals are much better off after the surgery than before. A large part of this literature is proper and appropriate sex role behaviour as potential transsexuals. anecdotal, and the standards of measuring post-surgical well being are ill-defined. It seems To a certain e~tent, 1 have discussed the principle of beneficence in the context of to me that supporters of a procedure as physically intrusive and irreversible as transsexual transsexual surgery. Another principle that is always raised as part of the informed consent surgery should he able to provide evidence of its worth beyond that which is c~ntly process is the principle of autonomy. Informed consent has traditionally been based on available. To what extent can the final word on the procedure's success depend enurely on autonomy, beneficence, and competency. Within the traditional debate, however, these testimonials about improved self image and confidence? ~rinciples have been largely treated in a very individualistic and interpersonal context, that One can also apply this standard to the more invasive forms of plastic surgery. Why is ts the autonomy of the individual patient vis a vis the doctor or medical research context. It such extreme and extensive surgery justified by criteria of improved self-image and con is almost as if they are rarefied. They seem to exist outside any social or political context fidence? There are social considerations regarding transssexual surgery that are at least as which can undennine individual. autonomy or competency. equal in importance to an individual's avowed improvement of self image. What we are It is also necessary to discuss the conditions for autonomy. With medical procedures that facing in these medical situations is the way cultural images and stereotypes have trans are as controversial as transsexual surgery, both because of their mutilation of healthy formed themselves into therapeuiic criteria, so that they have become accepted standards organs and their reinforcement of negative and oppressive cultural images and stereotypes, by which to measure the success of very extensive and interventionii:;t surgeries. autonomy must be based on awareness - awareness of what? Awareness of how transsex Jn fact these stereotypes are so clinically institutionalized that transsexuals prove they are ual surgery reinforces the negative stereotypes of masculinity and femininity; awareness of viable canrudates for treatment and surgery by their ability to 'pass' successfully as mem the ways in which, within a gender-defined society, it is easier to adjust the transsexual's bers of the opposite sex. 'Passing' requirements evaluate everything from an inruvidual's body to his mind if the transsexual's mind cannot fit well with the roles that society gen feminine dress, to feminine body language, to so called feminine positions in intercourse. erates; awareness of how transsexual surgery only helps the transsexual to exchange one Most clinics require candidates for surgery to live out rigidly defined opposite sex behav stereotype for the other at great expense to one's body; and awareness of how all of these iour and roles for periods of six months to two years. things reinforce the fabric by which a sexist society is held together. I see the conveying of Such requirements to 'pass' have a tremendous power of coercion. Add to this the cul ~ this information as a condition for autonomy to be exercised. For autonomy to prevail, tural coercion of sex role stereotyping that encourages sex role conforrruty. Just as many higher and more expansive standards of awareness must become part of the informed con commentators have asked how a truly informed consent can be obtained in a coercive sent process that precedes transssexual and many plastic surgeries. context, such as a prison or mental institution, I would pose the question: how can a Autonomy and 'respect for autonomy', as Faden and Beauchamp have pointed out are transsexual truly give informed consent and freely choose to convert to the opposite sex 'terms loosely associated with several ideas, such as privacy, voluntariness, self-mastery, ...... 48 49 choosing and accepting responsibility for one's choices.' Autono1?y as: it is. supp~sed to One test of such an info1med consent process might be to !ape-record the conversations function in the informed consent process supposed Iy promotes the mtenuonaht Y, will, and between doctor and patient about critical medical consent decisions. In America, there is an choice of the patient. But if transsexual surgery reinforces social conformit~ by encoura~ increasing tendency to do this, although I am aware that the informed consent situation in ino- the individual to become an agreeable participant in a role-defined society, then ult1- Australi~ i~ different than ~n the States. In America, such tapings were instituted to protect m:tely the individual is not autonomous. While the individual pa~e~t is seen as. the l?cus t1te phystc1an from a possible malpractice suit. But the positive side of this is that it also of choice the individual's choice is really displaced. lronically, this ts a paradoxical situa protec~s the patien_t and insures comprehensive disclosure. Another benefit of tape tion wher~ individual autonomy is denied under the guise of fostering individual autonomy· recordmg conversations between doctor and patient in these selected cases of extreme sur That is, the patient's right to choose is confined to a surgery that promot~s .individual and gery is that the patient may take the recording out of the doctor's office and ponder it with social conformity. The way in which choice gets focused is an extremely hmt~d concept of time and leisure in the privacy and relaxed atmosphere of his or her home. choice where indeed the so-called choice itself becomes the way of confonmng. The Journal of Medical Ethics in its November 1985 editorial, postulated that the reason Witltln a <>ender-defined society, the cafeteria of choices is extremely limited. Only \~h~ the standard le?al doctrine. of informed consent (particularly in America) is as widely certain 'choi~es' are there for the choosing, and medicine itself, instead of enlarging the disliked by the medical profession both in America and in Britain is that Americans have choices can actually constrict the available choices by offering such treatments as transsex refined infonned consent. That is, 'instead of being informed ~greement between two ual surgery. Fw1her, as certain 'choices' become ~vai~able, .the~ _fast become the o~y so ration~! and mutually well-regarding parties it has become a mere piece of paper covered in called options. Options become obligations. The dissatisfied md1V1du~ .ends up de~~ved of extensive, often barely comprehensible, medical information.' As Lidz and his colleagues other choices such as rebelling against the prescribed gender role by hvlllg out qualltles t~at suggest, 'Consen.t forms are viewed by many doctors as a substitute for talking to patients, go beyond the prescribed stereotypes. Ultimately the medical solutio~ becomes a 'soctal and by many patients as nothing but paperwork.' tranquilizer' reinforcing sexism and its foundation of sex-role confornuty. . . Whether or not this is true of American and British physicians, J would agree that With the increased availability of transsexual surgery and the more role-enforcmg plasttc consent fonns have become a substitute for talking to patients. However, I would add that surgeries, more and more people will feel that they lack something - that they don't have a new fonn of talking is necessary. If informed consent is to be re-vitalized in any situation the no-ht-sexed body; that they lack an adequate-sized penis or breasts, an~ on and on. where social and ethical issues impinge upon a person's decision to undertake treatment lnfo~ed consent docs not address the responsibility of the medical profession for estab the talking that is necessary between doctor and patient must include a wider coverage of lishing a technology that generates the need and the demand for it. the social and ethical issues. •. The offerin<> of more technical information and technological 'options' does not neces If we arc really serious about doing something about sexism and the ways in which 0 sarily open up more choices. In fact, if informed consent is interprete~ as ~e provi~ing of people suffer from sex role stereotyping, then we should look beyond the provision of more and more medical/technical info1mation by the doctor to the patient, Jt may remforce transexual surgery. Medical professionals, as well as others, have the responsibility to ask the notion that a person suffe1ing from gender dissatisfaction h~s o~ly one "~ay to go - in about the why behind transsexual suffering and propose ways of dealing with such pain that the direction of surgery. By providing only this kind of techrucal 1nformatto~, t~e ~octor co~front the .total situation. Transsexual surgery, and the more interventionist plastic sur reinforces the fact that gender dissatisfaction is a medical proble~. The medicahzauon of ?ene~ that r~mforce gender images, are a limited quick fix to the problem of gender dissat- gender dissatisfaction known as transsexual surgery promotes the ideology that the pr~blem 1sfactton.• •Smee transsexual surgery already exists, stricter reouJationl:> and control of such of gender dissatisfaction cannot be confronted on an autonom~us l~vel ~ut needs the a.nter su~genes ts !1ecessary. ~xpanding the infonned consent process is a good place to start. vention of the medical and surgical specialties to remedy the d1ssattsfact1on by convertmg a This .expansm~ makes informed consent a matter of ethical principle, not only a legal person to the opposite sex. . . . doctrme and gives adequate recognition to the social and political consequences of medical A genuine autonomy must be based on a full range of cho!~es that are u~ tum ?ased on a treatment. full range of information in which both the social and poht1cal con~xt m which gender It has been the purpose of my paper to expand t11e discussion of informed consent dissatisfaction arises, is taken seriously. Furthermore, transsexual existence also depends beyond the traditional foreground issues to important background issues. Only then will the on lifelong sustenance from hormone treatments. Thus the transsexual becomes dependent actual context in which informed consent operates, that is the medical context, become an almost totally for his or her well-being on the medical profession. arena where t1te larger ethical and social issues can be raised. In this way, info1med con sent can move out of its restricted role as a legal formula and courtesy and become a livino It is my opinion that there are certain treatments that pl~ce a he~vy burde~ upo~ th~ 0 medical practitioner to justify. Transsexual surgery an~ pla~tJ.c surg~n.es of a hight~ ~nte1- principle and process. ventionist nature are in this cateoory. One method of insurmg physician accountabthty to an extent that does not happen ~t present is to place an enormous responsibility on the physician to disclose all relevant medical, social and ethical information. Measured by the eno1mity of the surgery and by its propensity for mutilating healthy organ~, 1_.am sug~est ing that no information, no hint, no suggestion of medical and social harm ts d1sproport1on ate to the extreme nature of these kinds of treatments. Some will ask, can I really expect informed consent processes to cover an of the soci~l and ethical infonnation that is relevant here? Isn't this a bit much, a bit extreme, and a btt demanding. But transsexual surgery, as well as other drastic p_lastic surgeries are a bit much, a bit extreme and a bit demanding. They are extreme medical procedures that warr ant just as extreme an informed consent process. 50 51 increased_ utilization of services. Whatever the predicted or actual scenario, it is apparent that the _crrcumstances of the future aged will depend very much on community perceptions and social arrangements that either integrate or segregate the aged in social Jife. INFORMED CONSENT AND THE Attitudes towards the aged in society Jn our industrialized, youth-<.>riented society, the elderly have been accorded relatively little ELDERLY: PROFESSIONAL DEFENCE respect or opportunity for self-detennination. The core attitudes, values, beliefs, stereotypes and myths that have shaped society's policy and behaviour toward the elderly OR CONSUMER RIGHT? affect both professionals and the elderly themselves. We live in a highly urbanized, indus trialized, technological society which emphasizes productivity and technical skills. Those who can contribute productively and skilfully to the economy are highly valued; those who Elizabeth Ozanne no longer can, or are no longer allowed to, are not valued. Predominant value orientations of materialistic individualism, residues of the work ethic and the equation of youthfulness with health, progress and adventure, leave the elderly in a vulnerable and devalued posi tion. We are dealing with a set of attitudes that are shaped by these predominant value orientations throughout society. Ageism also combines with sexism in late life for the much larger number of surviving females, to put them in double jeopardy. Given the prevalent INTRODUCTION negative stereotyping of the elderly in our society there has been a major push in recent The principal thesis of this paper is that most elderly people are poorly informed about the dec_ades, particularly in the United States, Britain and Europe, to challenge ageist The areas to be reviewed are as follows: The nature of the interaction between the general practitioner and the older patient is also a) General Practice: The general practitioner is the gate-keeper of health services for the complicated by attitudinal factors on both sides. Older people tend to be generally more elderly. In terms of both knowledge and orientation however, it is questionable whether acquiescent and compliant than younger patients and have lower expectations about their the general practitioner is the most appropriate informer and decision taker in the emerg entitlement to help. They are also considerably more anxious about ill-health and the pos ing long-term care systems. sibili ty of hospital admission and surgery. They are more likely to adopt a 'sick role', to b) Medication: Older people are high users of medication, yet there is considerable evi regard the physician with reverence and awe, and to regard medical science as an amazing dence to suggest that neither professionals nor clients are well informed as to the actual revolution that has occurred in their lifetime and therefore not necessarily with.in their amount of drugs being consumed, the effect of different drugs and drug dosages on understanding. older persons and the consequences of multiple drug use. General practitioners on the other hand tend to see elderly patients as an expanding c) Surgery: Surgery is a major body invasion and preparations for infonncd cons.ent to it demand population but one of limited responsiveness to curative interventions and there is are vital. Currently however there are few formalized procedures for appropriate pre considerable medical pessimism about the cost/benefit balance of intervention. The type of aod post-operative consultation and orientation of older people or any provision for long-term care required by many older people aJ.so does not fit the acute disease/diagnosis/ friend/advocates to assist elderly patients in decision-making. cure model in wh.ich the general practitioner has been trained. Yet, faced with the helpless d) Death and Dying: The right to die with dignity and to exercise self determination as to ness and anxiety of many older people, and family abdication of responsibility, the the manner and time of one's death are rights increasingly being discussed and debated physician is more often than not the reluctant actor even on the basis of very limited in our society. Yet we still know very little about the major circumstances under which jnfonnation. older people die, nor how older people are processed at the point of death by medical The different settings in which the general practitioner interacts with the older person, be personnel. they nw·sing home, office, hospital or home, have also been shown to be associated with e) lnstitutionalization!Deinstitutionalization: Decisions to institutionalize and/or deinstitu- time spent, the doctors' perception of the patient and the treatment recommended; negative tionalize older people in our society are usually medical decisions. To what degree older ly in the case of more institutionalized settings and positively in the case of the home people are either informed or consenting to such decisions however is far from clear. ln envirorunent. fact the exact opposite appears more the norm than the exception. A number of authors have suggested that there needs to be major changes in medical f) Dementia: The elderly confused would appear to be the least informed and consenting education to assist general practitioners to move to more bio-psychosocial systems models and those whose rights are most at risk in medical and surgical interventions. The need of diagnosis and treatment as contrasted to more reductionist biomedical approaches. Simi for protection under the law and provision of formal advocates for the confused appears larly, it has been suggested that the doctor/patient relationship should be expanded to warranted. include.family and significant others and that a more holistic view be taken of elderly We lack substantial empirical research data on the older client's experience of decision- patients and their special attributes as human beings. Medical diagnosis becomes increas making in the health care system in Australia. What follows therefore is predominantly ingly comple11. in old age because of multiple pathology, use of many medications and based on United States and United Kingdom sources where procedures ensuring informed complicating psychosocial factors. The duration of illness is longer, recovery slower and it consent arc more in place and integrated than in Australia. is important to intervene at an early stage and utilize appropriate rehabilitation facilities. The importance therefore of a thorough psychosocial assessment in relation to the elderly is a) General Practice increasingly recognized with the establishment of geriatric assessment teams in Australia. Older people frequently consult medical practitioners. A recent Australian National Univer This however iniroduccs a new level of complexity and multiple participants into an arena sity study indicated that 67% had visited a doctor in the preceding month, an additional previously the sole domain of the general practitioner and his or her patient. Yet older 28% in the preceding six months and that only 9% had not consulted a practitioner in the people have the right to appropriate multi-disciplinary assessment and access to case preceding year. The importance of general practitioner (GP) contact for older people is that management systems that are able to provide both social as well as medical/institutional GP's are the major controllers of access to health care facilities and monetary reimburse solutions to their longer-term support and care needs. Long tenn care systems are com ment for medical costs. In fact the general practitioner has consid~rable power conferred on posed of social care, rehabilitative care, psychological care and medical care and the future him not only by the health care system itself, but also by patients and families who look to of services to the chronically disabled rests on a multi-disciplinary base developed within the GP as advisor and consultant at points of crisis. the context of a social/health care system where individual patient need and preference and There are however a number of general critiques of the adequacy or otherwise of older not professional status or reimbursement mechanisms are the prime determiner of outcome. person/general practitioner encounters. Firstly few GP's are trained in geriatrics or have Given that such a system has yet to evolve in Australia, there are considerable constraints specific knowledge of the diseases of old age and there is some evidence to suggest a on the range of options a general practitioner is able to offer an older person. relatively high incidence of mis- or under-diagnosis of conditions in the elderly that in younger persons would receive much more thorough assessment. A number of studies have b) Medication indicated that time spent with patients decreases as they age, yet older people would appear Aged persons report relatively high consumption of medicines. The Australian Health to require more rather, than less, time to be properly infonned. Overuse of drugs when Survey (1978) indicated that 74. 7°/o of people 65+ had taken some medication in the two other types of interventions might be more appropriate, for example bereavement counsel days prior to their interview, compared to 47 .4 % of the rest of the population under 65 ling, has also been indicated. Though general practitioners are the major first contact of years. Of aged persons taking medications 72.8% were taking only prescribed drugs, older people and their families in time of crisis, they often are not well informed referrers 16.3% taking both prescribed and non-prescribed drugs. The major reasons for which to other than institutionalized health facilities, in that their knowledge of social support medicines are taken are heart conditions, blood pressure and fluid control. Women appear services in the community is limited. to be higher users than men of psychotropic drugs like vali.um and librium. 60 61 · Bliss ( 1981) in a comprehensive review of phannaceutical use by the elderly listed seven prolapse of the rectum, cataract, aortic aneurysm and diseases of the peripheral arteries reasons why the aged are in fact the main victims of modern drugs and the system by Additional operations justified in younger persons are not indicated in old age except in which they are administered. Firstly, the high incidence of multiple pathology in the unusual circumstances, examples being open heart surgery, renal transplantation, cholecys elderly makes them vulnerable to polypharmacy, that is, being treated by a number of tectomy or extensive reconstructive dental procedures. different drugs at the same time. Also the elderly have increased sensitivity to dnigs and to A major type of emergency surgery which occurs in late life is that related to fractures of their side effects yet doctors Lack specific training in geriatric prescribing. Much drug the neck of the femur as a result of falls and accidents consequent upon osteoporosis or packaging and instruction is also quite unsuitable for older persons in that it is rufficuh to decalcification of the bones. The modem treatment of fractured hips either involves the manage and read. The supervision of older people on drugs can often be poor, particularly fixation of the head of the femur to the shaft by metal pins, or the excision and replacement also when there is dual prescribing by hospital and general practice. Older people them of the head of the femur with a metal prosthesis. As a result, the patient is able to walk selves because of poor sight, confusion or general frailty also find it rufficult to cope with a again, in a short period, and is relieved of pain. Contrasted with the treatment of complete complex pattern of tablet taking without assistance. bed rest for weeks, which was required a few decades ago, followed by the common The trends show that prescribing for the elderly is increasing compared to other age complications of bed sores, pneumonia and pulmonary emboli, it is obvious that the new cohorts and that a higher proportion of the elderly take psychotropic drugs and preparations techniques are a tremendous advance. However, the organizational management of elderly which act on the cardiovascular system and the kidneys. Although elderly people are more fractured neck of femur patients in public hospitals presently leaves much to be desired. prone to adverse reactions because of reduced excretion, slower metabolism and also prob Given that most of these patients come in under emergency circumstances they receive lems of increased sensitivity, they seem to be less aware of the possibilities of side effects. little pre-operatiye consultation and consent is usually taken while they are under consider They are also more likely to obtain repeat prescriptions without seeing a doctor which able duress and on pain-killing· drugs Also, because the aged have a lower status in the again increases the possibility of side-effects. operation queue·relative·: to younger emergencies, they are more often seen in the maximum There appears to be ruffering expectations of information and disclosure between doctors rather than the minimul)l time after admission. After their operation they are most likely and patients in relation to medication. Bliss suggests that more doctors give prescriptions not to go to a rehabilitation centre but to be returned either to a nursing home or to their than patients expect to receive. Older people are also high self prescribers of various types own home where they 'are unlikely to receive any ongoing rehabilitation or appropriate of ingestive remedies. counselling. Hoppel (1985) suggests that an adequate foundation for proper drug therapy requires six This area of surgery is important because it is one where there has been a virtual revolu conditions 1. a proper diagnosis, 2. a decision that phararnaceutical treatment is necessary, tion in procedures for the better. It represents a major call on the health budget in terms of 3. clearly defined objectives, 4. an informed patient and/or family unit, 5. a decision that numbers of operations done and facilities utilized. Most patients are still, however, pro as few drugs as possible will be administered as simply as possible and 6. an understanding cessed a<; emergencies with little preparation or follow-up to what is a very disorienting that therapy will be assessed taking compliance into consideration. procedure. There is also Little consumer information available despite the fact that this is Most researchers who have examined this area suggest that a total overhaul is needed in one of the major operations performed on older women. drug prescribing methods to overcome problems of drug toxicity due to excessive dosage; Another leading surgicaJ procedure performed on the over 65 population is cataract sur doctors' lack of knowledge of the extent to which dosage in old age should be reduced gery. It is a relatively risk-free procedure, done with a local anaesthetic and recovery is compared to the middle-aged and the young; problems of polypharmacy which are com rapid. ln about a quarter of all cataract operations an intraocular lens is inserted to replace pounded by patients use of non-prescribed drugs and GP's lack of knowledge of the pre the cataract clouded natural lens. Despite the high incidence of this operation in the over 65 scribed drugs a patient is on. This requires both better education of doctors and better age group however, there is little printed information available to potential patients or record-keeping procedures. It also suggests a more collaborative approach to the whole opportunity provided for them to discuss pre- and post-operative consequences of their issue of compliance. It is no longer enough to ensure that the patient gets the right prescrip changed vision. tion. The doctor today must think ahead and consider if the patient understands the treat With older people the importance of pre-admission preparation for surgery appears criti ment, agrees with it and is likely to take it; that is, that the patient is a fully informed cal. This tends to be better handled with elective than emergency surgery, though even collaborator in his own treatment. older people undergoing elective hip replacement surgery in Australia are given very little infonnation compared with that provided in other countries more conscious of consumer c) Surgery Surgery is a major body invasion the risks of which increase with age. In old age pro rights. The availability of handbooks published either by hospitals (US Columbia Presby phylactic surgery to prevent future ills becomes of much less importance while surgery to terian Hospital) or aged persons organizations like Age Concern England, goes some way give relief for serious illness that, if unresolved would fill the remaining life with pain or towards ameliorating this situation as. does the arrangement of group orientation sessions disability, is much more common. Both electjve and emergency operations are common in with prospective patients and follow-up groups post surgery. This type of informing of the late life. In old age, the major emergency operations are for fractured hips. strangulated patient is however more the exception than the rule, w1th private patients often being even hernias, complications of gallstones, intestinal obstructions, peripheral emboli, intra less informed because they do not have access to the public counselling and rehabilitation abdomina.I vascular catastrophies (for example, ruptured aortic aneurysm or mesenteric paramedical services. Given that the decision for surgery is a critical one for an older thrombosis). Though patients in the ninth decade of life tend to tolerate operations quite person, the individuals should be advised of their rights about gaining a second opinion as well, they are more prone to post-operative complications and, when this occurs, other to the necessity of the operation; being able to take a nominated advocate to discussions health problems are apt to follow. Major elective operations of late life include those for with their surgeon and staff; being able to participate in groups with other individuals cancer (particularly of the breast, colon and uterus), inguinal hernia, urinary incontinence, contemplating the same operation or undergoing the same procedures; having access to 62 63 appropriate materials that spell out in detail pre- and post-operative phases of rehabilitation Not using_ extra~r~i~ary means t~ prolong life. Today the enormous facilities provided by and appropriate support services. anaesthesia, antib1ottcs and the like make it more difficult for the physician to withhold New approaches to the prediction of surgical outcome hold the promise that such tech treatment which ii~ tenninal cases may serve only to prolong suffering. Nursing homes niques as cosVbenefit analysis and decision trees can now permit surgeons to apply infor usually return pattents to hospitals when serious complications occur. When such ill mation from extensive past experience to systematic and logical decision-making about the patients are admitted to the hospital with many doctors in attendance, none of whom know probability of a successful outcome with patients characte1ized by specific risk factors. the patient or family, it is difficult to restrain the system that aims to provide an the These newer models also require a much more informed and participating patient in the machinery of ~odem medicine to prolong the life of the dying patient. Somerville suggests decision for surgery and follow-through with rehabilitation regimens. that Ja~vyers, J~dgcs and communities have combined to make it difficult and painful for d) Death and dying the pauent to die. On the other hand, 'right to die' groups have urged that it is an individ Older people in industrialized nations are more likely to die in a hospital or health facility ual r~g~t for a patient who is _mentally competent, with the agreement of the family and the than at home. The most common place of death is the acute hospital. Approximately a phys1c1an, to refuse extraordinary means to prolong life. quarter of all deaths occur at home. There is an aJmost equal chance of an elderly person Living wills and enduring powers of attorney. One way in which elderly persons can have dying in a long-term care facility as in their own. home (27 .3% compared to 26. 7% ). some control over what happens to them in tenns of medical treatment should they become Metropolitan/ public and private hospitals and rural base hospitals together account for in_competent, especial.ly \~hen they are dying, is the use of living wills and enduring powers 44% of all deaths (Howe 1985). · of at~orney: Such leglslat1on where it exists can either be limited to governing the rights of The predominant causes of death amongst the elderly are neoplasms (cancer), ischaemic ternunally ill persons to refuse treatment or it can be of a broader nature and deal with rights to refuse medical treatment in general. heart disease, cerebrovascular disease and other heart and circulatory illnesses. Together these account for 80% of all deaths of people 50 and over. Variations are found in cause The living will consists of a document signed by the patient directin In recent decades care of t11e dying has been greatly improved by tl1e growth of the support or hostel living might be more appropriate. What seems to be indicated is that older hospice movement with its concept of appropriate treatment and t11e enabling of a good people as consumers of various accommodation options in Late life are not particularly well death and the development of specialist skills in relieving pain without clouding conscious infonned as to the most approp1iate alternatives available to tllem and there has been a ness. However, it is much easier to exercise a careful and hwnane judgement concerning tendency for iliem to choose more institutionalizing or dependency creating options in the prolonging of life in a hospice for the dying, where the avowed object of the institution ignorance of other available courses. Though different agencies in tlle community like the is to enable people to die well, than it is in a hospital where the principal avowed object is Victorian Council on the Ageing and ilie Wesley Central Mission have been attempting to to treat disease. assist older people in making more informed decisions, via publications and initiating pub In some Health Authorities in England, policies for 'a good dying' have actually been lic discussion in this area, generally ilie level of information available is poor. Recent instituted at a regional Level across both health and welfare facilities to draw the attention abuses in Victoria where a number of nursing homes and retirement villages have got into of professional staff to the potential of undue interference and indignities which can easily financial difficulties, putting elderly people's funds at risk, have led to a tightening up of be inflicted on the aged in the last phase of Life (Muir Gray, 1985, Oxfordshire Health legislation and closer monitoring by tbe Victorian Health Department. Plan). The Oxfordshire Health Plan suggests specific interventions to facilitate the possibil However, other types of institutional abuse of the elderly have been less well monitored. ity of older people dying in their own home rather than in health facilities, by the provision Until recently an informal coalition of professionals was one of the few groups monitoring of evening nursing and night sitting services, development of hospice education and train nursing home standards and blacklisting facilities where abuses repeatedly occurred in ing for community health workers, the setting up of hospice day hospitals and ilie more patient care, management and nutrition. Given the expected expansion of long-term care widespread use of pain control, mouth care and skin care interventions. The outcome of facilities in Australia with the ageing of the population, the whole issue of quality of care such policies is measured by the percentage increment of deaths occurring at home rather and its monitoring has still not been satisfactorily addressed by Federal or State Govern than in local health facilities. In relation to informed consent, such a plan provides an older ments. Although ilie Commonwealth has now brought out guidelines addressing expected person with options for a way of death not otherwise available. standards, ilie promised statement on 'residents' rights' in institutional care has yet to emerge. /nstitutionalizationldeinstitutionalization With the present push to community care as an alternative to institutional placement, and The risk of institutionalization before death appears to relate to being poor, female, without the development of new programmes to 'deinstitutionalize' older people from nursing social suppo11s, having a chronically disabling condition, being old, unmanicd or widowed homes and hostels back into their own homes, refusal of deinstitutionalization and the right and living alone. It is estimated t1lat about 5% of those 65 and over arc vulnerable to to refuse is likely to be an emergent issue in the future. Yet there are few guidelines for institutionalization t1lough the rate of institutionalization is also noted to vary according to professionals or older people in tenns of how such situations will be confronted from an available beds. States having higher numbers of nursing home beds have higher rates of infonned consent perspective. institutionalization. Nearly two out of three aged persons in nursing homes and aged per sons' homes/villages were female, aged 75 and over at the last census. The major medical Dementia conditions associated with institutionalization are confusion, stroke, heart disease, fractures Dementia appears often to be discussed in the legal literature simply as a matter of the and a.t1hritis. measurement of competence in situations of ideal knowledge and professional manpower. The decision to institutionalize an older person is usually a medical one made at the Tn the present circumstances in Victoria, however, there is still a very limited data base point of discharge from an acute hospital or by a G.P. at a point where a family feel iliey available on the incidence and prevalence of this disease and its many manifestations and can no longer continue to care for their relative at home. Mi:nichello (1986) in his examina few available assessment resources for its accurate diagnosis. There are even fewer tion of t1le decision-making process suiTounding nursing home admission indicates that resources available for the appropriate management and care of sufferers and support of often professionals, rather than the older person themselves, arc likely to make and take their families. this decision by way of proxy for the older person. Given that older people rarely vohm Informed consent to medical and surgical procedures or placement under such circum tarily accept nursing home placement and iliat there are usually few options offered at the stances is t1lus likely to be tokenism. Given the inadequate public facilities for the diagno point of hospital discharge, there appear to be considerable elements of coercion involved sis and management of dementia, it has been left to advocacy and self-help groups like the in placement. Also in many hospitals there are still no formal discharge planning pro· Altzheimers and Related Disorders Society and a few voluntary agencies to push for more cedurcs to ensure early identification of older patients who are wilikely to be able to return extensive provision of rnultidisciplinary assessment, t1le creation of more innovative facil home. The right to have a 'choice', to have access to appropriate discharge planning, and ities for care of the confused and the development of appropriate home and day care pro even to refuse placement, are not tights older people are then able to exercise. grammes for supporting families or sufferers. Generally, options for care of the confused Risks associated with relocation from one facility to another in late life, in tenns of elderly are extremely limited and many patients are consigned to private nursing homes for increased confusion and mortality are rarely satisfactorily or systematically monitored by lack of other available alternatives where their disturbing behaviour is managed by high professionals making placements. These risks are rarely taken into consideration at the levels of drugs. The need therefore to develop more options for care both in institutions and point of discharge yet research evidence suggests a high incidence of such risk particularly the community seems urgent to allow an element of choice in care and management. The with a frail aged population. Guardianship Bill goes some way towards recognizing the need to protect the rights of Many older people do not put themselves on nursing home waiting lists yet if they did confused, institutionalized, elderly persons, but until the options and standards of care they would gain a sense of future security should they become ill. When such waiting lists generally provided for tllis group are greatly improved, this will provide only limited are examined it is found that many individuals on them do not require nursing home place protection. ment at all and that in the event of increased frailty, less institutional options such as home 66 67 HAUG M, Elderly Parient.t and their Docrors, Springer Publi~hing Co, 1981. CONCLUSION GOSS .MARY E W, 'Situational Effects io Medical Care of the Elderly: Office, Hospital and Nur~ing Home', in One of lhe major conclusions from the above analysis is that informed consent is rarely a Haug M. Elderly Patients and their Doctors Springer 1981. contract between two individuals acting autonomously, nor should it be the unilateral right BLOOMS W, & SPEEDLING E J, 'Strategies of Power and Dependence in Doctor-Patient Exchange.~ ·, Chaptcc 14 in Haug M, Elderly Patiellls and their Doctors, Sp1:inger 1981. for one individual to decide for another chat consent has been given. The norms and set. HOWE ANNA, 'Beginning at the Et1d: Patterns of Death AJnOng the Aged', Community Heailh Studies, Volume tings of health care practice are shifting. Decisions are increasingly taken in multidisciplin. VI No.3 1982. ary and interorganizational settings. The aged and their families are also demanding lo KASTEN BAUM R. 'Death. Dying and Bereavement in Old Age: New Developments and Their Possible lmplica· tions for Psychosocial Care'. Aged Cure and Services Review, Vol I No.3, 1984. participate more fully in the decision process and there is a need for much more for. National Institute on Ageing, U.S. Depru11Ilent of Health and Human Service.5, Ageinl( and the Circumsran,·e1 of malized, participatory and collaborative decision structures to be developed. In this chang. Death, Monograph Prepared for White House Conference on Ageing, 1981 . ing environment, older consumers must act with much greater vigi lance on lheir own NORMAN AUSON I, Rights and Ri.vk: A Discussion Do<"umem on Civil Liberry in Old Age, National Corpora· behalf, both as individuals and collectively. They will require better health education and tion for the Care or Old People, 1980. JlRADS.11AW I, et al, Found Dead: A Study of Old People Found Dead. Age Concern Occasional Paper 5 May access to information concerning the major health conditions that affect them in middle and t978. late life. They will need to be more articulate as to their rights in and to health care and Social Developrnent Committee, Firs/ Report 011 Inquiry into Options for T>ying with Dig11iry, Mar<.:h 1986, their access to formal advocates. They will also need to be better socially and politically VGPO, 1986. VINCENTE L, WILEY J A, and CARRINGTON RA, 'The risk of institutionalization before death', The Geren· organized to put their claims in public forums. tologist, 1979, 19:361. Health care professionals in this environment will thus be required to be increasingly SOMERVILLE MARGARET, (Series of Paper3 to be published), The Law and Mental Health Care For Compe· accountable and collaborative in their practice which will more probably occur in interdis 1ent and Incompetent Elderly Person (In press) 'Legal and Ethical Aspects of Dt:cision-Making by and for Aged ciplinary settings. There will need to be much better monitoring and review practices in Persons in the Contt:xl or P~ychiatric Care' in Saladay SA, Ethics in Me111al Heulth Practice, Un i ve~ity of Nebraska Plenum (In Press) ' Legal Is~ues in Surgical Care of Eklerly Per.:ons: Developing the Analysis of these seltings and more sophisticated decision models which maximize the client's oppo1iu Rights "to" and "in" Health Care' in Surgirnl Care of Elderly Persons published by Green and Stratum ([o nity for self-determination. Press) . . In this changing environment, the law will be increasingly eaJJed upon to regulate HICKS N, 'The Structural Conditions for Informed Consent', Paper delivered at Informed Consent Seminar, Law relationships between clients, medical care organizations and professionals, in the client's Reform Commission, 8th April, 1986. (see this volume) PARRY JOAN K, 'Informed Consent: For Whose Benefit?' Social Cu.vework: rile Journal of Contemporary best interests. Social Work, F.S.A.A. 1981 62 (9) p.537-42. The broader societal context will also act as a major determiner of where the needs of the SOMERVILLE MARGARET A, Conscm to Mediwl Care: Protection of Life Series, A Study Paper Prepared for elderly will stand among the demands ·of other population groups in the debate about the Law Refonn Olmmission of Canada, 1980. Australian Council on the Ageing and Department of Social Security, The Aged at Home: Report of A Survty, resource distribution. The outcome will depend on how the aged are valued in the society A.G.P.S., 1985. relative to other groups and whether resources will be allocated to improve the opportunity LOWY L, Sot:ial Work 111i1h the Ageing: The Challenge and Promise of the Laier Years, Harper & Row 1979. range for a substantial number of the aged or expended on the extension of life for a few by POLLARD A H & G N. 'The Demography of Ageing in Australia', in A. Howe (ed), Towards an Older extraordinary technological means. .4.ustralia, Univeusity of Queensland Pres~. 1981. DAY L H, 'Social and Economic lmplica1ions', in A. Howe {ed) Towards an Older Australia, University of It can only be hoped chat the interpretation of the doctrine of informed consent in this Queensland Press, 1981. changing environment evolves in the direction of its original intent - to maximize the ORA Y J A M, •A Slrategy for Health in Old Age', in A. Smith (ed), R ecent Advances in Communir;.· Medidne, client's right to self determination. Cheshire Livingstone, 1985. SELECTED BIBLIOGRAPHY Australian Bureau of Statistics, Aus1ralia's Afted Popula1iot11982, Canberra 1982. Australian tnstit.ute of Multicultural Affairs, Commu11iry and Institutional Care for Aged Migrants in Australia, Research Report, March, 1986, A.G.P.S., 1986. Department of Immigration and Ethnic Affairs, Aus1ralia's population trends a11d prospects 1984. A G.P.S. 1984. KENDIG H L, GIBSON D M, ROWLAND D T, & HEMER JM, Health, We/fare and Family in Larer Life, Ageing and the Family Project, Research School of Social Sciences, Australian National Univen;ity, Novemhcr 1983. Puhli~hed hy N.S.W. Council on the Agdng. MINICHlllLO M V, 'Social proce~scs in entering nursing hom~s ', Axeing and Families Allen & Unwin J986. p 149. FRIES J F, 'Ageing, Natural Death, and the Compression or Morbidit}'', The New Et1l(lu11d Journal of'Medici11e. July 17th, 1980 p.130-135. CARTWRIGHT ANN, & ANDERSON R, The Use. of Medicines by rhe F.lderly, Tn~titute for Social Studies in Medical Care, March 1983, U.K., 1983. HOPPEL C L, 'The Uses and M isuses of Pharmacology', in Haug M. et al, The Phvs1cal and Mental Health of Aged Wome11, Springer Pub Co, 1985. · BLISS MR, 'Prescribing for the elderly·, British Medical Joumrd 283, 1981 p.203-20. WELCH C F. . 'Surgery and Aged Women: Indications and Contraindicatiuns', in Haug M . The Phy.vicnl and Meneal lleu//h of Aged Women. Springer Pub Co. 19115. The Law fwndation of New South Wales and C.C.H. Australia Limired , Personal Aff01rs Managemenr for Retire£-.< A Legal Guide C.C.H. 1986. 68 69 THE EFFECT OF THE CRIMINAL LAW _Mrs. Gillick originally alleged that a doctor prescribing contraceptives to a woman under 16 would be aiding and abetting a man to have unlawful sexual intercourse. The issue was MINORS AND CONSENT TO MEDICAL considered by all .five Law Lords. Lord Fraser noted that by the time the case reached the Court of Appeal, counsel for both sides conceded that whether a doctor was so liable TREATMENT: REFLECTING ON •would depend on the circumstances'7 and the most relevant circumstance was the doctor's intention. 'This appeal is concerned with doctors who honestly intend to act in !he best interests of the girl, and I think it is unlikely that a doctor who gives contraceptive advice GILLICK or treatment with that intention would commit an offence under s.28. 's Lord Fraser went on to say that he regarded the question as irrelevant to the matter to be decided because, he Jenny Morgan argued, if the doctor committed an offence, he did so even where the parents consented.9 Lord Scarman and Lor.d Bridge were both happy to rely on the analysis of Justice Woolf in the original Gillick decision. 10 Justice Woolf had also emphasised the intention of the doctor: A doctor who is misguided enough to provide a girl who is under There are further difficulties with finding a health care worker guilty of aiding and abet about some matter that he knew of it, and, perhaps, refrained from inquiry so that he could ting the criminal offence of under age sexual intercourse. These difficulties are separate deny knowledge, it is nevertheless actual knowledge which must be proved ... '21 Cbief from, but related to, the lack of the relevant intention. Justice Gibbs suggests that wilful blindness is enough, but only because 'it virtually Lord Goddard in Wilcox v Jeffery 11 said that a person will be liable for aiding and amounts to knowledge'. What is required is 'deliberately refraining from making inquiries' abetting 'provided that the aider and abettor knows the facts sufficiently well to .know that rather than merely ' neglecting to make such inquiries as a reasonable and prudent person they would constitute an offence jn the principal'. [sic] It seems difficult to suggest !hat a would make' .28 I suggest that even with Chief Justice Gibbs' approach, a medical prac doctor giving contraceptive advice or prescribing contraceptives to a young woman would titioner is not wilfully blind and does not therefore have the necc.~sary intention for liability ' know the facts sufficiently well' . For example, at least in Victoria, lhc commission of the for aiding, abetting, counseUing or procuring the offence of under age sexual intercourse. offence of 'ta1cing part in an act of sexual penetration with a person between 10 and 16 I would like to return briefly to Lord Brandon's argument that to allow docrors to pro years of age' is dependant on the age of the young woman's partner as well as her own age vide contraceptive treatment to minors would be contrary to public policy. The public (s.48(4)(b)). 1s That is, consent is a defence if the accused was no more than two years palicy Lord Brandon appears to be referring to is the provision of the UK criminal Jaw older than the 'victim'. The doctor would not be likely to have this information especially which makes it a criminal offence to have sexual intercourse with a woman who is under if the woman visited the doctor alone. There are other defences to the crime, for example, 16. He suggests that to allow a young woman to consent to her own contraceptive treat that the accused reasonably believed the 'victim' to be over 16 (s. 48(4)(a)). Furthermore, ment would be 'to undennine or circumvent the criminal law which Parliament has enac for liability as an aider and a better, presence at the commission of the crime appears to be ted. The criminal law and the civil law should ... march hand in hand on all issues. •29 required.1? As Justice Woolf said referring to the normal state of knowledge of a doctor Glanville Williams3o has pointed oot that the criminal law and civil law often diverge: to conceming the alleged crime: '[S]he would know no more than that there was a risk of give but one example, the level of proof in criminal matters is 'beyond reasonable doubt' sexual intercourse taking place at an unidentified place with an unidentified man on an and, in civil matters, on the 'balance of probabilities'. There seems to be no reason why unidentified date' .w they should not diverge here. Would a health care worker who prescribed contraceptives for a woman under 16 be l would also note the complexities of drafting that would be required if the law on guilty of counselling or procuring? In Attorney-General's Reference (No.I of 1975)21 Lord minors' consent to medical treatment was to comply with the Jaw on sexual offences. Widgery stated: 'a person who counsels the commission of a crime by another, almost Presumably it would have to allow a minor to consent to her own contraceptive treatment if inevitably comes to a moment when he is in contact with that other, when he is discussing she was married, and if she was unmarried and her partner was less than two years older the offence with that other ...'. The Court of Appeal suggested that for aiding, abetting or than her, she may also be able to consent to medical treatment; but if she was between 16 counselling some sort of 'agreement or discussion as to the form of the offence' was and 18 years of age, she should be able to consent to medical treatment if her partner was required. Again a doctor prescribing contraceptives is unlikely to come to any agreement less than 5 years older than her because, according to the criminal law, her consent wouJd about the form of the offence. The same court defined procure as 'to produce by be a defence to a charge of sexual penetration of an under age person. And that is only a endeavour. You procure a thing by setting out to see that it happens and taking the appro brief and partial survey of the Victorian position. priate steps to produce that happening'. A doctor providing contraceptives to a young To summarise: a majority of the Law Lords in Gillick decided that a doctor prescribing woman is not endeavouring to procure unlawful sexual intercowse, but rather to prevent its contraceptives would not be liable for aiding and abetting the criminal offence of unlawful/ consequences. Of cornse, if the health care worker encouraged the commission of the underage sexual intercoUTse. She would not have the necessary intention or knowledge. offence of unlawful sexual intercourse, the situation may be different though, again, ques tions of knowledge of the offence are raised. It is also important to note that when a doctor A MINOR'S LEGAL CAPACITY TO CONSENT TO MEDICAL provides contraceptives to a young woman the doctor does not usually have contact with TREATMENT the principal in the unlawful sexual intercourse, that is the young woman is not guilty of an Most of the Law Lords considered the statutory context in which the decision as to a offence (unless her prutner is also under 16 as the Crimes Aci offences are non-gender minor's legal capacity had to be made. In the United Kingdom, the Family Law Reform Act specific), only her male partner may be. The cases on participation in a criminal offence provided that a minor of 16 or over could consent to, amongst other things, medical treat are generally premissed on some contact with the principal offender: there is none in the ment. The Act also provided: standard provision of contraceptive advice and contraceptive devices to young women. S. 8(3): Nothing in this section shall be construed as making ineffective any consent The necessity for intention to aid or abet a crime and/or knowledge of that crime, in which would have been effective if this section had not been enacted.3t order to found liability for secondary participation, has been confirmed by the High Court What effect did this Act have on the consent of minors under 16? Lord Fraser stated jn Giorgianna v R.22 All members of the Court held that 'knowledge of the circumstances':n '[This subsection] leaves open the question whether consent by a minor under 16 would or 'knowledge of the essential matters'24 was necessary for liability as an aider or abettor. have been effective if the section had not been enacted.' We are therefore back with the In other words, recklessness, or advertence to the probability that, to give a relevant exam common Jaw, and thus the position in Victoria. ple, unlawful sexual intercourse might occur, was not enough. The court similarly held that Various other statutes dealing with minors including the Education Act and Mental an intention to aid and abet was required.ZS There was some disagreement as to whether Health Act were considered, but none gave a definitive answer (nor were they particularly 'wilful blindness' may be enough to constitute the relevant intention. 'Wilful blindness, has helpful) to· the question at issue: the legal capacity of minors under 16 to consent to their been defined as 'When a person deliberately refrains from making inquiries because he own medical treatment. Gerber and Rahemtula in a note on the Gillick case in the Austral prefers not to have the result, when he wilfully shuts his eyes for fear that he may learn the ian Medical Journatn bave attempted a survey of the Australian 'statutory context': one truth ... •u; Justices Wilson, Deane and Dawson sugge.c;t that: 'although may be a proper it would be similarly reluctant to draw a defiIDtive conclusion from the statutory ages de- inference from the fact that a person has deliberately abstained from making an inquiry 72 73 scribed there. For example, a minor may leave school at 14 in Victoria but not until 16 in that at least some minors have the legal capacity to consent to some types of m~ical Tasmania, and may own a fireann at 15 in South Australia, at 16 in Western Australia and treatment, and a majority of the Law Lords (Lords Bridge, Fraser and Scarman) decided Tasmania, but not until 18 in New South Wales, Queensland or Victoria. that this legal capacity also allows consent to contraceptive advice and treatment. As the statutory context provided no answer, Lords Fraser and Scannan (Lord Bridge agreeing) looked to the common law. Lord Scarman referred to the age of discretion cases. These were where a parent applied for return of her/his child when s/he had left home PARENTAL RIGHTS without consent: return was refused if the child had reached the age of cliscretion, wruch A pasitive response to the question of minors' legal capacities does not end the debate. was 14 for boys and 16 for girLc;. Lord Scarman rejected the notion that a court in 1985 was Mrs. Gillick was asserting a right both to be infonned of her children's consultations on to be restricted to the specific age, originally specified in the 16th century. He relied on contraception and to veto their treatment. The Court had to consider parental rights and what he saw as the reasoning or basis of these decisions: the appropriate age would vary duties, or parental legal capacities.41 from individual to individual and was 'the attainment by a child of an age of sufficient Lords Fraser and Scannan resolved the issue of parental rights in different ways. Both discretion to enable him or her to exercise a wise choice in his or her own interests. '33 He judges dismissed the 19th Century decision in Agar-Ellis42 which upheld the right of a 4 referred to a recent English case of kidnapping, R v. D. 34 One of the issues in that case was father to control a minor's 'person education and conduct' until the age of majority 3 and whether a child under the 'age of discretion, could give a consent to her or his 'kidnap affirmed Lord Denning's view in Hewer v. Bryant44 where he said '[custody] is a dwindling ping', thus providing a lawful excuse to the kidnapper, or whether the consent had to be right which the courts will hesitate to enforce against the wishes of the child, the older he given by the child's parent. The House of Lords concluded: js. It starts with a right of control and ends [at 181 with little more than advice.' Lord I see no good reason why, in relation to the kidnapping, of a child, it should not in all Scannan went on to explicitly decide that once the minor has 'sufficient understanding and cases be the absence of the child's consent which is material, whatever· its age may be intelligence to be capable of making up his own mind on the matter' the parental rights to ... ln the case of an older child . . . it must ... be a question of fact for a jury consent tenninate.45 Lord Fraser"s views are not so clear cut. He stated that once one whether the child concerned had sufficient understanding and intelligence to give its rejects the notion of the absolute authority of parents '[the] solution depends on a judgment consent.3s of what is best for the welfare of the particular child. '46 He goes on to say that the parents Lord Scarman concluded from this that a minor has the legal capacity to consent to her1 are usually the best judge of that welfare, but in some circumstances the doctor is a better his own medical treatment when s/he 'achieves a sufficient undcrstancling and intelligence judge. to enable him or her to understand fully what is proposed. '36 He went on to explicitly The only practicable course is . . . to entrust the doctor with a discretion to act in recognise what the North Americans call the 'mature-minor' doctrine, quoting with approv accordance with his for her] view of what is best in the interests of the girl who is his (or al Justice Addy's statement in Johnswn v. Wellesley Hospita[. 37 'I feel that the law on this her] patient.47 point is well expressed in the volume on Medical Negligence (1957) by Lord Nathan He proceeded to lay down five matters on which a doctor should be satisfied before the (p.576): doctor treated a young woman without her parents, consent or knowledge: It is suggested that the most satisfactory solution of the problem is to rule that an infant 1) that the young woman will understand the advice; who is capable of appreciating fully the nature and consequences of a particular opera 2) That she cannot be persuaded to tell her parents or allow the doctor to inform them; tion or of particular treatment can give an effective consent thereto, and in such cases the 3) That she is 'very likely' to commence or continue sexual activity with or without consent of the guardian is winecessary; but that where the infant is without the capacity contraception; any apparent consent by him or her will be a nullity, the sole right to consent being 4) That unless she received contraceptive treatment her physical or mental health will be vested in the guarclian.' likely to suffer; Lord Fraser concentrated in his judgment on the issue of parental rights and duties but 5) That her best interests require him [or her] to give her contraceptive advice, treatment or stated: both without the parental consent. '48 .. . provided the patient, whether a boy or girl, is capable of understanding what is Now, of course, neither of these views necessarily represents the ratio of the case. Lord proposed and of expressing her or his own wishes, I see no good reason for holding that Bridge, who made up the majority with Lords Scarman and Fraser, stated that he agreed he or she lacks the capacity to express them validly and effectively and to authorise the with both Lord Fraser and Lord Scarman. Given that 'the decision' (whatever that is) medical man for woman] to make the examination or give the treatment which he [or though not binding on an Australian court, is likely to be highly persuasive, it is worth she] advises)s while exploring in more detail the implication of these two views. He based this conclusion on the fact that minors can enter into contracts (within limits), Both judgments (together with Lord Bridges, concurrence and Lord Templeman's agree can sue or be sued, can give evidence on oath and can consent to sexual intercourse so as ment, at least for some forms of medical treatment) establish that children have the legal to prevent the ac;sailant being guilty of rape.39 capacity to consent to their own medical treatment. But what about a minor's right to Although Lord Templeman is described as being a dissenter in the judgment, as be consent to her own treatment, independently of her parents and indeed, against their disagreed on the relevance of the criminal law to contraceptive treatment, he did agree that wishes? Lord Scarman, though he did refer to parental rights in his judgment, said minors have the legal capacity to consent to some forms of medical treatment: unequivocally that 'parental right yields to the child's right to make his [or herj own The effect of the consent of the infant depends on the nature of the treatment and the age decisions when LsJhe reaches a suffi cient understanding and intelligence ... '49 Lord Tem and understanding of the infant. For example, a doctor with the consent of an intelligent pleman was also of the view that the opposition of parents is no bar: ·A doctor may boy or girl of 15 could in my opinion safely remove tonsils or a troublesome appendix.411 lawfully carry out some forms of treatment with the consent of an infant patient and Thus four out of five Law Lords (Lords Fraser, Scannan, Bridge and Templeman) held against the oppositi.on of a parent based on religious or any other grounds. 'so 74 75 Lord Fraser, on the other hand seemed to suggest that although a minor has the legal In the Report's draft legislation, clause 21 protects a medical practitioner from criminal capacity to consent to her own treatment, she does not necessarily have the capacity to liability (arising from Jack of parental consent) if she acts without the consent of the parent decide what ii. in her best interests. Then, he suggested, that although parents are usually and in her opinion - the best judge of what is in a minor's best interests, sometimes a doctor may be a better a) the child was capable of understanding and consenting to the medical treatment. judge. Parkinsons1 has argued that Lord Fraser was passing the right to consent not from Tb.is form of wording does not introduce any proviso that the minor's judgment must be the parent to the minor but from the parent to the doctor. With respect, I suggest that Lord sound, which is surely preferable. The draft legislation only purports to protect the medical Fraser's view may be misconceived. Surely it is at lea~t arguable that, if the minor has the practitioner from any criminal liability arising out of the lack of parental consent. To capacity to consent to medical treatment, she also has the capacity to decide what is in her clarify once and for all the question of tortious liability, it would of coUise need to be best interests - that is part and parcel of making an informed treatment decision. expanded. Even if it does not follow 'as a matter of strict Iogic'52 that once you decide there is no New South Wales has already legislated some years ago to protect medical practitioners legal bar to allowing minors to consent to their own treatment, and that they have sufficient in the Minors (Property and Contracts Act). The legislation provides, in part: matUiity to do so, that parents have no necessary role to play, I suggest it is the better s.49(2) Where medical treatment or dental treatment of a minor aged fourteen years or view. And, equally, that we should not be encouraging doctors to play that paternalistic upwards is carried out with the prior consent of the minor, his consent has effect in parental role. Eekalaar53 suggests that it is perfectly consistent with our legal tradition to relation to a claim by him for assault or battery in respect of anything done in the course find that minors can consent to medical treatment, but that parents (or doctors) maintain a of that treatment as if, at the time when the consent is given, he were aged eighteen supervisory role. years or upwards.' I suggest that such an approach only muddies the issue and is impracticable particularly This dearly addresses itself to the issue of tortious liability. But it does not necessarily in the case of minors seeking contraceptive advice and treatment. It muddies the legal issue provide answers to the complicated questions that arose in Gillick; that is the legal capacity in that four out of five law lords in Gillick's case stated that minors had the legal capacity of a minor to consent to her own medical treatment independently of her parents or against to consent to their own medical treatment: once this is accepted (and it is clearly in line their wishes. The Legislation was considered in K v Minister for Youth and Community with the common law)54 the doctor is protected from a criminal law action for assault and Services.61 In that ca~e. K, a 15 year old ward wished to have an abortion, and permission from liability for trespass to the person, provided the minor patient gives an informed was refused by her guardian, the Minister. One of the arguments put in that case, on K's consent to any touching. It has been suggested that any failure to comply with steps (2) to behalf was that s. 49(2) of the Minors Property and Contracts Act gave the minor a power (5) in Ll>rd Fraser's judgment (which includes the requirement that the doctor has decided to consent to her own treatment independently of the wishes of her guardian. This was not that the contraceptive treatment is in the minor's best interest) could be reason for disciplin accepted. Justice Helsham said that what the Act did was to take away a right of a minor (a ing by the doctor's professional body55 but would not make the action unlawful. The right to sue for assault or battery); it did not confer a right to give a valid consent to impracticability arises out of the need for minors to be able to make their own decisions medical treatment which 'set at nought a guardian's power in this area' .62 independently of their parents; and that capacity should not be diminished by the substitu Justice Helsham's views suggest that any legislation in Victoria which aims to clarify the tion of one form of paternalism for another. The health care worker, under the common common law, or perhaps to change it, to allow minors to consent to their own treatment law, has a difficult enough role in deciding whether the particular minor has lhe capacity to independently of their parents, or against lheir wishes, is going to have to be more explicit. give an informed consent. I would also support specifying a fixed age above which minors are deemed to be able to Lord Fraser's five point test is not, of course, 'the decision, in Gillick. Indeed if one was give an infonned consent to medical treatment, with an assessment of capacity or factual counting judges, three Law Lords (Lords Scanna:n, Templeman and Lord Bridge, because competence to be made by the medical practitioner below that age. Such a move would he agreed with both Lords Fraser and Scarman), a majority, took the view that parental reduce the discretionary power of medical practitioners and indeed make their job easier. rights extinguished once the child had the actual ability (or factual competence)s6 to consent There is enough reliable psychological evidence to support a finding that many minors of to her own treatment. Given the confusion a process of common law decision-making can 14 and over are capable of giving an informed consent.63 Below that age, an individualised engender, it seems sensible to move for legislative clarification. assessment of a minor's capacities may be more appropriate. WHAT SHOULD BE DONE? REFERENCES l have argued elsewheres7 that there is enough evidence from psychological research to l. [1985] 3 ALL E.R. 402. support the view, implicit in the above discussion of Gillick that some minors do have the 2. Private Eye, 623, l. l J. 85 actual ability to give an informed consent to medical treatment. Such a consent would be 3. [1984] 1 All E. R. 365. 4. [1985) I All E. R. 533. intelligent, knowing and voluntary. ss I would consequently support the thrust of the recom 5. [1985] 3 All E. R. 402. mendation of the Camey Report.59 6. Tdat405. Legislation should provide that minors may give a valid and sufficient consent to a 7. Id. at 413. medical procedure, provided that their maturity and understanding, bearing in mind the 8. Id. at 425. Section 28 of the Se.x11al Offtnces Act (UK) provides 'It is an offence for a person to cause or encourage . . . the commission'. nature of the procedure, is such that they can form a sound and reasonable judgment of 9. Id. at 428. the issue. 10. (1984] l All E. R. 365. The difficulty with the recommendation relates to the phrase 'sound and reasonable judg IL Id at 37 l. Sec.t.ion 6 of ttic SeA11al Offences Act provides: 'It is an offence ... for a man to bave unlawful sexual intercourse with a girl under the age of sixteen.· (See s.48 Crimes Act (Vic.)). ment'. I would argue that minors should be able to make unsound, judgments if they are 12. [bid. at 431. giving an intelJigent, knowing and voluntary consent.6Cl 76 77 13. The issue of the rights and duties of parents and doctors is taken up later in the paper. It seems unlikely that Lord Templeman is presenting the view that parental consent prevents criminal liability. The view that criminal liability, if it arises, arises regardless of whether the parent or minor is the appropriate person to consent to the minors' medical treatment, is preferable. 14. Ibid at 429. I 5. And probably Lord Templeman. INFORMED CONSENT TO MEDICAL 16. Ibid at 372. 17. [1951 l 1 All E. R . 464 at 466. CARE BY PERSONS OF DIMINISHED 18. Note that the Victorian legislation is non-gender specific. 19. Russcll [1933j VLR 59. 20. [1984] 1 All E. R. 365. CAPACITY 21. [1975) 2 All E. R. 684 at 686. 22. (1985) 59 ALJR. 23. Per Gibbs CJ, id. at 465; cf. per Mason J at 470. 24. Per Wilson, Deane and Dawson JJ at 472. Alan Rassaby 25. Sec, e.g. per Wilson, Deane and Dawson JJ at 472. 26. R v Crabbe (1985) 59 AUR 417. 27. op. cit. at 474. 28. Roper v Taylor's Central Garages (Exeter) Ltd [1951) 2 TLR 284 at 289, quoted by Gibbs CJ, op. cit. at 465. 29. Gillick (1985] 3 All E. R. 402 at 431. 'The physician may well sympathise with former Supreme Court Judge Justice Potter 30. 'The Gillick Saga -Part I', (1985) 135 NL/ 1156 at !158. Stewart, who, wrestling with the problem of developing a standard for obscenity, opined 31. Id. at 408. Lord scannan holds the same view (at 419). Lord Bridge (at 428) agreed with Lords Scarman and Fraser on these points. that he could not develop a clear rule but l know it when l see it'* 32. 'Who has the right to Advise on Birth Control?' (1986) 144 MJA 419 at 422. 33. Ibid at 423. INTRODUCTION 34. [1984) 2 All E. R. 499. 35. Thid. at 457 per Lord Brandon. lt is worthwhile noting that Lord Brandon dissented in Gillick. In this paper, I intend to explore issues arising out of consent to medical care by persons of 36. [1984) 2 All E. R. 449. diminished capacity. It should be recognised at once that the group with which we will deal 37.(1971) 17 D.L.R. (3d) 139 at 145. is not an homogenous one. Diminished capacity may occur, inter alia, through mental 38. (1984] I All E. R . 365 at 409. 39. R v Howard (1965] 3 All E. R. 684. illness, intellectual disability, senility, Alzheimer's Disease or brain damage. Depending 40. f] 984] I All E.R. 365 at 432. on the source of the disability, the type and extent of incapacity may be very different. For 4 I. Jt is worth noting that the judgments continually mention parental righrs (and duties) and children's legal instance, in contrast to intellectually disabled people, people who are mentaJly ill or have capacities. Lord Scarman was the only Law Lord to mencion children's rights. (Ibid. at 422). Alzheimer's Disease may alternate between periods of lucidity and incompetence. Never 42. (1833) 24 Ch. D. 3 17. . 43. Lord Fraser said at (1985) 3 All E. R. 402 at 412, 'I regard it as an historical curiosity'. Lord Scannan theless, for simplicity, I will refer to persons in this group by the use of the generic term described the decision as 'horrendous' und said it was 'rightly remaindered to the hi story books.' 'disabled'. 44. (1969] 3 All E. R. 5789. The limits of this paper should be stated at the outset. I intend to deal only with non life 45. (1985] 3 All E. R. 402 ac 423. 46. Id. at 412. saving procedures, thus avoiding the myriad of issues which arise in connection with with 47. Id. at 413. holding of nutrition from neonatals and the termination of life support systems. 48. Ibid. In Part A of the paper, I examine the dynamics operating when someone other than the 49. Id at 422. disabled person is called upon to consent on their behalf. In addition, I will analyse two 50. Id at 432. 51. 'The Gillick case - Just What Has it Decided?' (1986) 16 Family Law I I. recent developments in Victorian law - the Guardianship and Administration Board Act 52. EEKALAAR JOHN, 'The Eclipse of Parental Rights' (1986) 102 Law Quarterly Review 4 at 5. and the Mental Health Act. Part C contains some concluding remarks. 53. [d.at 7. 54. Sec MORGAN J, 'Minors and Consent to Medical Treatment Related to Fertility Conrrol' (1986) 12 Monash The other side of the informed consent coin: choice Universiry Law Review 161. 55. Eekalaar (l986) op. cic. 7. The law tells us that a medical practitioner may not treat any person without that person's 56. See, for example, SOMERVILLE MARGARET A, 'Refusal of Medical Treatment in 'Captive' informed consent or, in event of incapacity, without the informed consent of a person Circumstances? (1985) 63 Canadian Bar Review 59 at 61. legally authorised to consent on their behalf. For consent to be effective, there must be 51. MORGAN J, ~·cit. 58. GRISSO T, and VIERLING L, 'Minors' Consent to Treatment: A Developmental Perspective' (1978] reasonable disclosure to the patient about the treatment, including any associated risk, and Professional Psychcwgy 412. the consenting party must have voluntarily consented and be competent to consent. Every 59. CARNEY T, Child Welfare Practice and legislation Review Report: Equity and Social Justice for Children, medical intervention is prima facie illegal and informed consent constitutes a defence to an Families and Communities Victoria, 1984, at 291. action in battery. The philosophical basis for informed consent is respect for the autonomy 60. See MEJSEL A, ' The Exceptions to the Informed Consent Doctrine: Striking a Balance between Competing Values in Medical Decision Making' (1979] Wisconsin Law Review 413 at 446; MOROAN J, op.cic. of the individual. 61. [1982) l NSWLR 311. At this point, I suggest that we step back from the issue of informed consent and attempt 62. Id at 321. to place it in · a broader context. 63. MORGAN J, op.cit. The danger of over-focussing on the doctrine of informed consent (as lawyers are wont to do) is that it tends to obscure the broader issue of access to medical services. lt is 78 79 important to acknowledge that if access to medical services is restricted or if the only one contrasts two definitions of intellectual disability. The current definition of the Ameri services to which one has access are of a poor quality, the issue of consent becomes can Association Mental Deficiency (AAMD) defines it as 'significantly subaverage general relatively unimportant. This has been recognised in the USA where, throughout the past intellectual functioning combined with deficits in adaptive behaviour manifested during the two decades, litigation on infom1ed consent has proceeded hand in hand with litigation 011 developmental period.'4 In contrast to this static approach, Marc Gold's definition reflects a the right to medical services and discrimination in the provision of medical services. 1 dynamic view. Turning the definition on its head, he defined it 'as level of functioning The issue is pertinent particularly for institutionalised, intellectually disabled and mental which requires from society significantly above average training procedures and superior ly ill people. In Victoria, the large institutions for these two groups a~e run dir~~tly by the assets ia adaptive behaviour on the part of society, manifested throughout the life of both State (in contrast to public hospitals which are autonomous). Medical practllloners are the society and the individual' .s directly employed in these institutions. Options for merucal care to reside~ts of the.s~ insti I suggest that true respect for autonomy of the individual will reflect itself through adop tutions are limited by the effective lack of access to advice by other medical practtt10ners. tion of the dynamic approach. In the case of civilly committed mentally ill people, where treatment may be given without The tests of competency consent, there is no legal right to a second opinion. !his should be con:rasted to menral The starting point in the search for a test of competency is an article by Roth et al, where it health legislation in England, where involuntary patients now have a nght to a second is suggested that questions of competency arc usually determined on the basis of applica 2 opinion from a psychiatrist independent of the service delivery system. The quality of tion of one or other of five tests.6 services for intellectually disabled people is inhibited by the practice (declining in recent The first test is satisfied if the patient evidences a choice. Under this test, the competent years) of employing overseas medical practitioners, unqualified to practise in Australia, and person is the person who can express a preference for or against a particular form of conferring on them a (limited) registration to practise only in the institution w~ere the~ are treatment. The second test focusses on the outcome of the choice. If the reasonable, right employed. These constitute systemic disincentives to provision of a good quality service. or responsible decision is made, the person is said to be competent. The third test looks at The problem is not limited to institutionalised people but extends to other devalued the patient's reasons for the decision. If the reasons are rational, then the person is regarded people living in the community. Treatment available to non-disabled members of the com as competent. The authors rightly acknowledge that this test is capable of being manipu munity may be denied to disabled people. Until relatively recently, open heart surgery was lated by medical personnel to ensure the desired outcome. For eic:ample, how does one a procedure denied to children with Down's Syndrome. Another example would be reversal know whether a delusional patient has refused ECT because he/she has a normal fear of tubal ligations. 1 suspect. that it may be considerably easier on occasions to find a doctor reaction? The fourth test requires the patient to have the ability to understand. The decision who will tie the tubes of an intellectually disabled woman than to find one who will reverse need not be rational and unwise choices are permitted. The fifth test requires actual under the procedure. . . standing. Here the obligation is on the treating doctor to ensure that her/his patient has I return then to my original point. The informed consent doctrine should not be divorced actually understood all the major implications of a proposed course of treatment. from the broader issue of the need to ensure that disabled people have access to the same I do not propose to elevate one of these tests above the other as the preferred option. In quality and range of merucal services as other members of the community. This means that my view, the tests are entirely interconnected. Actual understanding (the fifth test) in rela society must address the fundamental attitudinal issues surrounding disability and remove tion to very simple medical procedures, such as the delivery of first aid for cuts and the systemic disincentives to good quality services. These issues will be discussed in great bruises, may be evidenced by the indication of a preference (the first test). In applying the er detail later in this paper. 'actual understanding' or ' ability to understand test', it would be almost impossible to exclude from consideration the outcome of the decision, as this would give some insight PART A - CONSENT BY A DISABLED PERSON into the way in which the person is processing information received.7 Rather than search for a single test of competency (described by Roth as a search for the What is competence? Holy GraiJB), it is suggested that a great deal can be learned by exploring the factors which The dynamic and the static views of competence influence a decision by a medical practitioner as to competence. Of these, the primary Central to the question of consent by a rusabled person is the issue of competcnc~. Jf a factors appear to be attitude to the client group and treatment bias. person is not competent to consent to treatment, their consent if given does n_ot constitute a Attitude to Client Group valid defence to an action in battery. So what is competence and at what pomt can one be It is suggested that attitudes of medical personnel to disabled people significantly affect the said to lack capacity? In answering this question, two approaches should.be ~ontrasted. I provision to them of merucal services. Wolfensburger and Thomas have written about some refer to these as the static and the dynamic view of competence. The static view suggests of the common images which the public associates with intellectually disabled people. that competence is something intrinsic to the jndividual and therefore unrelated to external These include the roles of: events. (Crudely it can be summarized in the words 'either you've got it ?r you have~'t'). a) subhuman, for example, animal vegetable or object The dynamic approach sees competence in relation to the surrounding envrronmenl. It is an b) object of dread or menace approach which acknowledges the potential for develop~ent in each in?-ividu~ and recog c) person to be pitied nises also that development does not occur unless the envrronment provides smtable oppor d) burden of charity to be reluctantly supported (usually on a base subsistence level) by tunities for its occurrence.3 Proponents of the latter view will look for new ways of other people in more valued roles providing disabled people with information on which· they can base decisions abollt medical e) a person who has not grown into maturity, perhaps never wilJ , or who has regressed care. . back to the childhood level The difference between these approaches in one particular area becomes clearer when f) a holy innocent, unaware of good or evil, and incapable of doing wrong, perhaps in 80 81 need of protection from a less pure society; and Explaining a proposed treatment to a disabled person in a manner which gives the person g) a sick or diseased organism. 9 an opportunity to understand, may be a time consuming process. It is a responsiblity which Society reinforces these images, dressing adults as children and referring to them as the treating doctor should not bear alone. Rather, I see the process for information trans 'kids', by teaching them children's games but not about sex education and by the use of mission as shared between the doctor, the caregiver (where appropriate) and a disabled nomenclature such as 'Angel's Haven' to describe their places of residence.Jo person's advocate. In this context, the growth in Victoria in recent years of advocacy I suspect that medical practitioners also, on occasions, share these images. 1f a m~dical schemes must be seen as a welcome development.20 practitioner views a particular adult as a child or childlike, it is fair to assume that ~s/her Competence of captive persons with special reference to research judgement of the ability of the person to care for children will be influenced accordmgly. This might, in turn, affect her/his estimation of the patient's competence. If the procedure participation in question is a tubal ligation, a low threshhold of capacity may be required. 11 On the other It is sometimes suggested that 'captive persons' are never competent to consent or, more hand, if the procedure is for a reversal of tubal ligation, a high threshhold mi_ght_ be set: correctly, that the consent should never be regarded as voluntary. The term 'captive per As mentioned earlier these attitudes influence not only what test of capactty is apphed sons' tends to be used loosely to refer on occasions to persons legally detained (such as but also whether a p~icular form of treatment will be offe~ed. The sad .reality _is that civilly committed mentally ill people) and at other times to institutionalized people, even procedures which are common place in the outside commumty are sometimes withheld though not formally detained. I will use the latter definition. The theory is that because from elderly and older disabled long-term residents of institutions. T can remember the captive persons are entirely dependent on caregivers, they are more susceptible to duress difficulty I had some years ago in trying to persuade a surgeon to carry out a cateract and undue influence.21 While the theory is accurate, it is suggested that any application of operation on a multiply disabled resident of an intellectual disability facility. ~o the care the theory which denies totally the right of captive persons to influence their own health providers with whom he lived, a successful operation would greatly enhance his .de~elop care, is an unacceptable rejection of the autonomy of the individual. Nevertheless, we ment, even though he would continue to be severely disabled. To the surgeon, it simply cannot afford to be unconcerned at the opportunity for exploitation which is afforded by the was not worth it! congregation of large numbers of disabled people in one environment. The opportunity for exploitation is nowhere greater than in the area of research. I define Tl'eatment bias research to mean 'a systematic investigation designed to develop or contribute to gen A number of commentators have suggested that medical practitioners are biased towards eralizable knowledge' .n Drug trials arc a common form of research. Drug trials on captive treatment and that they tend to find competence among agreeable patients and incompe persons might have one of three aims. First, a trial might be designed to test the effect of a tence in uncooperative patients.12 Roth claims that this is a manifestation of the 'reasonable new drug on persons with a certain disability (for example, Schizophrenia) in anticipation outcome' test and notes that to the extent that a reasonable outcome is detennined by the that the new drug will be more effective than current treatment. This anticipates a direct congruence between the patient's decision and that of the doctor, it is biased in favour of benefit to the individual. Second, a trial may be designed to expand knowledge about decisions to treat.13 persons with that particular disability without anticipation of any benefit to the patient. Third, it might be designed to expand knowledge about some area unrelated to the dis Competence and the provision of information ability of the patient, for example, to test the effectiveness of a new cold tablet. The debate around informed consent often centres upon the amount of information which Roth and Appelbaum's review of the literature in this area raises considerable doubt should be disclosed to a particular patient. about the adequacy of actual understanding of mentally ill people who 'voluntarily' consent Consent forms are sometimes pitched at a level well beyond the understanding of the to participate in research. 23 They quote a study by Park and his colleagues carried out in the average reader.14 For instance, a readability analysis of consent forms used for patients of 1960's, showing that depressed or anxious psychiatric patients participating in research US Veterans Administration Hospitals in connection with participation in proposed were frequently unknowledgeable about the research dimensions of their case. Patient sub biomedical research showed that a college level education was required in order to under jects viewed their participation as largely another aspect of their treatment and misunder stand the document.I' Though most of the patients voluntarily participated in the research, stood the rationale for placebo administration even after the facts were explained. Park et al a subsequent study indicated that 28% were unaware of their participation despite having attributed this to patient trust of the investigator clinician.24 A similar result was obtained signed the forms.16 Participants' understanding of the research was generalJy low. by Lidz et al regarding administration of Elavil or a placebo to depressed hospitalized Simplified consent forms are only the first step toward redressing this situati?n. For patients .25 mentally ill people, intellectually disabled people, older confused people and bram dam Appelbaum refers to this phenomenon as 'therapeutic misconception', and Roth and aged people, greater care should be taken in the manner of transmission of the information. Appelbaum describe it as follows: For the latter three groups, a combination of praise with special teaching techniques such as Because of their psychological needs, patient-subjects sometimes distort even clear com the effective use of repetition and use of lifelike anatomical models and other audio-visual munications from investigators over such important matters as random assignment, materials might significantly increase understanding of a proposed treatment.17 One option placebo and nature and rationale for double-blind procedures. Patients thus misconstrue which offers itself when in doubt about a patient's level of understanding is to introduce a research as probably beneficial for them, even when this is not necessarily so.26 two part consent process. First, the party from whom consent is sought is provided the My analysis of this area leads me to three conclusions. First, it would be unfair to regard information necessary for an intelligent decision. Second, he/she is quizzed about that all captive persons as incapable of consenting to medical care. Second, the potential for information with respect to several important categories such as the benefits, risks, pur undue influence of captive persons should be recognised, particularly in respect of partici poses and alternatives.•& This technique might also be appropriate when testing the under pation in research activities. Third, in order to ensure that institutions do not become easy standing of a guardian who is called upon to give consent on behalf of a disabled person.19 testing grounds for research, captive persons should not be asked to participate in research 82 83 if the research is unrelated to the person's disability. For example, using residents of a cal practitioners, particularly in the light of the inaccessibility of current guardianship laws. psychogeriatric facility to test out a new cold tablet is unacceptable.27 This should e~tend Lawyers have sought to dose this perceived gap in the law by either inventing new not only to drug research but to behavioural and social science research. Ethics Committees doctrines or by extending existing ones. Sir Norman O'Bryan, a former Victorian Supreme should surpervise research lo ensure that consent is informed, that appropriate methodology court Judge, has suggested that the consent of a de facto guardian may be a sufficient is employed and that captive persons are not exposed to u11J1ecessary risk. defence to an action in battery. 34 Skegg, rejecting de facto guardianship as a legal fiction , argues somewhat more plausibly that the doctrine of necessity may sometimes justify treat Towards greater respect for individual autonomy: summary of part A ment without consent.ls Speller's argument is that the medical practitioner should get the Despite ongoing attempts to define competency, 2K the reality is that there is no simple patient's consent (for what it is worth) and asserts that hospital and staff may go ahead formula which we can use. A person's ability to comprehend a proposed treatment depends anyway and do what is 'reasonably necessary' _36 Sharpe and Sawyer argue that in view of upon a variety of factors including their previous experience with the health care system the legal uncc1tainty, seeking the consent of relatives is the best practical option. They and the manner in which the information is conveyed. A medical practitioner's perception dispute Speller's view that the hospital should be able to authorise treatment as agents of of her/his patient's competence will be also affected by a variety of factors, including necessity, arguing that this extends the function of the institution into the realm of guar whether or not he/she believes that the outcome of the interaction is a positive one. More dianship thereby pla<-'ing hospital staff in an untenable 'conflict of interest' situation.37 important than any one test is to be.aware of dynamics tha~ operate when a dis~bled pers?n Two Australian commentators have sought to resolve this dilemma by recommending needs medical attention. These dynamics underscore the importance of ensunng that dis that the law should be changed to enable a person standing in loco parentis to an intellec abled people are fully integrated into the community and that they have ac~ss to the same tuall y disabled person, in certain circwnstances, to consent to therapeutic treatment of the range and quality of medical services as other members of the community. They aho person.38 A medical practitioner acting on this consent would then be able to use a reason remind us of the importance of looking for new means of impat1ing informatio? to disa~led able grounds defence to an action in battery _39 people so that they become the subject rather than the object of the doctor/patient relauon In my view, a rule of this kind would be a serious error. First, it challenges the legal ship. Finally, they tell us to be wary of the potential for denial of individual autonomy presumption that all persons are competent until the contrary is proven. Indeed, this is when large numbers of devalued people are congregated together. implicit in the use of the words loco parentis. (When is a caregiver in loco parentis and of what relevance is the concept of parenthood to a disabled adult?). Second, it assumes that PART B - THE SUBSTITUTE DECISION MAKER Victoria's new Guardianship and Administration Board will not be sufficiently flexible or accessible to respond quickly to circumstances as the need arises. 40 Any change to the law Finding someone to give consent which would enable medical practitioners to treat without consent or to choose a relative to What can be done when it is impossible to obtain infonned consent to a particular treat consent, would be subject to the additional objection that it places the doctor in a conflict ment? In the event of an emergency, where treatment is necessary to preserve the life or of interest. health of the disabled person, the law permits treatment without consent provided that it is impractical at the time to obtain consent. i~ Emergencies aside, the law provides t\vo Victoria's Guardianship and Administration Board Act mechanisms whereby treatment can proceed. Under the Public Trustee Act 1~58, the Su preme Court is empowered to appoint a guardian for ce11ain persons who. are mcapa_ble of The scheme described managing their own affairs.3o The procedures set out in the Act are peculiarly archaic and The lives of disabled people may be significantly altered with the proclamation of Victo have been used on only a handful of occasions over the past 20 years.31 The second mecha ria's new Guardianship and Administration Board Act. 4 1 nism is civil commitment under the Mental Health Act 1959. Unlike the guardianship The significant principles underlying the reform are threefold. First, persons are pre procedwe. this scheme applies only to persons who are 'mentally ill' or ·~te~~ally sumed competent until the contrary is proven. Second, when interference in a person's life defective' ..12 Where persons are civilly committed, the superintendent of the mst1tubon to is desirable in order to protect them, the interference should be the minimum necessary to which the person is committed, subject to a few exceptions, is empowered to con:>ent to achieve the desired goal.42 Third, the functions of service delivery and protection of rights any medical treatment of the person.33 • are incompatible. Therefore, where guardianship is imposed on an individual, it should be The relevant provisions of the Public Trustee Act and the entire Mental Health Act will through a system independent of tbe service delivery system. It follows that the guardian be repealed upon proclamation of the recently enacted Guardianship and Administration should never be a staff member of a facility in which a disabled person resides.43 Board Act 1986 and Mental Health Act 1986. Both of these Acts will be dealt with later in The Guardianship & Administration Board (hereafter referred to as the Guardianship this paper. . . . Board) is likely to be a regionally based body sitting in panels of three or five members, So much for the theory! The reality is that in the case of a non-obJectmg (unassertive) each chaired by a lawyer. Its jurisdiction is limited to 'disabled people', a term which disabled person, it is common in the event of incapacity to seek the consent of a relative or applies to persons with 'intellectual impairment, mental illness, brain damage, physjcal the principal caregiver. I refer to this as informal guardianship. disability or senility'. 44 Any person may apply to the Guardianship Board for the appointment of a guardian for Informal guardians - do they exist? any disabled person who has attained the ag~ of 18 years.4 :1 The Board, however, may Let me say at this point that there is no firm authority in law to support the proposition th~t appoint a guardian only where the disabled person a medical practitioner is justified in treating an 'incompetent' disabled person on the basis i) 'is unable by reason of disability to make reasonable judgment<> in respect of all or any of a consent given by the person's relative or principal caregiver, unle~s the latter hav.e of the matters relating to her or his person or circumstances; and' been fonnally appointed as guardians. This situation has caused some anxiety among med1- ii) 'is in need of a guardian'.46 84 85 This is a combination of Roth's 'reasonable outcome' and 'ability to understand' testS.47 believed that this protection was justified because these procedures share in common three A significant feature of the legislation is that the Board can appoint a plenruy guardian things: (with the full range of 'parental' decision-making powers) only where the appointment of a • they have potentially grave implications for the disabled person limited guardian would be insufficient to meet the needs of the disabled person.44! Fut1her, • they are irreversible or often irreversible when appointing a limited guardian, 'the order made must be the least restrictive of the • they are open to abuse. 02 person's freedom of decision and action as is possible in the circumstances' .49 One can Earlier drafts of the legislation specified these procedures, but under intense lobbying by envisage that a variety of orders might be made. For instance, a guardian might be empow Opposition parties which objected to any mention of the words 'sterilization' or 'termina ered to consent to a specific medical procedure only, (for instance, an appendectomy) to tion of pregnancy', the government amended the BiU.1>.1 The result is a more flexible Act surgery only, or to the full range of medical procedures. The appointment might be limited which enables a quick response to be made as new abuses come to light. It also has the in time or ongoing. It might be conditional (for example, on consultation with the disabled advantage of having removed from the political area some very controversial ethical issues. person or principal carer) or unconditional.so This represents an important departure from One can expect the Guardianship Board to be less responsive than the Parliament of Victo the current inflexible 'all or nothing' guardianship51 and reflects the legislature's concern ria to the lobbying tactics of organizations like the Right to Life Association (which figured for individual autonomy. prominently in the public debate on the legislation). A second feature indicating a concern for individual autonomy is the requirement that the Relatively m·gent procedures. disabled person be consulted during all significant phases of the process. For instance, the Relatively urgent procedures may be defined as those which fall short of emergencies, but disabled person must receive notice of an applications2 and is entitled to be present and be which cannot wait for between 14 and 30 days. Late stage termination of pregnancy might heard in person or represented.53 In choosing a guardian, the Board is required to take into fall into this category. As with non-urgent procedures, relatively urgent procedures might account the wishes of the disabled person.54 be major ones (as defined by the Board). Application to medical procedures For such cases, the legislation provides a special application procedure. The Board, To w1derstand the implications of this scheme for medical care of disabled people, it is when hearing cases, is constituted by the President alone and the normal J4 Board Act does, however, is to provide a legislative framework which enables these issues The distinction between psychiatric and non-psychiatric treatment to be resolved on a case by case basis. It is worth noting that the power of the guardian to First, unlike the 1959 Act, the 1986 Act distinguishes between psychiatric and non consent to health care is expressly limited to health care that 'is in the best interests' of the psychiatric treatment; informed consent is required for non-psychiatric treatment.76 Consent disabled person67 and the guardian is required to 'give effect to the wishes of the disabled must be in writing and there is an obligation to provide the involwttary patient with 'a clear person, wherever possible'.68 explanation of the proposed non-psychiatric procedure and the reasons why it is neces The Guat·dianship Board as a policy maker sary' .17 Where the involuntary patient is incapable of giving informed consent, the consent The Guardianship and Administration Board Act constitutes one of the most important of the person's guardian or, if there is no guardian, of the authorised psychiatrist, will reforms of the Victorian Government and represents one of the fruits of its Social Justice suffice. 7~ If the non-psychiatric procedure is a major medical procedure (as defined by the Strategy. The success of the Guardianship Board will be judged largely by its ability to Guardianship Board) however, the consent of the guardian or the authorised psychiatrist 'mesh' the cases which it hears into a set of coherent policies on such issues as research will not suffice and the dual· consent of a guardian and the Guardianship Board will be 7 involving disabled people, sterilization, abortion and use of depo provera, to name a few. required. Y This means that the Guardianship Board may play a significant role in policy These are precisely the areas where government has hitherto failed to develop policy. I development within State psychiatric facilities. attribute this in part, to the conflict of interest facing departments, like the Health Depart I anticipate that the 'non-psychiatric' treatment provisions of the Act may initially be ment and Department of Community Services, which are required both to set standards and quite difficult to administer. Non-psychiatric treatment is referred to as treatment 'the pri to provide a direct service delivery system. mary purpose of which is not the treatment of mcntaJ illness or its effects'. Some doubt has An important step in the policy setting process will be the issuance of guidelines outlin been raised about whether this would include treatment prescribed to relieve the side ing what are major medical procedures. For reasons outlined in the Cocks Repo11, I believe effects of psychotwpic and other medication. In my view, it does not. Nevertheless, to that sterilizations and abortions should be the first to be declared major medical pro relieve these and other conems, the Health Department should develop protocols to accom cedures.69 Consideration should also be given to declaring certain research activities as pany the legislation which clarifies the position. major medical proceduresJO I am hopeful that the Public Advocate will play an active role Electroconvulsive Therapy in bringing other significant medical procedures to the attention of the Board. Indeed, The new Act also marks the first regulatory control of electroconvulsive therapy {ECT). judicious but persistent agitation by the Public Advocate will be necessary if this scheme is During the preparation of the legislation, the Bills Committee was lobbied by certain to be an effective mechanism for the promotion of the rights of disabled people. organizations to make ECT a procedure of last resort. The final form of the Act indicates a Victoria's Mental Health Act: significant features rejection of this approach. The Committee's conclusion was that ECT may be the most appropriate option for ce1tain patients, for example, those with severe endogenous The Act depression. so A second major refonn of the law affecting disabled people occurred with the enactment of The Committee's response to community concern was to license premises on which ECT the Mental Health Act 1986. is administered&' and to impose detailed requirements for informed consent. s2 Effectively, This Act sets out the circumstances under which a mentally ill person may be involun involuntary and security patients are presumed to be capable of giving informed consent. tarily detained. A considerable improvement on its predecessor, it is firmly based on the Where they arc incapable, the authorised psychiatrist may authorise the procedure though least restrictive alternative principle.7• A practical expression of this principle can be found curiously, he/she is required wherever possible to seek the consent of the person's 'primary in the changed criteria for involuntary commitment. Whereas the 1959 Act enables the carer', that is the person primarily responsible for providing support or care to the patient.83 involuntary admission of any person who 'is suffering from a psychiatric or other illness 'Urgently needed' ECT can also be adminstered without consent to 'patients'. M which substantially impairs mental health', the new Act introduces several criteria In all other cases, the informed consent of the patient is required. Interestingly, the including: amount of information which must be given before a consent is info1med is defined with • that the person should be detained for their health or safety or for protection of the great specificity. For instance, the person must be advised of any beneficial alternative public; and treatments; receive a full disclosure of any financial relationship between the treating doctor • that the person cannot receive adequate treatment in a less restrictive ~nvironment. 72 and a clinic where the procedure is performed; and receive statements of her/his legal The latter requirement, in particular, gives committed patients a 'toehold' from which rights. The explanations must contain sufficient information to enable the person to make a they can dispute tl1e legality of their detention. balanced judgment and benefits, discomforts and risks must be disclosed without exaggera Not only does the Act give patients criteria which can be disputed, it also provides them tion or concealment. 85 with an independent forum before which disputes can be brought; namely 1l1e Mental It should be noted that the Act is drafted so as to preclude a guardian from consenting to Health Review Board. By contrast, the 1959 Act provides no effective review or appeal ECT on a person's behalf. mechanism independent of the service delivery system.7l The Board will be empowered, Psychosurgery inter alia, to hear any appeal by an involuntary patient against her/his detention. 74 In addi Controls over psychosurgery are considerably stricter than in respect of ECT. No psy tion, it is required to review the continued detention of a patient between 4 and 6 weeks chosurgery can proceed without the authorisation of an independent Psychosurgery Review atler admission and thereafter at intervals not exceeding 12 months.14 Board. 86 lnfonnation disclosure is onerouss1 and the Board cannot agree to the procedure A detailed analysis of the provision of this Act is outside the scope of this paper. Never unless satisfied, inter alia, that informed consent has been given and that the treatment is theless, three important developments in consent are wo11h noting. effectively a last resot1 (87). Proposed psychosurgery on persons who are incompetent or of 88 89 doubtful competence must be referred for determination, to a Judge of the Supreme A, 'Competence to Co~n t to Treatment as a Psycholegal Construct' (1984) Law & Human Behaviour 8 (3- 4) 205-220, 206. Court.89 8. Op cit Fn 6 at p283. A wide range of people are deemed to be incapable of consenting including unmarried 9. WOLFENSBERGER W & TiiOMAS S, PASSING: Program Analysis Of Service Systems' lmpleme.ntarion minors, prisoners and persons charged with offences.9<1 I would argue that this is justifiable Of Normalizatinn Goals, L983, NCMR, Ontario at p.36. on the basis that the implications for the individual of psychosurgery are so great that 10. Ibid. 1I. eg See case of Judy Foster, who voluntarily consented to a tubal ligation in 1980 but was unable to persuade society should afford maximum protection to all vulnerable people. the same hospital which undertook the original procedure to reverse the operation in 1982. Di.rabled Woman who was sterilized now wants to have her own child, The Age, 19 March 1986, p3. A system without choice 12. ROTH et al, op cit fn 6 p28l, TEPPER & ELWORK, op cit fn 7 p.2 13, SOLNTCK P, 'Proxy Consent for The Mental Health Act 1986 reflects a greater concern for individual autonomy than the Incompetent Non Tenninally llJ Adult Patients', Journal of l,egal Medicine (1985) 6 ( I) 1-49, 6. Mental Health Act 1959. Nevertheless, for involuntary patients receiving psychiatric treat 13. Op Cit Fn L2. ment, the system provides no choices. This should be contrasted to the UK mental health 14. ROTH L & APPELBAUM P, ' Obtaining Informed Consent for Research wilh Psychiatric Patients' (1983) Psychiatric Clinics of North America 6(4) 551-565, 556-558. system, where the treating doctor must obtain a second opinion from an independent psy 15. RIECKEN H W & RAVTCH R, 'Informed Consent to Biomedical Research in Veterans Administration chiatrist before he/she can administer ECT to a detained patient. 9t Similarly, second opin Hospitals', JAMA 248:344, 1982. ions are required for the administration of medication to non-consenting detained patients, 16. Ibid. provided 3 months or more have elapsed since the medicine was first administered during a 17. See dramatic results obtained when these techniques combined with prnise were used in a sex education program with a 30 year old in1ellectually disabled women, SHAPIRO E and SHERIDAN C, 'Systematic period of detention. Such a system is not without its problems and there is a danger that Assessment and Training of Sex &!ucation for a menwlly retarded woman', Applied Research In Mental .medical practitioners, always reluctant to interfere with colleagues' judgments, may treat Netardation 1985 6(3) 307-317: the process as a rubber stamp.92 However, it would serve the desirable ends of being a 18. TURNBULL HR (ed), Consent Handbook, American Association on Mental Deficiericy USA, 1977. 19. JAFrE R, 'fnforme 41. For commentaries, see CARNEY T & SINGER P, Hrhical & Legal Issues in Guardia11ship Options for 81. Mental Health Act I9!l6 (Vic), s7S. Jntellec111ally Disadvantaged People, Human Rights Commission, Monograph Series No.2, AGP.S Canberra g2. Ibid s72. 1986, Cocks Report op cit Fn 31 RASSABY A, 'Intellectually Disabled POQple in Society', Australian 83. Ibid, s73 (3). Rehabilitutum Review (1983) 7 (4) 14-17, Rassaby A, 'Guardianship Tribunal Act for Victoria', l.aw l11stilute 84. Ib~d, s73(4) 'Patients' include voluntary, involuntary and security patients. Journal (1985) 952-955. 85. Ibid, s72. 42. This principle i~ referred to as the 'least restrictive alternative' See HR TURNBUU.., 111 (editor) The I.east S6. Ibid, s64. Restrictive Ahernative: Principles & Practices, AAMD, Washington, 198I . 87. Ibid, s55. 43. For further elab<>ration of these and other principles, see Cocks Repori op cit Fn 3 L, Chapter 9. 88. Ibid, s65(b) and (0. 44. Guardianship & Administration Board Act 1986 (Vic), s3. 89. Ibid, s64(d) and (e). 45. Cbi the so-called 'therapeutic privilege' of non-disclosure of dysfunctional or counter therapeutic information. The primary concern of the paper is with research undertaken in university-affiliated hospitals and clinics, where medical and related health staff may have both therapeutic and teaching responsibilities. Such staff will tend to hold university COERCION AND INDUCEMENT IN appointments, perhaps of a nominal character, but may derive their salaries less from their universities than from their hospitals and/or payments by patients or on their behalf, for MEDICAL EXPERIMENTATION instance from patients' health insurers. The discussion that fo llows will consider patients generically, without regard to their special characteristics as members of a pediatric, geriatric, mentally impaired, pregnant or Bernard Dickens otber population, unless such association is mentioned as of specific relevance. Such mem bership may weJI affect the patient's capacity to exercise autonomy, however, and may aggravate the problems posed by the potential for coercion and for inducement. When patients are engaged in research, they will usually be described as 'subjects', as will be explained below. Further, many subjects are not patients of the institution in which the research is conducted, but are, for instance, staff members, laboratory technicians or INTRODUCTION graduate (or other) students. The decision whether to have medical treatment is not itself a medical decision. It is a personal decision to be made by the party who will bear the dir~ct personal con~equenc~s THE DEFINITION OF INSTITUTIONAL RESEARCH of the decision, namely the potential patient. Evolving law reqmres t~at the ch01~ tha~ ts Universities often insist that reseaTch done by their staff members or students, or in their to be made - either to have or not to have active treatment, and if to have it, which facilities (including teaching and other affiliated hospitals), or on patients of such hospitals, treatment to have - must be adequately infom1ed. Relevant information includes medical constitutes university research and must conform to university guidelines. Such guidelines data concerning, for instance, potential risks and advantages of treatment, no.n-treatment may require pre-clearance by an appropriately composed ethical review committee. In the and postponed treatment, and con~erni~g ~he implications ?f ~~ treatment 0~~1ons for. th: United States, they are governed by the Code of Federal Regulationss under the tile 'Insti prospective patient's personal choices m hfe. The expresston mform~ dec1s1on-makmg tutional Review Boards'. (lRBs). In the National Health and Medical Research Council of or 'informed choice' is to be preferred to 'informed consent'; the latter incorrectly sugge.'lts: Australia's 'Statement on Human Experimentation', they are called Institutional Ethics • that the purpose of informing is to gain consent Committees. • that refusal of treatment options need not be as informed as a consent to a treatment ~d One still may ask, however, which research work within a hospital constitutes university • that if a potential patient refuses treatment it is because the patient lacks appropriate research. In a number of studies sponsored by, for instance, pharmaceutical companies or information. medical device manufacturers, investigators may argue that they are not primarily promot lt also suggests that all the information is given by a physician, and that the ~r~spe ctiv e ing new knowledge for universal publication, but are engaged in a private (or 'moonlight patient simply responds affirmatively or negatively. In fact,. ho~ever , a ph~s1c1an often ing') capacity to develop data that, for instance, a drug company seeks for submission to a needs information that only the patient can give about the patient s preferred hfe-style and national drug administration authority for grant of a licence to market its product. Investi future intentions in life, in order to be able to assess what medical means arc available to gators may say that the university has no control over their extra-cunicular activities, for serve the ends identified by the patient. The physician knows medicine and. health ca.1-e, which they may receive independent payment, in fees or in kind. Alternatively, though which the patient often does not, but the patient knows how he or she wishes to hve with less credibility, investigators may invoke their academic freedom of inquiry as univer (regarding health, other factors in life, and the prio!ity to be giv~n to each in the patient:s sity members. future), which the physician often does not. Accordingly, the parties must exchange data m The lack of generation of new knowledge is often real. When a drug manufacturer is an equal relationship.' developing, for instance, a so-called 'me-too' drug, designed to duplicate the proven prod More will not be made here of legal doctrine on informed medical choice.2 It need only uct of another company but with sufficient difference to evade patent law restrictions be emphasized that the purpose of disclosing material medical. information is to contrjbute (where generic drugs are lawful, this difference is unnecessary), testing the efficacy and to the patient's autonomy, itself an ethical goal.3 Informed c?mce m~y be seen as an ~pee~ safety of the product adds nothing to science; its only contribution is to commerce. Accord of free choice, since in the absence of material informatnm (which need not be .full ingly, the investigator's claim may have substance that the study fulfills a purely service information) a person ca1mot act responsibly and independently. However comprehens1vely function and is not part of scholarship or scientific development. The analogy may be informed a person is, however, on both medical and n~n - medical. matters, there may be drawn with medical staff members who take time off to serve as medical directors at other factors at play that vitiate true freedom of chmce. Coerc10n and, more s~~t~y, children's summer camps, with university economists who advise governmental or private inducement may cause a person to exercise the decision-making power and respons1b1hty agencies or who write in popular journals, or with law faculty members who practise Jaw, without freedom. perhaps as consultants to law firms, as a side-occupation. This paper addresses the interaction of coercion and inducemen~ i~ t~e special setting of One might reply, of course, that such work involves neither university facilities nor medical experimentation. 4 The experimental context affor~s the ~nd~v1dual full autonomy university hospital patients, and that where such facilities as secretarial services are used, (because research treatment, by definition, is not therapeutically rnclicated), and precludes the university is reimbursed by the faculty member, presumably from professional fees. As 94 95 against this, however, the investigator may point to the research sponsor's contribution to presentation of data. In particular, patients may be invited to join studies as subject~ in hospital or university facilities. For instance, the free supply of products or support-staff wa~s shad~d to encourage ~eir participation; they may also be discouraged from exercising salaries, as reimbursement evidence that the research is not university-supported. Further, their free nght to leave studies when withdrawal would prejudice the statistical validity and when hospital patients are offered only clinically indicated drugs or dosages, secondary use value of the results. of resultant data for comparative purposes will be the only research element in their treat Subjects may have their freedom of choice compromised because investigators and their ment (see below). This may also be the case when patients are allocated at random, with staffs are induced to perform ' well' in a study. Inducement is often subconscious, and may their free and informed consent, to either of two or more distinct treatment regimes each of arise from an .investigator's awareness, for instance, that an external sponsor is providing which is therapeutically appropriate. It may accordingly be claimed that clinical care is not free therapeuuc as well as test drugs, or that salaries are being provided for support staff substantially affected by such studies, and that they fall outside the ambit of university who are thereby available for other functions of separate service to the investigator and/or guidelines. the investigator's hospital or university. The sponsor in effect may subsidize staff salaries Universities tend to resist this analysis and seek to compel compliance with their and support services within the institution. Obligations to colleagues and support staff can guidelines. They may also require that, for instance, if the sponsor fails or refuses to be very compelling. An investigator who has worked closely and amicably for some time publish resultant data within a determined time, such as 12 months from study completion, (~easured in years) w~th a Iabor~tory assistant whom the investigator knows has young investigators shall be free to pursue independent publication. Since nothing of scientific children to support, will not easily forfeit the external research funding that covers the interest may have been learned, however, this requirement may be of little force. A univer assistant's salary, nor reduce the prospect of receiving renewed funding. If a drug company sity may also point out that the university affiliation affords the investigator the personal finds that data from an investigator's study become unobtainable due to ethical restraints on status to attract the research contract, and that the university's presumed undertaking of achievement of the protocol, or that they do not lead to drug marketing approval when data ethical screening gives the study credibility, both with the government agencies to which from another investigator are successful, the company may choose to fund future research resulting data will be submitted and wilh the public at large, which trusts the university to with the latter rather than the former. exercise vigilance. Similarly, research assistants such as graduate students have incentives to incline The investigator may respond, however, that many university staff use their status for towards research outcomes their principal investigators are believed to favour, on the basis private profit, for instance through consultancies. Indeed that these very means to supple of ~he ~rinc~p.al's ~resum~d allegiance to the study sponsor and to the product being tested. ment university income, permit universities to have the services of able staff, while paying Thts d1spos1t1on 1s cons1stent with the increased likelihood of an assistant being found them lower salaries than would be req~ired to engage their undivided time by purely com reliable ~~d with subsequent studies being funded by the same source, creating future mercial criteria. opportumtJes for research employment and acquisition of experience. When university stu Some uncenainty therefore exists about what sort of roodical study constitutes research dentships or bursaries are meagre, students' inducements to seek renewal of their assistant that universities, as such, may undertake to monitor, both prospectively and in progress, by ships may reflect economic coercion. ethical criteria governing human experimentation. There is additional uncertainty about The major risk of coercion, however, affects the dependent populations from which whether legislation should attempt to answer this question through a uniform regularizing voluntary research subjects may have to be recruited. provision, or whether universities should be left to act, perhaps in consultation and agree ment with faculty associations or representatives, to resolve uncertainties through the pri DEPENDENT SUBJECTS vate, consensual law on university contracts of employment. A theoretical limit to the former approach is the appearance of governmental intrusion in university administration Medical patients and academic freedom. An empirical limit to the latter is the universities view that the The most obvious dependent subjects of medical research are medical patients, especially obligation 10 submit proposals to university ethical scrutiny is already an implied tenn of those ~ho are hosp~~ised . Others include prisoners (on whom such pharmaceutical experi the employment contract. mentation was trad1t1onally undertaken in the United States),6 nursery and school children Further complexities involving staff members' terms of employment by their hospitals and members of the police or aimed forces. Members of disciplined forces are trained not and hospitals' affiliation contracts with w1iversities, will not be pursued here. The issue only to do but also to anticipate what their superiors in rank are known or believed to would perhaps be of reduced significance if investigators were immune from distorting favour, and official support for or accommodation of a study may cause lower ranks to inducements. Evidence indicates that they are not. 'volunteer' to participate because they believe it is expected of them. In a less systematic way, patients may also react according to what they believe their physicians expect. The INDUCEMENT OF INVESTIGATORS so-called 'demand' effect describes the general psychological tendency of persons to make the responses they consider are expected of them. Scientifically valid research protocols, confirmed as such by ethical review and included or The special nature of the research relationship is often obscured, to both patients and independent peer review, may nevertheless accommodate areas of subjective assessment. physicians, by the therapeutic bond. In the doctor-patient relation, the doctor serves the Even when hard data are objectively measured, the determination of a product's clinical patient's health interests, ofteq expressed as 'needs', and the patient perceives his or her safety and effectiveness may depend on assessments and comparisons that have subjective own advantage in 'following doctor's orders.' The investigator-subject relation is the components. Such research techniques as randomization and double-blind administration diametrical reverse of this benign relation however; it is the investigator who seeks the help (both of products being tested and of measures of effects) are designed to reduce personal an~ has .the needs and the subject who may be able to serve the investigator's goals. bias. Margins of subjectivity often remain, however, notwithstanding observance of legal of research often suppose, however, that it is directed primarily to relief and ethical doctrines on research subjects' autonomy, in such areas as recruitment of sub Pat1e~ts mfo~ed of their cond1uons and that doctors proposing their participation are primarily motivated by jects, research staffs' and subjects' compliance with protocols, and the compilation and 96 97 their benefit. Tendencies to suppose unintended benefits, may accompany concomitant ten. Questionnaires may be administered in research arising in a medical setting but be under dencies to downplay risks, since doctors profess to seek to 'do no harm.' For this reason, it taken pursuant to the discipline of the social (not the medical) sciences. In social science may be a useful discipline always to refer to physician-researchers as 'investigators', and to experimentation deception (followed perhaps by debriefing) remains a legitimate technique. patient-recruits as 'subjects', and to eschew the labels 'doctor' and 'patient' where research Accordingly, special attention should be given to explanation of risks when dependent is concerned. persons are to be invited to participate in 'easy' procedures. This is not to deny, of course, that patients may genuinely and autonomously wish to Procedures proposed under the name of research are sometimes intended primarily to be ass.ist their physicians. Feelings of commitment, gratitude, respect and confidence operate beneficial to the patient-subjects . Between ordinary therapy and pure research is an area of no less powerfully than feelings of dependency aod fear of appearing recalcitrant or therapeutic innovation that may be a source of analytical perplexity.9 A patient may present ungrateful. Patients, no less than others, have legal and ethical entitlements to volunteer to a condition or a combination of pathologies for which no routine therapy exists or for enter research as full and free partners. To obstruct this right may be unjustifiably pater which standard treatments have become contraindicated or discredited. An unproven treat nalistic7 and may discriminate on grounds of handicap.a ment, dosage or route of treatment, or a new combination or sequence of treatments, may Instruction may be gained from the law's approach to unequal relationships. In interac then be proposed in order to assist the patient, from the use of which new knowledge will tions such as may arise between, for instance, doctor and patient, lawyer and client and also be gained. There is a sense, of course, in which routine administration of regular priest and penitent, the law observes the power of knowledge possessed by the former and treatment has a potential to produce new knowledge, due to a patient's idiosyncratic the dependency · of the latter. If any advantage beyond a reasonable fee passes from the responses, but therapeutic innovation differs in that it is undertaken in the anticipation that latter to the former, the law's initial presumption is that it was induced by an exercise of resulting data will be of scientific interest and possibly of value. It may be proposed, undue influence. The advantage will be voidable and unenforceable without positive evi however, that if the innovation is therapeutically indicated, t11e treatment itself is therapy dence of the · client's free will. This is not to condemn the testator's lawyer to whom a rather than research. It attracts, for instance, the physician's therapeutic privilege of non bequest is left or, for instance, the priest to whom or to whose chw-ch a gift is made; it disclosure of counter-therapeutic information. Its research component, which a resear:ch simply requires the beneficiary to show that the dependent party took (or at least had access ethics review committee will address, is not the treatment itself, but the secondary use to) independent counselling before favouring the more powerful partner in the relation. made of the resulting data. Access to these data involves the patient-subject's confiden Equally, when investigators who are physicians or comparable health professionals propose tiality rather than physical integrity. A patient whose care depends on novel treatment may to recruit .research subjects from among patients, they must discharge the duty of showing come under heavy pressure, of course, to approve this separate, non-invasive research or that no undue coercion or inducement is operative, and must establish strategies if neces experimental component of the management proposed. Research can be more easily isolat sary that neutralize any dependency patients may reasonably feel or perceive. This precau ed when acquisition of research data requires more frequent or more invasive monitoring tion may be less burdensome when investigators are not their intended subjects' attending than would be necessary for the patient's therapy. physicians, but it is applicable in principle in all cases of inequality. Although physicians attract a high level of ethical scrutiny when they propose to recruit, Prisoners and others under institutional constraint in their own research, patients for whom they are therapeutically responsible, recruitment is Prisoners may exist in an inherently coercive environment. A Michigan court has held that not necessarily impermissible. On the contrary, such physicians often have the highest this fact in itself precludes free consent to non-therapeutic medical treatment; 111 other motivation to tackle the patients' distinctive conditions. The research may be feasible only courts, however, have held that this is not necessarily so.u In the same way that detainees, through employment of affected patients alJ of whom within a given catchment area will be including prisoners and, for instance, involuntary mental health patients, can be pressured charges of the investigators. Further, as attending physicians, the investigators may have into compliance with a research protocol, they may also be liable to inducement. Modest the highest responsibility and motivation of all to ensure that no harm befalls the potential payments that outside prison may seem derisory can be powerful motivators in the internal subjects. The limitation of this perception, however, is that the harm that may befall the (largely non-monetary) institutional economy. The prospect, for instance, of relief from patients is not just to their physical integrity, but also to their dignity, confidentiality and tedium, of exercising a measure of autonomy, of controJling an aspect of one's environ autonomy. Ensuring their physical welfare may not discharge duties to these other dimen ment, of meeting non-detainees other than guards, of seeming actually important to some sions of their personalities. Accordingly, rendering attending physicians accountable in one in the world beyond the walls and of interacting with female nurses may be sufficient advance to external review presents a safeguard for protection of subjects' multidimen to induce detainees to accept properly explained risks of the proposed procedure. The US sional interests. history of prisoners' easy and cheap inducement to run considerable physical risks in medi The importance of protecting prospective subjects' freedom is not diminished by the cal experimentation has caused a protective reaction of prohibition in some jurisdictions. 12 relative triviality of the intervention proposed. The same freedom should govern consent to In Canada, by contrast, where the Federal Government has long declined to allow give access to a medical record, to respond to a questionnaire, to have an electrode fixed to research involving prisoners, it is now being argued that nothing should be withheld from the forehead or to donate an additional 3 c.c.s of blood or urine for research during a prisoners unless its denial is necessary for their secure detention, and that no such need routine collection for therapy or monitoring as governs heart catheterization or a spinal tap. exists to preclude voluntary consent to research participation. Limits may be set to the Indeed, the very triviality of a proposed procedure may induce a prospective subject to range of acceptable risks, and research ethics boards may include representatives from accept it without paying special attention to the risks. Medical records, for: example, may prisoners' rights groups or, for instance, the John Howard Society (which is dedicated to disclose highly sensitive information about patients and their families, of which patients prisoners' welfare), but the mere difficulty of monitoring proposals against excessive themselves - never having inspected their own medical records nor had the contents fully inducement is not necessarily a reason to deny prisoners this dimension of choice and explained to them - are often unaware. Blood may show illegitimacy, recent pregnancy responsibility. and sensitive genetic traits; urine may disclose illicit and perhaps criminal use of drugs. Specific features of life in schools, police forces and, for instance, the armed forces need 98 99 not be elaborated for the purpose of demonstrating how consent to participate_ in .me~ical ment of prisoners, of course, that they are easily exploitable. The 1970 Report wisely research can be coerced or induced. For those in the disciplined ranks of such mstLtutlons, added the limit that 'the amount should be reasonably related to the effort and discomfort coercion and inducement are simply different sides of the same coin, which circulates in a anticipated.' This focus seems preferable to a focus on risk, since payment for running a suspect (though not necessarily debased) ethical curren~y. _The ~egi.slative question is risk of serious injury appears more objectionably inducive the higher the payment. ts The whether the law should provide the Gold Standard that mamta.Ins faith m the currency. ethical ideal is that a volunteer participate as a partner in the research, not just as a paid hand or a well compensated acceptor of risk of injury. Staff members Staff members at different levels in research institutions such as universities and hospitals Students are also liable to experience some of the coercions and inducements that affect dependent Graduate or other students may be distinguishable from junior staff members principally in populations. Jn a sense they may also be dependent on senior. personnel for e~ployment their greater vulnerability to coercion and susceptibility to inducement. They may be liable opportunities and security, for merit rais~s, for r~k. ~romotlons ~nd for vanous_ other to more subtle inducement, however, by virtue of their ambitions. In many leading teach indulgences. University departments are built on semontt~s and ho~p~tals can be part1cul~ ing institutions, senior faculty members are relatively inaccessible to students through ly hierarchical within and between professions. Jumor phys1c1ans defer .to senior classroom, seminar and graduate supervision contact. Their research provides a means, physicians, nurses defer to physicians (or used to b_efore emer~enc~ of profes~1onal self however, by which students may meet and become favourably known by them for pur 13 confidence based on a concept of independent nursmg professJonahsm), so~1a! workers poses, for instance, of appointments to minor offices and academic references. Students often defer at least to senior nurses, and operating room and laboratory technicians often who cannot join research enterprises as junior researchers may be willing to join as sub accept their low status as health professionals...... jects. Students may make a shrewd risk-to-benefit assessment that makes risks tolerable When physicians such as medical professors and. s~mor res~archers mv1te the!r JU~1or because of the promise of career advantage. Payments associated with subject status may colleagues, nurses or, for instance, laboratory .techmc1ans to _give (anon~mous) b10Jog1cal further reinforce motivations to participate. samples, perhaps for establishment _of typologies, _07 otherwise to contribute to rese_arc~, While this type of motivation or manipulation of students may be a regrettable fact of the invitation may be difficult to resist except by gtvmg a good reaso~. An appare_nt mdif academic life, its foundations may be ethically suspect and its effects are open to mitiga ference or lack of commitment to an institution's major research mterest, \~h_1c~ may tion. Financial alternatives for srudents induced by payments may be impracticable to find, embody a current bid for fame, prestige and future research f~nding , may_ seem 1mm1cal to since other means by which students may earn money may involve a less educational use of one's employment progress. Further, while patients who decb~e r~se~ch 1~volvement may their time, comparable risk and modesty of status, more inconvenience and less gratifica never be identified to the investigators they turned down, an mv1tat1on, gwen e~en by ~ tion, even supposing that local employment levels and patterns leave jobs for students to apparently general notice, to a narrowly targeted population whose accep~~s w1ll_be.~1s take. Lack of accessibility to staff can be mitigated, however, by encouraging greater ible, may leave non-acceptors no Jess visible. Accord_ingl~ , a s~andard condition of u:iv1tmg student conlact with senior faculty members and by universities recognizing that visible staff-members' participation in research may be non-1dent1ficat:1on of t~ose who dec_l.in~ .. In research productivity can be traded against a higher quality of students' experience of the same way that physidans may be called on to make a very special case ~or mv1ttng faculty members. A difficulty is that universities often gain the prestige that attracts their own patients to become research subjects, investigators may have to_ d1sch~ge an resources through the calibre and volume of their research output. This matter may be more equal responsibility in order to justify inviting junior staff-members servmg the1r own credibly addressed through developments in perception and through funding policy than laboratories, units, wards or departments. . . . . through legislation. In assessing the propriety of permitting such invitatlons, attention will. ~ave to ~.given Undergraduate students may sometimes earn additional course credits by relatively to the relative status of investigators and potential subjects, to the pre~a.Jh-?g co~dition of innocuous involvements in research. Lower year psychology courses, for instance, often the labour market and to ways in which potential subjects may perceive rnvesagator~ as offer students opportunities to earn extra credits by being questionnaire subjects or, for being able to harm or promote their careers. Strategies_ of maint~in~ng .arms-length deal1;11gs instance, by submitting to simple tests of cognitive functions. Where medical research and of maximizing the confidentiality of those who re1ect such 10v1tat1ons may be reqmred participation is induced by this means, it may be mitigated by offering students alternative in order to remove coercion and it may be necessary to eliminate the fact and appear~ce of means to earn such credits that are not more burdensome, such as by writing book reviews favouring volunteers in order to eliminate inducements. The latter may be particularly or making presentations. This suggestion affects the ethics not only of medical research difficult where investigators have the power and feel the need to appoint or ~~omote to regarding free consent, but also those of teaching and scholarship. responsible positions staff members they know and trust to be competent, dthgent and compatible. . Auto-experimenters The most blatant inducement is the offer of money or like advantage. Such reward has a curious ambivalence in attracting true volunteers. In its 1970 report on staff volunteers, for Investigators themselves may offer the highest conceivable level of informed consent in instance the Association of the British Phannaceutical Industry observed that 'The pay being subjects of their own research. Further, they may make the honourable claim that ment of' a reward in cash or kind would tend to establish the voluntary chai:acter of the they have not asked others to do anything - including undertake risks - that they are not It service.' 1• Money may well condition motivation, but a. point comes at which an of!~r willing themselves to suffer. bas been claimed that 'Auto-experimentation ... is one of assumes such a proportion that it cannot be refused, even 1f the narure ?r ~xtent of the nsk the strongest traditions in medical research. '16 The celebrated 1947 Nuremberg Code on is considerable. The point may be identified subjectively rather ~an objec~1vel~ , for a poor human experimentation, however, addresses auto-experimentation ambiguously; Article 5 person may be more easily motivated by money (~nd th~y mduced ~nto_ 1mpruden~(. provides that than a more financially affiuent or secure person. It is the baSts of the ob1ect1on to recrui No experiment should be conducted where there is an a priori reason to believe that 100 101 death or disabling injury will occur; except, perhaps, in those experiments where the 9. See the analysis proposed in BM DICKENS, 'What Is a Medical Experiment?' ll3 c ~--'' experimental physicians also serve as subjects. ( 1975) 635. · a,._.an Med. Assoc. J. It is doubtful that this constitutes an acceptance of hazardous research unless that the 10. See Kaimowirz v. Michigan Department of Mental Health (1973) l Mental Disability L.R. l47 (Mich.Cir.Ct., Wayne County). ' investigator has a death-wish. In 1968, the US National Institutes of Health issued 'A Code JI. See Freeman v. Home Office (No. 2), (1984] 2 W.L.R. 802 (C.A.). for Self-Experimentation' that more helpfully intended 'to provide the same safeguards for 12. But see note 8 above. 13. Although courts continue to accept physicians as competent expert witnesses the sta daro f . the investigator-subject as for the normal volunteer.' 00 0 0 Scientific objections to auto-experimentation, particularly investigator bias, need not be are professionally obliged to maintain. s <:are nuises 14. The Report of the Comminee U> lnv~tigate Mtdical Experiments on Staff Volunreers The A · · f th considered here. Of concern, however, are the pressures and inducements that may cause British Pharmaceutical lnd~try. (1970), para. 3.2. ' s.c;ociallon o e investigators to experiment on themselves. Impatience may ex.plain some investigators 15. The Australian NH & MRC Statement on ffoman Experimentation provides in secti'on 13 th , b "d f · · . · a1 vo 1unteers beginning human trials on themselves, when the convenience of ~ccess to their own bodies ~ay e pa1 or ~n~nvemcoc:e and time spent. but such payment should not be so large a be mducement w participate .• s 1O an seems irresistible but another pressure may be more compelling. An investigator with a 16. L K ALTMAN, 'Auto-Experimentation: An Unappreciated Tradition in Medical Science' 286 Ne E land time-limited research grant, or coming to the close of a degree programme or other press J. Medicine 346 (Feb. 17, 1972). ' w ng ing deadline and urgently having to undertake a human study, may find no practicable 17. See note 7 above. alternative to auto-experimentation. Far from being cautious (because others, given an appropriate explanation and invited to take the risks of being a subject, have declined), an investigator may be driven reckless by desperation, feeling that no choice exists but to undertake self-experimentation. A safeguard for aU potential subjects of research is ethical review of the research propo sal; this applies equally to investigators who intend to act as their own subjects. They may object that, although they require ethical approval to approach others, they ought to need no such consent for themselves. They may indeed claim that committee review itself violates their autonomy, and that ethics committee claims to jurisdiction to protect investi gators against theµiselves show unethical paternalism.11 Nevertheless, it is submitted that, as part of the discipline universities and hospitals may reasonably require their staff members to exercise, is that their proposals for auto-experimentation should be submitted for prior approval. This is not because investigators are necessarily presumed ~ be fool hardy, but because it is appropriate to monitor features of all proposals such as scientific merit and prospective subjects' vulnerability to vitiating incentives or coercion. Defiance of this requirement by auto-experimentation may not be easily prevented, however, it is a fact which raises the pervasive issue of institutional and related sanctions and the role of the law. REFERENCES l. In declining to follow the propositions established in the United States in Canrcrb11ry v. Spence (1972), 464 F.2d 772 (U.S.C.A., D.C.) and Cobbs v. Grant (1972) 502 P.2d I (Cal. S.C.), adopted by the Supreme Court of Canada in Reihl v. Hughes (1980), 114 D.L.R. (3d) 1, the English House of Lords, in Sidaway v. Beth/em Royal Hospital Governors, [1985] I All E.R. 643, tolerates a degree of medical patemalJsm now rejected in most of North America. 2. See generaJly BM DICKENS, 'The Doctrine of 'Infonned Consent : lnfonnod Choice in Medical Care', in R SABELLA and ML ROTHMAN (eds.) Justice Beyond Onvell (1985) 243. 3. See The (U.S.) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The 'Belmont' Report, April 1979), explaining the basic principles of respect for persons, beneficence and justice. 4. The di~tinction is sometimes drawn that 'research' means non-invasive scudy, such as of medical records, and 'experimentation' means intrusive treatment of a subject. That distinction is not drawn in this paper, which treats the expressions synonymously. 5. 45 CFR 46 - Protection of Human Subjects (revised as of March 8, 1983). 6. See [U.S.] National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Prisoners: Reporr and Recommendations (1976). 7. On justified and unjustified paternalism, see C M CULVER, and B GERT, Philosophy in Medicine: Concepfllal and Ethical lss11e.r in Medicine and Psychiarry (1982), chs. 7-8. 8. lo the United States, indeed, some prisoners' groups have objected to limits on their participation in pharmaceutical reseach on the ground that protective restrictions unjustifiably prevent them from earning money by taking risks acceptable to themselves. 102 103 Choice and its constraints Feminist debates and activism around abortion, sexuality and contraception have had as a slogan a 'woman's right to choose'. But we need now to closely consider this issue of CHOICE, CONTROL AND ISSUES OF choice within the new dilemmas posed by the reproductive technologies through which women are being slowly but surely divorced from control over procreation.3 What feminists INFORMED CONSENT: THE NEW really mean by 'a woman's right to choose' is 'a woman's right to control'. Women claim the right to bodily integrity, to autonomy and to respect as moral beings capable of making REPRODUCTIVE AND PRE-BIRTH difficult decisions in this area. Jf 'choice' with respect to abortion means control, we have to ask the same question with respect to reproductive technology. Does it necessarily increase the control of women over their lives or over that technology. l argue that it does TECHNOLOGIES not and that, in fact, the desire of some individual women to 'choose' this technology, places the social group 'woman' at risk of alienation from the procreative process. Civil Robyn Rowland libertarians and liberal feminists have argued for rights, and 'free choice' for women. The development of this position within feminism comes from the liberal theory stream. Where as socialist feminism has dealt with reproduction through the Marxist concept of production and radical feminism has held that women own their bodies and should therefore control them, liberal feminism has stressed the issue of rights. It was the liberal feminist stream which was strong in the resurgence of the women's movement in the sixties, stressing an INTRODUCTION individual woman's right to paid work and education. But there is a basic problem with the concept of rights in general, in that it is a static concept 'abstracted from social conditions'. In Australia, particularly in Victoria, there has been heated public debate about the social It does not challenge social structures of inequality nor the relations of production and implications of the new reproductive technologies. One of the initial arguments put forward reproduction. Through its stress on individual rights, liberalism places these rights io the by the medical researchers for introducing this technology was that 'women want it'. This private sphere. This contributes to the split between the private and public spheres which catchcry has been slightly rephrased recently by both the medical researchers and the users many feminisLc; have seen as responsible for reinforcing women's oppression. of this technology. The emerging argument is that a woman should have 'the right to An important element in feminism has been the slogan that 'the personal is political', choose' to use the technologies. Feminists have argued that women have been used as acknowledging that the experiences of women in private (for example, an act of rape in experimental subjects and living laboratories on reproductive technology programs. The marriage) are political acts representing the relationships of power between one social very evidence of women's experimental status which has been produced by feminists, is group (men) and another social group (women). But though it is an important part of now being used to argue an informed consent theme by use.rs of the technology and civil feminism, the personal alone is not enough as I have argued elsewhere.4 As individual libertari1'\IIS. Inherent in this line of debate is the assumption that if women are fully women we live out our lives within a social context. We are constrained and shaped by the informed , there are no problems with the technology and all is well. forces of economics, social ideology, personal psychology, and the various power struc I will analyse both these claims: a woman's right to choose and the demands for tures which mould our actions. informed consent. I argue that at the base of both is an individualism which conflicts with There are social constraints operating upon choice, many of which are concerned with the social implications of the technologies which themselves have an impact on all mem the social control of all persons but in the case of women, the world operates on inequities. bers of society, but particularly on women as a social group.1 There is no equality in the alternatives offered to people as 'choices' and there is no l agree that women should be fully informed of the outcomes, risks and implications of equality between those who are 'choosing'. Decisions made between Wldesirable or nega these technologies and will present the information which they should be given. By exam tive alternatives hardly amount to free choice. The choices of some individuals are finnly ining this information we can see that full informed consent is not possible considering the based upon the Jack of choice of others. social context within which the medical profession operates. As Bernard Barber writes: Choices are impinged upon by ideological constructions, for example, the pressure on First by social and self-selection, then by their training in medical schools and in intern women to be mothers, which we will address later. In addition the forces of capital and ships and residencies, and finally by the structure of medical practice, physicians engag commerce blur for people, a clear delineation of their needs as individuals and the needs ing primarily io therapy are strongly pushed toward and become committed to the value which are socially constructed for us. People are expected and encouraged to choose social of individualism . . . Steeped in individualism, the physician naturally resists standards ly acceptable alternatives. This makes it very difficult for women during pregnancy and set by outsiders, whether they are medical peers, patients, private or public bureaucrats, birth, for example, to resist the use of new technologies. They can be accused of being or government \egislators.2 selfish if they are not thinking of the child first. The 'maternal' consciousness is shaped to I conclude that the social implications of the new reproductive technologies must take be responsive to these arguments and to be responsive to science and medicine as precedence over the individualistic notions of choice and consent. Informed consent cannot 'problem-solvers'. be used to validate experimental research which uses women as living laboratories and Choices are hedged around by structured constraints depending on a woman's race, gives medical science control over our social destiny. class, age, marital status, sexuality, religion, culture and sometimes disability. We do not 104 105 Jive in a world with no power imbalances. We live in a world structured along hierarchies Physician concern for advancing medical knowledge can blind the doctor to the patient's with some people deliberately given more advantages over o~ers. . . best interests.s Within the oppressive structures of race, class and so on, It seems muve to discuss the Informed consent itself has as one of its historical sources the standards for research and right to have 'free choice'. By whom and for whom is this rig?t claimed? It is ui1dersta_nd treatment which are derived from the Nuremberg code involving voluntary, competent, and able that women make this claim on an individual basis, commg as we do from a society informed consent. In his analysis of an excellent example of medical experimentation with which denies us autonomous will in most spheres of our lives. But the individualism it out social accountability, George Annas looks at the 'Baby Fae' case where the heart of a represents is often in conflict with ideas of genuine community. We cannot ~onstantly talk baboon was transplanted into a new born baby. Annas successfully argues that consent was about allowino individuals to maximise their desires without any understandmg of the dra not adequate in this case and that the Nuremberg code itself was violated, as well as the matic impact fuese particular desires will have for other women and for society in general. necessary prerequisite for human experimentation, that there be sufficient prior animal We should argue for equality of access to the technologies, but stress that there is a selec experimentation. This example is very similar to that of women on IVF programs where tion process operating with respect to women which divides women into ' fit ' and 'unfit' procedures have not been tested on primates first. 9 A Federal Ethics Board in the United mothers or 'worthy' or 'unworthy' of access to assisted motherhood. States of America in 1979, which held hearings on IVF, noted that there had been insuf So the discussion of 'choice' and 'rights' is based in an individualism linked to the ficient controlled animal research designed to detennine the long range effects of in vitro private sphere; it relies on a 'just world hypothesis' where ·~.l~ things being eq~al' people fertilisation and embryo transfer. 10 The board commented that this was noteworthy because can exercise their choice; is simplistic, ignoring the complcx1t1es of the constraints around there were available primate models. 'Models' now being used, of course, are women. choice and it is divorced from the social context. Feminism, though it has su-essed the right In general, the literature supports the push for further informed and educated consent of the individual to fulfil her potential, and has stressed the personal as political, has also from both medical research subjects and patients. However there is cynicism with respect stressed the accountability of women to other women and the need to foster women as a to whether the medical profession will take part in this exercise. As Jngelfinger has written: social group. ... the process of obtaining 'informed consent', with all its regulations and conditions, is no more than an elaborate ritual, a device that, when the subject is uneducated and Informed consent and its limitations uncomprehending, confers no more than the semblance of proprietary on hwnan experi We come now to the concept of informed eonsent. Informed consent is usually discussed in mentation . 11 two settings: the medical situation ·where a person needs to make a ~ecision about medical Bernard Barber has extended the concept of the risk-benefit ratio involved in informed intervention and the situation where a person is to be a research subject and has to make a consent by including moral injury as part of the damage which may be done to the individ decision about whether to allow themselves to be such a subject. There are two points ual. Injury may include not just the results of medical or experimental intervention but 'an worth mentioning here with respect to reproductive technology. The first is that infertilit_y injury to the social or moral person'. 12 As we will see from the accounts of the humiliating itself is not a life-threatening situation, so the person is not making a life and death dect and debilitating procedures of IVF, this technology itself creates such an injury. sion. The second is that it is very difficult when looking at in vitro fertilisation for exam Barber points out basic flaws within the analyses of informed consent. One is the indi ple, to determine whether the person fits into the first _or the secon~ cate~ory; with r:spe~ vidualistic error which assumes that the transaction occurs between only two people, the to consent. There is evidence to suggest that we are, io fact, not dtscussmg therapy as tt doctor and the patient. In fact a variety of other people may be involved in the decision. is often called, but experimental procedures. I will explore this later in the paper. And again we cannot look at that decision without looking at the structure of the social There is considerable debate within the legal and philosophical literature about the con system which determines a person's behaviour when dealing with informed consent. Barber cept itself. The characteristics of an informed consent are identified as competence, volun warns about medical re..~ers who tariness, the disclosure of information about the diagnosis and therapy, its risks, benefit~ ... display all the individualism and autonomy of therapists and add to those values the and alternatives and comprehension of such information. Meisel and Roth write: prerogatives of those who strive to be creative and original scientists. Their goal is to At its best the decision making process involves conversation, negotiation, reflection, conduct research in their own terms. They too are impatient or contemptuous of calls for and debate,among the patient, the doctor, and possibly many other persons. At its worst, informed consent from their peers, their subjects or government regulation.13 the doctor makes a recommendation and announces it to the patient in the manner of a Though the doctrine of informed consent has been operating for over twenty years in fait accompli and obtains the patient's signature on a piece of paper, thus fonnally North America, doctors are failing at this new skill. 'Failure to inform' bas been behind the ratifying the decision.s bulk of all 'wrongful birth' law suits.14 A number of problems have been seen to arise with the concept. Many writers acknow~ The informed consent debate places a great deal of faith in the individual's ability to edge that it is difficult for the person to exercise the right to withhold consent. 6 There is make choices, in the doctor's beneficence and in patient autonomy. But as Janice Raymond also a difference between an informed and an educated consent. For example, in one study, has written, it 'seldom addresses the context in which. choices are made, the patient's only half of the families given genetic counselling had actually grasped ir:" ~m~a ~t. 7 In motivatioo to choose in certain ways, and the conditions that are necessary for a genuine addition, it is difficult to ascertain whether a person makes a free consent or 1s mtim1d~ed autonomy to be exercised in the informed consent process', is The patients themselves may by a variety of aspects of the procedure. A person can hardly exercise freedom of choice be unwilling to hear the information delivered,, The condition of being in need of help when hospitalised, frightened and/or in pain. She or he often relinquishes power to the makes a person vulnerable to manipulation and the socialisation of doctors is not conducive person who may heal them or solve their problem. Writers point out the diffic~lty of to empathic negotiations.16 Again, the concept is individualistic. obtaining consent when experimental procedures are involved. Richard Simpson wntes: The possibility of exploitation is even greater where experimental treatment is involved. 106 107 NEW REPRODUCTIVE TECHNOLOGIES ·woman's greatest desire to present her husband with his offspring. These kinds of ideologi We can now consider whether choice and informed consent could operate within the new cal pr~~sures to 'ch~ose' motherhood, c~eate a strong need within women. This ideology reproductive technology framework. I have written extensively on these technologies and a~d thts need are r_einforced by economJc structures, for example, within capitalist coun will not detail them here.1 1 But for our purposes let us consider the most simple of them: in tnes, the consumption of goods is focused within the family unit. vitro fertilisation (1VF). This is a procedure in which an egg and sperm are put together in The s~rength of the ideol~gy of. motherhood is rettectcd in the constant pursuit of it by a Petri dish to become an embryo. This embryo is then placed back inside the woman, who w~men m t~e ~ace of .mountt.ng .evidence that men are relinquishing responsibility for their may be the woman the egg came from or may be another woman. children wh1.I~ mcreasmg their nghts over women and children.24 It is seen in the queues of I agree with Janice Raymond's comments that the social context of decision-making women awa1tmg IYF which is known to be an unsuccessful technology. Part of the ideol needs to be considered. So let us consider the social context of informed consent on IVF ogy of.motherhood has been self-obliteration and self-sacrifice. Mothers are encouraged to programs. This context must include that of the development of reproductive technology ~ut.theu own needs last. We could argue that this self-sacrifice in the name of motherhood itself. This development has taken place within the increased medicalisation of life. is hved .out through women on ryF progran:i~· ~ho constantly widergo an assaultive pro Richard Taylor has clearly outlined the way that social problems are now becoming medi cess ~hie~ they themselv~s descnbe as humil1aung and emotionally draining. cal issues. He also talks of the 'diseasification of pregnancy and childbirth'. He writes: This bnngs us .to .the thud. aspect of the context behind IVF, infertility. I have described Normal people are being patientised, social problems are being individualised and medi elsewhere th~ p~~ful cxpenences of infertile people.is The knowledge of infertility is a calised, and the individual is being blamed for maladaption to society rather than the shoe~ to ~he mdiv1dual becau~e we all assu~e ow- fertility, protecting ourselves against it' present social and economic system being held culpable for such maladaption on a grand showm~ itself at unwanted ti.mes. The testmg process to detect infertility is intrusive, scale. ts ex~austm~ and bas been descnbed as 'assaultive', because women arc required to 'expose There are a number of contextual elements worth elucidating here: the scientific ethic, t~eir bodies for tests and procedw·es' and to 'expose the intimate details of their sexual prouatalist ideology, the experience of infertility, and the relationship between medicine hves and their motivations for pregnancy' .26 and commerce. ~he experience of infertility in a pronatalist context can be a life crisis. Something over Science, which forms the basis of medicine, has presented a masculine face. The scien which a .person thought they had control was in fact not within their control. Many women tific ethic is based on exploitation and domination. 19 It is concerned with the control of, feel parttcularly frustrated and resentful if they have been using a contraceptive device for rather than a collaboration with, nature; is narrowly focused, dealing with small segments many years for no good reason or if the device itself caused the infertility. The Jack of of information and knowledge; and is characterised by a neglect of the wider social impli c~m~ol a pe~s~n feels can lead them to experience low self esteem. The experience itself is cations of its actions.21> sim1 l ~r to gnef a~ter ~he death of a loved one. Barbara Eck-Menning discusses the woman's Scientific researchers more and more are concerned with making reputations and with ~xpenence of bemg 1so~at~d through infertility and of suddenly seeing fertility everywhere malcing money, as exemplified in the development of IVF Australia.21 Rather than working ~ th~ _world .except w1thm herself.27 There is no loss for us in validating the pain of in the less glamorous areas of community health and the prevention of infertility, doctors infert1hty. This should not, on the .o th~r h~nd ,_ lead us to coJlabordte in maintaining women race for hi-tech fixes for the problem. In so doing they neglect to deal with infertility ?n !~F programs, because the social 1111phcat1ons of those programs reach further than the caused by their own technologies, for example IUDs, and by their own medical misman mdiv1dual. agement as in post-operative infection. Dr. William Keye of the American College of The fo~rth. charac.teristic of the context for the development of the new reproductive Obstetricians and Gynaecologists discussed the 36 per cent rate of iatrogenic (doctor technologies is the mcreasing relationship between commerce and medicine. There are caused) illness in one hospital service noting that 'our experience also suggests that ~lany financial institu.tions which have a power base rooted in women's biology. These iatrogenic infertility is common' .22 Some doctors are becoming increasingly concerned mclude the reproducuve supermarket systems being established in North America 2x the about the damage to the pelvic area followed by infertility, which occurs as the result of drug co~anies wh.ich are. manufacturing the fertility drugs used in reproductive res~arch, gynaecological or obstetrical surgery. or even from the more simple procedures. commcrc1al .enterpnses bemg established in Australia such as NF Australia, and at times A further characteristic of the context in which these developments are taking place is the state actmg as entrepreneur. 29 Petchesky has written that: that of pronatalist ideologies. Inevitably the question of why people have children arises. · · . this .conjunctur~ of meclical, corporate and state interests in the 'management' of Jalna Hanmer points out that women's choices in the reproductive area are related to reprod~ctrnn has defined the choices of all women, but in a way that is crucially different women's reproductive consciousness.n This consciousness is socially created. There is a dependmg on one's class and race.3n strong pronatalism operating which says that having children is good. People parent T~e relationship bet~~n medicine and commercial enterprise has its own history. As because it draws social approval: it satisfies their need for a sense of continuity and immor ~alhleo and then Darwm s explanations of the world became accepted, the power of reli tality. Structures from religion and government to psychological structures deem parenting gion was ex~h~ged for the power of science. Science became the new authority and to be good; or people parent because they like children. It marks the status passage from developed w~thtn the market place, emerging within a capitalist framework. 'It took the childhood to adulthood; a mature person is a parenting person. most revolutionary a~pect~ of the business mentality - its loyalty to empirical fact, its For women, motherhood is deemed to be the true fulfilment of femininity. For many ~ard-beaded prdgmausm, its penchant for numerical abstraction - and hammered them women internationally, it brings little power in real terms, but for many it is the only power mto a precision tool for the understanding and mastering of the material world' .31 base from which they can negotiate the tenns of their existence. Women learn to like In her analysis of 'the captur.ed womb', Ann Oakley has considered the increasing medi themselves in the motherhood role because it allows them experiences of love and power, cal ~ontrol over preg~ancy, with the division of medicine into various specialties, repre not easily found in other situations. The ideology of romantic love also deems that it is a sen~ng. the segmentall?~ of women's bodies: obstetrics, gynaecology, pediatrics, neo-natal ped1atncs, foetal med1cme, and reproductive medicine. She points out that 'womanhood 108 109 and motherhood have become a battlefield for not only patriarchal but professional This means that they are given doses of hormones or fertiljty drugs to increase the number supremacy' .n But all of these sub-specialties are supported by enormous commercial enter of eggs produced per cycle. They are given these drugs even though such a use is contrain prises, feeding them with technological assistance and drugs. So women's bodies are also a dica~d in the MIMS, 1985.37 A woman's body nonnally produces one egg per month, but battlefield for commercial profit-making enterprises. medical researchers need to replace more than one embryo in order to have a chance of a Associated with this is the increasingly articulated attitude to babies as products. This is successful pregnancy. They therefore super-ovulate the woman so that she produces more true within so-called surrogate motherhood transactions, but also in reproductive technol th~n one egg per cycle, usually five or six, but on occasion up to eleven. 38 Her body is ogy programs. Commercialization has made this point crassly. For example, there has been bemg asked to produce at least five or six times the normal number of eggs for that month. the 'floating' of a public company called PIVET-Australia (programmed In Vitro Fertilisa !he drugs most commonly used are clomiphene citrate and a gonadotrophin usually tion and Embryo Transfer) and 'soon the general public will be able to buy shares in the gomg by the brand name Pergonal. The possible detrimental side effects of constant use of test-tube baby business' .33 As one newspaper report stated: 'Test-tube babies are about to these hormones arc yet to be investigated. There are, however, some dangers which have hit the stock market'.34 already been discussed in the literature. Hyper-stimulation of the ovaries is one problem.J9 Apart from being seen as 'products', babies are fa lsely seen as a 'cure' for infertility, An article in The Medical Journal of Au.vtralia has indicated other potential problems: tbe which they are not. They are the 'fix' for the problems of infertility and the resulting trauma. body's defence mechanism against super-ovulation is overridden, and there may be mater Should we allow children to be used to meet the needs of adults? Is this symptomatic of nal risks associated with ovarian hyper-stimulation, such as 'Meigs-like' syndrome and other uses/abuses of children, for example, sex.ual abuse? An article in the Los Angeles thrombosis. 40 Times in 1979 indicated that one couple had decided to conceive a child for tl1e purposes of The higher rate of multiple births can cause concern, as does an unexpected low preg using it as a bone marrow donor for its sibling. Will this process ultimately lead commer nancy rate and a higher incidence of ectopic pregnancies.41 Henriet et al comment that cial enterprises to the creation of children for spare parts?3s ' _super-ovulation is not a simple multiplication of a normal ovulation'.42 So we are yet to So within reproductive teclmology we have a socially constructed need expressed by one find out the long tenn effects of super-ovulating women in these ways. group of women which is taken up and validated by the medical profession for their own ~omen on programs themselves comment on the side effects of these hormones, though purposes. They then introduce a technology based on this need for the production of drugs their statements appear to be ignored. One woman on a program, who was a doctor herself, and specific technological implements. Now, through IVF Australia, they even sell their said that the honnones had induced enormous emotional turmoil even though she was told expenise. there would be no side effects. Another woman said: Throughout this process women scrabble to maintain control. Although constrained as th.~ professor tells us that according to the labels in his books, they don't have side we all are by ideological beliefs and by power structures, the women on IVF programs effects. Once someone comes out and is brave enough to say 'you get side effects' other themselves are maintaining a resistance to the encroachment of medicine. They argue for a women say so too. I think that's what he's worried about - that side effects are place within policy making and for improvement in the conditions for users of IVF, for catching. 43 example introducing stricter regulations about informed consent. But these attempts to im There is, therefore, the pain and discomfort, the risk of the anaesthetic under which a prove conditions do nothing to change the material, social and ideological conditions in laparo_sco~y takes plac~, the risks from super-ovulation drugs and the possible disappoint which the relationships between medicine, commerce and users is taking place. (Note, I do ~cnt if f~lure ensues_ m terms of a pregnancy. Women should be warned that they are in not use the term consumer, as within the new reproductive technologies we are all consum fact expenmental subjects on these programs. The work is to a large extent unsuccessful ers. They have an impact on all members of society). and successes are not always replicable. Doctors have been concerned about the risks of Iaparoscopy and have been developing IVF and informed/educated decision-making. new forms of egg 'harvest'. For example, one new method of egg collection is TUDOR I want now to consider some of the information which women on IVF programs should be (Transvaginal Ultrasound Directed Oocyte Recovery). It was supposed to be a method given if they are to make a fully informed consent or informed choice. I would argue that which avoided general anaesthesia and which would be cheaper and safer. they should first know the context analysed above in which the technology is being devel The woman's bladder is emptied with a catheter, then refilled with a sterile saline solu oped and marketed. Women should then be told what the 'simple process' of IVF entails. tion. A needle is introduced through the vagina, a hole is made in the bladder and the The practical experience of the IVF program is painful, costly, and emotionally exhausting. needle guided in the direction of the ovary via ultrasound. 44 But there are problems with Within in vitro fertilisation, after infertility testing itself, there is again a series of tests this technique as it is very difficult to grip the ovary. For the woman, the experience is which the woman must undergo. An IVF cycle lasts for at least two weeks. Mao and Wood 'very difficult' too. Renate Klein writes: write: .... as for the alleged ease and painlessness, women undergoing TUDOR report that it is This involves about a week of outpatient monitoring by the daily estimation of plasma pamful aod when the ovary is touched they report some sort of a 'cramping sensation'. l 7-Beta-Oestradial levels. The daily scoring of cervical mucous, and one of two ovarian Many doctors go back to using general anaesthesia or trying out 'various medications' to ultrasound examinations. This is followed by another week of inpatient care, involving numb the paifl.4s frequent hormonal assays, the laparoscopic collection of oocytes and, in the event of To date this form of egg harvesting has not been as successful as laparoscopy. Indicating successful oocyte collection and fertilisation, the embryo transfer.36 the experimental nature of the technique Dr. John Kerin, at that time working in Adelaide, A Japaroscopy is carried out to collect 'ripe' eggs for fertilisation. This is an operation said: 'all of us had to develop - and are still developing - operator skill with this done under general anaesthetic with all the attendant risks. The woman's abdomen is technique.46 The technique itself is not without risk. 'Broad ligament haematomas have inflated with inert gas. A fine suction needle and a guide are inserted into the uterus and led resul We as patients, are not in a position to comme~t obje~tively .a?out m~y ~VF issues. head of Zeus after he swallowed her !710ther, and she was known to be a goddess who was Always we are conscious of the fact that we are m the compn~mg pos1uo~ . For most not kind to women. couples our dearest wish is to have a child so we do not publicly complarn a~out the Not only are there symbolic appropriations of women's procreative power by men, but endless experimental procedures, the dehumanised method of treatment, the pa1~, cost science itself has constantly created theories to disempower women io this area. In the and emotional strnin that is an internal part of IVF. I have known some to complam, but seventeenth and eighteenth centuries sperm was claimed to have carried miniscule versions only to incur the wrath of the IVF team.62 of man, and woman was merely the vessel that housed the seed. The gradual consumption The possibility of informed consent and choice by male medicine of midwifery and the introduction of the harsher elements of birth, such as forceps or 'hands of iron', are evidence of man's attempts to stop himself from becom We have seen the scepticism about the potential of medical researchers to .full.y i~fonn ing dispensible within the procreative process. This desire by men to be the creators is patients and, if my criteria for educated decision-making. are follo~ed'. this likelihood canied through to fVF scientists. Language constantly betrays thi.s fact. One of the St~ptoc recedes further. But other issues are also involved. In analysmg the obbgat10ns of research- and Edwards team was named 'Father of the Year', and when discussing the role of John ers to patients, Davis writes: . . Yovich in Pivet, the Bulletin noted that 'He produced his first pregnancy in 1981 '.67 We are The scientist and the clinician both have ethical obligations to provide disclosure of talking here about the social control of women's bodies, and the encroachment of men into information that includes the proclamation of benefits, the warning of risks, and_ the women's procreative power. discussion of quandries in order to obtain a truly informed consent from a sub3ect The beginning of the alienation of women in terms of reproductive consciousness has patient. In the last analysis, only the integrity and ethic_s of such groups a~ drug ~om begun with the harvesting of eggs from women's bodies. Women who give up their eggs panies, the health care professions and researchers will safeguard the nghts of the for fertilisation must now face the possibility that the 'wrong' embryo is placed back inside subject-patient-consumer. 63 • . them. If the widespread genetic screening of embryos takes place, women's alienation will We must discount the so called ethics of drug companies as expenences with, for exam increase. ple, the Dalkon shield, have led women to be very ~uspicious of ~e care which such The use of women as living laboratories should be a concern for all members of society. companies might give to women when deeply involved m _the profit mott~e. We have yet to Yet constantly the discussions of reproductive technology focus on experimentation on the see a systematic analysis of what information is actually glven to IVF pauents. ~t does s~em embryo, or that new character the 'pre-embryo'. Few people stop to ask where the embyros too that researchers continue to fail to recognise the rights of patients to full mformat1on, come from? They come from eggs. Where do the eggs come from? They come from tha; is, if the figures on claims for wrongful birth are any indication. women. Women should be the focus of concern. If full information is presented to a potential IVF client, it is possible that they would Women have ceased to have.faith io the 'experts' because they: withdraw immediately. This may be one of the reasons why the inform~tion is n?t. forth betrayed the trust that women had put in them. Claiming the purity of science, they had coming. Some patients, however, would still proceed with the techniques, wtlhng .to persisted in the commercialisation inherent in a commoditised system of healing ... 'sacrifice aU' for the possibility of a baby. But with such a strong context of pronatahst They turned out not to be scientists - for all their talk of data, laboratory findings, ideology discussed earlier, we can question whether that person is cxerci~ing 'ch?ice_'. clinical trials - but apologists for the status quo' .68 And, if such a choice is allowed to the jndividual, what are the wider social issues The history of the relationship between medicine and women's bodies does not give us involved here'? The first question is, who is paying? We have already seen that the cost to faith for the future of a program of informed consent. We have only to Look to our history individuals is substantial. In most instances the woman has given up paid work because of again and again for precedents. 4 the extensive time and energy needed for such a program.6 The cost of JV~ procedures ~o The controversy about diethylstilboestrol (DES), a synthetic oestrogen, is one example. the community is difficult to estimate because figures on the financial details are unav~1l It was used from the early .l.940s until 1971 as a prescribed drug for pregnant women who able. Recent figures in the report of the Family Law Council tabled in the Federal Parlia were prone to miscarriage. Some of the women took the drug as experimental subjects and ment in Australia, indicate that one pregnancy can cost the community from $10,000 up to were not told the truth about what they were taking. They were told it was a vitamin $1,000,000 depending on the care required for the mother and the post~ natal c~e of pre tablet.69 But there was a time bomb effect with DES and years later some of the daughters mature babies.65 Costs to society also include the use of hospital expertise, staff, resea~ch of these mothers are suffering cancer of the vagina and cervix at a rate higher than that of funding and the hospital facilities. In addition, hospitals will now be required to provide the female population of their own age. Problems have also been detected in some sons of counselling services. . . DES mothers. There is also occurring a higher than normal rate of infertility in both sons The cost to women may also be enormous in the long run. The history of med1crne and daughters. For DES daughters, there is an 'increased incidence of spontaneous abor indicates a growing control by a male dominated profession over wome~'s bodies through tions, premature deliveries and ectopic gestations'. 10 Though no longer prescribed as the the birth process and now through procreation. Mary O'Brien has argued m her con_ceptual drug for miscarriage DES in general, is still prescribed as a morning-after pill. There is oo isation of reproductive consciousness, that men feel alienated from the p~ocreative p~o evidence established which indicates that DES does prevent miscaniage or conception. cess;~" having once delivered the seed, they are no longer necessary for the hfe of the child Diana Sculley points out that women who were given it as a morning-after pill will still to come. In order to assuagt} their alienation they have developed structures to contr~I conceive sometimes and rape victims who are given it as a pill to stop pregnancy may end women and children. These structures include ideological, economic and religious princi up being pregnant. It is in the 'natural progression of science' that in-vitro fertilisation is ples and the nuclear fami Jy. Men envy women's procrcati ve power. Psychoanaly.sts have now hailed as a solution to tbe problems of DES. DES daughters are being offered IVP developed a theory of womb envy to account for this. Many cultures have symbohc repre pregnancies to overcome their infertility caused by medical mismanagement and experi sentations of envy and myth itself carries the tale. For example, Athena sprang from the mentation on their mothers. 11 114 115 Experimentation continues to go unchecked. Gena Corea discussed in detail what she CVB. How do we get any guarantees that women on whom this experimental procedure is considers to be the malpractice of physician James Burt who does what he calls 'love being performed, know of the debates carried in the medical literature? surgery'. 12 He believes that the female anatomical system is. faulty because women do not orgasm during penile penetration. Therefore he reconstructs the woman's vagina and geni FUTURE DILEMMAS talia dragging the clitoris closer to the vagina. Four thousand women have so far been Two possible problem areas which we can locate with respect to choice and informed treated by this man, many of them without infonned consent. Burt himself bas written that consent may be useful to com;ider here. The first is the developing area of foetal surgery, 'in many hundreds of these patients, the patient had not been informed that anything more sometimes called foetal 'thernpy'. The area of foetal surgery is a good example of both had been done to her than delivery and episiotomy and repair' after the birth of her child.n woman and foetus being used as living experimental object~. The literature discussing the So Burt has 'redesigned' the bodies of hundreds of women without their knowledge and foetus as 'patient' is horrifying in its representation of women as merely the capsule or continues to do so, even though he is shunned by his colleagues. The medical profession container for the foetus. A new journal to be launched onto the market reinforces foetal has done nothing to stop him from performing this surgery. It would seem that there is an status. Titled Foetal Therapy it will deal not only with the clinical and basic research inherent contradiction between the operation of medicine and the concept of women's elements of foetal surgery but also with moral and ethical issues and with 'the legal rights control. of the foetus and new concepts of foetal personality'. It wilJ be interesting to see if the new chorionic villus biopsy (CV.B) technique being The personalising of the foetus has meant that in three instances documented to date, introduced experimentally with women will be another example of medical mismanage women have been forced to undergo surgery because a judge and a doctor (both male) ment. This is a technique used for prenatal diagnosis which can be done in the eighth week judged the woman ill-equipped to assess and make decisions. 79 They decided that the foetus of pregnancy, searching for genetic defects in the foetus. Amniocentesis is the current as a patient, had rights over and above the woman. In these two instances the mothers method used, but it is done late in the pregnancy at about 16 to 18 weeks. It also takes 2 to refused caesarean sections but the physicians were able to obtain court orders to perform 4 weeks to get the results, but with CVB it only takes about 1 day. The debate around this them. The court orders did not have to be carried out. In one case the woman had refused procedure is already occurring in the medical literature. Dr. Homer Chin claimed at a the caesarean on religious grounds. She gave birth before the order could be executed. In conference on reproductive health that it is an effective genetic screening technique which another the mother was described as 'unco-operative and belligerent'. This mother relented does not carry substantial risk for the mother or the foetus.74 To date 10,716 women world when told of the judge's order. In at least two of the three cases, the medical diagnosis was wide have had chorionic villi sampling. incorrect, based on faulty prenatal scrccning.llli Bear in mind the morbidity risks for However, in a conference sponsored by the American Society of Law and Medicine, Dr. caesareans, which J gave earlier. Aubrey Milunsky, Director of the Centre for Human Genetics at Boston University School The precedent is unnerving particularly when applied to foetal surgery. At a recent panel of Medicine said that he is 'troubled by the three near-fatal cases of septic shock reported discussion on ethical dilemmas in obstetrics at a seminar at Maricova Medical Centre in thus far ... associated with passage of the catheter through an infected vaginal field' .75 Phoenix, doctors debated the treatment of a pregnant woman against her wishes. Dr. Frank One case resulted in a hysterectomy. Dr. Milunsky comments that 'to perform a chorionic Cbervenak indicated that the woman who refuses to have a caesarean section in labour biopsy and entertain maternal mortality as a possibility lends a completely different com when the foetus shows signs of distress 'may not be thinking rationally because of pain and plexion to the matter'. He also argues that because the body spontaneously aborts defective fear of labour' .81 In this case, the danger to the foetus overrules the woman's autonomy, foetuses in 90 to 97 per cent of cases, CVB may be coming into effect before the body can and he would be prepared to restrain the mother and do a caesarean. rid itself of the defect, 'interfering with the process, and introducing a set of iatrogenic Questions were also raised in this debate as to whether a woman could be incarcerated if [doctor induced] complications'. He also comments that another concern is with the occa she smoked during pregnancy or be prevented from physical activity if it might lead to a sional diagnostic discrepancies. premature delivery. It is becoming clear in these discussions that though the woman is In addition, Dr. Brambaie has reported a foetal loss rate of 13 per cent when CVB is deemed to have prior rights up to twenty-eight weeks when most abortions are carried out, performed before nine weeks gestation and a 17 per cent loss after twelve weeks. 76 So the it is the last trimester which is now at stake. A situation of conflict is being created by cumulative incidents of complications, foetal loss, and diagnostic discrepancies is 6.9 to medicine between the mother and the foetus. 14.7 per cent. For amniocentesis the range is 0.7 to 3.3 per cent. Dr. Rodeck, Director of 'Foetal personhood' challenges the autonomy of women. This challenge can include the Harris Birth Right Research Centre for Foetal Medicine, King's College, London, has actions to exclude women from jobs where work may be hazardous to reproductive capac also considered the increased risk of maternal infection and the risks involved. He says: ity. The personalisation· of the foetus will lead to increasing social controls on women, we're on the verge of doing the procedure on thousands of women, most of whom will particularly in the workplace. It has already led to sterilizations of women who wanted to have a normal pregnancy. I suspect we'll find it safe ... (but at this point) chorionic work in certain 'hazardous' places. At Willow Island, USA, a plant of the American Cyan villi sampling is a procedure about which we don't really know the long-term conse amid Company gave all women in eight of the plant's ten departments the 'choice' of quences. 77 losing their jobs or being sterilized. Five agreed to be sterilized. Ironically the department To date we do not have statistics on how many women in Australia are being experi closed a year later so the women were both jobless and sterile.s2 mented on in this way. However, in Perth, in July this year, one woman who was carrying Here is a quote from the National Council on radiation protection which is a private non twins underwent CVB and had one of the twins, a boy, destroyed because he was at risk of governmental organisation which helps to set radiation exposure levels: carrying haemophilia.1a Apart from the psychological impact on the woman of carrying the The need to minimise exposure of the embryo and the foetus is paramount. It becomes dead twin through the pregnancy and the potential psychological impact on the surviving the controlling factor in the occupational exposure of fertile women . . . For conceptual twin born, we can wonder whether this woman knew of the possible risks involved in purposes the chosen dose limit (of radiation) essentially functions to treat the unborn 116 117 child as a member of the public involuntarily brought into controlled areas. 83 consent appear simplistic and irrelevant revolve around the issue of men, but particulary These kinds of female exclusionary protections are problematic because they are focused transsexual men as mothers. In July 1984 a group of at least six male to female transsex on female employment in heavy industry and ignore other reproductive hazards to women uals requested admittance to the IVF program at the Queen Victoria Medical Centre in in traditional occupations, for example, hospital work. It also ignores the fact that harmful Melboume.90 How will our attitudes to 'choice' change when the reality of a baby for a mutagenetic and teratogenetic agents may be transmitted to the foetus through ~perm. Also transsexual man comes even closer? In May 1979, Margaret Martin· gave birth to a baby the treatment of all fertile women as potentially pregnant and therefore potenttaJly vulner girl having undergone an hysterectomy eight months earlier. The fertilised egg had lodged able ties women's destiny a~ child-bearers into employment rights and makes the rights of in her abdomen on her bowel where it received enough nutrients to grow to teem without wo~en for employment and the rights of the foetus diametrically oppo$ed. So the medical the aid of the uterus. Dr. Roy Henz has had success with transplanting fertilised eggs of a profession in alliance with corporations begins to ass~rt. a pr:otective relation~hip ?v~r the female baboon into the abdominal cavity of a male baboon. It appears that a foetus may be foetus. The concept of choice and informed consent within this context seem s1mphst1c and able to attach itself to any site which is rich in blood and nutrients. In about one thousand ludicrous. cases, a fertilised egg has worked its way into the abdominal cavity of a woman which can The questions which arise here for women revolve around choice. ~ersus coercion, the expand to accommodate the growing foetus. Approximately. nine percent of these women status of the foetus in conflict with the status of women and the abibty to choose not to have actually given birth to healthy babies. The mother runs an enormous risk during this undergo these forms of invasive surgery. But women who do no~ ~~e s_uch surgery will process and can often die from a massive haemorrhage. The possibility of men bearing have to deal with their guilt if something goes wrong, and the posstb1hty in the future of a children has already been seen in this precedent.9' law suit for 'wrongful birth'. . One possibility is the implantation of a fertilised egg in a male abdomnaJ cavity, admin We should also consider what so11 of success rates these fonm; of surgery are havmg. istering hormones to the 'male mother' to 'mimic that of a pregnant woman' and delivering According to the International Foetal Surgery Registry, survival statistics after foetal sur the baby through a laparotomy. Jt has even been suggested that a woman could conceive a gery are impressive for the child, but the progress of the children is not. ~etcher ar?~es fertilised egg which would be flushed out of her womb and implanted in the man. There that in many cases it is difficult to establish that the surgery is more beneficial than wattmg have been suggestions that transsexuals could have their sperm frozen before their conver until after the birth to treat a disorder. 'Only nine were felt to be 'normal', one to eighteen sion operation and use a donor egg with their own sperm. They would then be both mother months after birth. Three have 'moderate handicaps' and another nine have 'severe handi and father to the child - the patriarchal dream. As Dr. Shettles, who has done pioneering caps'. 84 Fletcher questions the difficulty of dealing with the situation in which the mother work in in-vitro fertilisation, comments: 'J don't think it's going to take as long as it did refuses treatment and comments that 'both surgery and caesarean delivery (which is usually with the in vitro program. I th.ink anyone who really wanted to get on with it now could but not always necessary) can limit the mother's future possibility for ~hild-bearing'.ll~ achieve success'. 92 The literature itself seems to indicate that these are clearly experimental procedures. Published interviews with transsexuals who are desiring to be involved in these kinds of Henig writes 'foetal surgery at this moment resides in an ethical gray zon_e, not quite programs are constantly reappearing. It is clear that what they want is to fulfill a research and not quite therapy' . lS6 He points out that doctors do not know which foetus to stereotyped view of feminine identity. One article in 1984 said: 'Phillip McKeman wants to treat and when. They cannot assess whether they are actually saving a foetus to become a give birth to prove something to himself - that he has finally made it as a woman',93 But profoundly retarded child or whether the foetus would have survived without the 'assis more recently in a 1986 article the issue was raised again by Professor William Wailers, tance' of the medical profession. who runs the transsexual conversion clinic at Queen Victoria Hospital and is part of the What is never addressed within these assessments is what the experience is like for the Monash IVF team. He claimed that he could quite understand the demand of transsexual woman involved and what are the implications of the rights of women here? Much of this Estelle Croot to have a baby. Said Walters, 'it is a natural corollary that they should want discussion now revolves around what to do if a woman does not consent to this particular to have children'. Estelle himself said: 'I am a woman and like any woman I want to feel kind of surgery and the obstetrician deems it to be necessary for the foetus. Elias and complete. I want to be fulfilled and for me that means having a baby' .94 Transsexuals to-0 Annas have commented that women could be compelled to undergo the procedure: are influenced by stereotyping and pronatalist ideologies. . . . when foetal surgery becomes accepted medical practice and if the procedure can be I will be interested to see how the civil libertarians will deal with the 'right' of transsex done with minimal invasiveness and risk to the mother and significant benefit to the uals to have babies. Feminists would do well to heed the chill winds of colonisation here. foetus, there is an argument to be made that the woman should not be permitted to reje~t Janice Raymond has argued convincingly in her book The Transsexual Empire that trans it. Such rejection of therapy could be considered 'foetal abuse' and, at a late stage m sexualism represents the final colonisation of women.9s Through transsexualism, which is pregnancy 'child abuse', and an appropriate court order sought to force .tr~atm.ent. 87 • mainly 'male-to-constructed-female' sex change, men are able to possess women's bodies, But there are strong argwnents against compulsory foetal therapy. Fenumst d1scusst0ns women's creative energies, women's capacities. These are the most 'feminine' women. It would not concern themselves with the rights of the foetus but with the rights of the woman is a woman made by a man to be as feminine as man deems fit. As one transsexual said: to bodily integrity, which would be intruded upon by such compulsory measures. It wo~ld 'genetic women are becoming quite obsolete' .96 Soon, the male-created-woman may be be forcing the procedure on the woman for die benefit of the foetus, an argument_ which able to have the male-created-baby. could then be extended to the forcing of a father to give up an organ for a child. As Fletcher has said: 'If society has gone that far in requiring parental sacrifice what else might it be willing to do to protect the life of the young?'ss Pregnant women should have CONCLUDING STATEMENTS an autonomy which overrides any claims by potential living beings. As Elias and Annas I have given you in this paper some examples of the complexity involved in reproductive say 'the right to make a mistake should continue to be the pregnant woman's, not the technologies and the social issues which arise from them. Although we must encourage aU physician's or the judge's' .89 A second area in which the issues of choice and infonned individuals to fulfil their potential and maximise the choices available to them, we cannot 118 119 do this without concern for the social implications and impact of the new reproductive 26. MAZOR M, 'Barren Couples', Psychology Today. 1979. 12. 101-112. p.104. 27. ECK-MENNING BARBARA, Infertility A Guide for the Childless Couple, New Jersey, Prentice-Hall, 1977. technologies. . . . . 28. See for an expo.~ of thi ~, COREA, The Motlier Machine. op cit. Women particularly should resist the continuing use of our bodies as lJvmg l abor~ton~~ 29. While the Victorian Government postured its concern about the de'1elopment of lVF Australia. its Victurian for ambitious and commercially motivated researchers. We shouJd learn from history. Economic Development Corporation is one of the big Institutional Shareholders in CP Ventures, who~e major Roberta Steinbacher's comments on the contraceptive pill still ring true: single inve!ltment so fat is 2.64 million dollars into lhe IVF Australia Trust. see MCINTOSH P, •Kernan to study 1VF sale plans'' The Age. 1st April, 1985; and SCHUMPSTER P, ' Why WC arc in debt to Who invented it, who manufactures it, who licensed it, who dispenses it? But who dies entrepreneurs', The Age, April 7th. 1986. from it?97 30. PETCHESKY ROSALIND POLLACK, Abortion-arul Woman's Choice. The Stale. Sexuality and Reproductive Freedom, New York, Longman, 1984. p. l l. REFERENCES 31. EHRENREJCH BARNARA, and ENGLISH DEIDRE, For Her Own Good. 150 Years Of The Expert's Advice To Women, USA , Anchor Books, 1979, p.17. 1. This paper is an extension of a paper delivered to: Liberation or loss? Women act on th ~ new_ reproductive 32. OAKLEY ANN, The Captured Womb. A History Of The Medical Care Of Pregna!ll Women, Oxford, Basil technologies, Canberra, Australia, May 1986, 'Choice or control? Women and our reh111onsh1p to lhe new Blackwell, 1984, p.254. reproductive technologies'. As such it represents a developing analysis of these issues. . . 33. MARTIN CATHERINE, 'A new and ferti le field for investment', The Bulletin, 1986, 24th June. 2. BARBER B, /nfonned Consent in Medical Therapy and Research. New Jer1>ey , Rutgers Univemty Press, 34. '1VF team in share issue bid', The Sun, 1986, 26th June. 1980, p.23. 35. Los Angeles Times, April 7, 1979 . 3. For evidence of this please see ARDITfl R, DUELLl-KLEIN R, MINDEN S, (eds), Test-Tube Women: 36. MAO K & WOOD C, 'Barriers to treatment or infertility by in vitro fertilization and embryo transfer', The What Future For Mmherhood? London and Boston, Routledge and Kegan Paul, 1984; COREA G. ct al, Man Medical Journal Of Au"tralia, 1984, April 22, 532-533, p.532. Made Women: How the Reproductive Technologies Affect Women, London, Explorations in Feminism Series, 37. For an anaJysis of this see Tonti-Filippini, N, Submission to the Senate Commission Hearing on the Hutchinson, 1985. experimentation on embryus, Australia, 1986. 4. Sec the paper mentioned in end note 1. . . . 38. WOOD C, ·1n vitro fertilization - the procedure and future development', Proceedings of1he 1984 Confer· 5. MEISEL A & ROTH L, 'Toward An Jnfonned Discussion of Informed Consent: A Review and Cnuque of ence on Bioerhics, St. Vincents Bio-ethic Centre, Melbourne, Australia, May. 1984. At a recent meeting at the Empirical studies', Arizona [.aw Review, 1983, 25 (2), 328-340, p.337. . . . Monash University on July 21 st, 1986, Dame Mary Warnock indicated that she knew of incidents when a 6. HULL R, 'Informed Consent: Patient's Righl or Patient's Duty', Journal of Medicine a11d Philosophy. 1985. woman had been super ovulated to produce fifteen eggs per cycle. 10 (2). 183-197. 39. PFEFFER NAOMl & WOOLLEIT ANNE, The Experience Of Infertility, London, Virago press, 1983. 7. INGELFINGER F J, 'Informed (But Uneducated) Consent', The New England Journal Of Medicine. 1972. 40. KOVACS, G et al. 'Induction of Ovulation with Human Pituitary Gonadotrophins', The Medical Journal of August 31, 287 (9), 465-466. . Australia. 1984. May 12, 575-579. 8. SIMPSON R, 'Informed ConseJll: From Disclosure to Patient Participation in Medical Decision Makmg', 41. BTRKENFELD A, et al., 'Effect of Clomophene on the Uterine and Oviductal Mucosa', Journal of 111 Vitro Nonh Western University Law Review, 1981, 76 (!) Fertilization and Embryo Tran.ifer, 1984, l, (2) p.99. 9. COREA GENA, The Mother M.achilie. From Artificial Insemination to Ariificial Wombs, New York., Harper 42. HENRIBT B, HENRlc"T L, HOLOYEN D & SEYNAVE V , 'The letal effect of ~uper ovulation on the & Row, 1985. embryo', Journal ofln Vitro Fertilization and Embryo Transfer 1984, I , (2). 10. Ibid. p.113. 43. Quotations from: BURTON BARBARA, 'Contentious issues of infertility therapy - a consumer's view', 11 . JNGELfllNGER. Op cit. p.466. P3Per given at the Aus1ralian Family Planning Association Annual Conference. March 1985. 12. BARBER. Op cit. p.3. 44. LENZ S, 'Ultrasonic-Guided Follicle puncture under. Local Anaesthesia', Journal une. Laboratories: The New Reproductive Technologies', in J. Figueira, McDonough and R. Sam (eds). Geruler. 1985, 26 (19). 11 - 13, p.12. Deviance and Social Patrol: Catch 22 Strategie.f in the Maintenance of Minority Stam.~, USA, Sage, Fonh· 51. SOULES M, 'The in vitro fcrtili2.11tion pregnancy rate: let's be honest with one another', Editorial, Fertility coming, 1987; and chapters in Arditti et al and Corea et al, op cit. and Sterility, 1985, 43. (4), 511-513, p.511. 18. TAYLOR R, Medicine our of co11trol. The Anatomy of a Malignant Technology, Melbourne, Sun Books, 52. Ibid. p.513. 1979. p.227. 53. CROWE CHRlSTINE, 'Women want it: In vitro fertilization and women's motivations for participation', 19. See for example ESLEA B, Science arul Se.xual Oppre.tsion. Patriarchys Confrontation with Woma11 and Women's studies International Forum. 1985. 8 ,(6) 547-552. Nature, London, Weidcnfeid and Nicholson, 1981. 54. MAO K, & WOOD C, 'Barners to treatment of infertility by in vitro fenili7.ation and embryo transfer' , The 20. See for example COREA GENA, 'The Reproductive Manhattan Project', given at the conference 'Liberation Medical Journal of Australia, 1984, April 28, 532-533. or Lo.~.<'. Canberra, May, 1986. 55. BURTON, op cit, and CROWE op cit. 21. See for example an article by BIRNBAUER B, 'Australia and US neck-and-neck in race to develop unisex 56. BURTON, op cit. pill' . The Age, May 2. 1986. 57. Ibid. 22. KEYE WR, 'Strategy for avoiding iatrogenic infertility'. Contemporary Obstetrics and Gyneacology 1982, 58. Ibid. 19 (Man:h). 185-195. 59. Ibid. 23. HANMER JALNA, 'Transfonning wnsciousness: women and the new reproductive technologies' in Corea et 60. ROBERTS Helen, Th.e Patient Patients. Women and their Doctors, London, Pandora Press, 1985. al, op cit. 61. BURTON, op. cit. . 24. See for example SlTITON JO , and FREIDMAN SARAH, 'Fatherhood, bringing it all back home' ~ 62. Personal correspondence from a woman who rum; an infertility self-help group in Australia - confidemial. FREIDMAN SARAH and SARAH ELIZABETH (eds) On The problem Of Men, London: The Womens 63. DA VlS ANNE, in Holmes Helen, Hoskins Betty & Gross, Michael (eds) in The Custom-Made Child? Press, 1982. Women-Centered PerspeCJives, New Jersey, The Hwnana Press. 1981, p.22. 25. See for example ROWLAND R, 'The social and psychological consequences of secrecy in artificial 64. CROWE, op cit. insemination by donor (AID} programs', Sodal Science in Medicine, 1985 21 4, 391-396. 120 121 65. Family Law Council. Creating Children. A Unifonn Approach to the Law and Practice of Reproductive Technology in Australia. AGPS. Canberra. Australia. 1985. 66. O'BRIEN MARY, The Politics Of Reproduction, London, Routledge and Kegan Paul, 1981. 67. MARTIN C, op. cit. 68. EHRENRETCH and ENGLISH, op cit, p.316. 69. SEAMAN Barbaro and SEAMAN, G. Women And TIU? Crisis in Sex Hormones, New York, Rawson, INFORMED CONSENT IN AsSQC iat e~ Publi~rs . 1977. 70. MUASHER S, GARCIA J, JONES H, 'Experience with diethylstilbestrol-exposed infertile women in a REPRODUCTIVE AND PRE .. BIRTH program of in vitro fertilization', Fertility and Steriliry, 1984, 42 (1) July. 20-24, p.22. 71. Ibid: also SCULI..EY DIANA, Men Who Control Women's Health. The Miseducation uf ObstetrU:icmJGyn eacologisrs, Boston: Houghton Mifflin Co, 1980. TECHNOLOGY: CHOICE OR CONTROL 72. COREA GENA, The Hidden Malpractice. How American Medicine Mistreats Women, updated edition, New York, Harper & Rowe, 1985. 73. JAMES B, quoted from bis book in Corea, ibid, p.317. 74. Cited in Ob!Gyn News, 1986, May iS-31, 21 (10), p.6. June Factor 75. Cited in Ob!Gyn News, 1986. May lst. 21 (9), p.23. 76. lbid. 77. Ibid. 78. 'One twin temlinated. the other survives world-first surgery'. The Advertiser, July 9. 1986. 79. CALLAHAN D, 'How tech11ology is reframing the abortion debate', Hastings CenJre Reportr 1986, 16 (!). February, 33-42. My presence at these seminars has something to do with my involvement with the Victo 80. CAM.A.HAN, op cit: FLETCHER J, 'Healing Before Birth: An Ethical Dilemma', Tcch11ology Review, 1984, rian Council for. Civil Liberties, but the views I express here are my own. The VCCL does January, 27-36. not have 'position' on reproductive and pre-birth technology - or rather, members hold 81. COCK SALLY, 'Treatment of Gravida against her wishes debates', Ob Gyn News, 1985. 20 (9). Jan, 26-27. a 82. MURRAY T, 'Who do foetal-protection policies really protect?', Technology Review, October, 1985. 12-20. a variety of views, probably not dissimilar in range to those held by the rest of the commu 83. Quoted in Petchesky' op cit, p.351, Her Emphasis. nity. VCCL discussion on this subject, although not extensive, does indicate an unease 84. FLETCHER, op cit, p.28. with certain rhetorical forms which have become part of the debate, as well as concern for 85. Ibid, p.33. 86. HENIG R, 'Saving babies before birth', The New York Times Maga2ine, 1982, February 28, 18-48, p.48. the well-being not only of all the adult parties involved but particularly of the child who is 87. ELIAS S & ANNAS G, 'Perspectives on Foetal Surgery', American Journal of Obslt'lrfrs and Gynecology, the purpose, as well as the 'product', of much of this technology. . 1983 April l, 807-812, p.811. . In her interesting overview of the notion of informed consent as a legal concept, Profes 88. FLETCHER, op cit. p.35. sor Margaret Somerville saw it as functioning properly only when three essential criteria 89. ELIAS and ANNAS, op cit. p.812. 90. TERESI D & MCA UUFrc KATHLEEN, 'Male pregnancy', Omni, December 1985, 51·118. Sirn:e this were met - the 'bac;ic pillars' of competence, voluntariness and information. How would article was published u number of newspapets and journals have carried similar stories in Australia. Professor Somerville's criteria apply in the ancient surrogacy case (pre-birth planning with 91. Ibid. out benefit of technology) involving Rachel, Jacob and Bil'-hah? 92. Ibid, p.11 8. And when Rachel saw that she bare Jacob no ch'ildren, Rachel envied her sister; and said 93. See 'TTansse)(uals see IVF prognuns as their chance 10 become mothers', Sydney Morning Herald May 7' 1984. . unto Jacob, Give roe children, or else I die. 94. 'The man who became a woman', New Idea, March 22, 1986. And Jacob's anger was kindled against Rachel; and he said, Am I in God's stead, who 95. RAYMOND JANICE, The Transsexual Empire. The Making of the Sht.-Male, Boston, Beacon Press, 1979. has withheld from thee the fruit of the womb? 96. Ibid, quoted page xvii. 97. STEINBACHER ROBERTA in Holmes, Hoskins and Gross, up cit, p.89. And she said, Behold my maid Bil'-hah, go in unto her; and she shall bear upon my knees, that I may also have children by her. And she gave him Bil' -hah her handmaid to wife, and Jacob went jn unto her. And Bil'-hah conceived, and bare Jacob a son. And Rachel said, God hath judged me, and hath also heard my voice, and hath given me a son ... And Bil' -hah Rachel's maid conceived again, and bare Jacob a second son. And Rachel said, With great wrestlings have I wrestled with my sister, and I have prevailed ... (Genesis Ch.30). The first criteria, competence, is reasonably accommodated, as all parties seem capable of understanding what is going on - although, as we know almost nothing about the maid, we cannot be certain in her case. Criteria two, voluntariness, is seriously broached. Jacob may or may not have liked the aIT'dngement (we ignore the confident assertion of those who argue that, being a man , he was sure to have been agreeable to the plan); in any case he was not asked, he was told what to do. The maid's permission was not sought either, and as she held a subservient and 122 123 dependant position in the household it is questionable whether her consent, had it been right to terminate an unwanted pregnancy. Yet these same groups challenge the right of the given, could be regarded as truly voluntary. infertile woman to utiJise forms of reproductive technology which give some chance of There doesn't seem to have been a great deal of discussion about the arrangement, so the conception but against which they hold ideological objections. Perhaps it would be more applicability of criteria three, information, is difficult to assess. However, knowing how accurate to say that they choose to challenge the reproductive technology rather than the unmysterious are the 'facts of life' to peasant peoples, we may reasonably assume that all women who wish to use it, but the result, where successful, is the same. Proponents of the participants had a fair notion of the consequences. view that it is merely inappropriate social conditioning which impels infertile women (or This old tale provides a simple illu.c;tration of the inadequacy of tackling complex and couples) to seek a technologically-based solution to their dilemma (a technology, they profound questions of hwnan life and relationships via the limited perspective of the law. caution, created by and in the interests of men) have formed an uneasy alliance with those To understand chapter 30 of Genesis we would have to take into account the culture of the who speak of the sacredness of the ovum and the sperm, who declare that in God alone times, including such matters as the attitude to polygamy, the preference for male offspring rests the prerogative to fashion life: mortals must not meddle in the reproductive process. and the reasons for such a preference, the relationship between servants and their masters Both groups, although bitterly opposed on issues such as abortion, find themselves united and mistresses, and contemporary views on sexual intercourse held by different social in their resistance to the extension of 'non-natural' means of reproduction. groups. Without an appreciation of the society in which these actions took place, no We discover that in the relatively 'low-tech' area of surrogacy, where a fertile woman evaluation of the actions other than through the prism of our own culture is possible. And bears a child for a non-fertile woman (an ancient, long-established practice, much older even after this. we have not begun to assess the emotional weight of the story - Rachel's than Genesis chapter 30), the law in Victoria does not permit assistance for such a pro pain, Jacob's anger, Bil'-hah's silence, the pathos of the line 'and she shall bear upon my cedure by the use of in-vitro fertilisation. Nor are any agreements made between the parties knees, that I may also have children by her'. in a surrogacy arrangement binding under the law. This is justified by argument against Fundamental to my argument is the conviction that an assessment of any law, medical 'trading' in human bodies, a form of which exists in the unwelcome American commercial procedure or scientific experiment must be founded on an appreciation of the historical, isation of swTogate motherhood. Yet the Victorian Government no longer considers prosti cultural and social context in which it occurs. When we approach the question of the kinds tution a crime - although here is a very old fonn of body trading. Would not most people of reproductive and pre-birth technologies we are prepared to sanction, or encourage, it consider the production of a human life, the joy such life can bring to those who dearly will not be enough to ensure that none take place without the informed consent of all desire to nurture and rear a child, a greater social good than the temporary relief of male parties. Strictly speaking this would be an impossibility, since one of the parties most sexual tension? centrally affected by reproductive technology, the infant, is not present at the time deci It should also be recognised that in our society the infertile who wish to become parents sions are made. It will be necessary to determine the course of action which fulfills, or at must satisfy goverrunent instrumentalities of their 'suitability' for parenthood; no such the very least does not bitterly offend, the values, interests and priorities of the community requiremenl<> limit the reproductive activities of the rest of the population. We have created in which the actions are planned. a system with special rules for a minority {the infertile would-be parents), and justify it by This is not to recommend a narrowly 'environmental' approach. As an example, the claiming the rules will protect the well-being of the children who are adopted, or conceived religious and traditional precepts of a small section of the Australian community which lead using reproductive technology. Tt has yet to be explained why, if such scrutiny is valid for to the infliction of pain and permanent sexual mutilation on female children (clitorectomy) one group of prospective parents, it should not aJso be applied to all parents-to-be. Does are not sufficient, or good, grounds for allowing such a practice to continue; the long term the act of sexual intercourse confer parental skills on its practitioners? We know that this is interests of those children are greater, I believe, than our responsibility to respect a particu nonsense and yet it is likely that most Australians woud resist any attempt to demand some lar sub-culture. Of course one could use the argument of informed consent here to achieve form of 'competency certification' before the state permitted them to mother or father a the same result: as the children have not given their consent, the act is illegal. But what if child. Why then do we discriminate against that small section of the coi,nmunity which we had a situation where, to take an extreme instance, a fascist regime engaged in medical must have recourse to non-sexual methods of reproduction? experiments on a group of young women, to discover a cure for infertility, knowing that Further, we must acknowledge the complexity of a situation in which medical treatment the outcome of the experiment would itself cause infertility, and not only did the bulk of has evolved down the long conidor of magic and superstition, from witch-doctor to god the corwnunity support these experiments, but at least one of the women gave her informed doctor. Today we emphasise patients' tights and the necessity for doctors to explain and consent also? I would say that a program of deliberate sterilisation of otherwise healthy and justify recommended therapies. However, our more critical and egalitarian perspective does competent young women contravenes a fundamental human principle: the actions of the not resolve the inherent contraruction between the desire of individual patients to utilise state, and certainly the medical profession, should not exploit or harm those it is meant to 'state of the art' techniques made possible by advances in science, and the priorities (and serve. The nature of fascism is, by this definition, inhumane, and therefore questions of prejudices) of the community in which they live. This contradiction lies at the heart of informed consent are no longer relevant as they are distorted by the sociaJ system in which much of the debate between infertile couples and their doctors on the one hand and those they must be asked. who are alarmed by the new technologjes, such as church groups and some feminists, on When we look, within the context of Australian society, at some of the issues raised by the other. the remarkable scientific advances of recent years in the fields of reproductive and pre-birth None of these remarks are meant to suggest that there are no cogent, logical and rational technology, we can observe a number of contradictions. This might be expected in a devel arguments against certain fonns of reproductive technology. It is now scientifically possible oped capitalist country with strong democratic traditions and a plethora of culturnl and to achieve a startling array of technical feats in this domain, and some seem more 'pennis religious groupings. There are groups who assert the necessity for the fertile individual's sible' in late 20th centllry Australia than others. control of decisions concerning contraception - that is control in order not to conceive - The list of existing or forseeable pre-birth technologies includes: and who declare that a woman must have total authority over her own body, including the • the fertilisation of the wife's ovum (Victorian law demands it be the wife's) with the 124 125 husband's sperm outside the wife's body, and then the implantation of the fertilised and doctors not t? experiment d.angerously, _or .who consider the world's pockets of hunger ovum in the wife's uterus and ?ver-populat?on a far more tmportant pnonty than the expensive development of repro • the fertilisation of another woman's ovum with the husband's spenn, that is donated ductive technology for the solace of a few. ovum (the use of donated sperm is now so commonplace it is rarely included in discus Tho~e who have dev~loped.and who a~ply the technology, on the other hand, insist on sions of reproductive technology, although it is as much a variant of traditional husband the eth1~l nature o~ their i:notwes and ac.trnns. They point to demand from sections of the wife seimal intercourse as donated ova) commuru.ty f~r theu servtces, and list a range of beneficial discoveries derived from • the froren storage of human embryos for later implantation (in Victoria, such implanta research m this field. Lay people, generally those who are participating in IVF and related tion may only occur in the uterus of the female 'owner' of the embryos), or for experi programs, have fonned organisations to counter what they regard as biased or inaccurate mentation (not permissible at present in Victoria) attacks on th~ e~ponents_ of. rcprod~ctiv~ technologies and on their methods. If nothing • the taking of sperm from the reproductive system of a male who is infertile if restricted el~e~ the cont1numg media mterest m this subject has ensured for most of us at least a to sexual intercourse, in order to fertilise his wife's ovum mm1mal familiarity with che issues in a complex. debate. • embryo transfer from one womb to another (at present illegal in Victoria) To .some extent we are all here participating in the old, fundamental argument about the • gamete intra-fallopian transfer, for women with damaged fallopian tubes morality of ends and means. ls the production of a healthy human life (where before there • embryo gender selection may have been no, or sickly life) a goal worthy of the community's financial and moral • embryo cloning (already achieved with a variety of animal species) support? Whose rights (ends) should be paramount: those of the state, the infertile woman • gene therapy, for the pre-birth eradication or treatment of diseases such as cystic fibrosis (or couple), the child-not-yet-born, the foetus, the embryo, the gamete, the ovum, the • male pregnancy spenn? What procedures are intrinsically unacceptable regardless of possible reproductive • ectogenesis, the development of the foetus outside the human body. success? ~ho sho~ld make these decisions? What role should the state, and the law play? It i~ interesting to observe in passing how opponents of some or all of these techniques Assummg that, ma democracy, legislation and its operation is meant to reflect the will occasxonally fix on a facet of the experimental procedures in order to disparage the whole of the majority but not permit the exploitation or oppression of minorities, there is a clear process. Thus, while it is true that much pre-birth technology was originally developed argument for. permitting,. indeed encouraging, the maximum freedom of thought, experi through experimentation on animals, this has very little relevance to our assessment of its ment and act.10n compatible with the rights of citizens. It is necessary to be cautious of va_lue and. appropriateness for humans. l11is is despite the way in which menacing legal or administrntive structures which may be used against the few by the many (or by a pnmaeval images of humanoid beasts or the post-Frankenstein nightmare of mad scientists powerful few to press their view upon the rest). Equally such a society is unlikely to unleashing rapacious animal-humans on a helpless world have coloured the sub-text at least support untrammelled scientific research. Ethical considerations about the value of the of some opponents of IVF. (A quite separate argument concerns the appropriateness of research as well as the morality of its methods can never be sacrificed to the short-term anim~l experimentation per se, but that is rarely part of this debate.) To reject reproductive interests o~ ambitious scientists, Jo governments who scent glory and financial growth, nor techruques because they were first used on animals requires that we logically omit from to the passions or obsessions of individual members of the community. medical prophylaxis and treatment, innoculations, antibiotics and a host of surgical pro . Of co~rse , difficulties arise as soon as we try to apply these principles to contemporary cedures. What is good or bad about a particular pre-birth measure must be detennined by hfe. Log1cally, such principles require that all scientific work concerned with mass destruc the application of ethical and humane criteria, not by the misappropriation of the language tion, whether nuclear or 'conventional', be outlawed, yet work of this kind sustains the of myth and melodrama. economy of the USA, which is at least in some respects a democracy. When it comes to a Underlying such opposition is a particular view of what is 'natural' in hwnan life. This is far less clear-cut issue, such as the validity of applying sex-selection techniques (which most evident when critics point to the animal experiments which provide much of the data may be used to pander to a cultural preference for male children or to avoid the con making ~ossible IVF, or when they declare that women's bodies are being colonised by tinuation of gen~r-rela~d illne~ses such as haemophilia), we find that opposing groups men; their natural reproductive functions being stolen from them, as it were. What these argue for_ opposmg pos1t1ons usmg the same principles. The exponents of pre-birth and critics are expressing (often unconsciously) is a romantic, idealised view of human beings. reproductive technology challenge the right of one vocal minority to prevent the develop Homo sapiens have developed on this planet by going far far beyond a state of nature and ment of methods of treatment intended to help another minority. Those who wish to see ~h~ can say _what that was: amoeba-like in the murky early oceans, or hanging by long cer~in of the teclmiques banned speak of the right of women (half the population) not to be si.nuan anns m the trees? Humans always function in a culture, a history, and even our s?c1ally coerced by the wishes or prejudices of some men (part of the other half). Both biology is tempered by social factors. Those who willingly accept contraception, new limbs s1d~s assert the logic of their own arguments and assure us of their interest in justice and and corneal gnfts must be wary of appealing to Mother Nature against new technology. equity. Here and there, Law Reform Commissions hold seminars hoping that light will There are many people in Australia who feel considerable anxiety about certain of the emerge from the heat of debate. available or soon-to-be-available pre-birth and reproductive techniques. A letter writer to Even s~ch a brief examination of some of the problems associated with pre-birth and the Melbourne Age in August this year who declared that 'experimentation with human reproductive technology suggests how limited is the concept of informed consent as a embryos would threaten the Christian concept of the sanctity of the individual, and would ~eans of overcoming the difficulties arising from scientific developments not yet integrated move society in the direction of the Marxist view of the supremacy of society over the mto .ow: ~u lture . Lawyers and legislators have the re.<;ponsibility to devise laws which pro individual' represents one dissident perspective. The Feminist International Network of tect mdivxduals and the whole populace from tyranny and chicanery, which do not violate Resistance to Reproductive and Genetic Engineering (FINRAOE) represents another. fund~ental va~ues about human life held by most people in our community, and which Between these two clearly enunciated positions we find the confused unease of those who pernut the m~1~~m freedom of expression and experiment compatible with these princi feel pity for the infertile but reject 'non-natural' reproduction, or who do not trust scientists ples. But the divlSlon of labour has assigned this responsibility to a very few, often narrow- 126 127 ly educated people whose recourse to legal concepts obscures the manifold complexity of the experiences they are attempting to codify so tidily. Perhaps all Law Reform Commis sions should, as a precaution, iuclude among their members a poet, a travelling salesman and a landscape gardener? INFORMED CONSENT - AN OVERVIEW J. Kenneth Mason It falls to my lot to conclude this fascinating series of symposia on lnfonncd Consent by way of an overview. Needless to say, I have agonised over how best to do this. In the end, I thought I would Lake my own line and use the previous contributions to demonstrate where I am wrong or to bring out any areas of manifest disagreement; I thought I might usefully go over some of the recent United Kingdom decisions in the area - which might be particularly useful as they probably represent the 'fullback' or 'long swap' position of the conservative tradition; and, finally, I thought it might be reasonable for me to look to the future which I can do in a dispassionate way as, of all the contributors to the sympo sium, 1 am the least likely to be directly affected by the future. My own conceptual attitude to consent is to regard it as a platform resting, or depending upon the integrity of, a tripod. The three legs can be stylised as: l Is consent legal? and, if so, 2 Can it be given? and, finally, 3 Has it been given? Which is what these symposia are all about. IS CONSENT LEGAL? l mention the first leg only for the sake of completeness. It is somewhat remote from the specific topic of informed consent. Yet it is, I think, worthy of passing thought as it serves to demonstrate the pervading fact that the law in this area is, to an extent, founded upon anomalies and uncertainties. These derive from its attempt to steer a course between the two poles of absolute autonomy on the part of the individual and the absolute duty of the State to protect its citizens against themselves in the interests either of the individual him self or of society. Thus, as to anomaly. I, as a non-lawyer, find it hard to see the logic of legalising sodomy or gross indecency between adult males acting in private while, at the same time, criminalising incestuous, but natural, intercourse between consenting adults when pe1formed in simlar privacy as is the position in the United Kingdom. Nearer to our present discussion, I wonder why the law allows suicide but criminalises any attempt to ensure that suicide should be as painless and effective as possible. That is the law of suicide in England but I doubt if it is the law of Scotland - and the word doubt takes me neatly into the realm of uncertainty. As I see it, we are all fairly clear in our minds as to what constitutes unlawful consent to assault but the foundations for those beliefs are not all that firm. In England, the limits of lawful consent are set by Mr Justice Swift's direction in the case of R v Donovan:i as a general rule it is [unlawful to act to another person so that] the infliction of bodily harm is a probable consequence as, when such an act is proved, consent is immaterial Codified Law is scarcely more specific. Thus, section 223 of the Criminal Code of Western Austra:lia merely states that: 128 129 the application of force by any person to the person of another may be unlawful although last section referring to prisoners, we might look at them straight away. it is done with the consent of that other person. The status of prisoners was discussed by Professor Bernard Dickens. He drew attention Codification is, however, of greater value in stating exceptions to general rules and P.ax:1i_cularly ~o. the .powers and inducements which act upon prisoners and lhe near impos section 259 of the same Criminal Code specifically excludes criminal responsibility in the s1b1hty of g1V1ng mformed, and therefore valid, consent to, say, therapeutic trials. The case of surgical operations performed in good faith and for the benefit of the patient. It was prospect of earning some money, of having personal relationships with outsiders and in certainly a matter of astonishment to me to find that the English law had to wait until the the event of something going wrong, the probability of changing a cell for a hospital bed Attorney-General's Reference No.6 of 802 for positive, confirmation of the accepted are the sort of problems with which we are all familiar and which have led the Canadians legality of, inter alia, reasonable surgical interference - this being justified as needed in for example, to prohibit research on prisoners. Professor Dickens did, however, also pojn~ the public interest. Consensual surgical operations would be covered in Scotland and, I to the reverse side of the coin. This was the possibility that, by excessive paternalism, the fancy, in most common law jurisdictions, through lack of intent to harm the patient on the State may prevent prisoners exercising their autonomous right to choose risk and this may part of the medical practitioner. · ~e an aspect of conse.nt. which per~ades all categories, not only those in captive popula But, although we might well dismiss the apparently academic problem on such lines, it !tons. We do not proh1b1t motor racing because the drivers take risks and are paid to do so, is worth taking time to note that the conditions are not static. The law, itself, may call a t~deed, we e_ndorse ~he n:iarket forces which dictate higher payments for higher risks. To halt as it has in the United Kingdom in the Prohibition of Female Circumcision Act 1985 single ~ut pnsoners m thlS respe~t smacks almost of self interest on the part of the State which, incidentally, specifically disallows a doctor who undertakes and operates on the :-vho will, of course, take the maJor share of the blame in the event of mishap. One may, genitalia to talce into account any beliefs of the patient as to iitual or custom. In this way, indeed, equally wonder if the massive check lists now being introduced, for example in the interpretations of adjectives or phases such as 'patient benefit', 'reasonable', 'good faith' or treatmen~ of breast c~cinoma, are only paying lip service to the patients' needs and are, in 'incentive to hann' are subject to evolution. Only 15 or so years ago, Meyers3 maintained fact, designed to extricate lhe doctor from a difficult duty. that consent to castration for whatever purpose could never be legal; today, sex-change Professor Dickens did not, however, extend his discussion to consent to treatments operations are carried out regularly and are legally justified as being acceptable treatment designed for behaviour control, a matter which seems of major conceptual importance. The for a severe psychiatric disorder. ?umber of persons who actually believe lhat castration or anti-androgen therapy can Perhaps I should divert for a moment to consider Professor Raymond's contribution to mftuence sexual behaviour is fast diminishing. Nonetheless, tltis surely is an area where the this series which, as I see it, attempts to broaden the issue into the socio-political sphere State could rightl~ ~a~l a halt. Effectively, such treatments offer a major benefit, liberty, ·and away from the doctor-patient relationship. I have just rather airily dismissed transsex freed~m from rec1d1v1sm and the like, in exchange for what can only be described as ual surgery as being admissible as a treatment for severe psychiatric disorder. This is not expe~mental pr~cedure~. But the more significant feature is that, in many cases, the the same as pandering to psychological well-being. I would suggest it is strong evidence of experunents are 1rrevemble. This, surely, is the rationale behind the well-known Kaimo the importance attached to valid consent that the centres which continue the operation and witz4 decision, which was to the effect that a prisoner was incapable of giving a valid which have high ethical standards, were affected by financial considerations and operate on consent to psychosurgery by reason of his position in society. I believe that this is some less than I% of applicants. Professor Raymond is quite right to argue the possible premise thing most of us would and should agree with. The Catch 22 element in the consent is such that mutilation of such magnitude should not be undertaken, or even allowed, but that is an ~at the State .should disbar its servants from putting proposals of this type, which is, in issue which is to be decided distinct from, and before, the question of consent is raised. 1t~el~, something of a sophistic approach in that, jf you do not make a proposal, you Once society has accepted the legality of sex change operations, the patient may choose the ebnunate argument as to the right to accept or reject it. treatment. But he or she chooses that treatment in the context of his or her social ambience, But ~sychotherapy leads. on to our second 'at risk' group, the mentally handicapped. a matter of which the doctor is unaware. It is frequently said that doctors are over con And this group also exemplifies the concern of the State to intervene when the capacity for cerned to make social judgments when they should confine themselves to the medical a valid consent is in doubt. decisions for which they were trained; it follows that consent should be based on infonna Th_e, mentally impaired are a vulnerable group for two reasons. Firstly, they cannot by tion which the doctor is qualified to provide and any other information should be sought defiruhon, be expected to understand what is asked of them. In England there must be from properly qualified sources. 'signific~1t ~mpairment of intelligence before categorisation'. Secondly, lhe built-in nature But, accepting that operations which are directed to extreme treatments of psychiatric of psychiatnc treatment is to induce some form of behaviour control. Mentally impaired disorder arc j'ustified, stops short of supposing that the operation of castration for other less persons are, accordingly, the only population to my knowledge whose consent to treatment obvious causes, such as the treatment of the sexual recidivist, is lawful. We have, perhaps, i~ re~ulat~ by statute. Mr. Rassaby has given us an excellent review of Australian Jegisla spent too long on the question of legality and this clear reference to prisoners leads me, tton m this field. For my part, I would Jike only to make a couple of observations on the with my passion for the cascading or derivative type of presentation, to the second leg of English Mental Health Act 1983. the tripod - can the patient consent? . Basically, consent to tre_atment is of three types. One, the matter of simple medication, is ex.empted from regulatmn. Consent to hazardous procedures, which include electro convulsive therapy and prolonged medication is subject either to valid consent or in lhe CAN THE PATIENT CONSENT? ~vent that the patient does not or cannot consent, to a second opinion. The second ~pinion There are a number of circumstances in which it may be possible to question the ability of is however, more than that as the doctor giving the opinion must be specially appointed and the patient to consent. The ethnic minority comprises a group which is often inadequately he must consult with two other persons who are involved with the patient's treatment. At considered. But I think we will confine ourselves to those which have been considered in the top of the scale are those treatments for which both consent and a second opinion are this series, that is, minors, the mentally handicapped and prisoners and, since I finished the required; it is then the function of the two advisors, one of whom must be a nurse and the 130 131 other neither a doctor nor a nurse, to confirm that the patient is able to consent and has ~h~ has consented, and he interpreted the Minors (Property and Contracts) Act 9 9 s consented. s1m1 ar y.10 1 7 , , . 49 This may represent careful protection of the patient but it is clear that a patient who is in 1 1 need of psychosw·gery may, for that reason, be incapable of consent; he is then, disbarred ~levlertheJess, I c~not leave the Gillick case without some personal criticisms Firstly Whl e must agree with the opinion )f L d D · · · ' from receiving that treatment by the terms of the Act. Our Parliament, however, regards . I f ( or ennmg m Hewer v Bryantll ru; to the decrea. this an acceptable price to pay for the protection of lhe majority. mg roe o parental control as children grow older J find Lo d s • s- In fact, the courts had, to an extent, pre-empted the legislature. In the very well-known ing age and the law somewhat disconcerting. He ~ay be ri;ht ~~:~ne s rcm~k:. concem- case of Re Ds, permission to sterilize a 15 year old mentally impaired girl was refused Jf the law should. impos~ upon the process of growing up, fixed li:K: w~~re nature mainly on the grounds that she might attain sufficient intelligence to be able to consent to knows only a contmuous process, the price would be artificiality and a lack of af . or refuse the operation. She was thus protected not only from the doctors but also from her an area wh:re the law ~us~ be sensitive to human deveJopment and social cha:e e tsm m parents, and parel'ltal control lies at the heart of the debate as to the rights of minors. theB~:l~h~/~f~~~o~:~cl~sron is .that all protc~ti~~ legislation which is age-related,gs~ch as As to consent by minors, I have to admit that I find the paper of Ms Morgan guilty of children against sexual ~~::-=t~~~~~: :S?~ns1b~.1ty for, fire risks'. the. protection of young special pleading. Whatever you think of Gillick6, you have to remember that Mrs Gillick say ' ood riddan . , . . ' e.su ~ect to mature-minor ~nsent. And if you won on a head count by five opinions to four. It is unreal, in my opinion, to exclude the baullc ~t child pom:;a;~~~ patcrnaJ1sm ' I imagine even the most ardent liberalist would unanimous opinion of the Court of Appeal from any discussion of the case. I do suggest that the Court of Appeal was concerned, in the main, not with parental rights but with laS~condl!', i~ seems to me that, whatever we do in this respect, we are effectivel on1 parental duties; any 1ights involved were the rights to carry out the duties imposed by P yrng. with figures. Thus, Lord Templeman can foresee a 15 year old . · y y append1cectomy which is not a far er fr h consenting to an statute law. On this basis, it is possible to have considerable sympathy with Mrs. Gillick's Section 49 of th~ Minors (Pro ert Y om t e statutory 16 year old. Similarly, I see case if not with her presentation of that case. age of consent from 16 to l Py y ~ C~~racts) Act 1970 (NSW) as me~ely moving the At the end of the day, however, Gillick is something of a damp squib. The spurious be the sam h 4 ears. e su sequent arguments as to rnatunty are going to interposition of the criminal aspects of contraception through Section 6 of the Sexual Off e w erever you place your age. ences Act 1956, Section 6 concentrated the minds of the House of Lords on the contracep to ~~dt!~~~~~o~~~~~eg~:adeeal;: the ~scussion' an~ of the political ~P!nions in this area tive issue. Anything related to the general capacity of minors to consent to medical valid and sufficient c Y ~ort: for .exam~lc, sug~ests that minors may give a treaunent is, effectively obiter and there is no way in which the case can be said to have ' B . . ons~nt ... p10~1ded that theJr matunty and understanding is such established the legal situation of minors in England. Thus, despite the trend in the judge ~~d~~st;di:gute~, there ts no. suggestron that consent can ever be valid in the absence of ments towards increased child autonomy, we have Lord Fraser not only laying down fairly '. . · e argument ts, to say the least, circular. Whtch bnngs us, all too late, to informed consent. rigid criteria which are related to the adjudged best interests, rather than any rights of the child, but also underlining this by the specific warning that 'the Gillick case was not to be regarded as a licence for doctors to disregard the wishes of parents whenever they found it HAS THE PATIENT CONSENTED? convenient to do so'. And, in parentheses the General Medical Council have found the So much has been written and s· · d th b · . plot the co t 'h 'h . ar on e su 1ect of informed consent that it is difficult to directions so open to interpretation that their consequent instructions complicate the situa ev rrec approac .. ere .. To some, anything J say must be stale news; others how- tion still further both from the child's and the doctor's perspectives. opini?ns. So the initiated must bear w'ith me Moreover, the Gillick decision does nothing to clarify the conditions for valid consent to fo;~ 1~~~ ~~~l~e ~odf~~~lt~t~.: ~ f~cts ~d - there are no Scottish is. to some recent English cases paediatric experimentation. At present, it seems to me that the legaJity of research on p:.ecC:en~ ~d ~st c~ f.~o analy~e h l h . . am, tn act, involved m the first Scottish case s children rests on the negative basis that there is no statutory or judicial statement to the per aps, s ould wait for 18 months or so before talk' • H ' . o, I simpl fi d mg. owever . . contrary. In other words, as Lord Scarman put it in Gillick, 'neither statute nor case law A. ~ cann.ot. ~ the re~erence to the person who said: · has ruled on the extent and duration of parental rights in respect of children under 16'. phrase begms life as a htcrary expression- its felicit leads t · J • • Skegg7 has reached the same conclusion in much the same way. repetition soon establishes it as a legal formu'ra ind· . y. 1 o Its azy repetiti?n; and Whatever the defects of Gillick, I am doubtful if English law really needs the case. We and sometimes contradictory ideas iscnnunate y used to express different have had abortion authorised for a 15 year-old girl despite her parents' oppositions and I ha;~~:~~·/ cu:;ot recollect a phr~se being so readily accepted into our vocabulary as have already referred to the case of Re D where parental pressure for a maiming operation may be at ~nbeornnoot ocf·onscnt' fand I thmk that this ready and almost unthinking acceptance was over-ruled. When it comes to more mundane treatments, l cannot conceive of any some o our troubles. court seriously departing from the common law stance enunciated in Johnston.9 The Gillick Some citat.ions ar~ so often used that they become a major bore. Nonetheless I am case is particularly irrelevant to one coming from Scotland where the Family Law Act 1967 ~~~~: ~~i~;ve Justice Cardozo credit for laying the foundation stone of informed donsent does not mo and where it is unlikely, although not impossible, that Mrs. Gillick would have obtained a hearing no matter now her case was presented. ~~:;~~~~ ~~:gb~ a~ultdears and sound mind has a right to determine what shall be Having said that, it would seem that the law in Australia, at any rate in New South consent commits an as!;u~t~ 13 a surgeon who perforn1s an operation without the patient's Wales, is not so clear. Chief Justice Helsham followed the English case of Re P as to abortion but in doing so gave his opinion that Johnstoll was no authority for proposi Disposal of one's body depe d d . any information It folio h n s upon un erstandrng and understanding depends upon tion at common law that there is not right in a guardian, to prevent treatment in a minor flawed con~ent and ~i: ~~ ~~pa~en~ ~nsent to trea.tmen~ in the absence of information is 1 e og1ca outcome of Justice Cardozo's statement. Justice - 132 133 Cardozo was, however, clearly referring to battery or trespass and it is here that we get into thoroughly grounded in the English cases as it is in the rest of the Commonwealth and the some difficulty. It is perfectly feasible to argue that flawed consent is no consent and thus United States. to lay down the conditions for trespass; and this was the early approach to consent based Where.the Engli.sh courts have take~ a particularly strong line is in the extent of that duty actions. and, particularly, m how that extent is to be measured - is it to be in the hands of the But, almost by a process of extra-sensory perception, the courts have turned their backs patients or of the doctors? on this concept and have distinguished broad consent, which excludes battery,14 from a As to the last, and most contentious, point, there is a line of decisions21 which detennin complete failure to consent to a specific battery as exemplified in the Canadian cases of edly. apply the Boim:z28 principle to the provision of information. Briefly, the.Bo/am princi Murray v McMurchy15 or more recently Schweizer v General Hospital. 16 This antipathy ~Je is that ~ doctor 1s not negligent if he acts in accordance with a practice accepted at the concerning assault has been recently underlined in England in Hills v Potter11 or in the time as bemg proper by a responsible body of medical opinion. And note 'a body' _ it rather special case of Freeman ix in which the court went so far as to say, erroneously in my does n?t have to be a unanimous decision and a court has been said to have been in error in opinion, that, additionally, recourse to the doctrine of informed consent was no longer prefer.nng one ~ody of opinion to another. 29 Thit> is a totally professional standard which available in England. This was, I think, a clear example of semantic complications. Quite eff~cttvely denies autonomy to the patient. But, contrary to the generally held view, I why the courts have taken this firm line is difficult to assess. My own view is that battery beh~ve that the celebrated ca1;e of Mrs. Sidaway has tom great holes in the Bolam test implies something of an evil intent and there is a deep reluctance to allow such an implica despite the fact that the general principle was upheld during her hearing. tion within the confines of the doctor-patient relationship. .Sid~way3o was the first consent based case to go to the House of Lords in England. In Be that as it may, it means that, for practical purposes, the consent based action is now ~nef, 1t concerned a lady who sustained tragic damage to the spinal cord. There was a risk available only in negligence, which, in some ways, is a harder fruTOW for the patient to mherent in the oper~tio~ in the or~er of I%. She was not informed. There is no denying plough. The simplest argument for a non-lawyer like myself to understand then runs on a that her case was d1sm1ssed Wlammoosly in all three judicial tiers but it was dismissed 'but for' basis: 'but for the fact I was not informed, I would not have had the treatment and becaus~ sh~ personall~ was regarded as having been given adequate information. It was the I would not be suffering from an accepted risk of the treatment'. Thus, causation is seen to genera1Jsat1ons made m the judgments which were of importance and these I must per- derive from failure of an anterior duty of care19 and the nature of that duty has been force, only summarise. ' succinctly put in the Massachusetts case of Harnish:20 Fundamentally, ~t was agreed that providing information was indistinguishable from any A physician owes to his patient the duty to disclose in a reasonable manner all significant othe~ aspect of patient care; the usual rules of medical negligence, that is Bolam, therefore medical information that the physician possesses or reasonably should possess that is applied. Nevertheless, only Lord Diplock, who appeared mainly concerned with the rea material to an intelligent decision by the patient whether to undergo the proposed sonable patient's capacity to understand, refused to move from the strict Bolam stance. The treatment. major inroad was in the Court of Appeal, where the Master of the Rolls Sir John Donald And it is at the signpost 'reasonable manner' or 'reasonableness' that the chosen road son ~ndertined the ~portan~ of the court as the final arbiter of medical opinion when he forks again. Is the reasonable route to be dictated by the patient or by the doctor? And what quah~ed proper medical practice as being that which is rightly accepted as proper. Further kind of a surface has the road, one laid by the actual (or subjective) patient or by the he said, ,'the law would not sit idly by if the medical profession ... denied their patients ~ reasonable (objective) patient? How is the reasonable doctor to be identified - by his peers free cho1ce ... The law would not allow the medical profession to play God'. And in the or by the courts? 1n other words, it .is the variations on a widely accepted theme that are in same court, _Lord Br~wne :Vilkinson said that, in carrying out this duty of care, the doctor dispute, not the theme itself. should take I~to cons.1~eration the 'patient's particular circumstances'. I find this very close Since I am running close to time, I propose limiting my discussion of the patient based to t.he ~anad1~n position. Using such criteria, both jurisdictions end up considering the test because, as we will see, it is only marginally applicable to the United Kingdom. My SU~Ject.Jve pat~e~t, but, while the Canadians would foUow the route of the reasonable summarised belief is that few jurisdictions, including those of the United States, will accept patient, the Bntish would follow the accepted responsible doctor. This also seems to be the an unadulterated subjective patient test by which to measure causation. The obvious reason Australian attitude as evidenced by F v R. for this lies in the power of hindsight. It is extraordinarily difficult to assess or examine ~hen we come ~o th~ House of Lords, Lord Scarman expanded this line of reasoning, evidence which is, at best, Jocked up in the recesses of an individual's mind. But it is gomg so far as to d1ssoc1ate therapy from infonnation-givi..ng because the choice which was important to interpose here that it is perfectly reasonable to accept the priJ.iciple of a based on that information must include non-medical matters of which the doctor himself patient's right to choose and yet to reject the subjective patient test. Failure to appreciate mig~t ~e only partially infonned. None of his colleagues would follow him the whole way this, happened in Freeman21 and it was, I believe, where Lord Dunn was in error when he bu~ ms1stence on the duty to inform and disclose risks ran through every speech. Lord said, in the appeal stage of Sidaway22 that 'the doctrine of informed consent forms no part Keith , for example, sai l. (19341 2 KB 488 at 507. 2. (1981) AB 715. 3. MEYERS D W, The Human Body and the Law, (1970) Edinburgh University Press, p.66. 4 . .Kaimowitz v Michigan Department of Healrh, 42 US LW 2063 (1973). 5. [1976] 2 WLR 279. 6. Gillick v West Norfolk and Wisbech AHA and the DHSS, [1985] 2 WLR 413, CA, [1985] 3 WLR 830, HL. ·7. KEGG PD G, 'English Law Relating to Expennentation on Children', [1977] 2 Lancet 754. 8. Re P (A Minor) , (1982] CLY W77. 9. Johnston v Welle.flty Ho.spiral, (1970) 17 DLR (3d) 139. 10. K v Minister for Yourh and Cammunil)• Services and an other, [1982] I NSW LR 3 11. 11. [ 19701 1 QB 357 at 369. 12. CARNEY T, Chi.Id Welfare Practice and lcgislatWn Review Report, (1984) Victoria, p.291. 13. 105 NE 92 (NY, 1914). 14. Clzatterron v Gerwn, (1981 ] QB 432; Reihl v Hughes, (1981) 114 DLR (3d) 1; Natanson v Kline 350 P 2d 1093 (Kan, 1960); F v R, (1983) SASR 189. IS. [1949] 2 DLR 422. 16. (1974) 53 DLR (3d) 494. 17. [19R4] T WLR 641. 18. Freeman v Home Office (No 2), [19841 2 WLR 802. 19. Ref 14 above, Reihl, per Laskin CJC at 10,11. 20. Harnish v Children's Hospiral Medical Centre, 387 Ma~s 152 (1982). 21. Freeman v Home Office (No 2) [1984) 2 WLR 802. 22. Sidaway v 1Jethlem Royal Hospital and Maudsle.y Hospital Health Authority and Others [198412 WLR 778. 23. KENNEDY I, 'The Parie11t on the Clapham Omnibus', (1984) 47 MLR 454. 24. 464 F 2d 772 (DC Cir, 1972). Z.5. Ref 14 above. 26. Ref 14 above. 27. Chatterton, Ref 14 above; Hills v Poirer, [J984] 1WLR641; Maynard West Midlands AHA , [19841 1 WLR 634, HL; Sidaway, ref 29 below. 28. Maynard, ref 27 11bove. 29. Maynard ref 27 above . 30. Ref 22 above, [ 1985] 2 WLR 480, HL. 31. Bauers/Jy ~ Touman and State 11fSou1h Ausrralia, (1985) 37 SASR 524. 32. [1986] All ER 497 , CA. 33. F v R, ref 14 above. 34. [19651 NZLR 191, CA. 35. Blyth v Bloomsbury AHA, (1985) Times, 24 May. 36. (1986] All ER 488, CA . 37. ROBERTSON 0 , 'Jnfonned Consent 10 Medical Treatment', (1981) 91 LQR 102. 38. Ref 23 above. 138 CONTRIBUTORS Professor Margaret Somerville Faculty of Law and Faculty of Medicine McGill University Dr. Nevme Hicks Department of Community Medicine University of Adelaide Professor Robert Eagleson Department of English University of Sydney Professor Janice Raymond Women's Studies University of Massachusetts at Amherst Dr. Elizabeth Ownne Department of Social Work University of Melbourne Ms. Jenny Morgan Faculty of Law Monash University Mr. Alan Rassaby Review of Health Legislation Health Department, Victoria Professor Bernard Dickens Faculty of Law University of Toronto Dr. Robyn Rowland School of Humanities Deakin University Ms June Factor Victorian Council for Civil Liberties Professor J. Kenneth Mason Medical School University of Edinburgh