Christ University Law Journal, 3, 1 (2014), 1-16 ISSN 2278-4322|doi.org/10.12728/culj.4.1 Informed Consent in Clinical Trials and the Role of Institutional Ethics Committees: A Socio-Legal Analysis P C Harigovind* Abstract Experimenting new drugs on human beings, is one of the crucial human right issues faced by the third world countries in the present century. It is true that the international law had taken high concern of this social issue after the Nuremberg Trials. The international law mandates informed consent to be obtained from the participants of clinical trials and this is the sole mechanism through which the rights of the trial subjects are being protected. The public health issues caused by illegal and unethical trials over patients are now evident in Indian health care system. The issue has come up for consideration before the Supreme Court of India recently. In India the law runs in tune with the international parameters for conducting human experimentation. The law on informed consent has a fatal impact over public health care issues, especially over the matter of clinical trials. Recent experiences in India reveal the threats caused to the society by clinical experimentations. Clinical trials and allied health issues are also brought to the notice of the judiciary. The law on informed consent in India is in its infant state. Exploring the doctrine of informed consent is crucial to this study. The present issue of clinical research which threatens the health care * Assistant Professor, Bhavans N A Palkhivala Academy for Advanced Legal Studies and Research, Ramanattukara, Kozhikode, Kerala, India; [email protected]. 1 P C Harigovind ISSN 2278-4322 system is analysed and the doctrine of informed consent to regulate the system is assessed to check its efficacy and veracity. Analysis of the issue will help to communicate to the public about the need for better exercise of the rights of those who are subjected to clinical researches. The law of informed consent is in many ways inadequate to deal with the issues relating to clinical trials in India. The doctrine of informed consent has to be redefined to a great extent. The institutional review boards and Non- Government Organisations (NGO) can play a vital role in assuring proper observation of rules relating to regulation of human trials. Keywords: Clinical Trials, Consent, Ethics, Experimentation, Health. Introduction Medical experimentations are something that takes place in every doctor‟s office. 1 These researches always involve high risk and responsibilities.2 The law prescribes that the voluntary consent of the trial subject is always essential for the experimentations.3 The laws made after the Nuremberg trial demands for the procurement of full consent from the trial subjects for conducting human experimentations. The Nuremberg code mentions it as voluntary consent and at present the rule has developed into informed consent. It is the duty of the physicians to appraise the trial subjects about the experimentations in detail. The consequences of being a party to the trial should be made known to the patient and with such knowledge in mind; the subject has to provide his consent. Thus the informed consent derived from a patient or trial subject has manifold implications over the entire process of human experimentation. Informed consent can thus be called as the elementary and imperative clause that regulates the entire process of human experimentation. 1 Michael B. Shimkin, The Problem of Experimentation on Human Beings, 117 SCIENCE NEW SERIES, 205 (1953). 2 Id. 3 See The Nuremberg Code, Trials of War Criminals before the Nuremberg Military Tribunals, 2 Control Council Law No. 10, 181 (1947). 2 Informed Consent in Clinical Trials Christ University Law Journal, 3, 1(2014) Jurisprudence of Informed Consent The term informed consent was not used by the Nuremberg Code but first appeared in the Helsinki Declaration 1964. 4 The declaration also gave the power to a trial subject to withdraw the consent at any time during the trial and to abstain himself from any further experimentations. To know the relevance and meaning of informed consent it is equally important to understand the role played by the doctrine in physician-patient relationship. Patient‟s right to know about the disease, treatment and its impact over life is well related to his quality of life.5 In the health care system, the concept of quality of life is an age old doctrine and well approved since the time of Greeks.6 In every case, the need of any patient is to have some affirmative action in preserving his life. This aspiration of a patient entitles him with the right to know about the kind of treatment administered to him. This aspiration is justified with the help of the hedonistic theory.7 The concept of good life and its effects on the quality of life is well addressed by hedonistic theory. The hedonistic calculus demands the health care system to offer maximum assurance to the quality of life so as to increase its utility. The patient‟s right to decide the outcome of his treatment is also a concern of informed consent. This proposition can be understood in situations of terminal illness. If no fruitful treatment is available, it is the right of the patient to decide for prolonged medication and treatment. This decision making power cannot always be recognized as a unique standard for the health care system. The power to exercise the right depends upon the gravity of the disease. For example in case of a cardiac arrest or a severe injury by motor accidents the patient may not be in a position to take an appropriate decision. However in most of the other cases, especially where options are available to a patient, he can make his 4See World Medical Association, Helsinki Declaration, (1964) Principles 22 & 23, available at http://www.wma.net/en/30publications/10policies/ b3/17c.pdf. 5 Ivan Barofsky, Patients’ Rights, Quality of Life and Health Care System Performance, 12 QUALITY OF LIFE RESEARCH 473, 481 (2003). 6Id. at 475. 7Id. 3 P C Harigovind ISSN 2278-4322 choice. The decision making power plays a vital role here as the physician prescribes a new method of cure where a known science is available. The decision made by the patient on the explanations given by a physician still casts some dilemma. The way in which the physician‟s explanations get into the mind of a trial subject is perplexing.8 Apart from the above reasoning, the need for consent is also evident from the doctrine of body autonomy. Human body is also recognized by law as a property and any interference with the body material against one‟s consent would amount to trespass and hence constitutes a criminal offence. It can always risk subject‟s health and life and is thus a matter of great concern.9 Autonomy is one of the fundamental values that should regulate any kind of experimentation over human subjects. The doctrine of informed consent completely relies on autonomy. Central to the concept of autonomy is the idea that people should be able to rule themselves rather than be ruled by others. The Kantian conception of man as an end in himself can be read with the concept of autonomy. Law discusses about two different concept of autonomy. One is the libertarian concept and another one is the liberal concept of autonomy. In the libertarian conception the state or any private interest will violate the right to autonomy while interfering with the decision making power of a person unless and until the decision amounts to a public wrong. This kind of approach does not have any paternalistic concern for the subject‟s right. On the other hand, the liberal concept is wedded with this paternalistic concern. Informed consent is addressed as liberal concept of autonomy. The law demands the consent to be informed, as it has a paternal care towards its subjects. On the other hand, the libertarianism stands for the actual consent of the subject irrespective of the fact how far it is informed. Thus the concept of autonomy has facilitated the construction of the doctrine of informed consent. The entire process of human experimentation 8 J. K. Wing, The Ethics of Clinical Trials, 1 J. MED. ETHICS 174 (1975). 9 M. Cheriff Bassiouni et. al., An Appraisal of Human Experimentation in International Law and Practice: The Need for International Regulation of Human Experimentation, 72 J. CRIM. L. & CRIMINOLOGY 1597, 1603 (1981). 4 Informed Consent in Clinical Trials Christ University Law Journal, 3, 1(2014) starts with the availability of volunteers for trials and this can be initiated by availing consent from the trial subjects. Informed Consent: The Legal Formalities From the Nuremberg Code and the Helsinki Declaration, informed consent is accepted as one of the prominent rule for human bioethics. The need for consent is also declared mandatory by the recent U.N. Documents.10 It demands for providing all adequate information with respect to the kind of treatment or experimentation done over a person.11 Apart from this it is also mandated that such trial subjects will be entitled with the right to withdraw their consent.12 The declaration also emphasises on the inter relation between the human dignity, medical ethics and informed consent. It is internationally recognized that the waiver of informed consent cannot be made ordinarily but in all exceptional cases, the investigator has to get the approval from ethical review committee. 13 This guideline in its commentary also attempts to draw an international definition for the term informed consent. It states that, “Informed consent is a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence, inducement or intimidation”.14 Thus the concept of contracting can be read into the makeup of every informed consent.