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Implications of the Concept of Minimal Risk in Research on Informed Choice in Clinical Practice

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Implications of the Concept of Minimal Risk in Research on Informed Choice in Clinical Practice Clinical ethics J Med Ethics: first published as 10.1136/medethics-2014-102231 on 24 June 2015. Downloaded from PAPER Implications of the concept of minimal risk in research on informed choice in clinical practice Kyoko Wada, Jeff Nisker Department of Obstetrics and ABSTRACT discussion of risk. A minimal risk concept in clin- Gynaecology, Schulich School The concept of a minimal risk threshold in research, ical practice could go beyond discussion of risks of of Medicine & Dentistry, Western University, London, beneath which exception to informed consent and ethics clinical therapies and procedures to include health Ontario, Canada review processes may occur, has been codified for over risks in the patient’s lifestyle such as unhealthy diet 30 years in many national research regulations and by or environmental chemicals. Correspondence to the Council for International Organizations of Medical A clinician’s failure to provide the patient with Dr Jeff Nisker, Department of Sciences. Although minimal risk in research constitutes pertinent information has ethical and potentially Obstetrics and Gynaecology, 910 Schulich School of Medicine & one of the criteria for allowing waiver of informed legal implications. As clinicians are under consid- 11 Dentistry, Children’s Health consent or modification to the consent process and a erable time constraints in their practice, a minimal Research Institute, Western large body of literature exists, discussion of a minimal risk concept, such as that well described in clinical University, London Health risk threshold in clinical practice has not occurred. One research, could be helpful in terms of assuring Sciences Centre, Victoria Hospital, Rm E2-620E, 800 reason for lack of discussion may be that implicit appropriate information provision to the patient. Commissioners Rd. E., London, consent is accepted for a wide range of routine clinical Although clinical research and practice have differ- Ontario, Canada N6A 5W9; practices. Extending the role of minimal risk in research ent objectives,12 13 informed consent is an essential [email protected] to clinical practice might assist clinicians in identifying ethical requirement in clinical practice as well as in circumstances for which implicit consent is indeed research.913Historically, the Nuremberg Code Received 9 May 2014 fi Revised 1 April 2015 suf cient and circumstances in which it is not. Further, (1947) articulated research ethics requirements. Accepted 8 June 2015 concepts from minimal risk in research might assist Over time, these requirements influenced clinical Published Online First clinicians regarding when information provision in health medicine (p.4).14 Legal proceedings in the 1950s 24 June 2015 promotion is required. We begin by reviewing concepts and 1960s resulted in clinicians acknowledging the in both minimal risk in research and informed choice in significance of obtaining consent upon disclosure of clinical practice. We then explore how a clinical minimal relevant information, both in clinical practice and risk concept may clarify recommendations for information research (p.515).13 Despite these common back- provision in clinical practice and support the patient’s grounds, informed consent is highly regulated in informed choice regarding therapeutic and diagnostic clinical research compared with clinical prac- procedures and also health promotion. Given that clinical tice.12 13 15 The differences of regulatory require- practice involves a broad scope of health information, ments between clinical research and clinical practice http://jme.bmj.com/ professional practice guidelines on information provision may evoke concern that patients may not be suffi- based on the application of the minimal risk threshold in ciently protected compared with research partici- research could be developed to guide clinicians in what pants (p.522).13 information must be provided to their patients. This paper explores the possibility of extending the minimal risk concept in research to information provision in clinical practice. First, we will discuss minimal risk in research regulations regarding on September 27, 2021 by guest. Protected copyright. INTRODUCTION informed consent. Second, as there is no minimal The concept of minimal risk in research as a risk concept in clinical practice, we will discuss the ‘sorting threshold’ (p.351),1 beneath which excep- existing elements and standards of information provi- tion to informed consent and ethics review pro- sion in clinical practice. Finally, we will explore how cesses may occur, has been codified for over minimal risk in research may be applied to informa- 30 years in many national research regulations as tion provision and informed choice in clinical prac- well as by the Council for International – tice. Acknowledging the existence of a large amount Organizations of Medical Sciences (CIOMS).1 7 Open Access of literature on risk, the risk concept used in this Scan to access more In regards to informed consent in research, paper will primarily refer to the expectation value of free content minimal risk constitutes one of the criteria for an undesirable event, determined by the probability allowing modification to all or part of the consent and severity of outcomes.16 We will argue that process18(45 Code of Federal Regulations (CFR) extending the role of minimal risk in research as a 46.116, 45 CFR 46.117; TCPS2, Articles 3.7; low risk threshold to clinical practice may assist clini- CIOMS Guidelines 4). In clinical practice, however, cians in understanding their obligation for informa- there is no concept comparable with minimal risk tion provision regarding risks in therapies, diagnostic in research that would provide a low risk threshold procedures and lifestyle choices. for considering waiver of consent or alteration to the consent process. Conversely, acknowledgement To cite: Wada K, Nisker J. J of a minimal risk concept in clinical practice could MINIMAL RISK IN RESEARCH Med Ethics 2015;41: insist that all risks above such a threshold require a In research regulations regarding human partici- – 804 808. formal consent process involving detailed pants, such as the US CFR (45 CFR 46.102(i))5 804 Wada K, Nisker J. J Med Ethics 2015;41:804–808. doi:10.1136/medethics-2014-102231 Clinical ethics J Med Ethics: first published as 10.1136/medethics-2014-102231 on 24 June 2015. Downloaded from and the Tri-Council Policy Statement of Canada (TCPS2) examination standard should rather be understood as risks (Chapter 2.B),7 risks may be considered below minimal risk involved in these examinations per se and not information col- when the likelihood and seriousness of harm or discomfort are lected alongside these examinations.1 Similarly, Resnik8 pro- comparable with those of daily life. In research regulations, such poses to employ only the routine clinical examination standard. as the International Ethical Guidelines for Biomedical Research He argues that rather than flexibility, the clarity of the standard Involving Human Subjects (CIOMS Guidelines) (Guidelines 4 and consistency in its application should take priority to secure and 9)6 as well as in the US CFR (45 CFR 46.102(i)),5 risks are fairness or justice. On the other hand, Freedman et al18 argue considered within minimal risk when the risks are not above the that the daily life standard is morally justifiable as (1) research risks of routine clinical (physical and psychological) examina- risks are substitutive due to people’s exposure to daily risks tions. Similar concepts of minimal risk are employed across while not participating in research and (2) daily risks are socially other national and international regulations with some differ- acceptable.18 The first point is criticised as daily risks are usually ences1 such as Guidelines on Ethics for Medical Research2 or associated with some purpose or benefits whereas research does Additional Protocol to the Convention on Human Rights and not guarantee any benefit to the participant.4 Indeed, the total Biomedicine Concerning Biomedical Research.3 benefit gained from the same time frame may likely decrease The risks of daily life or routine clinical examinations as particularly in research without potential therapeutic benefits to thresholds embedded in the minimal risk in research standard participants. The second point is also criticised as what is has received much scrutiny, including commentators inquiring socially acceptable may not necessarily be clear1 and daily risks whose daily life or routine clinical examinations should be refer- are not always socially acceptable but simply unavoidable.4 enced and why risks in daily life or routine clinical examinations Perhaps, a socially acceptable standard is what may be justifiable. should serve the role as a low risk standard.1417Although these discussions largely focus on research with children in non- INFORMED CONSENT AND MINIMAL RISK IN RESEARCH therapeutic situations and do not specifically discuss its rele- 417–19 Informed consent, independent ethics review and special protec- vance as a threshold in relation to informed consent, they tion to vulnerable populations are among the basic requirements may provide insight into how a low risk standard could be in conducting ethically sound research.21 Among these require- determined. ments, informed consent enables a person to protect oneself Two interpretations of minimal risk are discussed widely in 1417 through the opportunity to receive information and to give or the literature. The absolute interpretation
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