IRBs: Protecting the well-being of subject-participants with mental disorders that may affect decisionmaking capacity

Accountability in Research

Volumn 7, Issue 2-4, 1999, Pages 183-199

  Baylis, Françoise ^a  

^a DALHOUSIE UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; PSYCHOTROPIC AGENT;

ADVISORY COMMITTEE; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; CONFLICT; CONSUMER; DECISION MAKING; ETHICS; FREEDOM; GOVERNMENT REGULATION; GROUP PROCESS; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; MENTAL CAPACITY; MENTAL HEALTH THERAPIES; MENTAL PATIENT; METHODOLOGY; MISCELLANEOUS NAMED GROUPS; NATIONAL BIOETHICS ADVISORY COMMISSION; ORGANIZATION AND MANAGEMENT; PATIENT ADVOCACY; PATIENT PARTICIPATION; PATIENT SELECTION; PERSONAL AUTONOMY; POLICY; POLITICS; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RESEARCH SUBJECT; RISK; SOCIAL CONTROL; UNITED STATES; VULNERABLE POPULATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH; MENTAL HEALTH THERAPIES; NATIONAL BIOETHICS ADVISORY COMMISSION;

ADVISORY COMMITTEES; CLINICAL TRIALS; COMMITTEE MEMBERSHIP; CONSUMER PARTICIPATION; DECISION MAKING; DISSENT AND DISPUTES; ETHICAL REVIEW; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FREEDOM; GOVERNMENT REGULATION; GROUP PROCESSES; GUIDELINES; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; MENTALLY ILL PERSONS; ORGANIZATION AND ADMINISTRATION; ORGANIZATIONAL POLICY; PATIENT ADVOCACY; PATIENT PARTICIPATION; PATIENT SELECTION; PERSONAL AUTONOMY; PERSONS; PLACEBOS; POLITICS; PSYCHOTROPIC DRUGS; PUBLIC POLICY; RESEARCH DESIGN; RESEARCH SUBJECTS; RISK; SOCIAL CONTROL, FORMAL; UNITED STATES; VULNERABLE POPULATIONS;

EID: 0033289384     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989629908573951     Document Type: Article

References (41)

1. For example, World Medical Association Declaration of Helsinki. Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Geneva, June 1964, as amended, October 1996; Council for International Organizations of Medical Sciences in collaboration with the World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 1993.
2. For example, Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Title 45: Public Welfare: Code of Federal Regulations, Part 46-Protection of Human Subjects (June 18, 1991 revised).
3. For example, American College of Physicians. "Cognitively Impaired Subjects. " Archives of Internal Medicine 1989; 111, 843-848.
4. While the NBAC report "refers to persons on whom research interventions are performed. as "subjects, " consistent with the language in current federal regulations, " (p. 1, n. 1) I use the more respectful and accurate term "subjectparticipants. " This term, though not used in the NBAC report more closely fits with the claim made therein that "human research participants are partners in the study process rather than passive subjects. " (p. 149) National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity. October 20, 1998, www.bioethics.gov
5. Scientific validity is an ethical precondition for research involving humans. For an early statement of this ethical requirement see, David Rutstein, "The ethical design of human experiments". In: Paul Freund, ed. Experimentation With Human Subjects. New York: Braziller Daedalus Library, 1969, 383-401.
6. It is widely held that one of the ethical preconditions for research involving humans is a favourable harm-benefit ratio. Elsewhere, I have argued (with Jocelyn Downie) that research with a proportionate harm-benefit ratio might also be ethically acceptable. Françoise Baylis, Jocelyn Downie "An ethical and criminal law framework for research involving children in Canada" Health Law Journal 1993; 1:39-64.
7. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Title 45: Public Welfare: Code of Federal Regulations, Part 46-Protection of Human Subjects (June 18, 1991 revised). Subparts B-Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization, Subpart C-Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects and Subpart D-Additional DHHS Protections for Children Involved as Subjects in Research.
8. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity. October 20, 1998, 116. www.bioethics.gov
9. At the time of writing, the National Bioethics Advisory Commission's Report and Recommendations on Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (December 1998) had not been finalized. This paper, written in response to the October 20th Draft Report, was presented at a conference where members of NBAC were present. Happily, it appears that they were persuaded by some of the arguments in this paper. Particularly noteworthy is the change in wording in the Final Report regarding possible objections to research participation by persons with mental disorders that may affect decisionmaking capacity. Recommendation 3 of the Draft Report stipulates on obligation to honor a subject's refusal. Recommendation 7 of the Final Report (Which is on this same point) is more nuanced. The claim is that a subject's objections must be heeded.
10. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 147. www.bioethics.gov
11. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks. Title 45: Public Welfare: Code of Federal Regulations, Part 46-Protection of Human Subjects (June 18, 1991 revised). 46.107-IRB membership.
12. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 121. www.bioethics.gov
13. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 123. www.bioethics.gov
14. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 125. www.bioethics.gov
15. Hans Jonas. "Philosophical reflections on experimenting with human subjects" Daedalus 1969: 237.
16. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 124. www.bioethics.gov
17. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 126. www.bioethics.gov
18. Françoise Baylis, Jocelyn Downie and Nuala Kenny. "Children and decisionmaking in health research" IRB: A Review of Human Subjects Research 1999; 21: 6.
19. Robert J. Levine. "The impact of HIV infection on society's perception of clinical trials. " Kennedy Institute of Ethics Journal 1994; 4, 93-98; and Charles Weijer. "Evolving ethical issues in selection of subjects for clinical research" Cambridge Quarterly of Healthcare Ethics 1996; 5:334-345.
20. Charles Weijer. "Evolving ethical issues in selection of subjects for clinical research" Cambridge Quarterly of Healthcare Ethics 1996; 5:334-345
21. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research, Washington, D.C.: U.S. Government Printing Office, 1978, 4.
22. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 127. www.bioethics.gov
23. Carl Elliott. Caring about risks: Are severely depressed patients competent to consent to research?" Archives of General Psychiatry 1997; 54: 113-116.
24. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 61. www.bioethics.gov
25. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 63. www.bioethics.gov
26. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 63. www.bioethics.gov
27. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 63. www.bioethics.gov
28. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 127. www.bioethics.gov
29. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 130. www.bioethics.gov
30. National Bioethics Advisory Commission. Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20, 1998, 18. www.bioethics.gov
31. World Medical Association Declaration of Helsinki. Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Geneva, June 1964, as amended, October 1996.
32. Office for Protection from Research Risks. Protecting Human Research Subjects: Institutional Review Board Guidebook. Washington, D.C.: U.S. Government Printing Office, 1993, 4-17.
33. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethics Conduct for Research Involving Humans. Ottawa: Public Works and Government Services, 1998, 7.4.
34. Benjamin Freedman. "Equipoise and the ethics of clinical research" New England Journal of Medicine 1987; 317:141-145.
35. Benjamin Freedman. "Equipoise and the ethics of clinical research" New England Journal of Medicine 1987; 317:144.
36. Charles Weijer. "Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary?" Schizophrenia Research 1999; 35: 213.
37. Benjamin Freedman. "Placebo-controlled trials and the logic of clinical purpose. IRB: A Review of Human Subjects Research 1990; 12(6): 1-6.
38. Charles Weijer. "Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary?" Schizophrenia Research 1999; 35: 213.
39. JM Kane. "Schizophrenia. " New England Journal of Medicine 1996; 334:34-41.
40. Charles Weijer. "Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary?" Schizophrenia Research 1999; 35:214.
41. For a discussion of the scientific and ethical benefits of active control equivalence (ACE) studies, see Charles Weijer. "Placebo-controlled trials in schizophrenia: Are they ethical? Are they necessary?" Schizophrenia Research 1999; 35:211-218.