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Accountability in Research
Ethics, Integrity and Policy
Volume 7, 1999 - Issue 2-4
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Original Articles

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

Pages 183-199 | Published online: 11 Jun 2008

References

  • World Medical Association Declaration of Helsinki . June 1964 . Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects June , Geneva as amended, October 1996
  • Council for International Organizations of Medical Sciences in collaboration with the World Health Organization . 1993 . International Ethical Guidelines for Biomedical Research Involving Human Subjects Geneva
  • Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks . 1991 . Title 45: Public Welfare: Code of Federal Regulations, Part 46—Protection of Human Subjects , June 18 revised
  • American College of Physicians . 1989 . “Cognitively Impaired Subjects.” . Archives of Internal Medicine , : 111 843 – 848 .
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity October 20 , 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 “subject‐participants.”; 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) www.bioethics.gov
  • Rutstein , David . 1969 . “The ethical design of human experiments”; ” . In Experimentation With Human Subjects. , Edited by: Freund , Paul . 383 – 401 . New York : Braziller Daedalus Library . Scientific validity is an ethical precondition for research involving humans. For an early statement of this ethical requirement see,
  • Baylis , Françoise and Downie , Jocelyn . 1993 . “An ethical and criminal law framework for research involving children in Canada” . Health Law Journal , 1 : 39 – 64 . 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.
  • Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks . 1991 . Title 45: Public Welfare: Code of Federal Regulations, Part 46—Protection of Human Subjects , June 18 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.
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity October 20 , 116 www.bioethics.gov
  • National Bioethics Advisory Commission's Report and Recommendations . December 1998 . Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity December , At the time of writing, the 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
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. October 20 , 147 www.bioethics.gov
  • Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks . 1991 . Title 45: Public Welfare: Code of Federal Regulations, Part 46—Protection of Human Subjects , June 18 revised). 46.107—IRB membership.
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 121 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 123 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 125 www.bioethics.gov
  • Jonas , Hans . “Philosophical reflections on experimenting with human subjects” . Daedalus , 1969 237
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 124 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 126 www.bioethics.gov
  • Baylis , Françoise , Downie , Jocelyn and Kenny , Nuala . 1999 . “Children and decisionmaking in health research” . IRB: A Review of Human Subjects Research , 21 : 6
  • Levine , Robert J. 1994 . “The impact of HIV infection on society's perception of clinical trials.” . Kennedy Institute of Ethics Journal , 4 : 93 – 98 .
  • Weijer , Charles . 1996 . “Evolving ethical issues in selection of subjects for clinical research” . Cambridge Quarterly of Healthcare Ethics , 5 : 334 – 345 .
  • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . 1978 . The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research , 4 Washington, D.C. : U.S. Government Printing Office .
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 127 www.bioethics.gov
  • Elliott , Carl . 1997 . “Caring about risks: Are severely depressed patients competent to consent to research?” . Archives of General Psychiatry , 54 : 113 – 116 .
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 61 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 63 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 63 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 63 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 127 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 130 www.bioethics.gov
  • National Bioethics Advisory Commission . October 20 1998 . Draft Report Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity October 20 , 18 www.bioethics.gov
  • World Medical Association Declaration of Helsinki . June 1964 . Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects June , Geneva as amended, October 1996.
  • Office for Protection from Research Risks . 1993 . Protecting Human Research Subjects: Institutional Review Board Guidebook. , 4 – 17 . Washington, D.C. : U.S. Government Printing Office .
  • Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada . 1998 . Tri‐Council Policy Statement: Ethics Conduct for Research Involving Humans , 7.4 Ottawa : Public Works and Government Services .
  • Freedman , Benjamin . 1987 . “Equipoise and the ethics of clinical research” . New England Journal of Medicine , 317 : 141 – 145 .
  • Freedman , Benjamin . 1987 . “Equipoise and the ethics of clinical research” . New England Journal of Medicine , 317 : 144
  • Weijer , Charles . 1999 . “Placebo‐controlled trials in schizophrenia: Are they ethical? Are they necessary?” . Schizophrenia Research , 35 : 213
  • Freedman , Benjamin . 1990 . “Placebo‐controlled trials and the logic of clinical purpose . IRB: A Review of Human Subjects Research , 12 (6) : 1 – 6 .
  • Weijer , Charles . 1999 . “Placebo‐controlled trials in schizophrenia: Are they ethical? Are they necessary?” . Schizophrenia Research , 35 : 213
  • Kane , JM . 1996 . “Schizophrenia.” . New England Journal of Medicine , 334 : 34 – 41 .
  • Weijer , Charles . 1999 . “Placebo‐controlled trials in schizophrenia: Are they ethical? Are they necessary?” . Schizophrenia Research , 35 : 214
  • Weijer , Charles . 1999 . “Placebo‐controlled trials in schizophrenia: Are they ethical? Are they necessary?” . Schizophrenia Research , 35 : 211 – 218 . For a discussion of the scientific and ethical benefits of active control equivalence (ACE) studies, see
  • The Office of Bioethics Education and Research is supported by grants from Associated Medical Services Inc., Toronto and the Dean's Development Fund, Dalhousie Faculty of Medicine.

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