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Research With Cognitively Impaired Subjects: Unfinished Business in the Regulation of Human Research

Research With Cognitively Impaired Subjects: Unfinished Business in the Regulation of Human Research Abstract In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued an important report that addressed the difficult ethical issues arising in research involving subjects with mental disabilities. However, because of irreconcilable conflicts between the scientific community and rights-oriented advocacy groups, the federal government never issued the special regulations pertaining to these issues that had been envisioned by the National Commission. Because these important ethical issues have not yet been adequately addressed by policy-making bodies, protection of cognitively impaired subjects depends too heavily on the diverse ethical sensitivities of individual investigators and on ad hoc responses of particular institutional review boards. Researchers should support a credible and authoritative process for reexamining and resolving ethical issues relating to research with cognitively impaired subjects. This can be accomplished without leading to the stalemate that doomed the National Commission's proposals. The challenge is to forge a consensus on ethical guidelines and safeguards that will most reasonably accommodate the goals of protecting the dignity and well-being of research subjects while avoiding undue impediments to valuable scientific inquiry. References 1. Tufts A. Apologies for Nazi crimes . Lancet . 1994;344:808. 2. Rothman DJ. Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making . New York, NY: Basic Books Inc Publishers; 1991. 3. Annas GJ, Grodin MA. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation . New York, NY: Oxford University Press Inc; 1992. 4. Lifton RJ. The Nazi Doctors: Medical Killing and the Psychology of Genocide . New York, NY: Basic Books Inc Publishers; 1986. 5. Welt LG. Reflections on the problems of human experimentation . Conn Med . 1961;25:75-79. 6. Benson PR, Roth LH. Trends in the social control of medical and psychiatric research . Law Ment Health . 1988;4:1-47. 7. Beecher HK. Ethics and clinical research . N Engl J Med . 1966;274:1354-1360.Crossref 8. Office for Protection from Research Risks Division of Human Subject Protections. Evaluation of Human Subject Protections in Schizophrenia Research Conducted by the University of California Los Angeles . Los Angeles: University of California; 1994. 9. Appelbaum PS. Drug-free research in schizophrenia: an overview of the controversy . IRB Rev Hum Subjects Res . 1996;18( (1) ):1-5. 10. Katz J. Human experimentation and human rights . St Louis Univ Law J . 1993;38:7-54. 11. Bonnie RJ. A presidential commission on drug policy: instrument of reform or defender of the status quo ? Contemp Drug Problems . In press. 12. Department of Health, Education, and Welfare. Research involving those institutionalized as mentally infirm: report and recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . Federal Register . (March 17) , 1978;43:11328-11358. 13. Department of Health. Education, and Welfare. Proposed regulations on research involving those institutionalized as mentally disabled . Federal Register . (November 17) , 1978;43:53950-53956. 14. Fletcher JC, Dommell FW Jr, Cowell DD. A trial policy for the intramural programs of the National Institute of Health: consent to research with impaired human subjects . IRB Rev Hum Subjects Res . 1985;7:1-6. 15. American College of Physicians. Cognitively impaired subjects . Ann Intern Med . 1989;111:843-848.Crossref 16. High DM, Whitehouse PJ, Post SG, Berg L. Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position paper . Alzheimer Dis Assoc Disord . 1994;8:67-74.Crossref 17. College on Problems of Drug Dependence. Human subject issues in drug abuse research . Drug Alcohol Depend . 1995;37:167-175. 18. Protection of human research subjects and creation of National Bioethics Advisory Commission (executive order No. 12975). Federal Register . (October 3) , 1995;60:52063. 19. Federal policy for the protection of human subjects. Code of Federal Regulations. 45 §46.111 and 46.116. 20. Appelbaum PS, Grisso T. The MacArthur Treatment Competence Study, I: mental illness and competence to consent to treatment . Law Hum Behav . 1995;19:105-126.Crossref 21. Appelbaum PS. Patients' competence to consent to neurobiological research . Accountability Res . 1996;4:241-251.Crossref 22. Cournos F, Faulkner LR, Griffith EEH, Munetz MR, Winick B, Fitzgerald L. Consent to Voluntary Hospitalization . Washington, DC: American Psychiatric Association; 1993. 23. Buchanan AE, Brock DW. Deciding for Others: The Ethics of Surrogate Decision Making . New York, NY: Cambridge University Press; 1989. 24. Menikoff J, Sachs G, Siegler M. Beyond advance directives: healthcare surrogate laws . N Engl J Med . 1992;327:1165-1169.Crossref 25. Kapp MB. Proxy decision making in Alzheimer disease research: durable powers of attorney, guardianship, and other alternatives . Alzheimer Dis Assoc Disord . 1994;8:28-37.Crossref 26. Kapp MB. Implications of the Patient Self-Determination Act for psychiatric practice . Hosp Community Psychiatry . 1994;45:355-358. 27. Appelbaum PS. Advance directives for psychiatric treatment . Hosp Community Psychiatry . 1991;42:983-984. 28. Moorhouse A, Weisstub DM. Advance directives for research: ethical problems and responses . Int J Law Psychiatry . 1996:19:107-141.Crossref 29. Dresser R. Mentally disabled research subjects: the enduring policy issues . JAMA . 1996;276:67-72.Crossref 30. Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines . J Law Med Ethics . 1996;24:18-35.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of General Psychiatry American Medical Association

Research With Cognitively Impaired Subjects: Unfinished Business in the Regulation of Human Research

Archives of General Psychiatry , Volume 54 (2) – Feb 1, 1997

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References (33)

Publisher
American Medical Association
Copyright
Copyright © 1997 American Medical Association. All Rights Reserved.
ISSN
0003-990X
eISSN
1598-3636
DOI
10.1001/archpsyc.1997.01830140013002
Publisher site
See Article on Publisher Site

Abstract

Abstract In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued an important report that addressed the difficult ethical issues arising in research involving subjects with mental disabilities. However, because of irreconcilable conflicts between the scientific community and rights-oriented advocacy groups, the federal government never issued the special regulations pertaining to these issues that had been envisioned by the National Commission. Because these important ethical issues have not yet been adequately addressed by policy-making bodies, protection of cognitively impaired subjects depends too heavily on the diverse ethical sensitivities of individual investigators and on ad hoc responses of particular institutional review boards. Researchers should support a credible and authoritative process for reexamining and resolving ethical issues relating to research with cognitively impaired subjects. This can be accomplished without leading to the stalemate that doomed the National Commission's proposals. The challenge is to forge a consensus on ethical guidelines and safeguards that will most reasonably accommodate the goals of protecting the dignity and well-being of research subjects while avoiding undue impediments to valuable scientific inquiry. References 1. Tufts A. Apologies for Nazi crimes . Lancet . 1994;344:808. 2. Rothman DJ. Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making . New York, NY: Basic Books Inc Publishers; 1991. 3. Annas GJ, Grodin MA. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation . New York, NY: Oxford University Press Inc; 1992. 4. Lifton RJ. The Nazi Doctors: Medical Killing and the Psychology of Genocide . New York, NY: Basic Books Inc Publishers; 1986. 5. Welt LG. Reflections on the problems of human experimentation . Conn Med . 1961;25:75-79. 6. Benson PR, Roth LH. Trends in the social control of medical and psychiatric research . Law Ment Health . 1988;4:1-47. 7. Beecher HK. Ethics and clinical research . N Engl J Med . 1966;274:1354-1360.Crossref 8. Office for Protection from Research Risks Division of Human Subject Protections. Evaluation of Human Subject Protections in Schizophrenia Research Conducted by the University of California Los Angeles . Los Angeles: University of California; 1994. 9. Appelbaum PS. Drug-free research in schizophrenia: an overview of the controversy . IRB Rev Hum Subjects Res . 1996;18( (1) ):1-5. 10. Katz J. Human experimentation and human rights . St Louis Univ Law J . 1993;38:7-54. 11. Bonnie RJ. A presidential commission on drug policy: instrument of reform or defender of the status quo ? Contemp Drug Problems . In press. 12. Department of Health, Education, and Welfare. Research involving those institutionalized as mentally infirm: report and recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . Federal Register . (March 17) , 1978;43:11328-11358. 13. Department of Health. Education, and Welfare. Proposed regulations on research involving those institutionalized as mentally disabled . Federal Register . (November 17) , 1978;43:53950-53956. 14. Fletcher JC, Dommell FW Jr, Cowell DD. A trial policy for the intramural programs of the National Institute of Health: consent to research with impaired human subjects . IRB Rev Hum Subjects Res . 1985;7:1-6. 15. American College of Physicians. Cognitively impaired subjects . Ann Intern Med . 1989;111:843-848.Crossref 16. High DM, Whitehouse PJ, Post SG, Berg L. Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position paper . Alzheimer Dis Assoc Disord . 1994;8:67-74.Crossref 17. College on Problems of Drug Dependence. Human subject issues in drug abuse research . Drug Alcohol Depend . 1995;37:167-175. 18. Protection of human research subjects and creation of National Bioethics Advisory Commission (executive order No. 12975). Federal Register . (October 3) , 1995;60:52063. 19. Federal policy for the protection of human subjects. Code of Federal Regulations. 45 §46.111 and 46.116. 20. Appelbaum PS, Grisso T. The MacArthur Treatment Competence Study, I: mental illness and competence to consent to treatment . Law Hum Behav . 1995;19:105-126.Crossref 21. Appelbaum PS. Patients' competence to consent to neurobiological research . Accountability Res . 1996;4:241-251.Crossref 22. Cournos F, Faulkner LR, Griffith EEH, Munetz MR, Winick B, Fitzgerald L. Consent to Voluntary Hospitalization . Washington, DC: American Psychiatric Association; 1993. 23. Buchanan AE, Brock DW. Deciding for Others: The Ethics of Surrogate Decision Making . New York, NY: Cambridge University Press; 1989. 24. Menikoff J, Sachs G, Siegler M. Beyond advance directives: healthcare surrogate laws . N Engl J Med . 1992;327:1165-1169.Crossref 25. Kapp MB. Proxy decision making in Alzheimer disease research: durable powers of attorney, guardianship, and other alternatives . Alzheimer Dis Assoc Disord . 1994;8:28-37.Crossref 26. Kapp MB. Implications of the Patient Self-Determination Act for psychiatric practice . Hosp Community Psychiatry . 1994;45:355-358. 27. Appelbaum PS. Advance directives for psychiatric treatment . Hosp Community Psychiatry . 1991;42:983-984. 28. Moorhouse A, Weisstub DM. Advance directives for research: ethical problems and responses . Int J Law Psychiatry . 1996:19:107-141.Crossref 29. Dresser R. Mentally disabled research subjects: the enduring policy issues . JAMA . 1996;276:67-72.Crossref 30. Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines . J Law Med Ethics . 1996;24:18-35.Crossref

Journal

Archives of General PsychiatryAmerican Medical Association

Published: Feb 1, 1997

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