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R. Bonnie (1998)
A Presidential commission on drug policy: instrument of reform or defender of the status quo?Contemporary Drug Problems, 25
J. Berg (1996)
Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed GuidelinesThe Journal of Law, Medicine & Ethics, 24
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P. Appelbaum (1996)
Patients' competence to consent to neurobiological research.Accountability in research, 4 3-4
Brock DW Buchanan AE (1989)
Deciding for Others: The Ethics of Surrogate Decision Making
M. Adler (1995)
Human subject issues in drug abuse research. College on Problems of Drug Dependence.Drug and alcohol dependence, 37 2
Marshall Kapp (1994)
Implications of the Patient Self-Determination Act for psychiatric practice.Hospital & community psychiatry, 45 4
A. Tuffs (1994)
Apologies for Nazi crimesThe Lancet, 344
D. Rothman (1992)
Strangers At The Bedside: A History Of How Law And Bioethics Transformed Medical Decision Making
P. Benson, L. Roth (1988)
Trends in the social control of medical and psychiatric research.Law and mental health, 4
Grisso T Appelbaum PS (1995)
The MacArthur Treatment Competence Study, I: mental illness and competence to consent to treatmentLaw Hum Behav, 19
L. Welt (1961)
Reflections on the problems of human experimentation.Connecticut medicine, 25
Education Department of Health (1978)
Research involving those institutionalized as mentally infirm: report and recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchFederal Register, 43
Faulkner LR Cournos F (1993)
Consent to Voluntary Hospitalization
A. Moorhouse, D. Weisstub (1996)
Advance directives for research: ethical problems and responses.International journal of law and psychiatry, 19 2
P. Appelbaum (1996)
Drug-free research in schizophrenia: an overview of the controversy.IRB, 18 1
J. Menikoff, G. Sachs, M. Siegler (1992)
Beyond advance directives--health care surrogate laws.The New England journal of medicine, 327 16
Katz J (1993)
Human experimentation and human rightsSt Louis Univ Law J, 38
Dommell FW Jr Fletcher JC (1985)
A trial policy for the intramural programs of the National Institute of Health: consent to research with impaired human subjectsIRB Rev Hum Subjects Res, 7
J. Katz (1993)
Human experimentation and human rights.Saint Louis University law journal, 38 1
P. Appelbaum, T. Grisso (1995)
The MacArthur Treatment Competence Study. ILaw and Human Behavior, 19
Collegeonproblemsofdrugdepend (1995)
Human subject issues in drug abuse researchDrug and Alcohol Dependence, 37
W. Clinton (1995)
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G. Annas, M. Grodin (1992)
The Nazi Doctors and the Nuremberg Code Human Rights in Human Experimentation, 14
D. High, P. Whitehouse, S. Post, L. Berg (1994)
Guidelines for Addressing Ethical and Legal Issues in Alzheimer Disease Research: A Position PaperAlzheimer Disease & Associated Disorders, 8
R. Lifton (1986)
The Nazi Doctors: Medical Killing and the Psychology of Genocide
P. Appelbaum (1991)
Advance directives for psychiatric treatment.Hospital & community psychiatry, 42 10
M. Kapp (1994)
Proxy Decision Making in Alzheimer Disease Research: Durable Powers of Attorney, Guardianship, and Other AlternativesAlzheimer Disease & Associated Disorders, 8
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Mentally disabled research subjects. The enduring policy issues.JAMA, 276 1
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. 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Archives of General Psychiatry – American Medical Association
Published: Feb 1, 1997
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