Research with cognitively impaired subjects unfinished business in the regulation of human research

Archives of General Psychiatry

Volumn 54, Issue 2, 1997, Pages 105-111

  Bannie, Richard J ^a,b  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA SCHOOL OF LAW   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; BELMONT REPORT; BIOMEDICAL AND BEHAVIORAL RESEARCH; DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; LEGAL APPROACH; MEDICAL ETHICS; MENTAL CAPACITY; MENTAL DISEASE; MENTAL HEALTH THERAPIES; MENTAL PATIENT; METHODOLOGY; MISCELLANEOUS NAMED GROUPS; NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS; PATIENT ADVOCACY; PERSONAL AUTONOMY; PROFESSIONAL STANDARD; PSYCHOLOGICAL ASPECT; REVIEW; RISK ASSESSMENT; STANDARD; TREATMENT WITHDRAWAL; UNITED STATES; VULNERABLE POPULATION;

BELMONT REPORT; BIOMEDICAL AND BEHAVIORAL RESEARCH; DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE; LEGAL APPROACH; MENTAL HEALTH THERAPIES; NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS;

ADVISORY COMMITTEES; ETHICS COMMITTEES, RESEARCH; ETHICS, MEDICAL; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; MENTAL DISORDERS; MENTALLY ILL PERSONS; PATIENT ADVOCACY; PERSONAL AUTONOMY; PERSONS; RESEARCH DESIGN; RISK ASSESSMENT; UNITED STATES; VULNERABLE POPULATIONS; WITHHOLDING TREATMENT;

EID: 0031066845     PISSN: 0003990X     EISSN: None     Source Type: Journal    
DOI: 10.1001/archpsyc.1997.01830140013002     Document Type: Article

References (30)

1. Tufts A. Apologies for Nazi crimes. Lancet. 1994; 344:803.
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. NEngl J Med. 1966:274:1354-1360.
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 LawJ. 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 Biomédical 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 Subjectes Res. 1985:7:1-6.
15. American College of Physicians. Cognitively impaired subjects. Ann Intern Med. 1989;111:843-848.
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.
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.
21. Appelbaum PS. Patients' competence to consent to neurobiological research. Accountability Res. 1996:4:241-251.
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. NEngl JMed. 1992;327:1165-1169.
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.
26. Kapp MB. Implications of the Patient SelfDetermination 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.
29. Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA. 1996:276:6772.
30. Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines. J Law Med Ethics. 1996;24:18-35.