Proposed regulations for research involving those institutionalized as mentally infirm: A consideration of their relevance in 1996

IRB Ethics and Human Research

Volumn 18, Issue 5, 1996, Pages 1-5

  Levine, Robert J ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0344313264     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564615     Document Type: Article

References (16)

1. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations. DHEW Publication No. (OS)78-0006, Washington, D.C., 1978.
2. Department of Health, Education, and Welfare: Protection of human subjects: Proposed regulations on research involving those institutionalized as mentally infirm. Federal Register 43(223) (17 November 1978): 53950-56.
3. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and Their Implementation. Stock No. 040-000-00452-1, Washington, D.C.: U.S. Government Printing Office, 1981.
4. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Implementing Human Research Regulations: The Adequacy and Uniformity of Federal Rules and of Their Implementation. Stock No. 040-000-004781-8, Washington, D.C.: U.S. Government Printing Office, 1983.
5. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Research Involving Children: Report and Recommendations. DHEW Publication No. (OS) 77-0004, Washington, D.C., 1977.
6. Levine, RJ: Ethics and Regulation of Clinical Research Baltimore: Urban & Schwarzenberg, 1986.
7. Reatig, N: Government regulations affecting psychopharmacology research in the United States: Implications for the future. In: Human Psychopharmacology: Research and Clinical Practice, vol. II, ed. GD Burrows and JS Werry. Greenwich, Conn.: JAI Press, 1981.
8. Marini, JL: Methodology and ethics: Research on human aggression. IRB 1980; 2(5): 1-4.
9. Levine, RJ, and Lebacqz, K: Some ethical considerations in clinical trials. Clinical Pharmacology & Therapeutics 1979; 25: 728-41.
10. Levine, RJ: Total artificial heart implantation - eligibility criteria. JAMA 1984; 252: 1458-59.
11. Levine, C, Dubler, NN, and Levine, RJ: Building a new consensus: Ethical principles and policies for clinical research on HIV/AIDS. IRB 1991; 13(1&2): 1-17.
12. Levine, RJ: Treatment use and sale of investigational new drugs. IRB 1987; 9(4): 1-4.
13. Department of Health and Human Services: Expanded availability of investigational new drugs through a parallel track mechanism for people with AIDS and other HIV-related disease. Federal Register 57(73) (15 April 1992): 13244-59.
14. Fried, C: Medical Experimentation: Personal Integrity and Social Policy. New York: American Elsevier, 1974.
15. Shirkey, HC: Therapeutic orphans. Journal of Pediatrics 1968; 72: 119-120.
16. Levine, RJ: The impact of HIV infection on society's perception of clinical trials. Kennedy Institute of Ethics Journal 1994; 4(2): 93-98.