When Should "Riskier" Subjects Be Excluded from Research Participation?

Kennedy Institute of Ethics Journal

Volumn 8, Issue 3, 1998, Pages 307-327

  Wendler, Dave ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

AGE; ANALYTICAL APPROACH; ARTICLE; AUSTRALIA; BIOMEDICAL AND BEHAVIORAL RESEARCH; DECISION MAKING; ETHICS; FEMALE; FETUS; FREEDOM; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; HUMAN RIGHTS; INTERNATIONAL COOPERATION; KIDNEY DISEASE; MALE; METHODOLOGY; PATIENT; PATIENT SELECTION; PERSONAL AUTONOMY; PERSONNEL; PRACTICE GUIDELINE; PREGNANCY; PREGNANT WOMAN; PRENATAL EXPOSURE; PROFESSIONAL STANDARD; RESEARCH SUBJECT; RISK; RISK ASSESSMENT; SOCIAL CONTROL; SOCIAL JUSTICE; UNITED KINGDOM; UNITED STATES; VOLUNTARY WORKER;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH;

AGE FACTORS; AUSTRALIA; DECISION MAKING; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FEMALE; FETUS; FREEDOM; GOVERNMENT REGULATION; GREAT BRITAIN; GUIDELINES; HUMAN EXPERIMENTATION; HUMAN RIGHTS; HUMANS; INTERNATIONAL COOPERATION; INTERNATIONALITY; KIDNEY DISEASES; MEN; PATIENT SELECTION; PATIENTS; PERSONAL AUTONOMY; PHARMACEUTICAL PREPARATIONS; PREGNANCY; PREGNANT WOMEN; PRENATAL EXPOSURE DELAYED EFFECTS; RESEARCH DESIGN; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; SOCIAL CONTROL, FORMAL; SOCIAL JUSTICE; UNITED STATES; VOLUNTARY WORKERS; WOMEN;

EID: 0032151399     PISSN: 10546863     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. ANHMRC. Australian National Health and Medical Research Council. 1992. NHMRC Statement on Human Experimentation and Supplementary Notes, 1992. Canberra: Australian Government Printing Office.
2. British Paediatric Association, Ethics Advisory Committee. 1992. Guidelines for the Ethical Conduct of Medical Research Involving Children. London: British Paediatric Association.
3. Case Studies. 1986. Can a Healthy Subject Volunteer to Be Injured in Research? Hastings Center Report 16 (4): 31-33.
4. DHHS. United States Department of Health and Human Services. 1991. Protections of Human Subjects, Title 45 Code of Federal Regulations Part 46.
5. FDA. Food and Drug Administration. 1993. Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs; Notice. [HHS (FDA), 93D-0236.] Federal Register 58 (139, 22 July): 39406-16.
6. Mastroianni, Anna C.; Faden, Ruth; and Federman, Daniel, eds. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, volume 1, Report. Washington, DC: National Academy Press.
7. Moreno, Jonathan D. 1994. Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials. In Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, volume 2, Workshop and Commissioned Papers, ed. Anna C. Mastroianni, Ruth Faden, and Daniel Federman, pp. 29-34. Washington, DC: National Academy Press.
8. Royal College of Physicians. 1990. Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects: Report, 2d ed. London.
9. Sorahan, T.; Prior, P.; Lancashire, R. J.; et al. 1997. Childhood Cancer and Parental Use of Tobacco: Deaths from 1971 to 1976. British Journal of Cancer 76: 1525-31.