Moral problems in assessing research risk

IRB Ethics and Human Research

Volumn 22, Issue 5, 2000, Pages 3-7

  Kopelman, Loretta M ^a  

^a EAST CAROLINA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CHILD; HUMAN; HUMAN EXPERIMENT; PROFESSIONAL STANDARD; RISK ASSESSMENT;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CHILD; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; RISK ASSESSMENT;

EID: 0034286149     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564221     Document Type: Article

References (20)

1. Weijer C. Thinking clearly about research risk: implications of the work of Benjamin Freedman. IRB 1999; 21(6): 1-5.
2. Freedman B, Fuks A, Weijer C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Center Report 1993; 23(2): 13-19. Characteristically, Freedman sent me a copy of this paper encouraging me to comment. I regret it took me so long that he cannot respond to me.
3. Council for International Organizations of Medical Science (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland, 1993.
4. Kopelman LM. Children as research subjects: a dilemma Journal of Medicine and Philosophy 2000; 25(6):745-64. Some of the points made here are also made in that article, or adapted from it.
5. See ref. 1, Weijer 1999:3.
6. See ref. 4, Kopelman 2000; and Kopelman L. Estimating risk in human research. Clinical Research 1981; 29: 1-8;.
7. See ref. 4, Kopelman 2000.
8. "The MRC therefore defines negligible or less than minimal risk as equal to the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives of people in a stable society, or in the routine medical or psychological examination." South African Medical Research Council. Guidelines on Ethics for Medical Research,rev. ed. Tygerberg: MCR Corporate Communication Division, 1993.
9. See ref.4, Kopelman 2000; ref. 6, Kopelman 1981.
10. See ref. 2, Freedman et al. 1993.
11. See ref. 1, Weijer 1999.
12. See ref. 2, Freedman et al. 1993.
13. See ref. 2, Freedman et al. 1993:16.
14. See ref. 2, Freedman et al. 1993:18.
15. Janofsky J, Starfield B. Assessment of risk and research on children. Journal of Pediatrics 1981; 98:842-6.
16. Lascari AD. Risk of research in children [editorial]. Journal of Pediatrics 1981; 98:759-60.
17. National Bioethics Advisory Commission. Regulatory understanding of minimal risk. Testimony before the Human Subject Subcommittee of the National Bioethics Advisory Commission Meetings, Arlington, Virginia, 8 January 1998. Available at http:bioethics.gov/transcripts/index #jan98.
18. See ref. 4, Kopelman 2000.
19. See ref. 4, Kopelman 2000.
20. See ref. 4, Kopelman 2000.