Assessing research risks systematically: The net risks test

Journal of Medical Ethics

Volumn 33, Issue 8, 2007, Pages 481-486

  Wendler, D ^a   Miller, F G ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; ETHICS; HUMAN; HUMAN EXPERIMENT; MEDICAL RESEARCH; PROFESSIONAL STANDARD; RESEARCH ETHICS; RESEARCH SUBJECT; RISK ASSESSMENT;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; NONTHERAPEUTIC HUMAN EXPERIMENTATION; RESEARCH SUBJECTS; RISK ASSESSMENT;

EID: 34547774733     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2005.014043     Document Type: Article

References (11)

1. Department of Health and Human Services. Code of Federal Regulations 45 CFR 46.111 a.
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3. Weijer C. The ethical analysis of risk. J Law Med Ethics 2000;28:344-61.
4. Karlawish JH. Research involving cognitively impaired adults. N Engl J Med 2003;348:1389-92.
5. Weijer C, Miller PB. When are research risks reasonable in relation to anticipated benefits? Nat Med 2004;10:570-3.
6. Nuremberg Military Tribunal. US v Karl Brandt, et al. The Nuremberg Code. 1947, requirement 5.
7. Grimes v Kennedy Krieger Institute. 782 A.2d 807 (Md. Ct. of App. 2001, reconsideration denied, 11 Oct 2001).
8. Weijer C. The ethical analysis of risks and potential benefits in human subjects research: history, theory and implications for US regulations. In: NBAC report: ethical and policy issues in research involving human participants. Vol. II: Commission papers and staff analysis. Bethesda: NBAC, 2001:1-29.
9. Katzman GL, Dogher AP, Patronas NJ. Incidental findings on brain magnetic resonance imaging from 1000 asymptomatic volunteers. JAMA 1999;282:36-9.
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11. Institute of Medicine. Ethical conduct of clinical research involving children. Washington, DC: National Academies Press, 2004, http://www.nap.edu (accessed 5 Apr 2006).