Eliminating the daily life risks standard from the definition of minimal risk

Journal of Medical Ethics

Volumn 31, Issue 1, 2005, Pages 35-38

  Resnik, D B ^a  

^a NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMBIGUITY; ARTICLE; HEALTH HAZARD; HUMAN; MEDICAL RESEARCH; PHYSICAL EXAMINATION; PROBABILITY; PSYCHOLOGIC TEST; RISK ASSESSMENT; STANDARDIZATION; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

CHILD; CONSENSUS; ETHICS, RESEARCH; FETUS; HARM REDUCTION; HUMANS; INFORMED CONSENT; PRISONERS; RISK ASSESSMENT; SAFETY; TERMINOLOGY; UNITED STATES;

EID: 13444305478     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2004.010470     Document Type: Article

References (29)

1. CFR 46.102(i). See also 21 CFR 50.3(k).
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9. CFR 46.404.
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11. 45 CFR 46.406.
12. 45 CFR 46.407.
13. 45 CFR 46.404.
14. 45 CFR 46.306(a).
15. 45 CFR 46.207.
16. 45 C.F.R. 46.116(d).
17. 45 CFR 46.117(c)(2).
18. 45 CFR 46.110(b); see also 21 CFR 56.110.
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24. Grimes v Kennedy Krieger Institute, Inc, 782 A.2d 807 (Md. 2001). In the only other case to address minimal risk in research, a court ruled that a surrogate decision-maker may not consent to greater than minimal risk, non-beneficial research for a child or mentally disabled adult. See TD v New York State Office of Mental Health, 650 NYS 2d 173 (1996).
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