Are the new EPA regulations concerning intentional exposure studies involving children overprotective?

IRB Ethics and Human Research

Volumn 29, Issue 5, 2007, Pages 15-19

  Resnik, David B ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

CHILD; GOVERNMENT; HUMAN; HUMAN EXPERIMENT; LEGAL ASPECT; PEDIATRICS; REVIEW; UNITED STATES;

CHILD; HUMAN EXPERIMENTATION; HUMANS; PEDIATRICS; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY;

EID: 35348884163     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (22)

1. Resnik D. The new EPA regulations for protecting human subjects: Haste makes waste. Hastings Center Report 2.007;37(1):17-21;
2. U.S. Environmental Protection Agency. Protections for Subjects in Human Research. Federal Register 71(24):6137-6176.
3. Resnik D, Wing S. Lessons learned from the Children's Environmental Exposure Research Study. American Journal of Public Health 2007;97:414-418.
4. Emanuel E, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711.
5. Kahn J, Mastroianni A, Sugarman J. Changing claims about justice in research: An introduction and overview. In: Kahn J, Mastroianni A, Sugarman J, eds. Beyond Consent: Seeking Justice in Research. New York: Oxford University Press, 1999. p. 1-11.
6. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Department of Health, Education and Welfare, 1979, p. 7, http://www.hhs.gov/ ohrp/humansubjects/guidance/belmont.htm.
7. Mastroianni A, Kahn J. Swinging on the pendulum. Hastings Center Report 2001;31(3):21-28.
8. Kopelman L. Children as research subjects: A dilemma. Journal of Medicine and Philosophy 2000;25:745-764.
9. Food and Drug Administration. Best Pharmaceuticals for Children Act (2002). http://www.fda.gov/opacom/laws/pharmkids/contents.html.
10. 40 CFR 26.203.
11. 40 CFR 26.202(a).
12. American Academy of Pediatrics. Summer safety tips, part 1. http://www.aap.org/advocacy/releases/summertips.htm.
13. 45 CFR 46.404.
14. 45 CFR 46.102(1).
15. See ref. 3, Emanuel et al. 2000.
16. 45 CFR 46.406.
17. See ref. 7, Kopelman 2000.
18. Environmental Protection Agency. Children's Health Protection (2006). http://yosemite.epa.gov/ochp/ochpweb.nsf/content/homepage. htm.
19. Environmental Protection Agency, Human Health Research Strategy (2003). http://www.epa.gov/nheerl/humanhealth/HHRS_final_ web.pdf.
20. Resnik D. Intentional exposure studies of environmental agents on human subjects: Assessing benefits and risks. Accountability in Research 2006;14:35-55.
21. See ref. 2, Resnik and Wing 2007.
22. See ref. 18, EPA 2003.