The new EPA regulations for protecting human subjects: Haste makes waste

Hastings Center Report

Volumn 37, Issue 1, 2007, Pages 17-21

  Resnik, David B ^a  

^a NONE

Author keywords

[No Author keywords available]

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EID: 33847005060     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: 10.1353/hcr.2007.0013     Document Type: Review

References (22)

1. Environmental Working Group, "The English Patients: Human Experiments and Pesticide Policy" (Washington, D.C.: Environmental Working Group, 1998), http://www.ewg.org/reports/english/English.pdf. The EPA has the authority to regulate pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act and other laws.
2. D. Resnik and C. Portier, "Pesticide Testing on Human Subjects: Weighing Benefits and Risks," Environmental Health Perspectives 113 (2005): 813-17.
3. Ibid.
4. Croplife America v. EPA (U.S. Fed. Ct. App. Dist. Columbia, 2003).
5. National Research Council, Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues (Washington, D.C.: National Academy Press, 2004).
6. E. Stokstad, "EPA Draft Rules for Human Subjects Draw Fire," Science 309 (2005): 232.
7. Organic Consumers Association, "EPA & Chemical Industry to Study Effects of Known Toxic Chemical on Children," http://www.organicconsumers. org/epa-alert.htm; National Resources Defense Council, "EPA Head Defends Pesticide Testing on Children," http://www.nrdc.org/bushrecord/ health_pesticides.asp.
8. D. Resnik and S. Wing, "What Can We Learn from CHEERS?" American Journal of Public Health, forthcoming.
9. Ibid.
10. Statement by Stephen L. Johnson. Available at: http://www.epa.gov/cheers/ (accessed May 31, 2006).
11. Environmental Protection Agency, Protections for Human Research Subjects, 40 C.F.R. 9 and 26, Federal Register 71, no. 24 (February 6, 2006): 6138-76.
12. J. Jones, Bad Blood: The Tuskegee Syphilis Experiment (New York: The Free Press, 1993).
13. R. Dresser, When Science Offers Salvation (New York: Oxford University Press, 2001).
14. The 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, D.C.: Department of Health, Education and Welfare, 1979), http://www.hhs.gov/ ohrp/humansubjects/guidance/belmont.htm.
15. Department of Health and Human Services, "Secretary's Advisory Committee on Human Research Protections," index, http://www.hhs.gov/ohrp/ sachrp/ (accessed June 1, 2006).
16. Results of PubMed Search for "pesticide testing ethics human," February 14, 2006, not including letters to the editor or news stories. The articles were: Resnik and Portier; C. Oleskey et al., "Pesticide Testing in Humans: Ethics and Public Policy," Environmental Health Perspectives 112 (2004): 914-19;
17. A. Lockwood, "Human Testing of Pesticides: Ethical and Scientific Considerations," American Journal of Public Health 94 (2004): 1908-16.
18. See Institute of Medicine, Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (Washington, D.C.: National Academy Press, 2005);
19. Resnik, R. Sharp, and D. Zeldin, "Research on Environmental Health Interventions: Ethical Problems and Solutions," Accountability in Research 12 (2005): 69-101.
20. Resnik and Portier, "Pesticide Testing on Human Subjects."
21. E. Meslin, E. Thomson, and J. Boyer, "The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research Institute," Kennedy Institute of Ethics Journal 7 (1997): 291-98; National Human Genome Research Institute, "The ELSI Research Program," index, http://www.genome.gov/10001618 (accessed June 2, 2006).
22. Environment News Service, "EPA's Latest Human Pesticide Testing Rule Called Illegal, Immoral," http://www.ens-newswire.com/ens/jan2006/2006-01- 25-05.asp (accessed May 31, 2006).