Intentional exposure studies of environmental agents on human subjects: Assessing benefits and risks

Accountability in Research

Volumn 14, Issue 1, 2007, Pages 35-55

  Resnik, David B ^a  

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

Author keywords

Benefits; Environment; Environmental protection agency; Ethics; Exposure studies; Pesticides; Regulation; Risks

Indexed keywords

PESTICIDE;

ANIMAL; ARTICLE; ENVIRONMENTAL EXPOSURE; ETHICS; GOVERNMENT; HUMAN; RESEARCH ETHICS; RISK ASSESSMENT; UNITED STATES;

ANIMALS; ENVIRONMENTAL EXPOSURE; ETHICS, RESEARCH; HUMANS; PESTICIDES; RISK ASSESSMENT; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY;

EID: 34250011191     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/08989620601122842     Document Type: Article

References (43)

1. Amdur, R. (2002). Institutional Review Board Handbook. Boston: Jones and Bartlett.
2. American Cancer Society. (2006). Known and Probable Human Carcinogens. Available at http://www.cancer.org/docroot/PED/content/PED_1_3x_Known_and_Probable_Carcinogens.asp?sitearea=PED. Accessed October 3, 2006.
3. Ascherio, A., Chen, H., Weisskopf, M., O'Reilly, E., McCullough, M., Calle, E., Schwarzschild, M., Thun, M. (2006). Pesticide exposure and risk for Parkinson's disease, Annals of Neurology, 60: 197-203.
4. Burroughs, V., Maxey, R., and Levy, R. (2002). Racial and ethnic differences in responses to medicines: Towards individualized pharmaceutical treatment, J National Medical Association, 94(10 suppl.): s1-s26.
5. Cohen, S. (1995). Human relevance of animal carcinogenicity studies, Regulatory Toxicology and Pharmacology, 21: 75-80.
6. Coronado, G., Thompson, B., Strong, L., Griffith, W., Islas, I. (2004). Agricultural task and exposure to organophosphate pesticides among farmworkers, Environmental Health Perspectives, 112: 142-147.
7. Council for the International Organization of Medical Sciences (CIOMS). (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available at http://www.cioms.ch/frame_guidelines_nov_2002.htm. Accessed September 21, 2006.
8. Emanuel, E., Wendler, D., Grady, C. (2000). What makes clinical research ethical? JAMA, 283: 2701-2711.
9. Environmental Health Perspectives. (1993). Toxicity tests in animals: Extrapolating to human risks, Environmental Health Perspectives, 101: 396-401.
10. EPA. (2006a). Protections for Human Subjects in Research. Available at http://www.epa.gov/fedrgstr/EPA-GENERAL/2006/February/Day-06/g1045.htm. Accessed September 18, 2006.
11. EPA (2006b). Human Studies Division. Available at http://www.epa.gov/nheerl/hsd/. Accessed September 18, 2006.
12. EPA. (2006c). Risk Assessment for Carcinogens. Available at http://www.epa.gov/ttn/atw/toxsource/carcinogens.html. Accessed September 22, 2006.
13. EWG. (1998). The English Patients: Human Experiments and Pesticide Policy. Washington, D.C.: Environmental Working Group.
14. Forthofer, R. and Lee, E. (1995). Introduction to Biostatistics. New York: Academic Press.
15. Gallin, J. (2002). Principles and Practice of Clinical Research. San Diego: Academic Press.
16. Gerde, P. (2005). Animal models and their limitations: On the problem of highto- low dose extrapolations following inhalation exposures, Experimental Toxicology and Pathology, 57(1 suppl.): 143-146.
17. Glauert, H., Lu, Z., Kumar, A., Bunaciu, R., Patel, S., Tharappel, J., Stemm, D., Lehmler, H., Lee, E., Robertson, L., and Spear, B. (2005). Dietary vitamin E does not inhibit the promotion of liver carcinogenesis by polychlorinated biphenyls in rats, J Nutrition, 135: 283-286.
18. Goldman, L., and Links, J. (2004). Testing toxic compounds in human subjects: Ethical standards and good science, Environmental Health Perspectives, 112: A458-459.
19. International Conference on Harmonization. (2006). Good Clinical Practice Guidelines. Available at http://www.fda.gov/cder/guidance/959fnl.pdf. Accessed September 21, 2006.
20. Kato, I., Watanabe-Meserve, H., Koenig, K., Baptiste, M., Lillquist, P., Frizzera, G., Burke, J. (2006). Agency for Toxic Substances and Disease Registry. Case studies in environmental medicine: Lead toxicity. Available at http://www.atsdr.cdc.gov/HEC/CSEM/lead/. Accessed October 3, 2006.
21. Kerhl, H. (2006). Controlled human exposure studies within the EPA. Presentation at Duke-OHRP Conference on Research Ethics, Durham, NC, September 26, 2006.
22. Krimsky, S. (2003). Science in the Private Interest. Lanham, MD.: Rowman and Littlefield.
23. Levine, R. (1988). Ethics and the Regulation of Clinical Research. 2nd ed. New Haven, CT: Yale University Press.
24. Lockwood, A. (2004). Human testing of pesticides: Ethical and scientific considerations, Am J Public Health, 94: 1908-1916.
25. Memorial Sloan Kettering Cancer Center. (2006). Lung Cancer Risk Assessment. Available at http://www.mskcc.org/mskcc/html/12463.cfm. Accessed September 23, 2006.
26. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report. Washington, D.C.: U.S. Government Printing Office.
27. NIEHS. (2006). Strategic Plan 2006. Available at http://www.niehs.nih.gov/external/plan2006/home.htm. Accessed September 19, 2006.
28. NRC. (2004). Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, D.C.: National Academy Press.
29. Nuremberg Code. (1947). Available at http://www.hhs.gov/ohrp/references/nurcode.htm. Accessed September 27, 2006.
30. NTP. (2006). About the NTP. Available at http://ntp-server.niehs.nih.gov/. Accessed September 22, 2006.
31. Ratto, J., Wong, H., Liu, J., Fahy, J., Boushey, H., Solomon, C., and Balmes, J. (2006). Effects of multiday exposure to ozone on airway inflammation as determined using sputum induction, Environmental Health Perspectives, 114: 209-212.
32. Resnik, D. and Portier, C. (2005). Pesticide testing on human subjects: Weighing benefits and risks, Environmental Health Perspectives, 113: 813-817.
33. Resnik, D. and Wing, S. (In Press). What we can learn from CHEERS: A postmortem, Am J Public Health.
34. Robertson, H. and Gorovitz, S. (2000). Pesticide toxicity, human subjects, and the Environmental Protection Agency's dilemma, J Contemporary Health Law and Policy, 16: 427-458.
35. Sass, J. and Needleman, H. (2004). Industry testing of toxic pesticides on human subjects concluded "no effect," despite the evidence, Environmental Health Perspectives, 112: A150-151.
36. Shamoo, A. and Resnik, D. (2006). Strategies to minimize risks and exploitation in phase one trials on healthy subjects, Am J Bioethics 6(3): W1-13.
37. Straus, S., Richardson, W., Glasziou, P., and Haynes, R. (2005). Evidence Based Medicine. Oxford: Churchill Livingston.
38. Trautmann, N. (2005). The dose makes the poison-or does it? ActionBioscience, January 2005. Available at http://www.actionbioscience.org/environment/trautmann.html. Accessed October 3, 2006.
39. Toimela, T. and Tahti, H. (2004). Mitochondrial viability and apoptosis induced by aluminum, mercuric mercury, and methylmercury in cell lines of neural origin, Archives of Toxicology, 78: 565-574.
40. Trull, A., Demers, L., Holt, D., Johnston, A., Tredger, J., and Price, C. (eds.). (2002). Biomarkers of Disease. Cambridge: Cambridge University Press.
41. Wendler, D., Belsky, L., Thompson, K., Emanuel, E. (2005). Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit, JAMA, 294: 826-832.
42. Wood, A., and Darbyshire, J. (2006). Injury to research volunteers-the clinicalresearch nightmare, N Engl J Med, 354: 1869-1871.
43. World Medical Association. (2005). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at http://www.wma.net/e/policy/b3.htm. Accessed September 21, 2006.