Review of procedures for protecting human subjects in recent clinical studies of pesticides

Regulatory Toxicology and Pharmacology

Volumn 38, Issue 2, 2003, Pages 210-223

  Charnley, Gail ^a   Patterson, Jacqueline ^b  

^a HealthRisk Strategies   (United States)

^b Toxicology Excellence for Risk Assessment   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACEPHATE; ALDICARB; AZINPHOS METHYL; CARBAMATE INSECTICIDE; CHLORPYRIFOS; CHOLINESTERASE INHIBITOR; DICHLORVOS; DIMPYLATE; MALATHION; METHOMYL; ORGANOPHOSPHATE INSECTICIDE; OXAMYL; OXYDEMENTON METHYL; PESTICIDE; PHOSMET; TRIAZAMATE; UNCLASSIFIED DRUG;

CLINICAL PRACTICE; CLINICAL STUDY; DOCUMENT EXAMINATION; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; LEGAL LIABILITY; MEDICAL ETHICS; MEDICAL RESEARCH; PHYSICIAN; PRIORITY JOURNAL; PUBLIC HEALTH; REVIEW; STANDARDIZATION; TOXICITY;

EID: 0141615082     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0273-2300(03)00093-X     Document Type: Article

References (31)

1. Carly, J., 2000. Personal communication with J. Carly, US EPA, Office of Pesticide Programs. Update to list found in U.S. EPA 1999b. December.
2. Coulombe R.A. Natural toxins and chemopreventives in plants. Helferich W., Winter C.K. Food Toxicology. 2001;137-161 CRC Press, Boca Raton. Chapter 6.
3. CropLife America., 2002. Statement by Jay Vroom, CropLife America President, On the U.S. EPA letter regarding human testing. Available by contacting pgetter@croplifeamerica.org.
4. DeGeorge, J., Associate Director for Pharmacology and Toxicology, FDA Center for Drug Evaluation and Research. Presentation to the Joint EPA SAB/SAP meeting of the Data from Testing on Human Subjects Subcommittee. November 30, 1999. Meeting transcript pages 55-56. Available from http://www.epa.gov/oscpmont/sap/1999/november/jointsab.sap.pdf [accessed 31 January 2003].
5. Dourson M., Andersen M., Erdreich L., MacGregor J. Using human data to protect the public's health. Regul. Toxicol. Pharmacol. 33:2001;234-256.
6. Ebo D.G., Stevens W.J. IgE-mediated food allergy - extensive review of the literature. Acta Clin. Belgica. 56:2001;234-247.
7. FAO/WHO., 1998. Report of FAO WHO Joint Meeting on Pesticide Residues (JMPR). Rome, 21-30 September, 1998. Section 2.13 Procedures for estimating acute reference dose, p. 17. Food and Agriculture Organization/World Health Organization.
8. Freestone, S., 2002. Personal communication between Steven Freestone, Medical Director, Inveresk Research, and Abraham Tobia, Toxicology Fellow, Bayer CropScience. February 7, 2002.
9. ICH., 1997. ICH Topic E6, Guideline for Good Clinical Practice. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. CPMP/ICH/153/95. Available from http://www.emea.eu.int/pdfs/human/ich/013595en.pdf [accessed 3 October 2002].
10. Johnson, S., 2001. Letter from Stephen L. Johnson, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency (U.S. EPA), to Bruce Alberts, President, National Academy of Sciences. December 14, 2001.
11. Mattsson J.E. Do pesticides reduce our total exposure to food borne toxicants? Neurotoxicol. 21:2000;195-202.
12. McConnell E.E. The value of human testing of pesticides. Human and Ecological Risk Assessment. 7(6):2001;1575-1581.
13. MRC., 1999. Guidance on Good Clinical Practice and Clinical Trials in the NHS. Medical Research Council. Available from http://www.doh.gov.uk/research/documents/gcpguide.pdf [accessed 3 October 2002].
14. NAS/NRC., 1994. Science and Judgment in Risk Assessment. National Academy Press. Washington, DC. National Academy of Sciences/National Research Council.
15. NBAC., 2001. Ethical and Policy Issues in Research Involving Human Participants. Volume 1. Report and Recommendations of the National Bioethics Advisory Commission. Bethesda, MD. National Bioethics Advisory Commission. Available from http://www.georgetown.edu/research/nrcbl/nbac/human/overvol1.pdf [accessed 3 October 2002].
16. NRDC., 2001. EPA Reverses Ban on Testing Pesticides on Human Subjects. NRDC Backgrounder. November 28, 2001. Natural Resources Defense Council. Available from http://www.nrdc.org/media/pressreleases/011128a.asp [accessed 3 October 2002].
17. Nuremberg Code., 1947. Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949. Available from http://ohsr.od.nih.gov/nuremberg.php3 [accessed 3 October 2002].
18. Olson H., Betton G., Robinson D., Thomas K., Monro A., Kolaja, Lilly P., Sanders J., Sipes G., Bracken W., Dorato M., Van Deun K., Smith P., Burger B., Heller A. Concordance of the toxicity of pharmaceuticals in humans and animals. Regul. Toxicol. Pharmacol. 32:2000;56-67.
19. Robertson H.G., Gorovitz S. Pesticide toxicity, human subjects, and the environmental protection agency's dilemma. J. Contemp. Health Law Policy. 16:2000;427-458.
20. Sielken, R.L. Jr., Holden, L.R., 2003. The substantial power of human study data to contribute to the characterization of NOELs for cholinesterase inhibition in humans: a statistical analysis of recent studies. JSC Sielken, Bryan, TX. Unpublished report presented to the National Academy of Sciences Committee on the Use of Third party Toxicity Research with Human Research Participants on 19 March 2003.
21. Sneddon, P., 2002. Personal communication with P. Sneddon, Inveresk Research, on August 22, 2002.
22. Steinberg J.J. Environmental ethics. Editorial. Environ. Health Perspect. 108(3):2000;A108-109.
23. Toon, S., 2002. Personal communication with Steve Toon, CEO, Medeval Ltd., December 18.
24. U.S. EPA., 1998a. Guidelines for Neurotoxicity Risk Assessment. Federal Register 63(93) 26926-26954, 14 May 1998. Environmental Protection Agency. National Center for Environmental Assessment. Washington, DC.
25. U.S. EPA., 1998b. EPA Human Subjects Log, January 1-October 14, 1998. Environmental Protection Agency. Available from http://www.epa.gov/oscpmont/sap/1998/december/husuljc3.pdf [accessed 3 October 2002].
26. U.S. EPA., 1999a. Draft Revised Guidelines for Carcinogen Risk Assessment. NCEA-F-0644, July 1999. Environmental Protection Agency. National Center for Environmental Assessment. Washington, DC.
27. U.S. EPA., 1999b. Staff Background Paper for November 30, 1999 Meeting of SAB/SAP Joint Subcommittee on Data from Human Subjects. Environmental Protection Agency. Available from http://www.epa.gov/oscpmont/sap/1999/november/background-1130.pdf [accessed 3 October 2002].
28. U.S. EPA., 2000. Comments on the use of data from the testing of human subjects. A report by the Science Advisory Board and the FIFRA Scientific Advisory Panel. EPA-SAB-EC-00-017. Environmental Protection Agency. Science Advisory Board. Washington, DC.
29. U.S. EPA., 2001. Protection of the Environment: Protection of Human Subjects. 40 CFR 26. Environmental Protection Agency.
30. U.S. EPA., 2003. Human Testing; Advance Notice of Proposed Rulemaking. 40 CFR Chapter 1. Federal Register, vol. 68, page 42210. Wednesday, May 7, 2003.
31. WMA., 2000. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association. First adopted in 1964; most recent revision in 2000. Available from http://www.wma.net/e/policy/17-c_e.html [accessed 3 October 2002].