Testing toxic compounds in human subjects: Ethical standards and good science [2]

Environmental Health Perspectives

Volumn 112, Issue 8, 2004, Pages

  Goldman, Lynn R ^a   Links, Jonathan M ^a  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALDICARB; PESTICIDE;

ADULT; CLINICAL PROTOCOL; CLINICAL STUDY; DATA ANALYSIS; DOSE RESPONSE; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL IMPACT ASSESSMENT; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; LETTER; MALE; MEDICAL ETHICS; MEDICAL RESEARCH; METHODOLOGY; NORMAL HUMAN; PHYSICAL DISEASE; PRIORITY JOURNAL; PRIVACY; PSYCHOLOGICAL ASPECT; RISK BENEFIT ANALYSIS; STANDARDIZATION; STATISTICAL ANALYSIS; TOXICITY TESTING; VOLUNTEER;

CHEMICAL INDUSTRY; CONFLICT OF INTEREST; DRUG INDUSTRY; HUMAN EXPERIMENTATION; HUMANS; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PESTICIDES; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; RISK ASSESSMENT; SAMPLE SIZE; TOXICITY TESTS; TRUTH DISCLOSURE; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY;

EID: 3042556388     PISSN: 00916765     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Letter

References (14)

1. Charnley G, Patterson J. 2004. Ethical standards of studies involving human subjects [Letter]. Environ Health Perspect 112:A152-153.
2. Chart IS, Manley A, Youngren SH. 2004. Study criticisms unjustified [Letter]. Environ Health Perspect 112:A151-152.
3. FDA (Food and Drug Administration). 2003a. Protection of Human Subjects. 21CFR50.
4. FDA (Food and Drug Administration). 2003b. Institutional Review Boards. 21CFR56.
5. Goldman LR, Beller M, Jackson RJ. 1990a. Aldicarb food poisonings in California, 1985-1988: toxicity estimates for humans. Arch Environ Health 45:141-147.
6. Goldman LR, Smith DF, Neutra RR, Saunders LD, Pond EM, Stratton J, et al. 1990b. Pesticide food poisoning from contaminated watermelons in California, 1985. Arch Environ Health 45:229-236.
7. Haines RG. 1971. Ingestion of Aldicarb by Human Volunteers: A Controlled Study of the Effect of Aldicarb on Man. Union Carbide Corporation Study No. ALD-03-77-2215. MRID No. 00101911. HED Doc. Nos, 007601, 010450. Washington, DC:U.S. Environmental Protection Agency.
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11. Tobia A, Ayers A, Blacker A, Hodges L, Carmichael N. 2004. Aldicarb study misrepresented in human testing debate [Letter]. Environ Health Perspect 112:A155-156.
12. U.S. EPA (U.S. Environmental Protection Agency). 1998. EPA Statement on Human Testing. Available: http://www.epa.gov/scipoly/sap/1998/december/epastmt.htm [accessed 3 May 2004].
13. U.S. EPA (U.S. Environmental Protection Agency). 2000. EPA Comments on the Use of Data from the Testing of Human Subjects. EPA-SAB-EC-00-017. Available: http://www.epa.gov/sab/pdf/ec0017.pdf [accessed 3 May 2004].
14. Wyld PJ, Watson CE, Nimmo WS, Watson N. 1992. A Safety and Tolerability Study of Aldicarb at Various Dose Levels in Healthy Male and Female Volunteers. Rhone-Poulenc, Lyon, France. Inveresk Clinical Research Report No. 7786. MRID No. 42373-01. HED Doc No 010459. Washington, DC:U.S. Environmental Protection Agency.