Helsinki discords: FDA, ethics, and international drug trials

The Lancet

Volumn 373, Issue 9657, 2009, Pages 13-14

  Kimmelman, Jonathan ^a   Weijer, Charles ^b   Meslin, Eric M ^c  

^a MCGILL UNIVERSITY   (Canada)

^b UNIVERSITY OF WESTERN ONTARIO   (Canada)

^c Indiana University   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PRACTICE; DRUG MARKETING; HEALTH CARE ORGANIZATION; HUMAN; LAW; MEDICAL ETHICS; MEDICAL SOCIETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; STANDARD;

EID: 58049151944     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(08)61936-4     Document Type: Note

References (9)

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2. World Medical Association. Declaration of Helsinki (October, 2008). http://www.wma.net/e/policy/b3.htm (accessed Oct 25, 2008).
3. Department of Health and Human Services, Food and Drug Administration. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Fed Reg (April 28, 2008). http://www.fda.gov/cber/rules/forclinstud.pdf 22800-16. (accessed Nov 9, 2008).
4. Department of Health and Human Services, Food and Drug Administration. Guidance for industry: acceptance of foreign studies (March, 2001). http://www.fda.gov/cber/gdlns/clinical031301.pdf (accessed Nov 9, 2008).
5. Thiers F.A., Sinskey A.J., and Berndt E.R. Trends in the globalization of clinical trials. Nat Rev Drug Discov 7 (2008) 13-14
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7. National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries, vol 1 (2001). http://bioethics.georgetown.edu/nbac/clinical/Vol1.pdf (accessed Oct 25, 2008).
8. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries (2002). http://www.nuffieldbioethics.org/fileLibrary/pdf/errhdc_fullreport001.pdf (accessed Nov 9, 2008).
9. Friedmann T. The ASGT and ethical codes for research. Mol Ther 16 (2008) 1643-1644