Rethinking the responsiveness requirement for international research

The Lancet

Volumn 374, Issue 9692, 2009, Pages 847-849

  Wolitz, Rebecca ^a   Emanuel, Ezekiel ^a   Shah, Seema ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFRICA; ARTICLE; BURKITT LYMPHOMA; CANCER RESEARCH; CHILD; CHILDHOOD CANCER; DEVELOPING COUNTRY; DRUG INDUSTRY; DRUG RESEARCH; ENDEMIC DISEASE; HEALTH CARE INDUSTRY; HEALTH SERVICES RESEARCH; HUMAN; INFORMED CONSENT; KENYA; PRIORITY JOURNAL; RESEARCH ETHICS; RESEARCH SUBJECT; RISK BENEFIT ANALYSIS; UGANDA; WORLD HEALTH ORGANIZATION;

EID: 69449101734     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(09)60320-2     Document Type: Note

References (24)

1. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries (2002), Nuffield Council on Bioethics, London. http://www.nuffieldbioethics.org/go/ourwork/developingcountries/publication_309.html (accessed Jan 29, 2009).
2. National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries (2001), National Bioethics Advisory Commission, Bethesda. http://bioethics.georgetown.edu/nbac/pubs.html (accessed Jan 29, 2009).
3. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects (2002), CIOMS, Geneva. http://www.cioms.ch/frame_guidelines_nov_2002.htm (accessed Jan 29, 2009).
4. London A.J. Responsiveness to host community health needs. In: Emanuel E.J. (Ed). The Oxford textbook of clinical research ethics (2008), Oxford University Press, Oxford 737-744
5. World Medical Association General Assembly. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Int Bioethique 15 (2004) 124-129
6. Grady C. Ethics of international research: what does responsiveness mean?. Virtual Mentor 8 (2006) 235-240. http://virtualmentor.ama-assn.org/2006/04/pfor2-0604.html (accessed Jan 29, 2009).
7. Shapiro H.T., and Meslin E.M. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med 345 (2001) 139-142
8. Wertheimer A. Exploitation (1996), Princeton University Press, Princeton
9. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Moral standards for research in developing countries: from "reasonable availability" to "fair benefits". Hastings Cent Rep 34 (2004) 17-27
10. Gbadegesin S., and Wendler D. Protecting communities in health research from exploitation. Bioethics 20 (2006) 248-253
11. Carse A.L., and Little M.O. Exploitation and the enterprise of medical research. In: Hawkins J.S., and Emanuel E.J. (Eds). Exploitation and developing countries: the ethics of clinical research (2008), Princeton University Press, Princeton 206-245
12. Kant I., and Gregor M.J. Groundwork of the metaphysics of morals (1998), Cambridge University Press, Cambridge
13. Emanuel E.J., Wendler D., Killen J., and Grady C. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 189 (2004) 930-937
14. Schelling T.C. Hockey helmets, concealed weapons, and daylight saving: a study of binary choices with externalities. J Conflict Resolut 17 (1973) 381-428
15. Global Forum for Health Research. The 10/90 report on health research 2001-2002 (2002), Global Forum for Health Research, Geneva. http://www.globalforumhealth.org/filesupld/1090_report_01-02/01_02_front_matt.pdf (accessed Feb 6, 2009).
16. Kantor R., Katzenstein D.A., Efron B., et al. Impact of HIV-1 subtype and antiretroviral therapy on protease and reverse transcriptase genotype: results of a global collaboration. PLoS Med 2 (2005) e112
17. Sachs J. The end of poverty: economic possibilities for our time (2005), Penguin Press, New York
18. Resnik D.B. Developing drugs for the developing world: an economic, legal, moral, and political dilemma. Dev World Bioeth 1 (2001) 11-32
19. Sixty-First World Health Assembly. Global strategy and plan of action on public health, innovation and intellectual property. http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf (accessed March 2, 2009).
20. Kettler H. Commentary 5.2: bringing innovations for diseases of poverty to market-the case of paromomycin for visceral leishmaniasis. In: Lavery J.V., Grady C., Wahl E.R., and Emanuel E. (Eds). Ethical issues in international biomedical research: a casebook (2007), Oxford University Press, New York 97-102
21. Pécoul B. New drugs for neglected diseases: from pipeline to patients. PLoS Med 1 (2004) e6
22. Kremer M., and Glennerster R. Strong medicine: creating incentives for pharmaceutical research on neglected diseases (2004), Princeton University Press, Princeton
23. Racing down the pyramid: big drugmakers' love affair with America is coming to an end. The Economist (Nov 13, 2008). http://www.economist.com/business/PrinterFriendly.cfm?story_id=12601852 (accessed Feb 26, 2009).
24. Barton J.H., and Emanuel E.J. The patents-based pharmaceutical development process: rationale, problems, and potential reforms. JAMA 294 (2005) 2075-2082