Universality and its Limits: When Research Ethics Can Reflect Local Circumstances
Indiana University - Robert H. McKinney School of Law
March 10, 2012
Journal of Law, Medicine & Ethics, Vol. 30, p. 403, 2002
In recent years, many research trials in developing countries have been criticized because they would have been unethical in developed countries. For example, studies of therapy to prevent HIV-transmission from mother to child were criticized for employing a placebo control when a similar study in the United States would have required an active treatment control. In the view of many commentators, researchers may not employ a double standard in which studies that would be unacceptable in their own country are conducted instead in developing countries.
I argue in this paper that researchers can take into account local circumstances in applying universal principles of research ethics, with the result that studies may be ethical in some countries even though they are unethical in other countries. I further argue that while strong safeguards must be adopted to prevent exploitation of citizens of developing countries when local circumstances are taken into account, the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) are unduly strict. CIOMS requires that the therapy studied be made reasonably available in the host country after the clinical trial. By analogizing to non-research settings, I conclude that exploitation can be avoided by the provision of other kinds of benefit to the host country, such as royalty payments from sales of the therapy in developed countries.
Number of Pages in PDF File: 8
JEL Classification: I1Accepted Paper Series
Date posted: June 18, 2003 ; Last revised: March 12, 2012
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