The ethics of clinical trials in poor nations

(PhysOrg.com) -- Giving back to the community is one method of avoiding potential exploitation during clinical trials in the developing world, so writes Art Caplan in a piece published online this week in Clinical Pharmacology & Therapeutics.

Increased clinicalresearch is being carried out in developing countries, where there aredifficulties in adhering to the same ethical principles that governresearch in the developed world. The recent revelation that anexploitative experiment funded by the U.S. government was conducted inGuatemala in the 1940s is just one example of these issues. Well-intentioned research policies have been created to prevent humanrights violations, but these are not perfectly transferable to researchstudies in very poor nations. True informed consent may not beobtainable due to the subjects’ lack of understanding, dire livingconditions, or deference to religious leaders or family members. Given the difficulties of policy implementation, Caplan suggests that itis as important to decide “what will be given to those involved inresearch and their countrymen at the conclusion of clinical research asit is to battle over the nuances of research ethics requirements thatcannot in fact be implemented or monitored in any practical sense.” Byresearchers giving back to their trial subjects, an exploitativesituation - one in which those bearing all the risks receive none of thebenefits - would be avoided. However, the benefits would have to betailored to the needs and values of the receiving community and wouldhave to be monitored for efficacy.

More information:
DOI: 10.1038/CLPT.2010.208

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