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More Information on Ethics and Clinical Trials

National Bioethics Advisory Commission Report Dangerously Weakens International Protections

Report Provides Less Protection for Participants in International Research Than Declaration of Helsinki


April 30, 2001

The National Bioethics Advisory Commission (NBAC) today released a report that would put the U.S. in the unenviable position of endorsing ethics standards for American researchers that are lower than those required by the World Medical Association's Declaration of Helsinki. Whereas the recently revised (October 2000) Declaration actually strengthened protections in a number of critical regards, the NBAC has undermined some of these important steps forward, Public Citizen said today.

In three critical areas, the NBAC recommendations are inadequate:

  • Treatment for patients during clinical trials: While the Declaration made it clear that patients in the comparison groups in research of new therapies had to receive the "best current" therapy, regardless of where the research was conducted, the NBAC has created a loophole likely to be exploited by researchers who wish to provide only those therapies that are locally available: "Any study that would not provide the control group with an established effective treatment should include a justification for using an alternative design." (Recommendation 2.2)
  • Availability of treatment at trial completion: The NBAC would allow research to take place in a developing country even if there was no guarantee that any intervention proved effective during the trial would become available in the country of testing: "In cases in which investigators do not believe that successful interventions will become available to the host country population, they should explain to the relevant ethics review committee(s) why the research is nonetheless responsive to the health needs of the country and presents a reasonable risk/benefit ratio." (Recommendation 4.2)
  • American ethical review of American research: The NBAC report clearly states that, for the first time, studies submitted to the U.S. Food and Drug Administration (FDA) would require ethical review both in the U.S. and in the country in which the research is conducted, as opposed to the current situation where only foreign approval is required. While this appears to be a step forward, the NBAC has again made a loophole in its recommendation: "However, if the human participants protection system of the host country or a particular host country institution has been determined by the U.S. government to achieve all the substantive ethical protections outlined in Recommendation 1.1, then review by a host country ethics review committee alone is sufficient." (Recommendation 5.3) The requirements of Recommendation 1.1 are extremely vague; we are therefore concerned that in the future this will be used to permit research subject to U.S. government regulation without ethical review by American ethical committees.

"In each of these areas, the NBAC has carved a loophole that presents the real possibility of exploitation of developing country patients in trials subject to U.S. regulation," said Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group. "It is ironic that the very country that placed research ethics on the world agenda, by conducting the Nuremberg Trial of Nazi doctors for their experiments on prisoners, should now be leading the charge to weaken ethical protections."

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