Virtual Mentor. August 2001, Volume 3, Number 8.
Clinical Trials in Developing Countries
Those conducting Western-style clinical trial research in developing countries must consider the manner in which ethical principals are implemented within local standards of care.
Sam Huber and Faith Lagay, PhD
The past year has seen much discussion on participation by physicians from developed countries in research conducted in less-developed countries. The World Medical Association revised its Declaration of Helsinki, a statement of principles for the ethical conduct of medical research, in October 2000. Earlier this year, the National Bioethics Advisory Commission (NBAC) issued a report on ethical and policy issues in international research, and the AMA passed a new recommendation on ethical considerations in international research at its 2001 Annual Meeting in June. The Council for International Organizations of Medical Sciences is currently revising its 1993 guidelines for the ethical conduct of research involving human subjects.
Harold Shapiro and Eric Meslin, NBAC's chair and executive director, respectively, summarize their committee's position in Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries. In Research Involving Human Subjects in Developing Countries Greg Koski and Stuart Nightingale comment on the NBAC report and on the Declaration of Helsinki, and draw some conclusions of their own.
There is much agreement among NBAC, Helsinki, and AMA guidelines on many aspects of clinical research ethics. All subscribe to the need for fully informed consent; all require that the proposed research address a health problem within the host country, and that research protocols be approved by ethics review boards or committees. The main sticking point among various groups is over the study design—particularly the design of the trial's control arm. The authors of both articles cited here suggest that the Helsinki demand for a control that employs "the best current prophylactic, diagnostic, and therapeutic methods" available may be too rigid. Shapiro and Meslin grant that the "an experimental intervention should normally be compared with an established, effective treatment . . . whether or not that treatment is available in the host country." That, they say, is the "presumed standard." However, they can envision situations in which the condition being studied is not life threatening and the only useful research design (from the host country's point of view) may require a less effective control intervention than the current "best therapy" in developed countries. The authors stipulate that such an exception to the Helsinki Declaration would have to be approved by ethics review committees in both the host and visiting countries.
There is also disagreement over the necessity to make a successful new intervention available to research subjects after the trial is over. The Helsinki Declaration requires this, and, to the NBAC authors, it is "an especially important ethical obligation." Koski and Nightengale agree with the spirit of the requirement but believe that it will be difficult to implement for many reasons, not least of which is that "a single trial can rarely determine how best to treat or prevent a disease in all settings, or even in the setting in which it was conducted."
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