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David Wendler, PhD, Ezekiel J. Emanuel, MD, PhD and Reidar K. Lie, MD, PhD

The authors are with the Department of Clinical Bioethics, National Institutes of Health, Bethesda, Md. Reidar K. Lie is also with the Department of Public Health and Primary Health Care, University of Bergen, Norway.

Correspondence: Requests for reprints should be sent to David Wendler, PhD, Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892 (e-mail: dwendler{at}nih.gov).

We proposed conditions under which health investigators may provide research participants with less than the worldwide-best methods. Hyder poses a number of questions for this framework, and we consider his points in turn. First, as Hyder points out, current data suggest that social factors have a significant impact on health. Our claim that inequalities in health care have contributed to inequalities in health was not meant to deny the importance of the social determinants of health or to imply that inequalities in health care are more important than these factors.

Second, Hyder points out that it is important to develop a way of analyzing when interventions can be implemented in host countries. Our goal, however, was to establish a framework to ground the ethical relevance of the question of whether interventions can be implemented in the host country. In our view, this previous work was especially important given the argument, made by many commentators, that researchers have an obligation to provide research subjects with the best methods in all cases.

Third, our use of the Glaser Foundation example was not intended to imply that health researchers have an obligation to provide subjects with health services. Rather, this example was intended as a counterexample to the argument that researchers have an obligation to provide the best methods in all cases because they are clinicians. Specifically, the Glaser Foundation example reveals that clinicians do not have an obligation, in all cases, to provide the best methods in the clinical setting. This conclusion undercuts the argument that researchers’ status as clinicians entails such an obligation in the research setting.

Fourth, our framework is intended to facilitate research on interventions that may benefit those living in developing countries. As Hyder points out, standards, such as national research standards, are needed to ensure that such research does not, in practice, exploit its subjects.

Fifth, Hyder rightly points out that institutional review board competencies and the nature of institutional review board review for multinational research are important concerns.

Finally, we agree that individuals from the developing world should be more involved in the planning, conduct, and reporting of research trials. We hope our framework, which requires input from host communities, will help in realizing this important goal.

This Article Extract Full Text (PDF) Submit a response Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Wendler, D. Articles by Lie, R. K. Search for Related Content PubMed Articles by Wendler, D. Articles by Lie, R. K.