ADDRESSING HUMAN SUBJECTS’ PROTECTIONS IN INTERNATIONAL CLINICAL RESEARCH: COMPARING DOMESTIC INSTITUTIONAL REVIEW BOARD POLICIES AGAINST AN INTERNATIONAL ETHICAL FRAMEWORK
Moore, Kymberly Ellisse
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Engaging in international clinical research is a complicated endeavor that requires special considerations to ensure research participants in host countries are afforded the same protections as domestic subjects. This research sought to examine how well IRBs in the United States address international human subjects’ protections in federally funded clinical studies by comparing current IRB policies and/or guidance documents to an ethical framework based on top five current ethical challenges when conducting multinational research. A systematic review was conducted to identify the top five ethical challenges in multinational research in the last five years, followed by a query using the National Institute of Health’s (NIH) Research Portfolio Online Reporting Tools (RePORT) to identify institutions currently funded to conduct international clinical research projects. Available institutional policies were reviewed to see if the top five ethical challenges were addressed. Finally, statistical analysis was conducted to determine if there were variables that affected the number of ethical challenges addressed in institutional policies or guidance documents. The top five ethical challenges when conducting multinational research were informed consent, social value, community engagement, fair benefits, and local review committees. Institutions were scored and weighed based on how many challenges were addressed in their policy and/or guidance documents. 51% of institutions addressed all five ethical challenges and 95% addressed at least three ethical challenges. In addition, the study revealed a statistically significant correlation suggesting that institutions with separate policies for international clinical research are more robust, encompassing more ethical considerations. Finally, the study showed areas needed for improvement as only half of the institutions addressed challenges related to fair benefits, i.e. post-study access to treatment.