PHFI-Emory Partnership for Seamless, Thorough and Efficient Human Subjects Resear

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DESCRIPTION (provided by applicant): Ethically-engaged research requires a commitment to universal ethical norms, such as those expressed in the Declaration of Helsinki and the Belmont Report, tempered by a recognition that their implementation and the relative weight given to competing ethical principles and processes may vary across cultures. With global health becoming one of Emory University's signature themes and the consequent increasing globalization of Emory's research portfolio, the Emory University Institutional Review Board (EUIRB) has recognized a need to ensure that the review and oversight of protocols in which Emory and partner investigators collaborate incorporates policies and procedures that ensure that all human subjects research remains consistent with sound ethical principles and processes, yet acknowledge cultural and inter-country differences in their relative weights. Developing such an understanding, and demonstrating a model for its application in practice, is the focus of the present proposal. One of Emory's many partnerships is with the Public Health Foundation of India (PHFI), located in New Delhi, India. This partnership provides a microcosm of Emory's global health research portfolio. Emory is the developed country partner and PHFI the developing country partner for the NHLBI/Ovations funded Center of Excellence for Prevention and Control of Cardiometabolic Diseases in South Asia (COE). The COE, which is one of a network of eleven funded by NHLBI/Ovations, brings together researchers from PHFI and Emory, and from network partners the All India Institute of Medical Sciences, New Delhi (AIIMS); the Madras Diabetes Research Foundation, Chennai (MDRF); The Aga Khan University, Karachi (AKU); and the Centre for Chronic Disease Control (CCDC), New Delhi. The COE provides a vehicle for development of collaborative research projects, especially those involving complex multicenter investigations. These projects require efficient review of their human subjects research activities. We propose to develop and pilot a model for seamless, thorough and efficient review of collaborative humans subjects research. Starting with a review of Policies and Procedures, we will develop, pilot and implement processes for joint review of protocols across the range of those seen by the partners' IRBs, namely from Exempt research to that requiring review by a convened committee. Our proposal is predicated on a premise of that the policies and procedures will be observed to result in better protection of human participants in research and that they may, in fact be adopted widely within the partner institutions. Lessons learned will also be relevant to other institutions across the NHLBI/Ovations network for chronic diseases. We will also disseminate and share our findings through other NIH research networks that we are part of, thus enhancing the value added from this proposal. respect for the autonomy of each IRB. We expect PUBLIC HEALTH RELEVANCE: The goal of this proposal is to develop, pilot, and implement a process of seamless, thorough, efficient and respectful parallel review of human subjects research to facilitate the implementation of complex, multi- institutional federally-funded human subjects research being developed by the NHLBI/Ovations funded Center of Excellence for Prevention and Control of Cardiometabolic Diseases in South Asia. The model we propose is immediately generalizable to any other bilateral or multilateral research collaboration. Throughout, the emphasis will be on mutual respect and capacity building to ensure that the requirements of 45 CFR 46 are met.