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

描述（由申请人提供）：伦理参与的研究需要对普遍伦理规范的承诺，例如赫尔辛基宣言和贝尔蒙特报告中所表达的那些，并认识到其实施以及相互竞争的伦理原则和过程的相对权重可能因文化而异。随着全球健康成为埃默里大学的标志性主题之一，以及埃默里大学研究组合的日益全球化，埃默里大学机构审查委员会（EUIRB）已经认识到需要确保对埃默里大学和合作伙伴研究人员合作的方案的审查和监督纳入政策和程序，以确保所有人类受试者研究保持与合理的道德原则和流程一致，但也承认其相对权重的文化和国家间差异。本提案的重点是形成这样一种理解，并展示一种在实践中应用的模式。 埃默里大学的许多合作伙伴关系之一是与印度公共卫生基金会（PHFI），位于印度新德里。这种伙伴关系提供了一个缩影埃默里大学的全球健康研究组合。Emory是NHLBI/Ovations资助的南亚心脏代谢疾病预防和控制卓越中心（COE）的发达国家合作伙伴，PHFI是发展中国家合作伙伴。COE是由NHLBI/Ovations资助的11个网络之一，汇集了来自PHFI和Emory的研究人员，以及来自新德里全印度医学科学研究所（AIIMS）的网络合作伙伴;马德拉斯糖尿病研究基金会，钦奈（MDRF）;阿加大学，卡拉奇（AKU）;和慢性病控制中心（CCDC），新德里。COE为合作研究项目的开发提供了一个工具，特别是那些涉及复杂的多中心调查的项目。这些项目需要对其人体研究活动进行有效审查。 我们建议开发和试点一个模型，无缝，彻底和有效的审查合作人类受试者的研究。从审查政策和程序开始，我们将制定、试行和实施对合作伙伴的IRB所看到的一系列协议进行联合审查的流程，即从豁免研究到需要召集委员会审查的研究。我们的建议是基于一个前提，即政策和程序将得到遵守，从而更好地保护人类参与研究，而且这些政策和程序实际上可能在伙伴机构内得到广泛采用。所吸取的经验教训也将与NHLBI/Ovations慢性病网络中的其他机构有关。我们还将通过我们参与的其他NIH研究网络传播和分享我们的研究结果，从而提高该提案的附加值。 尊重每个IRB的自主权。我们预计 公共卫生相关性：该提案的目标是开发、试点和实施一个无缝、全面、高效和尊重的人类受试者研究平行审查过程，以促进实施由NHLBI/Ovations资助的南亚心脏代谢疾病预防和控制卓越中心开发的复杂、多机构联邦资助的人类受试者研究。我们提出的模型是立即推广到任何其他双边或多边研究合作。在整个过程中，重点将是相互尊重和能力建设，以确保45 CFR 46的要求得到满足。

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.