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

PHFI-埃默里大学合作开展无缝、彻底和高效的人体受试者研究

• 批准号: 8051372
• 负责人: Dorairaj Prabhakaran
• 金额: $ 5.42万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2012-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8051372
• 关键词: Adopted; Area; Asia; Belmont Report; Bilateral; Chronic Disease; Clinical; Collaborations; Communication; Complex; Country; Developed Countries; Developing Countries; Development; Diabetes Mellitus; Disease; Eligibility Determination; Ensure; Ethics; Foundations; Funding; Future; Goals; HIV; Helsinki Declaration; Human; Human Subject Research; India; Institutes; Institution; International; Investigation; Joints; Learning; Medical; Mission; Modeling; National Heart, Lung, and Blood Institute; Pakistan; Participant; Policies; Prevention; Procedures; Process; Protocols documentation; Public Health; Qualifying; Regulation; Relative (related person); Research; Research Activity; Research Ethics Committees; Research Personnel; Research Project Grants; Research Subjects; Science; Site; Specific qualifier value; Training; United States National Institutes of Health; Universities; Weight; abstracting; common rule; disorder control; expedited review; global health; human subject; human subject protection; meetings; member; practical application; programs; sound; symposium

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.

说明(由申请人提供)：伦理研究需要致力于普遍的伦理规范，如《赫尔辛基宣言》和贝尔蒙报告中所表达的准则，同时认识到这些准则的实施以及对相互竞争的伦理原则和程序的相对重视可能因文化而异。随着全球健康成为埃默里大学的标志性主题之一，以及随之而来的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)认识到有必要确保对埃默里大学与合作研究人员合作的协议的审查和监督纳入政策和程序，以确保所有人类受试者的研究都符合合理的伦理原则和程序，同时承认文化和国家之间的相对权重差异。发展这样一种理解，并为其在实践中的应用示范一种模式，是本提案的重点。埃默里的众多合作伙伴之一是与位于印度新德里的印度公共卫生基金会(PHFI)。这一合作关系是埃默里全球健康研究组合的一个缩影。Emory是NHLBI/OVATIONS资助的南亚心脏代谢性疾病预防和控制英才中心(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，以及来自网络合作伙伴新德里全印度医学科学研究所(AIIMS)、金奈马德拉斯糖尿病研究基金会(MDRF)、卡拉奇阿加汗大学(AKU)和新德里慢性病控制中心(CCDC)的研究人员。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的审查。我们建议开发和试点一个模型，用于无缝、彻底和高效地审查协作的人类主题研究。从审查政策和程序开始，我们将制定、试行和实施联合审查各伙伴机构所看到的议定书的程序，即从豁免研究到需要由召集的委员会审查的程序。我们的建议的前提是，将遵守政策和程序，以更好地保护研究中的人类参与者，事实上，这些政策和程序可能在伙伴机构内得到广泛采用。所吸取的经验教训也将适用于全国卫生与公众健康倡议/治疗慢性病网络中的其他机构。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成果，从而提高这项提案的附加值。尊重每个内部审查委员会的自主权。我们预计 与公共卫生相关：这项建议的目标是开发、试点和实施对人类受试者研究进行无缝、彻底、高效和相互尊重的平行审查的过程，以促进由NHLBI/OVATIONS资助的南亚心脏代谢性疾病预防和控制卓越中心开发的复杂的、由联邦政府资助的多机构人类受试者研究的实施。我们提出的模型可以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，以确保满足45 CFR 46的要求。

项目成果

Review of multinational human subjects research: experience from the PHFI-Emory Center of Excellence partnership.

跨国人类受试者研究回顾：PHFI-埃默里卓越中心合作伙伴关系的经验。

• DOI: 10.20529/ijme.2012.086
• 发表时间: 2012
• 期刊: Indian journal of medical ethics
• 作者: Somsekhar,Hemalatha;Prabhakaran,Dorairaj;Tandon,Nikhil;Rousselle,Rebecca;Fisher,Sarah;Stein,AryehD
• 通讯作者: Stein,AryehD