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）：符合道德规范的研究需要对普遍的道德规范做出承诺，例如《赫尔辛基宣言》和《贝尔蒙特报告》中表达的规范，并通过认识到这些规范的实施以及对相互竞争的道德原则和流程可能因文化而异。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) 认识到需要确保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确保所有人类受试者研究符合合理的道德原则和流程的政策和程序，但承认其相对权重的文化和国家间差异。发展这样的理解并展示其在实践中应用的模型是本提案的重点。 埃默里大学的众多合作伙伴之一是位于印度新德里的印度公共卫生基金会 (PHFI)。这种合作伙伴关系提供了埃默里大学全球健康研究组合的缩影。埃默里大学是 NHLBI/Ovations 资助的南亚心血管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 NHLBI/Ovations 资助的 11 个网络之一，汇集了来自 PHFI 和埃默里大学以及网络合作伙伴新德里全印度医学科学研究所 (AIIMS) 的研究人员；钦奈马德拉斯糖尿病研究基金会 (MDRF)；卡拉奇阿迦汗大学 (AKU)；和新德里慢性病控制中心 (CCDC)。 COE 为合作研究项目的开发提供了工具，特别是涉及复杂的多中心研究的项目。这些项目需要对其人类受试者研究活动进行有效审查。 我们建议开发和试点一种模型，用于对人类受试者协作研究进行无缝、彻底和高效的审查。从审查政策和程序开始，我们将制定、试点和实施对合作伙伴 IRB 所看到的范围内的协议进行联合审查的流程，即从豁免研究到需要召集的委员会审查的研究。我们的提议的前提是遵守政策和程序，以更好地保护研究中的人类参与者，并且实际上它们可以在合作机构内广泛采用。汲取的经验教训也将与 NHLBI/Ovations 慢性病网络中的其他机构相关。我们还将通过我们所属的其他 NIH 研究网络传播和分享我们的发现，从而提高该提案的附加值。 尊重每个 IRB 的自主权。我们期望 公共卫生相关性：本提案的目标是开发、试点和实施对人类受试者研究进行无缝、彻底、高效和尊重的并行审查的流程，以促进复杂的、多机构联邦资助的人类受试者研究的实施由 NHLBI/Ovations 资助的南亚心血管代谢疾病预防和控制卓越中心开发。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。自始至终，重点将放在相互尊重和能力建设上，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