Botswana Research Ethics Network: A Cross-National Approach to Ethics Review

描述（由申请人提供）：本提案响应RFA-OD-10-006，“加强美国国立卫生研究院支持的涉及人类受试者的全球健康研究计划”。具体而言，该提案响应了美国和发展中国家审查委员会之间的合作呼吁，“通过联合研讨会、短期交流和培训活动，提高审查委员会成员和工作人员与两个审查委员会审查的研究相关的行政、科学、社会文化和道德能力。”很明显，发展中国家的审查委员会工作人员和成员与他们在美国和其他发达国家的同行之间更大的沟通可以促进培训和提高当地审查的能力和质量的合作方法，以及增加发达国家的审查委员会工作人员和成员的文化和社会经济能力。建立协作计划的第一步是在irb之间建立关系和通信渠道。我们将召集国内审查委员会的代表、研究人员和博茨瓦纳的其他利益攸关方，以及在博茨瓦纳开展大型研究活动的美国机构——宾夕法尼亚大学、哈佛大学公共卫生学院、贝勒医学院和美国疾病控制与预防中心。在哈博罗内和费城举行的一系列为期一周的会议将侧重于确定研究人员和内部审查委员会面临的伦理、程序和文化挑战，探讨促进沟通和促进合作审查的战略，并制定实施计划。该项目的目的是为博茨瓦纳研究伦理网络奠定基础，该网络将：促进博茨瓦纳内部审查委员会与在博茨瓦纳开展主要研究活动的美国机构内部审查委员会之间的持续沟通；2. 提高博茨瓦纳和美国的IRB工作人员和成员的科学、道德和文化意识和能力；和3。制定方法，支持参与的内部审查委员会之间正在进行的协作审查过程，并制定实施计划。

DESCRIPTION (provided by applicant): This proposal responds to RFA-OD-10-006, "Program to Enhance NIH-supported Global Health Research Involving Human Subjects." Specifically, this proposal is responsive to the call for a collaborative effort among IRBs in the U.S. and developing countries to "Increase administrative, scientific, socio-cultural and ethical competencies of IRB members and staff related to research reviewed by both IRBs through joint workshops, short-term exchange and training activities." It is clear that greater communication between IRB staff and members in developing countries and their counterparts in the U.S. and other developed countries can facilitate a collaborative approach to training and improving the capacity and quality of local review, as well as increasing the cultural and socioeconomic competencies of IRB staff and members in developed countries. The first step in establishing collaborative programs is to establish relationships and communications channels amongst IRBs. We will bring together representatives of IRBs, researchers, and other stakeholders in Botswana and U.S. institutions that have large research activities ongoing in Botswana - the University of Pennsylvania, Harvard School of Public Health, Baylor College of Medicine, and the U.S. Centers for Disease Control and Prevention. A set of week-long meetings in Gaborone and in Philadelphia will focus on identifying the ethical, procedural, and cultural challenges that have faced researchers and IRBs, explore strategies to facilitate communications and promote collaborative reviews, and develop an implementation plan. The aims of this project are to lay the foundation for a Botswana Research Ethics Network that will: 1. facilitate ongoing communications among IRBs in Botswana and IRBs at U.S. based institutions with major research activities in Botswana; 2. enhance scientific, ethical, and cultural awareness and competencies of IRB staff and members in Botswana and the U.S.; and 3. develop methods that support an ongoing collaborative review process among involved IRBs and a plan for their implementation. PUBLIC HEALTH RELEVANCE: This project will open communication channels and facilitate collaboration among IRB staff and members in Botswana and their counterparts at U.S. institutions that have large research activities ongoing in Botswana. A set of week-long meetings in Gaborone and in Philadelphia will focus on identifying the ethical, procedural, and cultural challenges that have faced researchers and IRBs, explore strategies to facilitate communications and promote collaborative reviews, and develop an implementation plan. This effort will improve the capacity and quality of local review and increase the cultural and socioeconomic competencies of IRB staff and members in the U.S., resulting in higher quality ethical review of research.