Strengthening IRB Review and Monitoring of Research in Uganda by Enhanced Trainin

描述（由申请人提供）：在资源有限的国家，涉及人类受试者的全球卫生研究继续扩大。美国国立卫生研究院（NIH）等资助机构正越来越多地参与艾滋病毒/艾滋病和妇幼保健等具有伦理挑战性的科学领域。接受NIH资助或任何其他美国政府资助的研究人员必须获得在美国和外国机构进行合作研究的伦理批准。随着研究领域变得越来越复杂，显然需要更多地培训当地的内部审查委员会成员和工作人员。负责审查复杂协议的伦理委员会在行政、监管、社会、文化和伦理方面存在许多差异，这些差异导致研究延误和对研究参与者的保护受到损害。马凯雷雷大学-约翰霍普金斯大学（MU-JHU）研究合作已经参与了二十多年的NIH资助研究。他们参与了许多临床试验和相关的实验室研究，以解决艾滋病毒、结核病和疟疾共感染的相互作用。目前，他们参与了两个网络（MTN和IMPAACT）的研究，有大量的研究参与者。为了有效和可持续地开展这些研究，重要的是要有一个高效和训练有素的伦理委员会，能够独立审查和监督复杂的研究方案。这项拟议的研究旨在加强乌干达国家科学和技术委员会（UNCST）开发一套资源材料“机构审查委员会工具包”的能力，以协助其地方机构审查委员会履行其《机构审查法》的条款，并满足管理机构（如人力资源项目和美国食品和药物管理局）的期望。通过举办讲习班和教育项目，当地研究人员和社区代表可以为改进该国涉及人体受试者的协议审查和实践作出贡献。这些培训和实践指导将有助于国家科学技术中心制定监督临床试验和美国国立卫生研究院资助的研究的监测和评估计划。此外，将由当地民营局使用评价电子数据库跟踪系统是否可能通过国内当地民营局广泛实施。

DESCRIPTION (provided by applicant): Global health research that involves human subjects in limited-resource setting countries continues to expand. Funding agencies such as National Institute of Health (NIH) are becoming more involved in ethically challenging scientific areas such as HIV/AIDS and maternal and child health. Research investigators who receive NIH funding or any other US government funding are required to obtain ethical approval for collaborative research at both U.S. and foreign institutions where research will be conducted. As research areas are becoming more complex, the need for more training of local IRB members and staff are becoming evident. There exist many differences in the administrative, regulatory, social, cultural and ethical perspectives of the ethics committees responsible for reviewing the complex protocols which result in research delays and compromised protection for research participants. Makerere University- Johns Hopkins University (MU-JHU) Research Collaboration has been involved in NIH funding research for over twenty years. They have been involved in many clinical trials and related lab studies addressing the interaction of HIV, TB and Malaria co- infections. Presently they are involved in studies with two networks (MTN & IMPAACT), with large study participants. In order to carry out these research efficiently and sustainably, it will be important for the site to have access to an efficient and well-trained ethics committees who are able to independently review and monitor complex research protocols. This proposed research is intended to strengthen the capacity of Uganda National Council for Science and Technology (UNCST) in developing a set of resource materials "Institutional Review Board Toolkit" to assist its local IRBs in meeting the terms of their FWA and the expectations of regulatory bodies such as OHRP, and the U.S. Food and Drug Administration (FDA). Through conducting workshops and educational programs, the local researchers and Community Representatives can contribute to improvement of protocol review and practices involving human subjects in the country. These trainings and hands-on mentoring will facilitate UNCST's effort in developing a monitoring and evaluation plans for overseeing clinical trials and NIH-funded studies. In addition, an electronic data base tracking system will be evaluated by use by local IRBs for possible wide implementation through the local IRBs within the country. PUBLIC HEALTH RELEVANCE: This proposed research is intended to strengthen the capacity of Uganda National Council for Science and Technology (UNCST) in developing a set of resource materials "Institutional Review Board Toolkit" to assist its local IRBs in meeting the terms of their FWA and the expectations of regulatory bodies such as OHRP, and the U.S. Food and Drug Administration (FDA). Through conducting workshops and educational programs, the local researchers and Community Representatives can contribute to improvement of protocol review and practices involving human subjects in the country. These trainings and hands-on mentoring will facilitate UNCST's effort in developing a monitoring and evaluation plans for overseeing clinical trials and NIH-funded studies. In addition, an electronic data base tracking system will be evaluated by use by local IRBs for possible wide implementation through the local IRBs within the country.