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

描述(申请人提供)：在资源有限的国家中涉及人类受试者的全球健康研究继续扩大。国家卫生研究所(NIH)等资助机构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调查人员，在进行研究的美国和外国机构进行合作研究时，必须获得伦理上的批准。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IRB成员和工作人员。负责审查导致研究延误和对研究参与者的保护的复杂方案的伦理委员会在行政、监管、社会、文化和伦理观点上存在许多差异。Makerere大学-约翰霍普金斯大学(MU-JHU)研究合作已经参与NIH资助研究超过20年。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、结核病和疟疾联合感染之间的相互作用。目前，他们参与了两个网络(MTN和IMPAACT)的研究，研究参与者很多。为了有效和可持续地开展这些研究，重要的是该网站能够接触到一个高效和训练有素的道德委员会，这些委员会能够独立审查和监测复杂的研究方案。这项拟议的研究旨在加强乌干达国家科学和技术委员会(UNST)开发一套资源材料“机构审查委员会工具包”的能力，以帮助其地方IRBs满足其FWA条款和OHRP等监管机构以及美国食品和药物管理局(FDA)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类主体的方案审查和实践做出贡献。这些培训和实践指导将有助于联合国科学技术委员会努力制定监测和评估计划，以监督临床试验和NIH资助的研究。此外，一个电子数据库跟踪系统将由地方机构使用进行评估，以便可能通过该国的地方机构广泛实施。 公共卫生相关性：这项拟议的研究旨在加强乌干达国家科学和技术委员会(UNST)开发一套资源材料“机构审查委员会工具包”的能力，以帮助当地IRBs满足其FWA条款和OHRP等监管机构以及美国食品和药物管理局(FDA)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类主体的方案审查和实践做出贡献。这些培训和实践指导将有助于联合国科学技术委员会努力制定监测和评估计划，以监督临床试验和NIH资助的研究。此外，一个电子数据库跟踪系统将由地方机构使用进行评估，以便可能通过该国的地方机构广泛实施。

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.