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

描述（由申请人提供）：涉及资源有限国家的人类受试者的全球健康研究继续扩大。国家卫生研究所等供资机构越来越多地参与艾滋病毒/艾滋病和妇幼保健等具有道德挑战性的科学领域。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美国和外国机构的合作研究的伦理批准。随着研究领域变得越来越复杂，对当地IRB成员和工作人员进行更多培训的必要性变得越来越明显。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，导致研究延误和对研究参与者的保护受损。马凯雷雷大学-约翰霍普金斯大学（MU-JHU）研究合作组织参与NIH资助研究已有二十多年。他们参与了许多临床试验和相关的实验室研究，解决艾滋病毒，结核病和疟疾合并感染的相互作用。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，研究中心必须能够获得高效和训练有素的伦理委员会，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技术理事会（UNCST）在开发一套资源材料“机构审查委员会工具包”方面的能力，以帮助其当地IRB满足其FWA的条款以及OHRP和美国食品药品监督管理局（FDA）等监管机构的期望。通过举办研讨会和教育项目，当地研究人员和社区代表可以为改进方案审查和涉及该国人类受试者的实践做出贡献。这些培训和实践指导将有助于科技委努力制定监测和评价计划，以监督临床试验和国家卫生研究院资助的研究。此外，当地IRB将对电子数据库跟踪系统进行评估，以便通过国内当地IRB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技术理事会（UNCST）在开发一套资源材料“机构审查委员会工具包”方面的能力，以帮助其当地IRB满足其FWA的条款以及OHRP和美国食品药品监督管理局（FDA）等监管机构的期望。通过举办研讨会和教育项目，当地研究人员和社区代表可以为改进方案审查和涉及该国人类受试者的实践做出贡献。这些培训和实践指导将促进UNCST制定监督临床试验和NIH资助的研究的监测和评估计划的努力。此外，当地IRB将对电子数据库跟踪系统进行评估，以便通过国内当地IRB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.