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

Johns Hopkins University, Baltimore MD

Investigators

Abstract

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.