Pacific Institute for Research and Evaluation (PIRE) seeks to strengthen the human subjects protection system and infrastructure of one of its international collaborating partners, the University of Liberia by providing training and technical assistance in establishing a human subjects protection program to ensure that all future research is conducted in accordance with OHRP guidelines. PIRE was recently awarded an NIH grant to conduct a randomized community trial to evaluate HIV/STD prevention intervention in partnership with investigators based at the University of Liberia Medical School. PIRE expects that this partnership will enhance the University's capacity to conduct much needed medical research in the future. Presently, the University of Liberia does not have an Institutional Review Board or systematic procedures for protection of human subjects. PIRE's new partnership with the University of Liberia and the NIH grant 1S07 RR018149-01 PIRE received last year to enhance its human subjects protection infrastructure creates a unique opportunity to share technology and resources with this extremely resource-poor country. The overall objective of the proposed project is to assist the University of Liberia in establishing an Institutional Review Board and systematic procedures for protecting human subjects in the conduct of its research. To accomplish this objective, PIRE will implement three main activities to support this initiative: (1) provide technical assistance to University of Liberia administrators, staff and faculty; (2) train University of Liberia staff and faculty; and (3) export and transfer technology developed by PIRE to enhance protection of human subjects. (1) PIRE will provide technical assistance to University of Liberia administrators in setting up an IRB committee, establishing IRB policies and procedures, recruiting, selecting and reviewing qualifications of potential IRB committee members and establishing procedures for investigators to use in submission of protocols. PIRE scientists will also provide technical assistance to investigators in developing protocols for current studies that are in compliance with NIH human subject protection guidelines. (2) PIRE will collaborate with the University of Liberia to create training opportunities both in Liberia and at PIRE's corporate office in Calverton, Maryland. These training activities will focus on proper procedures for establishing and administering an Institutional Review Board, providing training to Liberian investigators on the safe and ethical conduct of clinical research, establishing tracking systems for monitoring human subject protocols and coordinating adverse event reporting. (3) PIRE will engage in a number of technology transfer activities designed to establish culturally sensitive human subjects protection protocols in consideration of Liberian customs and norms. PIRE will establish mechanisms for Liberian IRB members and investigators to access PIRE's electronic archive of protocols, training materials, consent forms, templates, interviewer scripts, etc. that have been approved for other projects by PIRE's IRB.
| Kennedy, S B; Harris, A O; Oudemans, E et al. (2006) Developing capacity to protect human research subjects in a post-conflict, resource-constrained setting: procedures and prospects. J Med Ethics 32:592-5 |
