Creating Internet-based Research Review, Approval, and Monitoring for Global Heal

Case Western Reserve University, Cleveland OH

Investigators

Abstract

DESCRIPTION (provided by applicant): This pilot project aims to reduce the barriers to joint review of protocols by the University Hospitals Case Medical Center Institutional Review Board (UHCMC IRB) and the Papua New Guinea Institute of Medical Research Institutional Review Board (PNG IMR IRB), promote a common research compliance monitoring program and provide education exchanges and bioethics training. This project will be an active and integrated collaboration between three groups-The Center for Global Health &Diseases (CGHD) of the CWRU School of Medicine, the University Hospitals Case Medial Center IRB (UHCMC IRB), and the Papua New Guinea Institute of Medical Research IRB (PNG IMR IRB)--who are all interrelated stakeholders in the submission, review and conduct of jointly reviewed research studies in Papua New Guinea (PNG). Each represents a significant and individual player in the overall submission and review process for research protocols. In addition, there will be active participation from representatives and IRB members of the CWRU IRB, the CWRU Cancer IRB, and the Department of Bioethics (CWRU). The impact of this pilot project will allow timelier review of joint protocols. The time from submission of a protocol for IRB review and the time when the study can actually begin in the field will be radically reduced from current review and approval time (from one year+ for a new study and 3-4 months for an amendment). This will allow the NIH and other funded studies to be implemented and completed in a timelier manner. The education programs will provide social and cultural education about Papua New Guinea for the members of the UHCMC IRB that will aid them in their understanding and review of jointly reviewed protocols. Bioethics training will provide members of the PNG IMR IRB with needed perspectives of the bioethics issues related to various types of research studies, especially those involving vulnerable populations, conducted in PNG. The interactions among the PNG IMR IRB members and the CWRU IRB (SBER IRB) and CWRU Cancer IRB will provide mutual exchanges of policies and procedures to assist in review of international studies at CWRU and enhance protocol review capabilities of the PNG IMR IRB. The outcomes of this pilot project will allow timelier joint reviews of protocols, research compliance monitoring program that will provide quality improvement and evaluation of research studies conducted in Papua New Guinea, and education programs to provide greater understanding of the social and cultural issues involved in conducting research in PNG, and finally bioethics training for members of the PNG IMR IRB to facilitate their review of research studies conducted in their country. An important outcome of this project will be programs and monitoring tools that can be adapted by US based IRBs working partnership with collaborators at other international research sites. PUBLIC HEALTH RELEVANCE: The goals of this pilot project are to reduce regulatory barriers and enhance harmonization of the joint review of protocols, develop and implement a targeted research compliance monitoring program, and provide education and bioethics training for the members of the University Hospitals Case Medical Center Institutional Review Board (UHCMC IRB) and the Papua New Guinea Institute of Medical Research IRB (PNG IMR IRB) that will assist them in the review of joint protocols and strengthen human subjects protections. The outcomes of this pilot project will allow timelier joint reviews of protocols, research compliance monitoring program that will provide quality improvement and evaluation of research studies conducted in Papua New Guinea, and education programs to provide greater understanding of the social and cultural issues involved in conducting research in PNG, and finally bioethics training for members of the PNG IMR IRB to facilitate their review of research studies conducted in their country. An important outcome of this project will be programs and monitoring tools that can be adapted by US based IRBs working in partnership with collaborators at other international research sites.