Restructuring and Building Capacity for Ethics Review at the Kenya Medical Research Institute (KEMRI)

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Investigator: Craig Cohen, MD, MPH
Sponsor: NIH John F. Fogarty International Center

Location(s): Kenya

Description

The volume and complexity of research conducted at the Kenya Medical Research Institute (KEMRI) has significantly increased in recent years. As a consequence of this desirable growth, current review systems have experienced a persistent strain and backlog due to the increase in research proposal submissions. This has necessitated the need for restructuring and expansion of office facilities, secretariat staff, and services. Building on the long-standing research and training collaboration between the University of California, San Francisco (UCSF) and KEMRI, this project will initiate a restructuring of the ethical review process at KEMRI. The project will establish an independent unit and will ensure it is appropriately staffed, trained, and resourced within the Institute to oversee the ethical review process at KEMRI. To achieve this, we will pilot the implementation of a multi-committee model in which several committees will work simultaneously to review protocols. We will further train reviewers for specialized review of highly complex protocols. To expedite and improve efficiency, we will design an electronic system for submission of protocols that will be accessible to all research centers in KEMRI. The independent unit will also provide bioethics training for scientists within the Institute and establish guidelines for review that will be utilized in the committees that will be created. UCSF, with its well developed bioethics unit and AAHRPP-accredited Human Research Protection Program (HRPP), is an ideal partner to support this initiative at KEMRI, particularly as a long-standing collaboration between the two institutions already exists. It is envisaged that partnership through this project will strengthen and enhance the Institute's collaboration with the UCSF Program in Medical Ethics, and will furthermore transform the research review system at KEMRI for use by all KEMRI researchers and affiliated collaborations. PUBLIC HEALTH RELEVANCE: Building on the long-standing and extensive research collaboration between the University of California, San Francisco (UCSF) and Kenya Medical Research Institute (KEMRI), this project will initiate a restructuring of the ethical review process at KEMRI. The project will establish an independent unit and will ensure it is appropriately staffed, trained, and resourced within the Institute to oversee the ethical review process at KEMRI.