Building a Joint International IRB for Moi University and Indiana University

Meslin, Eric

Abstract

The overall aim of the proposed research is to create and operate a new Ethics Review Committee between Indiana University and Moi University School of Medicine in Eldoret, Kenya This new international IRB will be responsible for reviewing and approving proposals undertaken jointly by these two universities or their partners in East Africa. In particular, our main objectives for this one-year grant are to first, establish the structural, ethical and legal framework for the joint committee, to be called the Moi University-Indiana University Ethics Review Committee (Moi-IU ERC) to provide timely and high quality ethical review of international collaborative research proposals;and, second to develop and provide specific training to the joint ERC members, administrators and staff to ensure that they have sufficient research ethics competency to undertake reviews of collaborative international protocols. Our program will provide training (in person and online) for committee members, reviewers and administrators at both institutions to ensure that they have the capacity to engage in review of collaborative international health research. Training will occur at specialized one-day workshops that will be a component of existing workshops called """"""""Teaching Skills in International Research Ethics (TaSkR), that are already funded by an existing Fogarty R25 grant. These sessions will provide both didactic and small group experiences (e.g., mock IRB reviews) to ensure that this new committee (consisting of faculty from Indiana University and Moi University) can work well together. It will be supplemented by an on-line module designed for this experience which will be added to the suite of modules developed by the Collaborative Institutional Training Initiative (CITI).The outcome of these initiatives will be ethics competency standards that will be required as a condition of membership on the new Moi-IU ERC. Our program is also intended to provide the respective institutions with knowledge about relevant and applicable local, national and international guidelines, regulations and procedures for undertaking collaborative ethics review. Given the breadth of these, including the Common Rule, FDA, and other US domestic policies, and those governing research in Kenya including local standard operating procedures at Moi, and those of the Kenyan National Council for Science and Technology, our project will also focus its efforts this year ensuring that the relevant administrative, legal, and policy authorizations have been met. The outcomes will be negotiated in appropriate SOPs and a Memorandum of Understanding involving relevant parties.

Public Health Relevance

The goal of the proposed research is to create and operate a new Joint Ethics Review Committee between Indiana University and Moi University School of Medicine. The new international IRB will be responsible for reviewing and approving proposals undertaken jointly by these two universities or their partners in East Africa. Our program will provide training (in person and online) for committee members and reviewers, and assess its capacity for ongoing success and sustainability. We believe that this new committee will improve the quality and efficiency of the review of collaborative international research both universities ensuring that the twin goals of human subjects protection and encouraging important science will continue be met.