Title: Assessing Institutional Ethics Committees in India Using the IRB-RAT
Abstract: Institutional ethics committees (IECs) are currently still in their infancy in low- to middle-income countries (LMICs), which may have important implications with regard to the oversight of the protection of human participants. Understanding how these IECs currently function is a critical first step in helping LMICs build infrastructures that support the protection of research participants and improve the scientific quality of health research worldwide. We assessed the functioning of the IECs at two medical colleges in Gujarat, India, by administering the Institutional Review Board Researcher's Assessment Tool (IRB-RAT) to 42 IEC and faculty members. The IRB-RAT includes eight scales assessing various domains related to how investigators and members perceive their ethics committees. Results from t tests revealed significant differences between ideal ratings and descriptive ratings on each of the IRB-RAT scales with ideal ratings being higher than current descriptive ratings on all of the scales (<.001). These findings suggest areas that can be targeted for improvement and also provide important information about the values of Indian IECs.