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.

Prioritizing initiatives for institutional review board (IRB) quality improvement

“…For example, PIs/PCs rated the actual IRB 0.81 points lower (95% CI: -0.94 to -0.68), thus magnifying the difference between the actual and ideal IRBs. This finding is also consistent with previously published data that demonstrate that investigators rate the IRB lower than IRB members (Hall et al 2015;Reeser et al 2008;Chenneville et al 2014), and that investigators who had served on an IRB scored the RAT higher than those who had not served on an IRB (Reeser et al 2008). As with the site-specific differences, the most interesting differences between PIs/PCs and IRB members/staff concerned the item-specific pattern rather than the overall magnitude of the difference.…”

A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India

“…The importance of competent committees and comprehensive standards for REC functioning in LMICs is highlighted in the literature (Adams et al, 2014; Chenneville et al, 2014; Makhoul et al, 2014; Matar & Silverman, 2013; Silverman, Edwards, Shamoo, & Matar, 2013; Silverman & Sleem, 2014; Silverman et al, 2014). Nonetheless, concerns remain.…”

Ethics Committees in India: Past, present and future

“…[ 66 ] The IRB Researcher's Assessment Tool (RAT) is one such tool,[ 67 ] which has been used in Gujarat to assess the functioning of the IECs at two medical colleges. [ 68 ]…”