Assessing Institutional Ethics Committees in India Using the IRB-RAT.

Area of Science:

• Medical ethics
• Global health research ethics
• Health research systems in LMICs

Background:

• Institutional ethics committees (IECs) are crucial for protecting human participants in research.
• IECs in low- and middle-income countries (LMICs) are often in early developmental stages.
• Understanding IEC functioning is vital for improving research participant protection and scientific quality in LMICs.

Purpose of the Study:

• To assess the functioning of IECs at two medical colleges in Gujarat, India.
• To identify perceived strengths and weaknesses in IEC operations from the perspective of IEC members and faculty.
• To provide data for targeted improvements in research ethics oversight in the region.

Main Methods:

• Utilized the Institutional Review Board Researcher's Assessment Tool (IRB-RAT) for assessment.
• Administered the IRB-RAT to 42 IEC and faculty members at two Indian medical colleges.
• Employed t tests to compare ideal and descriptive ratings across eight IRB-RAT scales.

Main Results:

• Significant differences were found between ideal and current descriptive ratings on all IRB-RAT scales.
• Ideal ratings were consistently higher than current descriptive ratings across all assessed domains (<.001).
• This indicates a perceived gap between the desired and actual functioning of the IECs.

Conclusions:

• The study highlights specific areas for improvement in IEC functioning in Gujarat, India.
• Findings offer insights into the values and perceptions of Indian IECs regarding research ethics.
• Results can inform strategies to strengthen research ethics infrastructure and participant protection in LMICs.