Institutional review boards: Challenges and opportunities.

Area of Science:

• Clinical Research Ethics
• Regulatory Science

Background:

• Concerns regarding clinical trial safety and ethical conduct have led to increased scrutiny of Institutional Review Boards (IRBs).
• Recent public and parliamentary discussions in India highlighted the need for enhanced subject protection programs.
• The Central Drug Standards and Control Organization (CDSCO) has amended Schedule Y, introducing new compensation rules and IRB registration requirements.

Purpose of the Study:

• To address the challenges faced by IRBs in India.
• To propose a framework for strengthening the subject protection program and IRB functioning.
• To advocate for enhanced support and oversight for IRBs.

Main Methods:

• Review of recent regulatory amendments by the CDSCO, including changes to Schedule Y.
• Analysis of the current challenges confronting IRBs in the Indian context.
• Proposal for the establishment of an independent advisory body for IRB support.

Main Results:

• Regulatory amendments have been introduced to improve compensation rules and IRB registration.
• IRBs in India encounter various operational and ethical challenges.
• The need for external support and expert guidance for IRBs has been identified.

Conclusions:

• Strengthening the subject protection program requires robust IRB functioning.
• An independent advisory body, free from regulatory influence, is essential to support and enhance IRB capabilities.
• Revamping the subject protection program presents an opportunity to bolster ethical research oversight in India.