Response to peers - Discussion 13 - ERM

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Institutional Review Boards (IRBs) are an essential link in the subject protection program, and their function defines the ethical credentials of research. There has been a furor in the country over the number of deaths in clinical research and allegations of unethical research. Clinical trials have been discussed in the medical and lay press, and even in the parliament, these discussions called for strengthening the subject protection program. The Central Drug Standards and Control Organization (CDSCO) amended Schedule Y by issuing three amendments to introduce new compensation rules and registration of IRBs. IRBs in India face a variety of challenges and need support from the regulators or independent experts (Qiao, 2018). It is also an opportunity to revamp the subject protection program and strengthen the IRB functioning. An independent advisory body comprising of experts who have hands-on experience in administering IRBs is essential to provide support to IRBs. It should be independent of regulatory influence and work with IRBs to strengthen them.

The Common Rule is a federal policy regarding Human Subjects Protection that applies to 17 Federal agencies and offices. It does not apply to federal agencies that have not signed the agreement (e.g., Department of Labor, etc.) The main elements of the Common Rule include:

Requirements for assuring compliance by research institutions. Requirements for researchers' obtaining and documenting informed consent (Mazur, 2012). Requirements for Institutional Review Board (IRB) membership, function, operations, research review, and record keeping.

IRBs are one of the most important mechanisms for protecting subjects. All efforts must be made to ensure that IRBs across the country are competent. There is an urgent need for oversight of IRB functions. The regulators need to have a division that will have oversight over IRB functions, monitor them regularly, auditing them sometimes, and protecting human subjects. To support the regulator, there should be national or regional ethics forums that will work with the IRBs so that issues are covered better and clinical research gains ground.

References

Qiao, Haiping. (2018). A brief introduction to institutional review boards in the United States. Pediatric Investigation. 2. 46-51. 10.1002/ped4.12023.

Mazur, Dennis. (2012). The IRB's Role in Risk Assessment. Joural of Cliinical Research Best Bractices. 8.