title: Institutional review boards: Challenges and opportunities.
abstract: Institutional Review Boards (IRBs) are an important link in subject protection program, and their function defines ethical credentials of research. Of late there has been a furore in the country over the number of deaths in clinical research, and allegations of unethical research. Clinical trials have been discussed in 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 the Schedule Y, by issuing three amendments to introduce new compensation rules and registration of IRBs functioning in the country. IRBs in India face a variety of challenges, and need support from the regulators or independent experts. This 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 in the country. This body should be independent of regulatory influence and work with IRBs to strengthen them.
authors.affiliation: Scientia Clinical Services, Pune, Maharashtra, India.
authors.forename: Ravindra B
authors.initials: RB
authors.lastname: Ghooi
keywords: Challenges; Institutional Review Boards; clinical research; ethics; guidelines
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