Ethics committee registration and re-registration with the regulatory authority in India.

ABSTRACT

Background: All ethics committees (ECs) that review and monitor clinical trials in India must be registered with the regulatory authority. We ascertained the status of registration and re-registration of ECs till December 2017. Methods: The ECs registered and re-registered with the Indian regulatory authority till December 2017 were extracted. The status of ECs was analysed according to the state, institute category and registration. Results: A total of 1260 ECs were registered, of which 14% were based in medical colleges, 2% in dental colleges, 61.2% in hospitals other than medical colleges and 8% as independent ECs. Of the recognized medical and dental colleges, only 37.3% and 10.9%, respectively, and 45.9% of ECs from teaching hospitals (other than medical and dental colleges) had registered with the regulatory authority. Of the 911 ECs eligible for re-registration, 516 (56.5%) had reregistered. Conclusion: A low proportion of registrations ofECs from eligible academic health institutions raises concern about adherence to regulatory guidelines and conduct of clinical trials in India. The lower re-registration of ECs helps in the identification of factors which should be addressed to facilitate clinical research in India.