Accreditation of ethics committees in India: experience of an ethics committee

Ragini Kulkarni, Usha Saraiya

DOI: 10.20529/IJME.2015.064


Abstract

Many ethics committees (ECs) approving clinical trials in India have got themselves registered with the Drugs Controller General of India as per regulatory requirements. However, there is still scope to improve their functioning. Accreditation, which entails adherence to national and international standards, helps an EC to protect the rights, safety and well-being of research participants. The National Institute for Research in Reproductive Health (NIRRH) ethics committee for clinical studies has received recognition, or accreditation, from the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). An EC receives recognition from SIDCER if it meets five standards related to its structure and composition; adherence to specific policies; completeness of the review process; after-review process; and documentation and archiving. The extent to which these standards have been met is assessed in various ways, such as review of the EC’s records, interviews of selected EC members and observation of a full board meeting of the EC. This paper describes the experiences of the NIRRH EC during and after the process of receiving recognition.

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