Ethics Committee Registration
In order to register a clinical trial, a sponsor, organization, or institution must have the approval of an Ethics Committee.
The ethics committee oversees research proposals involving human participants and the data they provide to ensure they comply with local and international ethical guidelines. In addition, they may also monitor studies once they begin and participate in follow-up actions after the research is completed, if necessary. Besides protecting the study subjects, they must also consider the potential risks to the community and the environment. The ethics committee is responsible for approving, rejecting, modifying, or stopping studies that do not adhere to the accepted standards.
National Ethics Committee Registry for Biomedical and Health Research (NECRBHR)
According to Chapter IV of the ‘New Drugs and Clinical Trials Rules 2019’, notified by The Ministry of Health and Family Welfare (Department of Health and Family Welfare), any organization conducting Biomedical and Health Research involving human participants, shall be required to have an ethics committee to review and oversee and conduct of such research as detailed in the ‘National Ethical Guidelines for Biomedical and Health Research Involving Human Participants’, specified by the Indian Council of Medical Research (ICMR).
In the New Drugs and Clinical Trials Rules, 2019, significant changes have been made to the constitution of ethics committees. New rules require the Ethics Committee to have a minimum of seven members with expertise in medical, non-medical, scientific, and non-scientific fields with at least
- One lay person
- One woman member
- One legal expert
- One independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian
- Ethics Committees are responsible for safeguarding human rights, safety, and well-being of trial subjects and ensuring ethical conduct of clinical trials in accordance with good clinical practices guidelines and regulations.
- In order for a clinical trial to be registered, it must be approved by the Ethics Committee.
- It is possible to initiate a clinical trial at a clinical trial site without having its own ethics committee if the protocol is approved by the ethics committee of another clinical trial site located within the same city or within a 50 kilometre radius of it.
- Form CT-01 shall be submitted to the Central Licensing Authority by the Ethics Committee for registration.
- A CT-02 registration is valid for five years from the date of issuance.
- The application for renewal of registration should be submitted 90 days prior to the date of the expiry.