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.

Ethics Commitee Registration

In order to register a clinical trial, a sponsor, organization, or institution must have the approval of an Ethics Committee. There are two types of Ethics Committees in India: Institutional Ethics Committees and Independent Ethics Committees. Biomedical and health research are overseen by Ethics Committees.

Ethics Committee Re-Registration

In India, an Ethics Committee must be registered with the Central Licensing Authority (CLA) in order to function. As part of the registration process, the Ethics Committees are required to adhere to transparency and control requirements during their constitution and operation.

Renewal of registration of Ethics Committee

After the validity period of registration expires, an application for renewal of registration must be made in Form CT-01 along with the required documents. In order to renew your registration, you must submit your application 90 days before it expires.

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

Constitution of Ethics Committee for Clinical Trial

Ethics Committee in a nutshell

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.