Ethics Commitee Registration

Ethics Commitee Registration

Any sponsor/organisation/institution who intends to conduct clinical trial is required to have Ethics Committee approval for the clinical trial registered. Ethics Committee ensures that the clinical trial is carried out in an ethical manner in accordance with Good Clinical Practices (GCP) guidelines and applicable regulatory requirements. The Ethics Committee reviews and approves the trial protocol; it also assesses the suitability of the investigators, facilities, and appropriateness of information to be used for obtaining informed consent from the subjects.

In India, two types of Ethics Committees have been defined – Institutional and Independent Ethics Committee. Ethics Committees oversees clinical trials, bioavailability and bioequivalence studies and biomedical and health research.

Constitution of Ethics Committee for Clinical Trial

The New Drugs and Clinical Trials Rules, 2019 have incorporated significant changes in the constitution of ethics committee. As per the new rules, the Ethics Committee should comprise a minimum of seven members from medical, non-medical, scientific and non-scientific areas 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

At least fifty percent of the Ethics Committee members should include individuals who are not affiliated with the institute or organization in which the ethics committee is constituted.

Every member of the Ethics Committee needs to undergo training and development as per the Central Licensing Authority’s (CLA) specifications, if not such a member will be disqualified. If there are any changes in the composition of the registered Ethics Committee, the same should be notified to the Central Licencing Authority (CLA) within a time frame of thirty working days.

As per the new clinical trial rules, when a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the Ethics Committee of another trial site; however, in such cases the approving Ethics Committee should take responsibility for the study at another site or center and the approving Ethics Committee should be located within the same city or within the radius of 50 kilometres of the clinical trial site.

Registration and Re-Registration of Ethics Committee Relating To Clinical Trial

The Ethics Committee in India cannot function without prior registration with the Central Licensing Authority (CLA). The registration process is laid down to establish transparency and control over the constitution and functioning of Ethics Committee and ensure quality during the conduct of clinical trials.

An application requesting the grant of Ethics Committee registration can be made to the CLA, by submitting Form CT 01 (Reference: New Drug and Clinical Trial Rules 2019) Along with the application, the following information needs to be submitted for registration of Ethics Committee. These requirements remain the same for all the Ethics Committees which oversee clinical trials, bioavailability and bioequivalence studies and biomedical research:

• Name of the Ethics Committee

• Authority under which the Ethics Committee has been constituted, membership requirements, the term of reference, conditions of appointment and the quorum required

• The procedure for resignation, replacement or removal of members

• Address of the office of the Ethics Committee

• Name, address, qualification, organisational title, telephone number, fax number, email, mailing address and brief profile of the Chairperson

• Names, qualifications, organisational title, telephone number, fax number, e-mail and mailing address of the members of the ethics committee. The information shall also include member's specialty (primary, scientific or non-scientific), member's affiliation with institutions and patient group representation, if any

• Details of the supporting staff

• The standard operating procedures to be followed by the committee in general

• Standard operating procedures to be followed by the committee for vulnerable population

• Policy regarding training for new and existing committee members along with standard operating procedures

• Policy to monitor or prevent the conflict of interest along with standard operating procedures

• If the committee has been audited or inspected before, give details

Once satisfied that the information and documents furnished with the application is in accordance with the requirements, the Central Licencing Authority (CLA) may grant registration in Form CT-02 (for Ethics Committees overseeing clinical trials, bioavailability and bioequivalence studies) and Form CT-03 (for Ethics Committees overseeing biomedical research).

Validity period of registration of Ethics Committee for clinical trial

The registration granted in Forms CT-02 and Form CT-03 are valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority (CLA).

Renewal of registration of Ethics Committee for clinical trial

On expiry of the validity period of registration, an application for renewal of registration can be made in Form CT-01 along with the required documents. The application for renewal of registration should be submitted ninety days prior to the date of the expiry.

If the application for renewal of registration is received by the Central Licencing Authority (CLA) ninety days prior to the date of expiry, the registration shall continue to be in force until an order is passed by the said authority on such application.

Fresh set of documents shall not be required to be submitted if there are no changes in the documents furnished at the time of grant of registration, and the applicant renders a certificate indicating that there is no change.

Show cause notice - Suspension or cancellation of registration of ethics committee

If the Central Licencing Authority (CLA) finds that the Ethics Committee fails to comply with any provision of the New Drugs and Clinical Trials Rules, 2019, it may issue a “show cause notice.” The notice would include specifications of the non-compliances and the period within which reply needs to be furnished by the ethics committee.

On receipt of reply for the show cause notice within the specified period, the Central Licencing Authority (CLA) may give an opportunity of being heard, in person to such Ethics Committee.

After completion of a clinical trial, the Ethics Committee needs to maintain all the data, record, registers and other documents related to the functioning and review of clinical trial for a period of five years. The information and records maintained should be furnished by the ethics committee as and when required by the Central Licencing Authority (CLA) or by any other officer authorised by the Central Licencing Authority (CLA).

We, at ClinExperts, understand your commitment for ethical conduct of clinical trials. We can assist you registration or re-registration of the Ethics Committees as per the rules of the New Drugs and Clinical Trials Rules, 2019; we will help you with the all supporting documentation and ease the process.

CDSCO encourages the online applications for registration and re-registration of Ethics Committees through SUGAM - An e-Governance solution for CDSCO. CliniExperts supports filing of the application to CDSCO via the SUGAM portal.

We can help identify gaps in the existing documentation or composition of the Ethics Committee. To expedite the registration process, we can follow-up on the application process and help address queries in a timely manner.

We can also support submission of any amendments or updates related to Ethics Committee functioning such as SOP changes or membership changes to ensure continued validity of registration.

Summary

• The main function of the Ethics Committee is to safeguard the rights, safety and wellbeing of trial subjects and ensure that clinical trial is carried out in an ethical manner in accordance with good clinical practices guidelines and applicable regulatory requirements.

• Any person who intends to conduct clinical trial is required to have Ethics Committee approval for the clinical trial registered.

• When a clinical trial site does not have its own ethics committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the ethics committee of another trial site located within the same city or within the radius of 50 kilometres of the clinical trial site.

• Ethics Committee shall make an application for grant of registration to the Central Licencing Authority in Form CT-01.

• The registration granted in Form CT-02 is valid for a period of five years from the date of its issue.

• The application for renewal of registration should be submitted ninety days prior to the date of the expiry.

Reference

New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).