An ethics committee is a committee dedicated to the rights and well-being of research subjects, also known as an Institutional Review Board but there are some little difference between Independent Ethics Committee(IEC) and Institutional Ethics committee (IRB) like IRB direct attached with site or institution and IEC usually independent.
In the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules), after rule 122 DC, the following rule are highlight.
“122 DD. Registration of Ethics Committee (EC)
(1) No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee with the licensing authority as defined in clause (b) of rule 21.
Provided that any Ethics Committee existing on the date of commencement of the drug and cosmetics (third amendment ) Rules 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty five days from the date of commencement of the drug and cosmetics (third amendment ) Rules 2013
(2) An application for registration of ethics committee shall be made to the licensing authority in accordance with the requirements as specified in the appendix VIII of Schedule Y.
(3) The licensing authority after being satisfied that the requirements of the rules have been complied with, may grant registration to ethics committee subject to such conditions as may be stated therein.
(4) The Ethics committee will review and accord its approval to a clinical trial and also carry ongoing review of the trial at appropriate intervals, as specified in Schedule Y, and the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding rights, safety, and wellbeing of the trial subjects.
(5) In case of any serious adverse events occurring to the clinical trial subjects during the clinical trial, the ethics committee should analyze and forward its opinion as per procedures specified under APPENDIX XII of schedule Y.
(6) The ethics committee shall allow inspectors / officials of Central Drugs Standard Control Organization to enter the premises of the committee to inspect any record, data, document etc. related to clinical trial and provide adequate replies to any queries raised by such inspectors or officials, as the case may be, in relation to in relation to the conduct of clinical trial.
(7) The registration, unless it is sooner suspended or cancelled, shall be valid for a period of five years from the date of issue.
Provided that if the application for re-registration is received by the licencing authority within three months before the expiry, the registration shall continue to be in force until orders are passed by the said authority.
Provided further that licencing authority shall be informed in writing in case of any change in the membership or the constitution of the ethics committee takes place.
(8) If the licensing authority is not satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and the conditions which must be satisfied before the registration can be granted.
(9) If the ethics committee fails to comply with any of the conditions of registration, the licensing authority may after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons there for, suspend or cancel the registration of the ethic committee for such period as considered necessary.
(10) The ethics committee whose registration has been suspended or cancelled by the licensing authority, may within ninety days of the receipt of the copy of the order by him prefer an appeal to the Central Government and the Central Government may after giving an opportunity of being heard, confirm, reverse or modify such order.
For more detail join our free e-course and you can also mail us your specific query for EC registration.
This Course has following modules:
- Ethics Committee Registration – Overview
- Origin of Ethics Committee and Guidelines
- Composition of Ethics Committee
- Standard Operating Procedures of Ethics Committee
- Functioning of Ethics Committee
- Submission of Clinical Trial Dossier to Ethics Committee
- Records Maintained by Ethics Committee
- Review and Approval Process of Ethics Committee
- Responsibility of Investigator Towards Ethics Committee
- Application to DCGI for registration of Ethics Committee