We support the constitution, registration and renewal of Independent Ethics Committee (IEC).
What is an Ethics Committee?
AnyĀ Sponsor/Organisation/Institution who is planning to conduct clinical trials in IndiaĀ is required to have an Ethics Committee approval for the registered clinical trials. Ethics Committee ensures that the clinical trials is carried out in accordance with Good Clinical Practices (GCP) guidelines and applicable regulatory requirements. The Ethics Committee reviews and approves the trials protocol. The Ethics Committee 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 ā€“ Institutional and Independent Ethics Committee.
Ethics Committees oversee clinical trials, bioavailability and bioequivalence studies and biomedical and health research.
Constitution and Registration of the Ethics Committee
As per the New Drugs and Clinical Trials Rules, 2019, the Ethics Committee should comprise a minimum of seven members from medical, non-medical, Science and non-science areas.
Every member of the Ethics Committee needs to undergo a mandatory training and development. If there are any changes in the composition of the registered Ethics Committee, the same should be notified to the Central Drugs Standard Control Organisation (CDSCO) within a time period of 30 working days.
As per the new clinical trial rules, when a clinical trial site does not have its own Ethics Committee, clinical trials at that site may be initiated after obtaining approval of the protocol from the Ethics Committee of another trials site. However, in such cases, the approving Ethics Committee should take responsibility for the study at another site and the approving Ethics Committee should be located within the same city or within the radius of 50 kilometers of the clinical trial site.
Registration and Re-Registration of Ethics Committee
The Ethics Committee needs a prior registration with the Central Drugs Standard Control Organisation (CDSCO). The registration process is established to lend transparency and control over the constitution and functioning of Ethics Committee and ensure adherence to quality standards during the conduct of clinical trials.
In India, Form CT-01 is the application form used to register an Ethics Committee for clinical trials with the CDSCO, essentially initiating the process of registering an ethics committee to review clinical trials either within an institution or as an independent committee. Form CT01 includes the basic details about the Ethics Committee, such as the name of the institution, contact information, members’ names, and the authority under which the committee is established.
Form CT-02 is typically used for providing detailed information about the composition and functioning of the Ethics Committee and is submitted alongside Form CT-01 to complete the registration process. Form CT02 includes more detailed information about the Ethics Committee’s structure, functions, Standard Operating Procedures (SOPs), member qualifications, and processes for reviewing clinical trials protocols.
Form CT-03 is used for registering an Ethics Committee overseeing biomedical research, as per the Clinical Trials Rules, and is used to officially document the registration of the committee with the relevant regulatory authority.
Registration and Re-Registration of Ethics Committee
The registration granted is valid for a period of three years from the date of its issue, unless suspended or cancelled by CDSCO.
Renewal of Registration of Ethics Committee
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 CDSCO 90 days prior to the date of expiry, the registration remains in force until an order is passed by CDSCO on the submitted application.
Fresh set of documents may not be required to be submitted if there are no changes in the Ethics Committee which was approved earlier. The applicant can submit a certificate indicating that there is no change.
