Ethics Committee Registration Support Service
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Any sponsor/organization/institution who intends to conduct a clinical trial is required to have Ethics Committee approval for the clinical trial registered. The 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 the 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 Committees. Ethics Committees oversee clinical trials, bioavailability and bioequivalence studies, and biomedical and health research.
Composition of IEC
The New Drugs and Clinical Trials Rules, 2019 have incorporated significant changes in the constitution of the 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 as tabulated below:
| Members | Comments / Eligibility / Count |
|---|---|
| Chairman | Not affiliated with Institute |
| Member Secretary | Affiliated to the Institute |
| Clinicians | More than 2 |
| Social Worker | At least 1 |
| Basic Medical Scientist | Pharmacologist/Pathologist |
| Lawyer | At least 1 |
| Lay Person | Not affiliated in any manner |
We, at SP Bioscience, understand your commitment to the ethical conduct of clinical trials. We can assist you with 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 all supporting documentation and ease the process.
Frequently Asked Questions (FAQs)
Why is an Institutional Ethics Committee (IEC) required?
The main function of the Ethics Committee is to safeguard the rights, safety, and well-being 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.
Whether ethics committee approval mandatory to initiate a clinical trial?
Yes. Clinical trials at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.
As per the New Drugs and Clinical Trial Rules, 2019, the ethics committee (EC) should be constituted of how many members?
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 a social scientist or representative of a non-governmental voluntary agency or philosopher or ethicist or theologian.
At least 50% of members are not affiliated with the institute or organization in which EC is constituted.
Every member of the EC shall be required to undergo such training and development programs.
What is the SUGAM portal?
The SUGAM portal is an e-Governance solution for CDSCO. SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committees, medical devices, vaccines, and cosmetics. SUGAM has a facility for users to possess multiple roles on the same registered ID. Applicants can register for different purposes with the assigned roles and forms.