We have submitted an application to renew the registration of the Ethics Committee (EC) with the relevant authorities. The EC, however, has yet to receive confirmation of renewal from these authorities. Is it permissible for the EC to proceed with the review and approval of proposals, as was the practice before, despite the absence of confirmed renewal?
Dr. Sreevatsa, please begin by reviewing the primary condition in the registration letter.
The registration is designated valid for five years from the date it is issued unless it is suspended or revoked by the Central Licensing Authority (CLA). Importantly, if the renewal application is submitted to the CLA at least ninety days before expiration, the registration remains valid until a decision is issued by the authority.
Provided the Ethics Committee filed the renewal application within the stated ninety-day window, it is authorized to continue reviewing and approving proposals, even without a formal renewal notice from the regulators. It is advisable to mention the re-registration application date in the approval letters for clinical trial proposals.
Regarding the dissolution of NAC-SCRT in 2023 and the abolishment of IC-SCR at the institutional level, the Institutional Ethics Committee (IEC), under the guidance of ICMR-DHR, is required to manage all stem cell research conducted within the institution. This committee must include two experts in stem cells. As the chairperson of the Ethics Committee formed under the ICMR-DHR, and having served on IC-SCR Committees at other institutions, can I, in my capacity as a chairperson, assess the submitted stem cell research documents and subsequently provide approval both as a chairperson and an ethics expert?
According to the National Guidelines for Stem Cell Research 2017, the requirement for expertise is clearly outlined:
The IC-SCR is expected to have at least two external experts specializing in stem cell/cell and molecular biology. These experts must possess a postgraduate (medical) or doctorate degree (non-medical) and have accrued a minimum of five years of experience in stem cell research post-degree.
Therefore, if your qualifications and experience align with the criteria mentioned, you are entitled to express your expert opinion as a stem cell specialist. Nevertheless, formal approval should be conferred by the Ethics Committee after a comprehensive evaluation of the stem cell proposal, coupled with the insights of a second stem cell expert.