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We have applied for renewal of registration of Ethics Committee (EC) to the regulatory authorities. However, the Ethics Committee has not received the renewal order from the authorities. Can the Ethics Committee review and approve the proposals as did before in the absence of renewal?
Dr Sreevatsa
Please check the first condition of registration letter.
The registration is valid for a period of five years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority (CLA). Provided that if the application for renewal of registration is received by the Central Licencing Authority 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.
If the Ethics Committee has applied for registration ninety days prior to the date of expiry, the Ethics Committee can review and approve the proposals even in absence of a formal letter of renewal from the regulatory authorities.
It would be helpful to quote the date of application for re-registration application in the approval letter the clinical trial proposals.
NAC-SCRT is dissolved during 2023 and IC-SCR at institutional level is also dissolved. Institutional Ethics Committee (IEC) at the institutional level under ICMR-DHR is supposed to oversee all stem cell research in the institute which also should have two stem cell experts. I am the chairperson of Ethics Committee constituted under ICMR -DHR. I was an ethics expert in IC-SCR Committee in two other institutes. Can I, as a chairperson review the stem cell research papers submitted and give the approval both as chairperson and ethics expert.?
Dr Sreevatsa
As per National Guidelines for Stem Cell Research 2017, the requirement of experts is defined as follows:
IC-SCR should have at least two stem cell/cell and molecular biology experts who should be from outside the institution. They should have a postgraduate (medical)/doctorate degree (non-medical) with a minimum of five years’ experience in the field of stem cell research after obtaining postgraduate/doctorate degree.
So, if you have the qualifications/experience as per above definition, you can give your opinion as a stem cell expert. But the approval should be given by the Ethics Committee after thorough review of the stem cell proposal and opinion of second stem cell expert.
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