The ‘National Guidelines for Stem Cell Research‘, issued recently by the Union health ministry, has put strict norms for procurement of foetal or placental tissue as a source of stem cells for research in the country.
According to the guidelines, termination of pregnancy should comply with all obligations under the MTP Act and the termination of pregnancy with a view to donate foetal tissue in return for financial or any other inducement is not permissible.
The guidelines further says that independent informed consent should be obtained for termination of pregnancy and for donation of the foetal material for research. The consent for donation of foetal tissue should be obtained in advance and not just before or at the time of the procedure. The parent should be given sufficient time to take decision regarding the donation.
The consent for donation should include permission for screening of the donor for transmissible infections and obtaining family history of genetic disorders. The purpose and use of donated foetal tissue should be fully explained to the parents and it should not be vague and open ended. The information sheet for the purpose should be carefully scrutinised and vetted by the Institutional Committee for Stem Cell Research (IC-SCR) and Institutional Ethics Committee (IEC).
As per the guidelines, the medical person responsible for care of the pregnant woman willing to undergo termination of pregnancy and the investigator using the foetal material shall not be the same. The donor shall not have the option to specify the use of the donated material for a particular person or in a particular manner. The identity of the donor should be kept confidential. Personal information of the donor, however, should be kept available for traceability in situations where the cells derived from the donated foetal tissue are proposed to be used for therapy.
The Union health ministry had recently issued the ‘National Guidelines for Stem Cell Research’ to provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country. These guidelines were jointly prepared by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).
- ICMR finalises ‘Guidelines for Stem Cell Research’, to be notified soon
- ICMR – National Guideline for Stem Cell Research 2013
- Guidelines for Stem Cell Research lists functions & composition of NAC-SCRT and IC-SCR
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This entry was posted in Clinical Trial, Department of Biotechnology, Indian Council of Medical Research and tagged clinical trials india, CRO india, Informed consent, Institutional review board, International Electrotechnical Commission, National Guideline for Stem Cell Research, Stem Cell, Union.