Draft National Guidelines for Stem Cell Research, 2017

 

Relevancy:

  • GS Prelims, GS Mains Paper II and III
  • Science and Technology, Stem cell research guidelines, ICMR. (more information about stem cells can retrieved from IAS Buzz App, article dated 19-06-2017)

 

Recently:

  • The Indian Council of Medical Research and the Department of Biotechnology have released the draft National Guidelines for Stem Cell Research, 2017.
  • The draft guidelines seek to ensure that all research with human stem cells is conducted in an ethical and scientifically responsible manner.
  • Use of stem cells has the potential for improving human health by restoring the function of cells and tissues damaged due to degeneration and/or injury.
  • Thus, stem cell biology has emerged as an important area of biomedical research with potential applications in developmental biology, disease modelling and drug development.

Key features of the draft guidelines include:

  1. Applicability: The draft guidelines are applicable to various stakeholders, including individual researchers, sponsors, and oversight/regulatory committees associated with both basic and clinical research involving human stem cells. The guidelines will not apply to research concerning non-human stem cells.
  2. Consent from the donor: Prior to the procurement of biological material for the isolation of stem cells, it is mandatory to obtain informed consent from the voluntary donor.
  3. Intellectual Property Rights associated with stem cells: Intellectual Property Rights (IPRs) associated with the outcome of research on stem cells may have commercial value. The option of sharing such IPRs should be indicated in the informed consent form which must be procured before the commencement of the research. Further, it is expected that a proportion of the benefit accruing from commercial use of donated tissue/cells will be returned to the donor and the community at large, which has directly or indirectly contributed to the product.
  4. Compliance with guidelines: A National Apex Committee for Stem Cell Research and Therapy currently monitors and oversees research activities at the national level. The Institutional Committee for Stem Cell Research approves and monitors stem cell research (both basic and clinical research) at the institutional level. These oversight committees will ensure that review, approval and monitoring process of all research projects related to stem cells is carried out in compliance with the national guidelines.
  5. Considering the application and advancement of stem cell research in India, critically examine the ethical issues emanating from this technology.

 

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