The ‘National Guidelines for Stem Cell Research’, issued recently by the Union health ministry, has elaborated about the functions and composition of the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and the Institutional Committee for Stem Cell Research (IC-SCR).
According to the Guidelines, the NAC-SCRT will be a multidisciplinary committee with a secretariat. It will have two main functions of general oversight of the field of stem cell research and therapy in India and formulation of policy related to it; and review of specific controversial or ethically sensitive research and proposals for therapeutic use of stem cells/differentiated derivatives.
There should be at least 15 members in the committee. The committee composition will include chairman, alternative chairman, member secretary, nominees from DBT, DST, CSIR, DSIR, ICMR, DCGI, DAE, MCI, DGHS and biomedical experts drawn from appropriate disciplines such as haematology, pharmacology, immunology, cell biology, microbiology, genetics, developmental biology, clinical medicine and nursing. Other members would include a legal expert, social scientist, and women’s representative. In addition consultants/experts could be consulted / invited for specific topics and advice.
The committee has the responsibility to examine scientific, technical, ethical, legal and social issues in the area of stem cell or their derivatives based research and therapy. It has to maintain a register of all institutions involved in any type of stem cell research and therapy including details of their IC-SCR. Besides, it has to review annual reports of these IC-SCRs for compliance with national guidelines and ethical practices. Use of chimeric tissue for research shall be reviewed by it and will review and update the national guidelines for stem cell research and therapy periodically, considering scientific developments at the national or
The NAC-SCRT has to respond to queries/representations from all the stakeholders in the community (investigators, industry, R&D institutions, entrepreneurs, media, patient groups, govt agencies etc). It also has to respond to controversial issues raised /received from NGOs, patients, individuals etc., and diverted to NAC-SCRT by other agencies like ICMR, DBT, DST, MCI, DCGI, etc.
Moreover, the committee has to monitor any unethical practices related to stem cell research and/or therapy being followed at any organization or any individual and bring them to the notice
of relevant authorities.
The IC-SCR will be a multidisciplinary body at the institutional level. Institutions involved in stem cell research are required to set-up a special review board to oversee research (basic science and clinical) in this field. It should be registered with the NAC-SCRT and should provide overview of all issues related to stem cell research at the institutional level.
The IC-SCR has to review and approve the scientific merit of research protocols and will function in compliance with all relevant regulations and guidelines. It should maintain a register of hES cell research conducted at the institution and hES cell lines derived or imported by institutional investigators and notify NAC-SCRT. It has to facilitate training of investigators involved in stem cell research and submit annual report to NAC-SCRT.
There should be at least seven members in the committee and it should include representatives of the public and persons with expertise in clinical medicine, developmental biology, stem cell research, molecular biology, assisted reproduction technology, and ethical and legal issues in stem cell research. It should have the resources to coordinate reviews of various protocols.
The chairman of the IC-SCR must have relevant medical/scientific background and be from outside the institute with no conflict of interest (COI). Members from law, ethics and social sciences must be from outside the institute and with no COI. Stem cell experts, if possible from outside the institute, can be the scientific/technical members. Member Secretary can be from the same institute and must not have any COI. Any member having COI with a particular proposal must abstain from the discussion and decision making process of that proposal.
IC-SCR members must be familiar with the current bioethical guidelines and guidelines for stem cell research.