Even after more than two and half years since the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has become operational, only 5 institutes across the country have got registration for the Institutional Committee for Stem Cell Research (IC-SCR) to review and monitor stem cell research at the institutes.
According to sources, till date 82 organizations/institutes across the country have applied for registration of their IC-SCRs with NAC-SCRT, out of which only 5 institutes have fulfilled the criteria and have been granted registration.
The NAC-SCRT is the apex body constituted by the Department of Health Research (DHR) to oversee the activities in the field of stem cell research in India. The NAC-SCRT will examine the scientific, technical, ethical, legal and social issues involving stem cell research and therapy in India.
As per the National Guidelines for Stem Cell Research-2013, the NAC-SCRT will monitor and oversee activities at national level and the IC-SCR at institutional level. These oversight committees shall ensure that review, approval and monitoring of all research projects in the field of stem cell research are done rigorously and effectively as per the National Guidelines. This mechanism of additional review has been accepted by the scientific community in the country and the NAC-SCRT has become operational after its notification by DHR on 29th October 2012.
The IC-SCR is 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.