Institutional ethics committees and stem cell research

The Indian Council of Medical Research, Department of Biotechnology has issued draft guidelines for stem cell research (1) in 2012. A thorough discussion among ethics committee members is necessary to improve these guidelines.

As per these guidelines, it is necessary to form a separate institutional committee for stem cell research (IC-SCR) to review and approve the scientific merit of research protocols. All institutes involved in stem cell research must register with the National Apex Committee for Stem Cell Research and Therapy through the IC-SCR.

The guidelines assert the need for a separate mechanism for review of stem cell projects. However, they then state that an institutional ethics committee (IEC) with appropriate expertise may also approve stem cell projects.

Though ethics committees have experts, they are expected to review the ethics and not the scientific and technical details of a project. However, the draft guidelines empower the IEC to approve the science of a project as well. This seems contradictory to the standard operating procedures of ethics committees.

Further, the draft guidelines do not specify the minimum number of scientific experts required in an IEC to approve a project, or the experts’ required qualifications. Nor do they discuss whether it is necessary to incorporate these experts as members with voting rights, or whether they need only be invited members for the work in hand.

The IC-SCR’s role includes registering the institute with the National Apex Committee and sending annual progress reports to this committee. If members of the National Apex Committee make visits to an institutional facility, the IC-SCR members may play a role in facilitating this process. The members are also expected to keep abreast of advances in the field as there is unpredictability in the translation of research in this area.

If IECs may approve stem cell-related projects, will they be able to carry out this role effectively? If they are expected to do so, the standard operating procedures of IECs will have to be revised accordingly. Further, this relaxation of the rules will be used by scientists to get stem cell projects approved through an IEC, instead of setting up a new IC-SCR even when experts are available. This could adversely affect the quality of research.