Challenges IRBs face numerous challenges, in establishment, composition, and their working. Some of these challenges are due to conflict of guidelines, some inherent to guidelines, and other reasons. There is need to study the problems of IRBs in depth to assess their needs, kinase inhibitor Imatinib Mesylate and provide the support, if subject protection is to become stronger and effective. Unless this is done, the future of clinical research will remain uncertain the advantages that the country offers come to naught. Structure and composition of IRBs The IRBs are set up by the institution involved in clinical research; the institute is likely to choose members who are known to the institute with some selection bias in the IRB. During selection of members, institute heads need to be clear about the qualifications of members required to constitute a compliant IRB.

When individuals who have little previous experience in ethical review are selected, they would need to be trained. Presently, there are hardly any organizations that can be called upon to train the members on their roles and responsibilities. Workshops on research ethics are held by some organizations, but there is no official recognition of these organizations for conducting training. Additionally, these training sessions are more of a business activity rather than a service, and not available when needed. Institute heads need to appreciate that the CDSCO requirements differ from the international guidelines and that these requirements are not flexible. IRBs in India must have at least seven members in place of five members required in the International Conference on Harmonization (ICH) region.

The institute should also provide for members who may remain absent, to prevent falling short of quorum. Thus, the optimal strength of an IRB can be anywhere between 10 and 12. Indian requirements specify that the Chairman must not be from the institute. It is clear that a regular employee of the institute cannot become the Chairman, but whether a consultant could play this role is not clear. Since consultants are not on the pay roll of the institute, they are very often the choice for the post of the Chairman, but the CDSCO has refused registration to at least one IRB on this ground. The CDSCO would do well to clarify this in a guidance document. The chosen IRB members need to be trained viz-a-viz ethical codes (both international and local) and their roles and responsibilities as members.

Due to differences in training, there is wide disparity among IRBs, and this may come in the way of their functioning.[8] IRB training must include local regulations and some countries have developed their own modules for ethics education.[9] The National Institutes of Health (NIH) office of extramural research has an online GSK-3 training module available Ganetespib Sigma at http://phrp.nihtraining.com, which is very suitable for IRBs operating in the US.