[7] As majority of NDAC members are clinicians lacking expertise in drug development, and as there is no guidance on how the review/decisions are made, there is a likelihood of subjectivity in decision making process. The EC, whose focus is on novel ethical aspects, usually accepts the scientific validity and risk: benefit assessment for a clinical trial, if it is approved by regulatory authorities. One of the biggest challenges for India is how to ensure fair subject selection and protection of vulnerable population. Indian GCP stresses on the need to protect vulnerable population e.g., poor or unemployed and recommends Effort may be made to ensure that individuals or communities invited for research be selected in such a way that the burdens and benefits of the research are equally distributed.

The observations and suggestions of EC should be given in writing in unambiguous terms in such instances. For vulnerable population, mode of consent should be carefully considered and approved by the EC. These recommendations do not provide specific suggestions as to what action an EC should take to protect vulnerable population. There is also no additional or specific guidance in Indian Council of Medical Research (ICMR) ethical guidelines.[8] The ICMR guideline for preparing Standard Operating Procedures (SOP) does not describe any SOP for protection of vulnerable population.[9] The independent review by EC suffers because of deficiencies in EC functioning. A recent survey of EC approval letters revealed deficiencies in composition, quorum, and review of insurance, and clinical trial agreement.

[10] Indian GCP discusses conflict of interest issue for a member, whose proposal is under discussion by EC. However, it does not describe conflict of interest in selection of EC members. This issue has become paramount in formation of ??independent?? ECs, most of which are formed by the investigator, with membership consisting of friends/relatives. As per US FDA checklist for Institutional Brefeldin_A Review Boards (IRB), policy on conflict of interest, the investigator cannot select IRB members.[11] Unless there are clear regulatory guidelines about how EC should function and make decisions, there will be deficiencies in the independent review process. The informed consent process and respect for enrolled Erlotinib chemical structure subjects are primarily responsibilities of the investigator. There is a difference between the understanding, training and practice of these principles between medical practice and clinical research. Additionally, the issues of patient’s poverty, illiteracy and vulnerability make the consent process quite demanding.