Institutional ethics committees: critical gaps.

ABSTRACT

The guidelines issued in 2006 by the Indian Council for Medical Research in India , for the formation and conduct of clinical trials in India, are still the benchmark by which the conduct of such trials is evaluated. Unfortunately, these guidelines have not yet got the force of law, since the bill is still pending in Parliament. An important section of the guidelines pertains to the constitution and conduct of the committees which should examine, permit and monitor clinical research in India. Information on how well the committees are functioning is not easily available. Personal observation and conversations with members of ethics committees in other institutions have revealed certain serious lacunae, which have the potential to entirely subvert the purpose of these committees.