It is with extreme pleasure that I welcome you to the launch of the Independent Ethics Committee - India (IEC). This committee is the first of its kind in this country - a national level, external and independent committee that serves the purpose of protecting human subjects participating in research, consistent with the principles that have its origin in the Declaration of Helsinki.

Over the past decade, there has been an increase in the number of clinical trials conducted in India. Hence, the medical community is facing new challenges, roles and responsibilities. Ethics committees have the onus to safeguard the rights, safety and well being of human subjects involved in clinical studies and to provide public assurance of that protection.

In India, traditionally the institutional ethics committees review the ethical aspects of the trial. However, many institutions are only beginning to develop their own ethics committees that will conform to the International Conference on Harmonization Guidelines for Good Clinical Practice (ICH GCP). ICH GCP is now recognized worldwide as the standard by which the quality of a clinical trial and the integrity of the research data will be judged, Hence, there is a need to establish a national-level and central Independent Ethics Committee that will review the ethics of human research in India under one umbrella.

The idea of IEC was conceived by the few of us (like-minded people) in the field of Medical Research. We took the initiative of an Independent Ethics Committee consistent with ICH GCP. The committee has a group of 11 founding members which includes members of both genders from the medical profession with diverse therapeutic expertise, a non-scientific person, a person with legal and drug regulatory affairs background, a social worker and a person devoted to religious activities. These members have come together to deliberate and form the infrastructure for this innovative effort in India.

I take pride in leading this committee forward to the challenge of performing their duties and accomplishing their goals. What begins today as a voluntary effort on the part of these esteemed individuals will soon become the productive reality of tomorrow's vision.

R D Lele, FRCP
Chairperson