Of ethics committee and informed consent
Dr K S Bhimwal

The controversy surrounding clinical trials using an experimental drug by clinicians at the in the Regional Cancer Centre Thiruvananthapuram, has snowballed into a major issue with accusations flying thick and fast about the role of ethics committee and on enrollment of poor patients without following proper procedures such as informed consent. As multinational corporations and foreign universities flock to India to test the latest innovations on Indian population, such controversies are only bound to increase. What are the steps that a hospital must take to conduct trials without getting mired in a controversy? A few opinions..

Qutub Inst Area

Clinical trials are a must in medicine. As far as the hospitals are concerned, whatever is planned to be done on a patient must have his or her informed consent. Besides a hospital, an ethics committee and the medical fraternity would do well to establish regulatory bodies comprising of eminent doctors, lawyers, community leaders and so on. This body must be the watch dog in all matters relating to trials, transplants, etc. In all such issues total transparency should be the key word.

Ram Nath Prasad
Hospital Administrator
Sankalp Hospitals Private Limited
Jamnagar

For the hospital to conduct trials without getting mired in a controversy, the following steps could be suggested:

1. The selection of the members of ethics committee must be done very carefully and responsibly. It must be ensured that the persons who are to be entrusted the job, are of highest integrity with uncompromising stand on moral and ethical issues. Such people at the helm of affairs will reduce the chances of controversy considerably.

2. The structure of ethics committee should be comprehensive and include well respected people from varied backgrounds. Apart from the medico personnel, other members could be from social, political or legal background. A human right activist, too, should be invited.

3. The guidelines/procedures to be followed must be crystal clear. There should be no room for ambiguity. These procedures must be defined after careful consideration of all relevant factors including the ever-changing social and cultural factors. There must be scope for revision, too.

4. The people to undergo trials should be well informed persons who know all relevant things about the trials and its consequences. Under no circumstances, the factors such as poverty, illiteracy, lack of knowledge, not passing all needed information before taking consent, should be allowed to creep in. The ethics committee must consider their job as very sensitive, observe high moral standard and act accordingly.

5. The ethics committee should have a advisory body to advise and help them to arrive at a decision. Advisory committee will consider various issues pertaining to human rights, moral & ethical matters. Also, it will prevent ethics committee from taking a hurried decision.

6. The moral and ethical views should always prevail upon legal ones and no attempt should be made to take advantage of the situation under the shield of legal validity.

7. The foreign universities and MNCs must not be allowed to take advantage of the conditions such as poverty of our people, low level of awareness/knowledge etc. No temptation should be allowed to creep in. Therefore, I re -emphasise that members of ethics committee must be the people who believe in the spiritual values and not driven by the materialistic influences.

8. All data and information must be available about the persons who have volunteered for the trials. A secret inquiry may be conducted to reveal

the deliberately guarded information, if any. It must be ensured that the person has not surrendered for the clinical trial for making money or due to lack of sufficient information or any other unethical grounds.

9. There must be provisions for strict punitive actions, too, for those who violate the procedures and indulge into unethical practices.