Informed Consent in Clinical Trials and the Role of Institutional Ethics Committees: A Socio-Legal Analysis

Abstract

Experimenting new drugs on human beings, is one of the crucial human right issues faced by the third world countries in the present century. It is true that the international law had taken high concern of this social issue after the Nuremberg Trials. The international law mandates informed consent to be obtained from the participants of clinical trials and this is the sole mechanism through which the rights of the trial subjects are being protected. The public health issues caused by illegal and unethical trials over patients are now evident in Indian health care system. The issue has come up for consideration before the Supreme Court of India recently. In India the law runs in tune with the international parameters for conducting human experimentation. The law on informed consent has a fatal impact over public health care issues, especially over the matter of clinical trials. Recent experiences in India reveal the threats caused to the society by clinical experimentations. Clinical trials and allied health issues are also brought to the notice of the judiciary. The law on informed consent in India is in its infant state. Exploring the doctrine of informed consent is crucial to this study. The present issue of clinical research which threatens the health care system is analysed and the doctrine of informed consent to regulate the system is assessed to check its efficacy and veracity. Analysis of the issue will help to communicate to the public about the need for better exercise of the rights of those who are subjected to clinical researches. The law of informed consent is in many ways inadequate to deal with the issues relating to clinical trials in India. The doctrine of informed consent has to be redefined to a great extent. The institutional review boards and Non- Government Organisations (NGO) can play a vital role in assuring proper observation of rules relating to regulation of human trials.