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DRAFT: CONSULTATIVE DOCUMENT ON ETHICAL GUIDELINES ON BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
( By Indian Council of Medical Research New Delhi )

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Preface

The need for uniform ethical guidelines in research on human subjects has been well recognised, and at the present time this need is more acute because, apart from the mandatory clinical trials on new drugs, a number of diagnostic procedures, therapeutic interventions and preventive measures including the use of vaccines are being introduced which require proper testing on human beings.

Further, the advent of new medical devices and radioactive materials as also the therapeutic benefits of recombinant DNA products have added a new dimension to ethical issues that need to be considered before evaluating these substances. With the setting in of the era of biotechnology (including genetic engineering) medical procedures and therapeutics have undergone tremendous changes and many techniques based on these advances are no longer in the realms of science fiction, but have become a reality today.

Recent advances in the field of assisted reproductive techniques, organ transplantation, human genome analysis and gene therapy offer unquestionable benefits to mankind but at the same time raise numerous questions of law and ethics, stimulating public interest and concern at various levels. On the one hand, there is a need to satisfy legitimate public concern, while on the other, one has to appreciate the need to encourage new scientific innovations for the benefit of mankind. It has therefore become imperative to provide specific guidelines for such research, taking into consideration all these new dimensions.

The Indian Council of Medical Research (ICMR) had brought out in February 1980, a document entitled, Policy statement on ethical considerations involved in research on human subjects prepared by the ethical committee under the chairmanship of Hon'ble Justice H.R. Khanna. This document has been widely used for 17 years by not only ICMR but also by other agencies and scientists. The document however needs to be updated in view of the recent developments in modern biology as also in different branches of medical science so that it could serve as an useful guide to all scientists and agencies involved in research on human subjects.

Therefore, a Central ethical committee on human research (CECHR) was constituted by the ICMR under the chairmanship of Hon'ble Justice M.N. Venkatachaliah to consider various issues related to the ethical, legal and social dimensions of research on human beings. The committee met on 10th September 1996 and identified following four major areas and the sub-committees for drawing up detailed guidelines :



  • Human Genetics research
  • Transplantation research including Fetal tissue transplantation
  • Clinical evaluation of Drugs/Devices/Vaccines/Herbal remedies
  • Epidemiological research

Apart from these the report of a separate committee drafting the technical and ethico-legal issues of Assisted reproductive technologies was also to be considered by this committee. The CECHR met on 10th August 1997 to consider the draft reports prepared by all the five groups and following detailed discussions the present draft has been prepared for wide circulation and subsequent national debate before finalisation. The Terms of Reference, list of Members of CECHR and the Sub-Committees are appended.


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