The ICMR’s ethical guidelines: no debate?

On September 24, I attended a public debate on a draft consultative document entitled ‘Ethical Guidelines on Biomedical Research Involving Human Subjects.’ produced by an ICMR-sponsored committee under the chairmanship of Justice MN Venkatachalaiah of the National Human Rights Commission. The public debate was organised for the Southern region by the National Institute of Nutrition and I believe there was a similar one in Mumbai and in Calcutta for the Western and Eastern regions and a Northern regional debate is planned in the next few weeks in Delhi. All these are being minuted and sent back to the committee for finalisation by the end of the year.

There was a sincere attempt by the organisers at NIN to elicit a broader dialogue and among others, various people-oriented, gender issue related and societal related issues were raised.

However, I did feel that the debate was not based on well-informed judgement and often personal prejudices or ‘status quo’ urges were overshadowing a deeper ‘ethical issue’ exploring process.

In discussions at length with Dr V. Muthuswamy, Deputy DG and Chief,Division of Basic Medical Sciences. ICMR, New Delhi, who is member secretary of the Commitee and coordinator for the whole process, 1 noted:

In spite of evidently circulating over 500 copies of the draft guidelines, they (ICMR) had not received the sort of interactive response they had hoped for.Of the 27-member committee, 19 were Delhi-based bigwigs and though they had five subcommittees (to produce ethical guidelines for Human Genetic Research, Transplantation Research, Clinical Evaluation of Drugs/ Diagnostics/Vaccines/Herbals, Epidemiological Research and Assisted Reproductive Technology research) which had a slightly broader representation, the people involved were either retired people or even senior practitioners and, quite surprisingly, mostly Mumbai doctors and seven Delhi ICMR and Ministry of Health and Family Welfare representatives. Do these represent a wide cross section of opinion?

On the whole, the guidelines are comprehensive and based on ethical issues and there are serious attempts to build in controls and checks, but all of you with your extensive experience in interactive dialogue could help ‘fine tune’ the emerging guidelines and detect those that have slipped in advertently or consciously to justify questionable research. So do not miss the opportunity to write to DrVasantha.

The last guidelines of ICMR in 1980 also mentioned the need for ethical committees, informed consent, etc. but was very brief. Eighteen years later, the recent document is definitely more comprehensive and live to the new developments, but there may be a long delay before the next update. So better engage now rather than debate or critique the guidelines later.