While there is legislation which governs all experimentation on animals and a policing mechanism to pull up violators, the latest guidelines are meant to be implemented and accepted on a voluntary basis by the researchers themselves
It may sound bizarre but anywhere in India today, it is easier to conduct any sort of experiments on human subjects than on animals. After a four-year long deliberation by the Indian Council of Medical Research (ICMR), a spanking new set of guidelines called `Ethical guidelines for biomedical research on human subjects’ were issued last week by Dr. C P Thakur, Minister for Health and Family Welfare, but, unfortunately even these woefully fall short of the stringent rules that scientists need to adhere to when conducting research on animals.
Is human life less precious than that of animals? Why then is animal experimentation more controlled than that on humans? The new guidelines stipulate that each research proposal that involves human testing will be vetted by an Institutional Ethics Committee, which will comprise 5-7 members and will mandatorily have the representation of a legal expert, a social scientist, a philosopher, a lay person from the community in addition to the subject experts.
Once a proposal has been cleared by the IEC, there are no further ethical review bodies stipulated in the guidelines. On the contrary, if researchers have to conduct even a single experiment on animals, they need prior clearance from a central committee headed by Maneka Gandhi, who literally personally monitors that unnecessary experiments are not conducted on animals. No such all-powerful body exists for supervising human testing, and it’s literally a jungle out there with fly-by-night operators, like the testing of the Quinacrine drug as a contraceptive on unsuspecting illiterate women.
As if this were not enough, Dr. Vasantha Muthuswamy, chief of basic biomedical research at ICMR, unveiled some startling facts of a survey carried out by ICMR of 30 leading research institutions, which only proves that Indian institutions are still not sensitised enough to larger ethical issues. Dr. Muthuswamy found that most of the 30 institutions which they surveyed did not have ethical committees looking after experimentation on humans. The few that did have committees did not have the right sort of representation on their committees; in fact, these so-called ethical committees hardly ever met.
These findings highlight the very urgent need to monitor and oversee the conduct of experiments on humans. In addition, the new one hundred-page document has other drawbacks. It touches only briefly on the larger ramifications of the Human Genome Project, and ignores any reference to the use of genetically modified organisms even as the Ministry of Environment and Forests gets ready for the release of genetically engineered cotton in the very near future.
Critics of the new guidelines are already pointing to the gross disparity that exists between the rules for conducting research on animals and humans. While there is legislation which governs all experimentation on animals, and a comprehensive policing mechanism to pull up violators, the latest human research guidelines are meant to be implemented and accepted on a voluntary basis by the researchers themselves. Dr Muthuswamy says there’s now a move to get these guidelines enacted as a legislation, but emphasises that “there is no way the ICMR can be the policing agency that would ensure the implementation of these guidelines.”
Today, the ICMR can only recommend that institutions should constitute ethics committees, which would oversee all human experimentation. Officials at the ICMR lament that the apex biomedical research body has no powers to punish institutions that have not set up proper ethics committees, for it is just not mandatory to have ethics committees overseeing research on humans. Women activists point out that it is this lack of a `dog which can not only bark but also bite’ that has led to the proliferation of unscrupulous operators who conduct research on unsuspecting illiterate women. They said it is probably for this reason that the private doctors continued to use the hazardous contraceptive practice of using the chemical Quinacrine even though it had been banned in the west.
A human rights activist is quick to point out that today in India, animals like rabbits, and rats are much better off as compared to humans. Today, no animal experimentation can be carried without the prior written approval of the institutional animal ethics committee, and it is now mandatory by law that institutions set up these bodies to oversee these experiments.
A leading doctor mused that there is no law in India from which the human ethics committees can derive its powers. To that extent, animals seem to have had a much better deal as any cruelty to them is punishable under Prevention of Cruelty to Animals Act. Not so for humans.