Whatever the nature of the vaccine, the issue of ethics and consent continue to be of primary importance. Health activists ask how real "informed consent" can be guaranteed in such clinical trials and whether the participants in the trials will be assured the best treatment in the event of any of them becoming infected with HIV, in the case of AIDS vaccine trials. The counter argument often put forward is that participants are promised the best "available" treatment in such an
eventuality. But in a poor country, with an inadequate health infrastructure, what is available is neither "best" nor even adequate to deal with such diseases. Is it fair then to put people through such a trial if at the end of it they might end up worse off than if they had never agreed to participate in it?
Also, although the ICMR has issued guidelines and there are bioethics committees that are supposed to apply them before biomedical research involving human subjects, there are several loopholes. There is also an absence of a legal framework that prescribes punishment for those violating the guidelines. Furthermore, in India we do not have the kind of independent monitoring boards that exist in most industrialised countries that keep a watch on such trials. Such boards have the power to insist that drug trials be modified or even abandoned if they are perceived to be violating bioethics codes. In the absence of such a regulatory system, there is a r!
eal
reason for concern about clinical drug trials. The Mumbai Bioethics conference took many of these concerns on board and identified HIV/AIDS as "an arena where massive bioethics, human rights and public health battles will be fought."
Few will argue for a ban on all human clinical trials as it is evident that they are essential to test the safety and efficacy of drugs and medical interventions. ICMR guidelines have also laid out the basic framework within which trials can be conducted. But unless the rights of the individuals who participate in the trials and their ability to get the best and most effective treatment in case of injury or infection are guaranteed, the trials will not be fair even if they yield useful scientific results. Ultimately, as Dr. T. Jacob John of the Christian Medical College, Vellore, said in his keynote address at the conference on "Bioethics and Public Health", "What is not in the best interests of the individual cannot be in !
the best
interest of the community."
Dr. R.Edwin Amalraj M.Sc., Ph.D.,
Research Officer (Statistics)
Dept. of Epidemiology
The TN Dr.MGR Medical University,
69,Anna salai, Guindy, Chennai - 600 032
South India
Telephone (off): 91-44-2235 3577; (res)91-44-2498 4172
e-mail:
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