After remaining dormant for over six years, the modified 'Biomedical Research Human Subjects Promotion and Regulation Bill' aimed at protecting the safety and rights of humans used in scientific research may soon go to the Union health ministry for final approval and submission before the Union cabinet.



The review committee set up by the Department of Health Research has given the final touches after consulting the stakeholders and the draft is ready for sending to the Health Ministry, sources indicated. The Department hopes that it will get the nod of the Cabinet soon so that it can be introduced in Parliament next year itself.



The committee has met recently and fine-tuned the bill as many of the features had become irrelevant since it was pending for many years which saw remarkable changes in the industry in general and the research in particular. The new draft has addressed all concerns of the stakeholders and the department has tried to make it comprehensive in line with the latest developments in the research like stem cells which were included in the prohibited category when the bill was first drafted, sources said.



The Bill seeks to protect the human subjects used in any form of scientific research – behavioural or intrusive—done by an academic institution or pharmaceutical company. At present, the research on human participants have been guided by the draft guidelines announced by the ICMR long back and the approvals given by the DCGI. The Bill is going to put these guidelines as statutes, so that it can be enforced sternly. Though the companies were asked to follow the guidelines, there are no provisions to take action against the errant researchers now.



The bill provides for setting up a Biomedical Research Authority to monitor research on humans. One of the key highlights of the bill is the provision for increasing the penalty for violation of ethical guidelines. The revised Bill increases the maximum penalty from Rs.1 lakh fine and six months imprisonment to Rs.10 lakh fine and an imprisonment between five and 10 years. Penalty would be graded as per the nature of violations like not taking consent of participants, misinformation to the ethics committee, serious injuries etc. The punishments also include debarring from research and forfeiting of registration, apart from imprisonment.



The Bill prepared by the Indian Council of Medical Research (ICMR) was in fact pending since 2004 after the first draft was made and later it was vetted by the law ministry in January, 2006. However, still it could not be cleared due to many reasons and the present ICMR director general Dr V M Katoch took initiative to put it back on the track on the priority basis.