Bill to regulate research on humans

Bill to have penal provisions for unauthorised research & unethical practices

A new law to regulate all bio- medical and health research activities involving human participants is in the making. The proposed law- Bio- medical and Health Research Regulation Bill, 2013, which is likely to go to the Cabinet in September seeks to have penal provisions for unauthorised research work and unethical practices and will have research related injury relief fund for paying compensation.

The proposed bill, once approved will cover research, clinical studies involving human participants or material for development and evaluation of tools and strategies for promotion, prevention, amelioration and rehabilitation of diseases, or development of diagnostic tests or procedures, storage and use of biological materials, and scientific investigations required to understand processes which affect health, cause disease and influence human well- being, and transnational study tak- ing new leads.

“Often human subjects are required for research work. The proposed bill focuses on the compensation entitlements of the participants, making them eligible for due reimbursement for the time spent, besides compensation of travelling and other expenses incurred in connection with his participation in the research work,” said a senior official.

The ethics committee formed under the law will decide on the amount as decided in the case of clinical trials. Significantly, the draft law doesn’t include clinical trails conducted for new drugs, vaccines, medical devices etc. As per the draft bill, the investigator and the institution shall take appropriate steps to safeguard the interest of special or vulnerable groups while the ethics committees shall ensure that individuals, groups or communities proposed to be subjected to research are selected by the investigator in such a way that the “burden and benefits’’ are equally distributed.

“Human biological materials or data shall be used only after the express consent of the human participant and for the primary intended purpose approved by the ethics committee, and any request for secondary use of the human biological material or data shall be separately examined by the ethics committee,” said the draft copy.