Government has proposed Biomedical and Health Research Regulation Bill, 2013 in order to regulate biomedical and health research involving human participants, whether in conventional areas, or in new evolving specialized fields. The Bill seeks to ensure ethical research in all institution with proper care and a compensation policy for human participants. With this Bill, all research on human participants will come under the government scanner by way of the proposed Biomedical and Health Research Authority.
Some key points about Biomedical and Health Research Regulation Bill, 2013:
- The Bill seeks to provide ways to safeguard ethical values in accordance with both local cultural values and international benchmarks so as to generate, maintain and reinstate public trust in research.
- As per the Bill, a Biomedical and Health Research Authority will be set up and it will be mandatory to register all ethics committees in research institutions, colleges, universities and other organizations involved in research with the Authority.
- The Biomedical and Health Research Authority will register, monitor and evaluate the performance of ethics committee, develop performance appraisal systems and norms and mechanisms for implementing transparency and accountability; and assess the need for providing protection to vulnerable sections.
- The Bill will confer statutory powers on the Ethical Guidelines for Biomedical Research on Human Subjects, drafted in 2000 by the ICMR’s Central Ethics Committee on Human Research, under the chairmanship of the former Chief Justice of India, Justice M. N. Venkatachaliah. The guidelines were revised in 2006.
- Human participants in a research will be entitled to “due remuneration, compensation or reimbursement for the time lost, besides reimbursement of travelling and other incidental expenses incurred in connection with his participation in research.’’
- The ethics committee will decide the amount and it will also ensure that the amount is not such which can be considered as inducement for participation in research.
- The investigator and the institution shall take necessary steps to protect the interest of special or vulnerable groups while the ethics panel shall ensure that research participants are selected by the investigator in such a way that the “burden and benefits’’ are equally distributed.
- Consent of the human participant will be mandatory for using human biological materials or data.
- Approval from the ethics committee will be mandatory for using human biological materials or data for the primary intended purpose. The ethics panel will separately examine any request for secondary use of the human biological material or data.
- Bio-banking of the human biological material will not be allowed without consent of the human participant which should be regulated by the specific principles of bio-banking.
- Researcher shall maintain strict confidentiality of all research data which might lead to identification of the individual participant to avoid any consequent stigmatization and discrimination unless he/she is under obligation to reveal the information to any official or the government department concerned under the provisions of any law.
- The investigator must obtain voluntary, documented, informed consent of individual participants after being fully informed of his involvement in the research and also to withdraw the consent given earlier.
- In case of an individual who is not capable of giving informed consent, for any reason, the consent of his legal guardian or legally authorized representative will have to be obtained.
- In case of investigation/study involving a group or community, legally acceptable representative or culturally appropriate authority of the group or community concerned may be contacted for permission.
- In no case shall a collective community agreement or the permission of a community leader or other authority be considered as a substitute for an individual consent.
- Clinical studies involving systematic study of new drugs, medical devices, vaccines and cosmetics on human subjects will be out of the purview of the Bill.
The decision to bring a new law for regulation of biomedical and health research comes in the backdrop of the report of the Parliamentary Committee on Health, pillorying the government and the Indian Council of Medical Research for failing to prevent deaths of adolescent tribal girls in Andhra Pradesh and Gujarat during post-marketing surveillance of anti-cervix cancer HPV vaccine. The surveillance had been jointly conducted by a foreign non-governmental organization, PATH, and the ICMR, and was suspended by the Ministry following the deaths of the participants.
Currently, only clinical trials with new drugs are regulated under the Drugs and Cosmetics Act, 1940 and this law is not applicable to the tremendous quantum of biomedical research being carried on in universities, medical colleges and hospitals on subjects ranging from basic sciences and clinical research to applied, operational or behavioural research.