Every biomedical and health research involving human participants, whether in conventional areas, or in new evolving specialised fields, will have to be conducted in accordance with the provisions of the proposed Biomedical and Health Research Regulation Bill, 2013.

Research on human subjects in the specified areas like assisted reproductive technology (ART); organ, tissue and cell therapy; genetic and genomic studies including techniques of genetic engineering and gene therapy; nano medicines; bio-banking; neurosciences, mental health studies and health related socio-cultural, economic and behavioural studies will all fall under the ambit of the proposed new law.

In the general areas of 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 translational study taking new leads will also be covered under the Biomedical Research Regulation Bill once it is approved by Parliament.

The purview

However, clinical trials involving systematic study of new drugs, medical devices, vaccines and cosmetics on human subjects will not fall under the purview of the proposed law.

In addition to this Bill, the existing laws including Drugs and Cosmetics Act, the Human Organ Transplantation Act, the Pre-Conception and Pre-Natal Diagnostic Techniques Act, the Medical Termination of Pregnancy Act and the Mental Health Act, too, will be applicable. The Bill focuses on the entitlements of a human participant during research making him eligible to be paid “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 amount shall be decided by the ethics committee and shall not be such which can be considered as inducement for participation in research.

According to the 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. Important, according to the proposed Bill, there would be no bio-banking of the human biological material without consent of the human participant which should be governed by the specific principles of bio-banking.

Further, the Bill says that investigator shall maintain strict confidentiality of all research data which might lead to identification of the individual participant to avoid any consequent stigmatisation and discrimination unless he/she is under obligation to disclose the information to any official or the government department concerned under the provisions of any law.

“The confidentiality clause shall be incorporated in the information sheet while obtaining consent of the participant,’’ the Bill says.

On the informed consent, the Bill says in every biomedical and health research involving human participants, the investigator must obtain voluntary, documented, informed consent after being fully informed of his involvement in the research and also to withdraw the consent given earlier.

Alternative

In case of an individual who is not capable of giving informed consent, for any reason, the consent of his legal guardian or legally authorised representative will have to be obtained.

“In case of research involving a group or community, legally acceptable representative or culturally appropriate authority of the group or community concerned may be contacted for permission. However, 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.’’

The proposed Bill is expected to control unethical practices in biomedical and health research by making it mandatory to register all ethics committees in research institutions, colleges, universities and other organisations involved in research with the Biomedical and Health Research Authority. It specifies penalty for contravention of the provisions of the proposed legislation.