Bioethics get top priority in the ICMR’s revised guidelines on biomedical & health research

New Delhi: The Indian Council of Medical Research (ICMR) has released its ‘Strategic Plan and Vision 2030’ which outlines the body’s agenda to deal with health challenges in the country.

The agenda is based on key points such as capacity building, data management, leveraging traditional medicine and strengthening program implementation through research. It aims at combating non-communicable diseases and improving maternal and child health in India.

The ICMR has also drafted ‘National Guidelines for Biomedical and Health Research Involving Human Participants – 2017’ and the ‘National Ethical Guidelines for Biomedical Research Involving Children’ to address newer emerging ethical challenges being faced in the country and to improve public trust in research.

Promoting bioethics among top priorities 

The revised ‘National Guidelines for Biomedical and Health Research Involving Human Participants, 2017, includes detailed guidance to help ethics committees in the process of review, guidance to researchers in conducting research, responsible conduct of research, obtaining informed consent, clinical-socio-behavioural research among others.

The document also highlights the needs for additional safeguards in the conduct and review of research carried out on vulnerable population including children, lower socioeconomic group, those with mental illness, or with rare disorders.

Union Health Minister, Mr J P Nadda praised the efforts directed by ICMR to ensure that the biomedical and health research is carried out in an ethical manner to maintain and improve the public trust towards the medical research. “I understand that the guidelines have been prepared considering the moral, ethical, social values and ethos of our diverse population,” he was quoted to have said at the release function.

From time to time, the concerns and issues have evolved over the ethical dilemmas faced by the scientific and ethics committees in the conduct and review of biomedical research. Therefore, the ICMR undertook an extensive exercise by engaging with stakeholders including patient groups, civil society, lawyers, clinicians, scientists, members of ethics committees and others through regional, national as well as public consultations in the process of preparing these guidelines.

Dr Soumya Swaminathan, DG-ICMR stated that the medical research is the need of the hour and therefore it was important to not only be responsive to emerging issues, but to also build greater trust towards research.

The ‘National Ethical Guidelines for Biomedical Research Involving Children’ have been developed specifically to address ethical issues of conducting research in children.

Revised stem cell research guidelines are crystal clear

The council has also released the National Guidelines for Stem Cell Research 2017 for all stakeholders including individual and organizations associated with basic and clinical research on stem cells and their derivatives.

The guidelines have been revised to ensure that while giving an impetus to research, it does not compromise on the safety of patients and vulnerable individuals, the statement said.

“The 2017 guidelines, reiterate that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present. Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice,” a statement issued by the ICMR said.

Responsible research must focus on harnessing the potential of science to improve our understanding of human health and illness, as well as discover newer ways to prevent and treat them, it said.

The research body in collaboration with the Health Ministry has awarded 86 scientists for finding solutions to important health challenges and for their contribution in biomedical science research. In an effort to encourage youngsters to join health research and choose it as a preferred career, ‘Short Term Studentship Excellence’ awards were also presented for the first time this year, the statement said.