ICMR- WHO Regional Consultation on National Ethical Guidelines for Biomedical and Health Research involving Human Participants

A regional consultation was jointly organised by WHO Country Office for India and Indian Council of Medical Research (ICMR) on National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016. The meeting took place at the National Centre for Disease Informatics & Research (NCDIR) in Bangalore on 4 October 2016.

ICMR is at the forefront for guidelines on bioethics and the setting norms and standards for ethical research in India.

The regional consultation deliberated on the Draft National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016. The Draft guidelines have been updated according to the recent developments in science and technology and national as well as international requirements for research involving human participants. Discussions took place to prepare for the national consultation scheduled at the ICMR headquarters in November 2016. The final drafts of the revised guidelines were posted on the ICMR website prior to the regional consultation, for public remarks and comments.

Following are some of the key discussions points:

  • General Ethical Issues, Informed Consent and Vulnerability
  • Ethical Review Procedures
  • Clinical trials and New Technologies
  • Epidemiological, Socio-Behavioural Research and during Humanitarian Emergency and Disasters
  • Human Genetics, Bio-banking and Datasets
  • International Collaboration and Responsible conduct of Research

The consultation was attended by relevant research stakeholders; scientists, physicians, researchers, civil society, lawyers, social scientists from across the country. Several eminent experts of repute, ethics committee members, civil society representatives, programmatic division representatives and pharmaceutical industry participated in the deliberations.

The ICMR guidelines are widely referred by researchers, institutions, medical colleges, universities engaged in biomedical research, NGOs, ethics committee members as well as other stakeholders who engage in biomedical and health research in the country.

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