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Perspect Clin Res. 2019 Jul-Sep;10(3):108-114. doi: 10.4103/picr.PICR_10_18.

Indian Council of Medical Research's National Ethical Guidelines for biomedical and health research involving human participants: The way forward from 2006 to 2017.

Author information

1
Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
2
IEC (Human Studies), Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
3
Department of Pharmacology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, India.

Abstract

The Indian Council of Medical Research (ICMR) recently published the third revised guidelines "National Ethical Guidelines for Biomedical and Health-Related Research Involving Human Participants" in 2017. The changes to the guidelines were needed to acculturate the rapid advances in the research environment and advances in science and technology. The revised guidelines propose substantial changes/ modifications compared to the previous version. These include the introduction of broad consent, ethical issues related to deception, review of multi-centric research by a single ethics committee and ethical issues involved in implementation research and other issues related to public health research. The revised guidelines also incorporate modifications and minor changes to the previous version. Although most of the changes in the revised guidelines are in parallel to most of the international guidelines, we have also highlighted the minor differences compared to other international guidelines.

KEYWORDS:

Ethics; Indian council of medical research; guidelines; human participants; research

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