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ICMR Bioethics Unit

Release

The Handbook on National Ethical Guidelines for Biomedical and Health Research Involving Human Participants was released on 26th March 2019, during the Symposium on Gandhi & Health @150, at ICMR Headquarters, New Delhi. This hand book is intended to provide students, researchers and ethics committees a simplified and quick reference to the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

Release of the Handbook on National Ethical Guidelines for Biomedical and Health Research Involving Human Participants by Dr. Shekhar C Mande, Secretary, DSIR & DG, CSIR during the Symposium on Gandhi & Health @150 at ICMR Headquarters, New Delhi on 26th March, 2019

Click here to view and download the Handbook

“Common forms for Ethics Committee review” were released on 7th December 2018. These are expected to facilitate proposal submissions to Ethics Committees. These forms have been pilot tested and are easy to use, adaptable and can be customized as per requirements of ECs across the country. A feedback form to share user suggestions and inputs is provided along with the download link. The Common Ethics Committee Forms are dynamic and will be updated based on these feedbacks received. The preparation of these forms was carried out by ICMR Bioethics Unit, NCDIR, Bangalore with funding support from Translational Health Science and Technology Institute (THSTI). The forms include the initial review form and other forms as annexures such as those required for expedited review, continuing review, SAE reporting, genetic studies, biobanking and others. The forms can be downloaded in PDF and word format and can be used by Ethics committees at various medical / research institutions/colleges in the country and would help to streamline submission to Ethics committees and to its review process.

A report with standardized definitions of terms which are used in limitation of treatment and providing palliative care at end of life has been prepared by an ICMR commission. This report was released on 12th March 2018. This document provides clarity and consensus related to different terminologies pertaining to End of Life Care (EOLC) and is expected to be useful for clinicians, patients and their families in improving their understanding of the terms and their definition.

The National Ethical Guidelines was revised and released in 2017 by the Hon’ble Union Minister, Ministry of Health and Family Welfare, Shri Jagat Prakash Nadda and Hon’ble Union Minister of State, Ministry of Health and Family Welfare, Smt. Anupriya Patel, in the presence of Dr. Soumya Swaminathan, then, DG ICMR & Secretary DHR and current Deputy Director General, World Health Organization, Dr. P N Tandon, Former Chairperson, Central Ethics Committee on Human Research (CECHR) and Dr. Henk Bekedam (World Health Organization Representative to India), Dr. Vasantha Muthuswamy, Chairperson Ethics Advisory Committee and others on 12th October 2017 at ICMR Headquarters, New Delhi.

Click here to Download National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

This document was released along with National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 on 12th October 2017 at ICMR Headquarters, New Delhi.