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VOLUME 18 , ISSUE 8 ( August, 2017 ) > List of Articles


Institutional Ethics Committee Regulations and Current Updates in India

Amit V Mahuli, Simpy A Mahuli

Citation Information : Mahuli AV, Mahuli SA. Institutional Ethics Committee Regulations and Current Updates in India. J Contemp Dent Pract 2017; 18 (8):738-741.

DOI: 10.5005/jp-journals-10024-2117

Published Online: 01-12-2017

Copyright Statement:  Copyright © 2017; The Author(s).



The aim of the review is to provide current updates on regulations for ethics committees and researchers in India.


Ethical dilemmas in research since time immemorial have been a major concern for researchers worldwide. The question “what makes clinical research ethical” is significant and difficult to answer as multiple factors are involved.

Review results

The research involving human participants in clinical trials should follow the required rules, regulations, and guidelines in one's own country. It is a dynamic process, and updates have to be learned by researcher and committee members. The review highlights the ethical regulation from the Drug Controller General of India, Clinical Trial Registry of India, and Indian Council of Medical Research guidelines.


In this article, the updates on Indian scenario of the Ethical Committee and guidelines are compiled.

Clinical significance

The review comes handy for clinical researchers and ethics committee members in academic institutions to check on the current updates and keep abreast with the knowledge on regulations of ethics in India.

How to cite this article

Mahuli AV, Mahuli SA, Patil S, Bhandi S. Institutional Ethics Committee Regulations and Current Updates in India. J Contemp Dent Pract 2017;18(8):738-741.

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  1. What makes clinical research ethical? JAMA 2000 May;283(20):2701-2711.
  2. The Nuremberg Code. J Am Med Assoc 1996 Nov;276(20):1691.
  3. The Belmont Report. Washington (DC): US Government Printing Office; 1979.
  4. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Vol. 850. Geneva: WHO Technical Report Series; 1995. p. 97-137.
  5. Standards and operational guidance for ethics review of health-related research with human participants. Geneva: World Health Organization; 2011.
  6. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Seoul: World Medical Association; 2008. [cited 2016 Aug 23]. Available from:
  7. Ethical guidelines for biomedical research on human participants. New Delhi: ICMR; 2006. [cited 2016 Aug 26]. Available from:
  8. Drugs and Cosmetics Act, 1940. As Amended up to the 30th June. India: CDSCO; 2005. [cited 2016 Aug 26]. Available from:
  9. Draft Guidelines on Audio-Visual Recording of Informed Consent Process in Clinical Trial. India: CDSCO; 2014. [cited 2016 Aug 26]. Available from:
  10. [cited 2016 Aug 26]. Available from:
  11. Indian GCP Guidelines. New Delhi: CDSCO; 2004. [cited 2016 Aug 24]. Available from:
  12. G.S.R. 611(E). 2016. [cited 2016 Aug 24]. Available from:
  13. S.R. 11(E). 2015. [cited 2016 Aug 24]. Available from:
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