Informed Consent form in Clinical Trial

  • Sunny Panwar
  • Hemant Pal
  • Amrish Chandra


Informed consent form is a vital requirement for research study on the human participant. It is the consent which is given by the subject before participate in clinical trial. Informed consent mainly came in existence after the Nuremberg trail and the other guideline line like Helsinki Declaration and Belmont Report also play an important role in there evaluation. Informed consent form mainly contents the complete information about the clinical trial, protocol, duration, potential risk and benefit of the trial. Informed consent is revised from time to time, as the new information is available. In some case waiver of consent done by proper review by Institutional Ethic Committees (IEC).

Keywords: Informed consent, GCP, IEC, Schedule Y


Download data is not yet available.


1. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products, World Health Organization WHO Technical Report Series, No. 850, 1995, Annex 3 [Internet]. APPS; 2011 Apr 20 [cited 2019 Mar 07]. Available from:
2. Understanding Informed Consent [Internet]. 2017 Feb 02 [cited 2019 Mar 10]. Available from:
3. Dalla-Vorgia P, Lascaratos J, Skiadas P, Garanis-Papadatos T. Is consent in medicine a concept only of modern times? Journal of Medical Ethics. 2001 Feb; 27(1):59-61.
4. Ethical Guidelines for Biomedical Research on Human Subjects. New Delhi: Indian Council of Medical Research, The Nuremberg code (1947); [Internet]. 2000. [cited 2019 Jan 10]; British Medical Journal No 7070 vol. 313:1448. Available from: /
5. World Medical Association declaration of Helsinki. Ethical principles for medical research involving human subjects) [Internet]. 2017 Jan 18. [cited 2019 Jan 11]. Available from: .
6. Kharawala S, Dalal J. Challenges in conducting psychiatry studies in India. Perspect Clin Res. 2011; 2:8-12.
7. DeCosta A, D’souza N, Krishnan S, Chhabra MS, Shihaam I, Goswami K. Community based trials and informed consent in rural north India. J Med Ethics. 2004; 30:318-23.
8. Kegley K. Ann J, Challenges to informed consent, EMBO Report. 2004 sep; p.65.
9. Levine RJ. Michigan: Urban and Schwarzenberg. The Ethics and Regulation of Clinical Research; 1981.
373 Views | 1090 Downloads
How to Cite
Panwar, S., H. Pal, and A. Chandra. “Informed Consent Form in Clinical Trial”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 41-46, doi:10.22270/ijdra.v7i1.307.