Published: 2019-12-24

A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

Nishanthi Anandabaskar, Mourouguessine Vimal, Amol Rambhau Dongre, Rajendrakumar Nivaratirao Kagne


Background: Informed consent is an essential pre-requisite for research on human participants. However, many studies have shown that informed consent documents (ICDs) are incomplete and lack many of the essential elements. The objective of the study was to assess the completeness of ICDs submitted to an institutional ethics committee (IEC) against the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants.

Methods: This is a retrospective cross-sectional study. The ICDs submitted to the IEC during the period from January 2015 to December 2017 were reviewed for completeness, with the help of a checklist which is based ICMR ethical guidelines for biomedical research on human participants 2006.

Results: A total of 212 ICDs were reviewed during the study period. More than 50% of the ICDs have clearly explained many of the essential elements like nature and purpose of the study (62.3%), voluntary participation (98.6%), procedures (68.9%), risks (71.2%), benefits (92.9%), alternative treatments (60.7%), maintaining confidentiality (99.1%), no loss of benefits on withdrawal from the study (87.8%) and contact details of principal investigator (99.5%). However, the other essential elements of the ICD are either not mentioned or not clearly explained.

Conclusions: This study has shown that although majority of the ICDs submitted for review by the IEC have mentioned many of the essential elements, some of the elements like contact details of Chairman of IEC, future use of sample, compensation for trial related injury and provision of counseling for consent of genetics testing have not been stated.


Informed consent form, Institutional review board, Participant information sheet, Research proposal

Full Text:



Indian Council of Medical Research. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: ICMR; 2017. Available at: default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf. Accessed on 4 June 2019.

Indian Council of Medical Research. Ethical guidelines for biomedical research on human participants. New Delhi: ICMR; 2006. Available at: default/files/guidelines/ethical_guidelines_0.pdf. Accessed on 4 June 2019.

Abeysena C, Jayamanna K, Dep S. Completeness of consent forms in research proposals submitted to an ethics review committee. Indian J Med Ethics. 2012;9:100-3.

Shetty YC, Marathe PA, Billa GV, Nambiar CPN.A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital. Perspect Clin Res. 2012;3:133-8.

Shah PC, Panchasara AK, Barvaliya MJ, Tripathi CB. A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Institutional Ethics Committee (IEC) of a Tertiary Care Hospital. J Clin Diagn Res. 2016;10:10-2.

Forum for ethical review committees in the Asian and Western Pacific region (FERCAP). SIDCER Recognition Programme. Available at: Accessed on 4 June 2019.

Rouse DN. Employing Kirkpatrick's evaluation framework to determine the effectiveness of health information management courses and programs. Perspect Health Inf Manag. 2011;8:1.

Ajuwon AJ, Kass N. Outcome of a research ethics training workshop among clinicians and scientists in a Nigerian university. BMC Med Ethics. 2008;9:1.

Trigotra S, Jaiswal S, Mittal A, Bhardwaj A. Impact of a Publication Ethics Orientation Program on the Knowledge and Attitude of Postgraduate Students of Health Sciences. J Clin Diag Res. 2019;13(2):4-9.

Asghari F, Samadi A, Dormohammadi T. Effectiveness of the course of medical ethics for undergraduate medical students. J Med Ethics Hist Med. 2009;2:7.

Maddineshat M, Yousefzadeh MR, Mohseni M, Maghsoudi Z, Ghaffari ME. Teaching ethics using games: Impact on Iranian nursing students’ moral sensitivity. Indian J Med Ethics. 2018;14:1-6.

Henderson GE, Churchill LR, Davis AM, Easter MM., Grady C, Joffe S, et al. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007;4(11):324.

Mansour H, Zaki N, Abdelhai R, Sabry N, Silverman H, El-Kamary SS. Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study. East Mediterr Health J. 2015;21(3):155-63.

Christopher PP, Stein MD, Springer SA, Rich JD, Johnson JE, Lidz CW. An exploratory study of therapeutic misconception among incarcerated clinical trial participants. AJOB Empir Bioeth. 2015;7(1):24-30.

Kimmelman J, Levenstadt A. Elements of style: consent form language and the therapeutic misconception in phase 1 gene transfer trials. Human Gene Therapy. 2005;16(4):502-8.

Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C. Disclosure of the Right of Research Participants to Receive Research Results. An Analysis of Consent Forms in the Children’s Oncology Group. Cancer. 2003;97:2904-9.