Knowledge, attitude and practice of informed consent process in biomedical research among postgraduate medical students

Amir Hussain, Abhay Subhashrao Nirgude, Himani Kotian


Background: Research is integral part of post graduate studies. Informed consent is a vital ethical and regulatory requirement for the conduct of biomedical research.

Methods: Mixed methods study was carried out from July to August 2017. Cross sectional part constitute quantitative component and forced field analysis (FFA) forms qualitative part. Approval from the institutional ethical committee was obtained. Pre-designed, validated, structured questionnaire was used to gather information from 114 participants about knowledge, attitude and practice (KAP) regarding informed consent process. FFA was employed to understand driving and restrictive forces in obtaining informed consent from the research participants.

Results: Out of the 114 study participants majority participants were males i.e. 69.3% and pursuing post-graduation in clinical subjects. There is significant association between knowledge (p=0.008), attitude (p=0.032) among postgraduates from clinical and nonclinical departments. Among clinical 51.7% and 48.3% among non-clinical have good knowledge and 67.7% among clinical and 32.3% among non-clinical have good practice. Main driving forces for informed consent process identified during FFP were ICMR guideline for biomedical research, feeling morally right to inform the participants about what the research. Main restrictive force was fear of losing the participant due to signing on informed consent.

Conclusions: There is good knowledge among postgraduates about informed consent process however there is scope of improvement in attitude and practice. Ethics training should address how to build trust with research participants and how to overcome the fear of losing the study subject.


Informed consent, Biomedical research, Knowledge, Attitude, Practice

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Emanuel FJ, Wendler D, Killen J, Grady C. What makes clinical research in developing countries ethical. The benchmarks of ethical research? J Infect Dis. 2004;189:930–7.

Ethical Guideline for Biomedical Research on Human Participants. New Delhi: Director-General Indian Council of Medical Research, 2006.

World Medical Association. declaration of helsinki – ethical principles for medical research involving human subjects. Seoul: 59th WMA General Assembly, 2008.

The Consumer Protection Act 1986. Available at: Accessed on 15.01.2014

Snyder L. American College of Physicians Ethics, Professionalism, and Human Rights Committee. American college of physicians ethics manual: Sixth edition. Ann Intern Med. 2012;156(1):73 104.

Paterick TJ, carson GV, Allen Mc, Paterick Te. Medical informed consent: general considerations for physicians. Mayo clin Proc. 2008;83:313-9.

Kaminski J. Theory applied to informatics–Lewin’s Change Theory. Canadian Journal of Nursing Informatics 2011;6(1):1251.

Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986.

Humayun A, Fatima N, Naqqash S, Hussain S, Rasheed A, Imtiaz H, Imam SZ. Patients' perception and actual practice of informed consent, privacy and confidentiality in general medical outpatient departments of two tertiary care hospitals of Lahore. BMC Medical Ethics. 2008;9:14.

Doyal L. Good clinical practice and informed consent are inseparable. Heart. 2002;87(2):103-5.

Yousaf RM, Fauzi ARM, How SH, Rasool AG, Rohana K. Awareness, knowledge and attitude towards informed consent among doctors in two different cultures in Asia: a cross sectional comparative study in Malaysia and Kashmir, India. Singapore Med J. 2007;48:559-65.