Willingness to participate in a clinical trial and understanding of informed consent information among medical students

Ashwin Kamath, Rathnakar UP, Ashok Shenoy K

DOI: 10.20529/IJME.2014.005


Abstract

Studies have shown that the decision to participate or not participate in a clinical trial does not necessarily imply that the volunteers have completely understood the clinical trial process. A study carried out among medical and non-medical student volunteers revealed that even though the former group had a better recollection of the key facts, their understanding was still below expectation. In our study, medical students were invited to voluntarily take part in a hypothetical exercise in which they were presented with an informed consent form to indicate their willingness to participate in an anti-malarial drug trial. They were encouraged to clarify their doubts and asked to answer a questionnaire to determine their willingness/unwillingness. They were asked to state their reasons and recall key information given in the informed consent form. Responses were submitted by 155 students and 51% of the respondents consented to participate in the trial. As many as 13.5% did not know the name of the drug under study, 14.8% could not recall the main adverse effects to be expected, and 12.3% did not know that they could opt out of the study, this being significantly more in those who had consented to participate (p0.0. As is evident from our study, even presenting a detailed consent form containing an explanation might leave a considerably large number of potential volunteers with an incomplete understanding of the study. Therefore, it is necessary to make an active effort to ensure that the counselling of the volunteers is based on their ability to comprehend the information provided.

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