Abstract
BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65).ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures).ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.
Highlights
In clinical research, obtaining informed consent from participants is an ethical and legal requirement
These guidelines define informed consent as “a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate” and the 9th principal of ICH International Conference on Harmonisation Good Clinical Practice (GCP) is that “freely given informed consent should be obtained from every subject prior to clinical trial participation” [2]
A total of 254 caregivers responded to the questionnaire over 12 information sessions: 65 in the control group, 63 in the pamphlet only group, 62 in the information session only group, and 64 in the pamphlet plus information session group (Fig. 1)
Summary
In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. The fact that many investigators view ICFs as mere legal proof of a participant’s agreement has increased their complexity, and reduced the participant’s ability to understand its content. This results in an informed consent process, which is legally correct, but does not guarantee the participant’s true comprehension of the study [8]. Interactive and engaging forms of conveying information are required where an ICF does not truly inform
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