临床研究与生物伦理学杂志

抽象的

Assessing Participants’ Understanding and Voluntariness of Informed Consent in a Clinical Trial in Nigeria

Babatunde Adewale, Theresa Rossouw and Lizette Schoeman

Background: The tension between the need for research and the possibility of exploitation of participants’ vulnerability mandates the development of reliable measures of ensuring that consent is voluntary and sufficiently informed.
Objective: This study assessed research participants’ understanding and voluntariness of informed consent in a malaria clinical trial in Lagos, Nigeria. Methods: It was a cross-sectional survey of 75 research participants using validated questionnaires and a forced-choice checklist. Data were analyzed using SPSS V 17.
Results: All the respondents involved in the clinical trial gave consent before they were recruited. Reasons for participation included: opportunity to get treated (28%); opportunity for diagnosis of ailments (32%); to prevent illness (36%); and to receive news about medical care (4%). Payment was seen as a potential incentive for participation by 8% of participants. Almost all the participants (98.7%) stated that they understood the information given to them during the consent procedure. However, while this was confirmed for most of the information in the formal assessment of understanding with a forced-choice checklist, only 37% and 29% had understood issues concerning randomization of participants and compensation issues on research related injury respectively, and only 13% could recall that risks associated with the study had been disclosed.
Conclusion: This clinical trial in Nigeria demonstrated no serious threats to understanding and voluntariness. However, voluntariness was influenced by factors based on the benefits participants would receive through their participation, such as access to diagnosis and treatment not available outside the research setting. There is therefore a need to ensure effective communication between the investigator and research participants during the informed consent process to facilitate the participants’ right to self-decision to participate in a clinical trial except when incapable of consenting.