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

Abstract

Introduction 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. This study assessed the research participants' understanding and voluntariness of informed consent in a clinical trial in Ijede, Lagos. Methods This is a cross-sectional survey of 75 research participants in a malaria clinical trial using questionnaires and a forced-choice checklist to assess voluntariness and understanding of informed consent. Data was analysed using SPSS V 17. Results All the respondents involved in the clinical trial gave consent before they were recruited. Reasons given for consenting to participate 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 motivational factor for participation by 8% of the participants. Almost all the participants (98.7%) stated that they understood the information given to them during the consent procedure. However, in the formal assessment of understanding with a forced-choice checklist, only 37% understood issues concerning randomisation of participants. 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. There is therefore the 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 trial except when incapable of consenting.