Assessing Participants’ Understanding and Voluntariness of Informed Consent in a Clinical Trial in Nigeria Babatunde Adewale 1* , Theresa Rossouw 2 and Lizette Schoeman 2 1 Public Health Division, Nigerian Institute of Medical Research PMB 2013 Yaba, Lagos, Nigeria 2 University of Pretoria, Pretoria South Africa * Corresponding author: Babatunde Adewale, Public Health Division, Nigerian Institute of Medical Research PMB 2013 Yaba, Lagos, Nigeria, Tel: +234 807 277 5897; E-mail: badewale@hotmail.com Received date: June 16, 2016; Accepted date: July 12, 2016; Published date: July 13, 2016 Copyright: © 2016 Adewale B, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Abstract 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. Keywords: Research participants; Informed consent; voluntariness; understanding; Clinical trial Introduction Respect for the autonomous choice of a person is based on the fundamental ethical principle of respect for persons and respect for human dignity [1]. Personal autonomy ideally encompasses self-rule that is free from both controlling interference by others and from certain limitations, such as inadequate understanding, that prevent meaningful choice. Terefore, a major trait of an autonomous person is the capacity for self-governance, which involves understanding, reasoning, deliberating, managing and choosing independently [2]. Researchers should always inquire in general terms about their participants’ wish to receive information and to make decisions, and they should never assume that because a participant belongs to a particular community or culture, he or she afrms that community’s worldview and values. Te fundamental requirement is to respect a particular person’s autonomous choices, whatever they may be, though other principles such as benefcence, non-malefcence and justice should also be taken into consideration. Respect for autonomy is not a mere ideal in health care, it is a professional obligation [3]. Te requirement of individual informed consent, which includes disclosure about the procedure, comprehension of the disclosed information, voluntariness, and competence to act, is the manifestation of respect for autonomy in healthcare and research [4]. It is universally recognized as a central component of ethical conduct of research and allows subjects to make informed and voluntary choices to participate or refuse to participate in a project where they will be asked to take risks for the beneft of others [5,6]. Te provision of information, comprehension of information and voluntary participation are foundational in the consent discussion [7]. Voluntary decision-making is a challenge in research settings, particularly in developing countries. Medical doctors and researchers occupy positions of authority and patients and participants are ofen unwilling or unable to challenge or question their opinion. Doctors have credibility and great infuence over patients because of the general belief that doctors will always “do good” for their patients. Furthermore, participants are ofen illiterate, uneducated or gullible and ofen do not question terms of participation [8,9]. Te distinction Adewale et al., J Clin Res Bioeth 2016, 7:4 DOI: 10.4172/2155-9627.1000279 Research Article Open Access J Clin Res Bioeth ISSN:2155-9627 JCRB, an Open Acces Volume 7 • Issue 4 • 1000279 Journal of Clinical Research & Bioethics J o u r n a l o f C l i n i c a l R e s e a r c h & B i o e t h i c s ISSN: 2155-9627