To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia

Abstract

We conducted a study to review the consenting process in a vaginal microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants' understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not attained from most of the participants since 77% (n = 154) of the participants had numerous questions about the study and 34% (n = 68) did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations.

Participants’ Understanding of Informed Consent in a Randomized Controlled Trial for Chronic Knee Pain

“…Our findings indicate that participants had a good understanding of the RCT and concepts such as randomization and placebo, and their consent appeared informed. These findings are in context of previous reports expressing concern about informed consent in RCTs, particularly those using a placebo, and in low-literacy populations (Manafa, Lindegger, & Ijsselmuiden, 2007; Munalula-Nkandu, Ndebele, Siziya, & Munthali, 2014).…”

Consent to Research in Madagascar: Challenges, Strategies, and Priorities for Future Research

“…Both junior and senior researchers worried about "cut and paste" approaches to consent forms that negated the importance of ensuring the language and information in forms were adapted to specific populations, participant education level(s), particular concerns, and prior exposure to information, studies, or methods. These practical complexities and concerns are well founded, and echo those raised by researchers and ethicists interested in the quality and challenges of informed consent in African clinical research (13,(31)(32)(33)(34). In a systematic review that looked at clinical research participant understanding for consent, across 21 African studies, over 50% of participants were found to have consented without understanding key concepts relevant to the study in which they volunteered (35).…”

Distinctive aspects of consent in pilot and feasibility studies

“…generally poor comprehension of the benefits and harms outlined in the consent process 44 and the empirical difficulties of securing understanding and recall. 16,42,45,46 This suggests that important aspects of PFSs that may not readily be grasped by potential participants should be actively explored with them, rather than simply being stated in consent documentation. 47 Asking participants to state their own understanding or expectations of the study at the outset may help.…”