Quality of Parental Consent in a Ugandan Malaria Study

Abstract

Objectives. We surveyed Ugandan parents who enrolled their children in a randomized pediatric malaria treatment trial to evaluate the parents’ levels of understanding about the treatment trial and the quality of the parents’ consents to allow their children to participate in the study. Methods. We conducted 347 interviews immediately following enrollment at 4 Ugandan sites. Results. A majority (78%) of the parents, most of whom where mothers (86%) had at most a primary school education. Of the participating mothers, a substantial percentage reported that they remembered being told about the study’s purpose (77%), the required number of visits (88%), the risks involved (61%), treatment allocation (84%), and their ability to discontinue their children’s participation (64%). In addition, most reported knowing the trial’s purpose (80%) and the required number of visits (78%); however, only 18% could name possible side effects from the drugs being administered, and only 19% knew that children would not all be administered identical treatments. Ninety-four percent reported that they made the enrollment decision themselves, but 58% said they felt pressure to participate because of their child’s illness, and 15% said they felt some type of pressure to participate from others; 41% reported knowing that they did not have to participate. Conclusions. The consent Ugandan parents provided to allow their children to participate in the malaria study was of mixed quality. Parents understood many of the study details, but they were not very aware of the risks involved or of randomization. Many parents felt that they could not have refused to participate because their child was sick and they either did not know or did not believe that their child would receive treatment outside of the study. Our results indicate that further debate is needed about informed consent in treatment studies of emergent illnesses in children.

Comparing the Understanding of Subjects Receiving a Candidate Malaria Vaccine in the United States and Mali

“…20,22 More than 90% of participants at all sites correctly answered the question regarding withdrawal of consent. This contrasts with other studies indicating that participants in the developing world are more likely to feel pressured into enrolling into research, 12,23 and often have a poor understanding of their right to withdraw. 10,20,24 Over 80% of Malian participants correctly answered the question about randomization ("Everybody in this study will get the same kind of vaccine," correct answer false).…”

“…However, there is not clear evidence of substantial differences in understanding between participants from developed compared with developing countries, 9 although there are some indications that developing country participants are more likely to feel pressure to enroll. [10][11][12] These conclusions are tentative, because these studies look at participants in widely varying clinical trials. For instance, many of the studies of understanding in developed countries were Phase I oncology studies, which are not currently conducted in developing countries.…”

Informed consent in Ghana: what do participants really understand?

“…This context may result in minimal evaluation and processing by subjects of information provided during the process of gaining consent, and consequently in poor knowledge—even though subjects may consider individual consent important. The cultural context may also affect the amount of information provided to subjects by fieldworkers 16 17. For example, if fieldworkers consider consent procedures unnecessary or feel under pressure to limit refusals, they may provide less information than was intended.…”

Assent of School-Age Bilingual Children

“…A few studies, however, examined the quality of informed consent of adults who were bilingual or who were from developing countries (Dein & Bhui, 2005;Fitzgerald, Marotte, Verdier, Johnson, & Pape, 2002;Lynoe, Hyder, Chowdbury, & Ekstrom, 2001;Pace et al, 2005). Although language was an issue in securing informed consent, obstacles to comprehension went beyond the linguistic barriers.…”