Quality of parental consent in a Ugandan malaria study.

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.