摘要：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. There is concern that illiteracy and limited education, lack of familiarity with research, and limited access to health care can jeopardize the ability of study participants, especially those in developing countries, to provide fully informed and voluntary consent. 1 – 4 Despite this concern, few studies have been conducted to examine the quality of informed consent in the aforementioned settings. 5 – 10 In developing countries, where children are involved in vital research on diseases such as malaria and dysentery, even fewer studies have evaluated the quality of informed parental consent for pediatric trial participants unable to provide their own consent. This aspect of informed consent also is understudied in developed countries. At 4 separate sites in Uganda, we interviewed parents and guardians whose children were participating in a randomized study of antimalarial treatments. Immediately after parents consented to enroll their child in the antimalarial study, we interviewed those parents about their motivations for enrolling their child in the study, their experiences with the informed consent process, their comprehension of the trial, and the extent to which the enrollment decision was voluntary.
