Quality of parental consent in a Ugandan malaria study

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 My 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.