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AJPH First Look, published online ahead of print Jun 2, 2005
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AJPH.2004.053082v1
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American Journal of Public Health, 10.2105/AJPH.2004.053082

Research and Practice

Quality of Parental Consent in a Ugandan Malaria Study

Christine A. Pace 1, Ambrose O. Talisuna 2, David Wendler 1, Faustin Maiso 2, Fred Wabwire- Mangen 3, Nathan Bakyaita 3, Edith Okiria 3, Elizabeth Garrett-Mayer 4, Ezekiel Emanuel 1, Christine Grady 1*

1 U.S, National Institutes of Health
2 Ministry of Health, Uganda
3 Makerere University, Uganda
4 Johns Hopkins University, USA

* To whom correspondence should be addressed. E-mail: cgrady{at}nih.gov.


  Abstract

Objective. Evaluate the quality of Ugandan parents/guardians' consent to enroll children in a randomized pediatric malaria treatment trial. Methods. 347 in-person interviews conducted at four sites in Uganda immediately after enrollment. Results. Mothers (85%) with at most primary school education (78%) remembered being told about study purpose (77%), required visits (88%), risks (61%), treatment allocation (84%), and possibility of quitting (64%). Most knew purpose (80%) and visit number (78%), only 18% could name any drug side effects. 19% knew that not all children would receive identical treatment. 94% made the enrollment decision themselves; 58% felt pressure because of the child's illness and 15% felt any pressure from others; 41% said they could have refused. Conclusions. Consent by Ugandan parents for children in this malaria study was of mixed quality. Comprehension of study details was good, but not of risks or randomization. Many felt they could not have refused because their child was sick, and either did not know or believe their child would receive treatment outside of the study. Further debate is needed about informed consent in treatment studies of emergent illness in children.

Key Words: Child and Adolescent Health, Ethics, Global Health, Social Science, Surveys




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