Pace Christine, Talisuna Ambrose, Wendler David, Maiso Faustin, Wabwire-Mangen Fred, Bakyaita Nathan, Okiria Edith, Garrett-Mayer Elizabeth S, Emanuel Ezekiel, Grady Christine
Section on Human Subjects, Department of Clinical Bioethics, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892-1156, USA.
Am J Public Health. 2005 Jul;95(7):1184-9. doi: 10.2105/AJPH.2004.053082. Epub 2005 Jun 2.
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.
We conducted 347 interviews immediately following enrollment at 4 Ugandan sites.
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.
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.
我们对那些让孩子参加一项随机儿科疟疾治疗试验的乌干达家长进行了调查，以评估家长对治疗试验的理解程度以及家长同意孩子参与研究的质量。
我们在乌干达的4个地点招募后立即进行了347次访谈。
大多数（78%）家长最多接受过小学教育，其中大多数（86%）是母亲。在参与的母亲中，相当比例的人报告说她们记得被告知研究目的（77%）、所需就诊次数（88%）、所涉及的风险（61%）、治疗分配（84%）以及她们让孩子退出参与的能力（64%）。此外，大多数人报告知道试验目的（80%）和所需就诊次数（78%）；然而，只有18%的人能说出所使用药物可能的副作用，只有19%的人知道并非所有孩子都会接受相同的治疗。94%的人报告说他们自己做出了参与决定，但58%的人说因为孩子生病他们感到有参与的压力，15%的人说他们感到来自他人的某种参与压力；41%的人报告知道他们不必参与。
乌干达家长为允许孩子参与疟疾研究而提供的同意书质量参差不齐。家长理解许多研究细节，但他们对所涉及的风险或随机分组不太了解。许多家长觉得因为孩子生病他们无法拒绝参与，而且他们要么不知道要么不相信孩子在研究之外会得到治疗。我们的结果表明，对于儿童紧急疾病治疗研究中的知情同意问题需要进一步讨论。
