Faculty of Dentistry, University of Otago, 310 Great King Street, Dunedin, 9016, New Zealand.
Stratford Dental, 82 Miranda Street, Taranaki, Stratford District, 4332, New Zealand.
J Bioeth Inq. 2021 Mar;18(1):141-150. doi: 10.1007/s11673-020-10085-w. Epub 2021 Jan 15.
There are differences in caregivers' literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers' understandings, of the process of informed consent that accompanied their child's participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants' perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent.
看护人在读写能力和健康素养方面存在差异，这可能会影响他们同意孩子参与临床研究试验的能力。本研究旨在探索伴随儿童参与牙科随机对照试验（RCT）的知情同意过程对其的有效性，以及看护人的理解。通过方便抽样，对参与 RCT 的每一位儿童的十名看护人进行了电话访谈。使用了预先测试的封闭式和开放式问题，研究结果来自对后者的归纳分析和对前者的描述性分析。参与者对 RCT 的目的只有有限的了解，并对知情同意书的可读性评价高于对研究的理解程度。所有人都认为知情同意至关重要，但一些看护人并未阅读同意书。一些看护人让孩子参与 RCT 是因为他们信任研究人员，而且大多数人希望改善儿童的牙科护理。尽管知情同意文件的可读性很高，但知情同意过程并非总是有效。研究人员必须考虑研究对象的健康素养，并且积极与看护人接触以实现有意义的知情同意可能具有挑战性。未来的研究可以探索健康素养较低人群对知情同意的看法，并评估对不理解与健康相关信息的潜在期望是否会成为知情同意的障碍。
