Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.
University of Washington School of Medicine, Department of Pediatrics, Seattle.
JAMA Netw Open. 2020 Jul 1;3(7):e209296. doi: 10.1001/jamanetworkopen.2020.9296.
Obtaining informed consent is an important ethical obligation for clinical research participation that is imperfectly implemented. Research on improving consent processes often focuses on consent forms, but little is known about consent forms' influence on decision-making compared with other types of engagement.
To evaluate whether parents decide whether to enroll their children in research before or after they receive the consent form.
DESIGN, SETTING, AND PARTICIPANTS: An online survey of 88 parents who enrolled or declined to enroll their child in a weight management intervention study between January 2, 2018, and June 24, 2019, was conducted; surveys were completed between February 2, 2018, and July 9, 2019. A 31-item survey asked about impressions of the study throughout the enrollment process, timing of enrollment decisions, and decision-making factors. Responses were summarized descriptively and subgroups were compared using the Fisher exact test or χ2 test.
Self-reported timing of enrollment decision.
A total of 106 parents were approached and gave permission for their contact information to be shared with the study team; 22 additional parents declined to allow their information to be shared, and 24 lost contact with the partner study before they could be asked for permission. A total of 88 parents (67 enrollees, 21 decliners) completed the survey (83% participation rate); 79 of 88 reporting gender (instead of sex, as biological sex was not relevant to survey) information were women (91%), 66 participants (75%) were non-Hispanic White, and 63 participants (72%) had annual household incomes greater than or equal to $70 000. No significant differences in respondent characteristics between enrollees and decliners were identified. Fifty-nine parents (67%) responded that they decided whether to enroll in the weight management study before receiving the consent form. Only 17 of 69 parents (25%) who remembered receiving the consent form responded that it taught them new information.
The findings of this study suggest that interventions to improve informed consent forms may have limited influence on decision-making because many research decisions occur before review of the consent form. It appears that regulatory review and interventions to improve decision-making should focus more on early engagement (eg, recruitment materials). Future studies should test timing of decisions in other types of research with different populations and clinical settings.
获得知情同意是参与临床研究的一项重要伦理义务，但执行情况并不完善。关于改进同意过程的研究通常侧重于同意书，但与其他类型的参与相比，人们对同意书对决策的影响知之甚少。
评估父母是在收到同意书之前还是之后决定是否让孩子参加研究。
设计、地点和参与者：2018 年 1 月 2 日至 2019 年 6 月 24 日期间，对 88 名父母进行了一项关于是否让孩子参加体重管理干预研究的在线调查；调查于 2018 年 2 月 2 日至 2019 年 7 月 9 日期间完成。一项 31 项的调查询问了父母在整个入组过程中对研究的印象、入组决定的时间以及决策因素。通过描述性总结和使用 Fisher 确切检验或 χ2 检验比较亚组来总结结果。
自我报告的入组决策时间。
共有 106 名父母被联系并同意将他们的联系方式提供给研究团队；另外 22 名父母拒绝允许分享他们的信息，24 名父母在被要求允许之前与合作伙伴研究失去了联系。共有 88 名父母（67 名入组者，21 名拒绝者）完成了调查（参与率 83%）；88 名报告性别（而不是生物性别，因为性别与调查无关）信息的人中，79 名为女性（91%），66 名参与者（75%）为非西班牙裔白人，63 名参与者（72%）的家庭年收入大于或等于 70000 美元。入组者和拒绝者的应答者特征无显著差异。59 名父母（67%）表示他们在收到同意书之前决定是否参加体重管理研究。在 69 名记得收到同意书的父母中，只有 17 名（25%）表示同意书让他们了解了新信息。
这项研究的结果表明，改善知情同意书的干预措施可能对决策的影响有限，因为许多研究决策是在审查同意书之前做出的。监管审查和改善决策的干预措施似乎应更多地侧重于早期参与（例如，招募材料）。未来的研究应该在不同人群和临床环境中测试其他类型的研究的决策时间。
