Department of Endocrinology and Metabolism, Charité Universitätsmedizin Berlin, Berlin, Germany.
Global Health Ethics Team, World Health Organization, Geneva, Switzerland.
BMC Med Res Methodol. 2020 May 13;20(1):114. doi: 10.1186/s12874-020-01000-3.
Enrolment in a research study requires the participant's informed consent. In the case of minors, informed consent of the respective legal guardian is obtained in conjunction with informed assent of the underage p articipant. Since comprehension of the information provided may be limited, effective interventions to improve understanding should be identified. Thus, it is the objective of this study to review quantitative studies that tested interventions to improve the understanding of information provided during assent processes in health research. The studied population consisted of minors that participated or were willing to participate in research. The primary outcome was the level of comprehension after intervention.
A systematic search was conducted in eleven databases including regional databases: PubMed, Web of Science, ERIC, PsycINFO, CINAHL, POPLINE, AIM, LILACS, WPRIM, IMSEAR, and IMEMR and included references from inception of the database until July 2018 except PubMed which spanned the period from May 2013 to July 2018. Search terms focused on Informed Consent/Assent, Minors, and Comprehension. To complement the search, reference lists of retrieved publications were additionally searched. We included all quantitative studies that were conducted in minors, tested an intervention, covered assent processes in health research, and assessed comprehension. One reviewer screened titles, abstracts, and full-texts to determine eligibility and collected data on study design, population, intervention, methods, outcome, and for critical appraisal. Interventions comprised enhanced paper forms, interspersed questions, multimedia format, and others.
Out of 7089 studies initially identified, 19 studies comprising 2805 participants and conducted in seven countries were included in the review. Fourteen studies (74 %) tested an intervention against control and ten (53 %) were randomized controlled trials. Heterogeneous methodology as well as incomplete outcome and statistical reporting impaired the reliability of the collected data. Positive effects were suggested for use of enhanced paper forms, interspersed questions, use of pie charts, and organizational factors.
Improving assent in health research is an under-researched area with little reliable evidence. While some interventions are proposed to improve understanding in assent processes, further investigation is necessary to be able to give evidence-based recommendations.
PROSPERO ID: 106808.
参加研究需要参与者的知情同意。对于未成年人，在获得相应法定监护人同意的同时，也需要获得未成年参与者的同意。由于未成年人对所提供信息的理解可能有限，因此需要确定有效的干预措施来提高他们的理解程度。因此，本研究的目的是综述旨在提高健康研究中同意过程中信息理解的干预措施的定量研究。研究人群由参与或愿意参与研究的未成年人组成。主要结果是干预后的理解水平。
在包括区域数据库在内的 11 个数据库中进行了系统搜索：PubMed、Web of Science、ERIC、PsycINFO、CINAHL、POPLINE、AIM、LILACS、WPRIM、IMSEAR 和 IMEMR，除了 PubMed 从 2013 年 5 月到 2018 年 7 月，其他数据库均从数据库建立开始纳入参考资料。搜索词集中于知情同意/同意、未成年人和理解。为了补充搜索，还额外搜索了检索文献的参考文献列表。我们纳入了所有在未成年人中进行的、测试干预措施、涵盖健康研究同意过程、并评估理解程度的定量研究。一位评审员筛选标题、摘要和全文以确定合格性，并收集研究设计、人群、干预措施、方法、结果和关键评价的数据。干预措施包括增强型纸质表格、穿插问题、多媒体格式等。
最初确定的 7089 项研究中，有 19 项研究（共 2805 名参与者）来自七个国家，被纳入综述。14 项研究（74%）针对对照测试了干预措施，其中 10 项（53%）为随机对照试验。不同的方法以及不完整的结果和统计报告降低了所收集数据的可靠性。增强型纸质表格、穿插问题、使用饼图和组织因素的使用被认为具有积极效果。
提高健康研究中的同意率是一个研究不足的领域，可靠证据较少。虽然提出了一些干预措施来提高同意过程中的理解程度，但需要进一步调查，以便能够提供基于证据的建议。
PROSPERO ID：106808。
