视频、应用程序与标准知情同意流程对生物标本研究决策影响的比较：一项随机对照试验
Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.
机构信息
The University of Utah, Salt Lake City, USA.
Case Western Reserve University, Cleveland, OH, USA.
出版信息
J Empir Res Hum Res Ethics. 2020 Oct;15(4):252-260. doi: 10.1177/1556264620913455. Epub 2020 Apr 3.
Abstract
Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet "app") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.
摘要
由于新生儿筛查期间环境繁忙，且对生物样本的未来、未指定的研究具有相对抽象的性质，因此获得知情同意进行血斑研究极具挑战性。在密歇根州的三家医院进行了一项随机对照试验，以比较密歇根生物信托健康中心中基于标准宣传册的标准知情同意书，以及使用视频和交互式平板电脑“应用程序”的两种不同同意书流程。结果表明，视频和应用程序组的知识得分更高，对信息的满意度、信息量和清晰度得分也显著更高。还需要更多的研究来找到用于知情决策的正确信息量，并需要更多的可行性研究来评估实施策略。
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本文引用的文献
1
Secondary research uses of residual newborn screening dried bloodspots: a scoping review.
Genet Med. 2019 Jul;21(7):1469-1475. doi: 10.1038/s41436-018-0387-8. Epub 2018 Dec 10.
2
An Assessment of a Shortened Consent Form for the Storage and Research Use of Residual Newborn Screening Blood Spots.
J Empir Res Hum Res Ethics. 2017 Dec;12(5):335-342. doi: 10.1177/1556264617736199. Epub 2017 Oct 26.
3
Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.
Am J Hum Genet. 2017 Mar 2;100(3):414-427. doi: 10.1016/j.ajhg.2017.01.021. Epub 2017 Feb 9.
4
Research participants' perceptions and views on consent for biobank research: a review of empirical data and ethical analysis.
BMC Med Ethics. 2015 Sep 9;16:60. doi: 10.1186/s12910-015-0053-5.
5
Broad Consent for Research With Biological Samples: Workshop Conclusions.
Am J Bioeth. 2015;15(9):34-42. doi: 10.1080/15265161.2015.1062162.
6
A randomized controlled trial of an electronic informed consent process.
J Empir Res Hum Res Ethics. 2014 Dec;9(5):1-7. doi: 10.1177/1556264614552627. Epub 2014 Oct 2.
7
Effectiveness of multimedia aids to enhance comprehension of research consent information: a systematic review.
IRB. 2012 Nov-Dec;34(6):1-15.
8
State laws regarding the retention and use of residual newborn screening blood samples.
Pediatrics. 2011 Apr;127(4):703-12. doi: 10.1542/peds.2010-1468. Epub 2011 Mar 28.
9
Assessing the understanding of biobank participants.
Am J Med Genet A. 2009 Feb;149A(2):188-98. doi: 10.1002/ajmg.a.32635.
10
Measuring trust in medical researchers.
Med Care. 2006 Nov;44(11):1048-53. doi: 10.1097/01.mlr.0000228023.37087.cb.
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