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Improving informed consent: Stakeholder views.

作者信息

Anderson Emily E, Newman Susan B, Matthews Alicia K

机构信息

a Neiswanger Institute for Bioethics, Stritch School of Medicine, Loyola University Chicago.

b Center for Clinical and Translational Science , University of Illinois at Chicago.

出版信息

AJOB Empir Bioeth. 2017 Jul-Sep;8(3):178-188. doi: 10.1080/23294515.2017.1362488. Epub 2017 Aug 2.


DOI:10.1080/23294515.2017.1362488
PMID:28949896
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5749407/
Abstract

PURPOSE: Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders-research participants and those responsible for obtaining informed consent-to inform potential development of a multimedia informed consent "app." METHODS: This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. RESULTS: We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. CONCLUSIONS: Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

摘要

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本文引用的文献

[1]
Barriers to Change in the Informed Consent Process: A Systematic Literature Review.

IRB. 2016

[2]
Ethics and Regulatory Challenges and Opportunities in Patient-Centered Comparative Effectiveness Research.

Acad Med. 2016-4

[3]
Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

J Empir Res Hum Res Ethics. 2015-12

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Clin Trials. 2015-12

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J Am Coll Dent. 2014

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Clin Trials. 2015-2

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Audio-visual presentation of information for informed consent for participation in clinical trials.

Cochrane Database Syst Rev. 2014-5-9

[8]
A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.

Am J Med Genet A. 2014-1

[9]
Participation in cancer clinical trials: why are patients not participating?

Med Decis Making. 2014-1

[10]
Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.

BMC Med Ethics. 2013-7-23

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