Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

Amy Corneli; Emily Namey; Monique P. Mueller; Jenae Tharaldson; Steve Sortijas; Thomas Grey; Jeremy Sugarman

doi:10.1177/1556264616682550

Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

Amy Corneli, Emily Namey, Monique P. Mueller, Jenae Tharaldson, Steve Sortijas, Thomas Grey, Jeremy Sugarman

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Research output: Contribution to journal › Article › peer-review

18 Scopus citations

Abstract

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

Original language	English (US)
Pages (from-to)	14-25
Number of pages	12
Journal	Journal of Empirical Research on Human Research Ethics
Volume	12
Issue number	1
DOIs	https://doi.org/10.1177/1556264616682550
State	Published - Feb 1 2017

Keywords

HIV
U.S. regulations
consent forms
informed consent
research ethics

ASJC Scopus subject areas

Social Psychology
Education
Communication

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abstract = "Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.",

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AU - Grey, Thomas

AU - Sugarman, Jeremy

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Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

Abstract

Keywords

ASJC Scopus subject areas

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