Evidence map›Paper›PMID 28078953›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2017

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

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
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  5. JAMIA open · 2022
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  6. Article
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  15. Can we make informed consent forms more informative?Archives of disease in childhood. Fetal and neonatal edition · 2018
    Article
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  17. Article
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  20. Informed Consent for Mobile Phone Health Surveys in Colombia: A Qualitative Study.Journal of empirical research on human research ethics : JERHRE
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Amy Corneli1 FHI 360, Durham, NC, USA.
Emily Namey1 FHI 360, Durham, NC, USA.
Monique P Mueller1 FHI 360, Durham, NC, USA.
Jenae Tharaldson1 FHI 360, Durham, NC, USA.
Steve Sortijas1 FHI 360, Durham, NC, USA.
Thomas Grey1 FHI 360, Durham, NC, USA.
Jeremy Sugarman3 Johns Hopkins University, Baltimore, MD, USA.

Funding

EDICT: Effective Delivery of Informed Consent TrialR56AI100695 · NIAID · FAMILY HEALTH INTERNATIONAL · PI CORNELI, AMY LYNN, SUGARMAN, JEREMY · 2013 to 2013
$620k
NIAID NIH HHS R56 AI100695
6 · The paper itself

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.

Indexed as

Biomedical ResearchCommunicationComprehensionConsent FormsInformed ConsentAttitudeHIV InfectionsHumansSurveys and Questionnairesconsent formsHIVinformed consentresearch ethicsU.S. regulations

Identifiers

PMID28078953
PMCPMC5821132

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.