Evidence map›Paper›PMID 38916109›Full record

ArticleClinical trials (London, England)2025

The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research.

Emily A Largent, Steven Joffe, Neal W Dickert, Stephanie R Morain

Abstract read
In one paragraph

Article in Clinical trials (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Ethical Frameworks for Conducting Social Challenge Studies.Journal of empirical research on human research ethics : JERHRE · 2026
    Review
  2. A Framework of Institutional Obligations for Pragmatic Clinical Trials.The American journal of bioethics : AJOB · 2026
    Article
  3. Article
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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

4 authors.

Emily A LargentDepartment of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.ORCID 0000-0002-7536-5077
Steven JoffeDepartment of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Neal W DickertDepartment of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA.ORCID 0000-0003-4415-3861
Stephanie R MorainBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0001-7278-7517

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI Vincent Mor · 2019 to 2026
$125.9M
NIA NIH HHS U54 AG063546
6 · The paper itself

Abstract

There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is

Indexed as

Clinical Trials as TopicCommunity ParticipationInformed ConsentPragmatic Clinical Trials as TopicEthics, ResearchHumansTrustConsentethicspragmatic trialswaivers

Identifiers

PMID38916109
PMCPMC11668908

What OpenQuestion holds

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Registered trials

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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.