Evidence map›Paper›PMID 42272868›Full record

ArticleJournal of clinical and translational science2026

Systematic review of approaches to informed consent in recent high-impact clinical trials.

Caleigh Propes, Jonathan D Casey, Matthew W Semler, Stephanie C DeMasi, Amelia L Muhs, Edward T Qian, Kevin P Seitz, Stephanie Morain

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Caleigh PropesJohns Hopkins Berman Institute of Bioethics, USA.ORCID https://orcid.org/0009-0002-3198-480X
Jonathan D CaseyDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, USA.ORCID https://orcid.org/0000-0002-0977-290X
Matthew W SemlerDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, USA.
Stephanie C DeMasiDepartment of Emergency Medicine, Vanderbilt University Medical Center, USA.
Amelia L MuhsSection of Pulmonary/Critical Care and Allergy/Immunology, Louisiana State University Health Sciences Center New Orleans, USA.
Edward T QianDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, USA.
Kevin P SeitzDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, USA.
Stephanie MorainJohns Hopkins Berman Institute of Bioethics, USA.ORCID https://orcid.org/0000-0001-7278-7517

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The U.S. Food and Drug Administration (FDA) recently harmonized its regulatory criteria for waivers and alterations of informed consent with the U.S. Common Rule. We conducted a systematic review of clinical trials in the two highest-impact clinical journals in the U.S. to better understand practice-changing trials that are being conducted in the U.S. without prospective written informed consent. One in ten trials in our sample were conducted without prospective written informed consent. Such trials accounted for 93.1% of patient-subjects in our sample, enrolling nearly 3 million individuals. Further guidance would support socially valuable research while ensuring appropriate oversight.

Indexed as

ethicsinformed consentpragmatic trialsregulatoryWaiver

Identifiers

PMID42272868
PMCPMC13247783

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.