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Views of consent approaches used in emergency and critical care research: an ERS Clinical Research Collaboration rapid, systematic review of the acceptability of alternative consent models

2025· article· W4416635776 on OpenAlexaff
Niamh Mahon, Leanne Hays, Eva Coy, Kate Ainscough, Aidan Burrell, Anthony Gordon, Bram Rochwerg, Brenda Lucas, Chunmei Wang, Daniel Harvey, Dhruv Parekh, Ewan C. Goligher, Fiona Toal, Hiroki Saito, John C. Marshall, Jonathan Stewart, Nina Gobat, Steve Webb, Timo Tolppa, I Icc-Ppi Group, Alistair Nichol

Bibliographic record

Venuenot available
Typearticle
Language
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsUniversity of British ColumbiaCanadian Institutes of Health ResearchUniversity of TorontoMcMaster University
Fundersnot available
KeywordsInformed consentContext (archaeology)Research ethicsClinical trialHealth careMEDLINEInclusion (mineral)Clinical research

Abstract

fetched live from OpenAlex

Background: The ability to obtain prospective informed consent can be limited in emergency research, including critical care. Opinions of alternative consent models are required and may vary among under-served groups and in the context of the COVID-19 pandemic. Research is needed to inform practice. Methods: We conducted a rapid systematic review of opinions of alternative consent models used in emergency research with searches carried out to July 31 2024. We included quantitative and qualitative studies and investigated under-served groups and pandemic settings. Results: Of 9974 citations, 147 eligible studies were included. Consent models included prospective informed consent (n=28), deferred consent (n=28), surrogate decision maker consent (n=40), healthcare professional consent (n=18) and waived consent (n=45). Groups represented included previous trial participants, relatives, patients, members of the public, healthcare providers, researchers, and ethics committees. In general, alternative consent models were acceptable, with an emphasis on the inclusion of the patient and/or relative in decision-making where possible, and the timing of consent in a high stress setting. Study staff highlighted limitations, such as relative unavailability. Pandemic studies indicated an increased need for alternative consent. Views of under-served groups did not show consensus, however, accommodations to support those groups were largely unreported. Conclusion: Alternative consent models used for emergency research were generally acceptable. This work has informed the consent model in the PANTHER platform trial.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.515
metaresearch head score (Gemma)0.735
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Research integrity
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Systematic review · Consensus signal: Systematic review
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.993
Threshold uncertainty score0.598

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.5150.735
Meta-epidemiology (narrow)0.0020.004
Meta-epidemiology (broad)0.0100.010
Bibliometrics0.0380.030
Science and technology studies0.0040.007
Scholarly communication0.0140.024
Open science0.0060.014
Research integrity0.0070.007
Insufficient payload (model declined to judge)0.0060.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.928
GPT teacher head0.726
Teacher spread0.202 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designSystematic review
DomainMethods
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2025
Admission routes1
Has abstractyes

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