Evidence map›Paper›PMID 33872426›Full record

ReviewAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2021

Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.

Neal W Dickert, Kathleen Metz, Michael D Fetters, Adrianne N Haggins, Deneil K Harney, Candace D Speight, Robert Silbergleit

Abstract readReview
In one paragraph

Review in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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

19 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Exception From Informed Consent Community Consultation Surveys-Do Respondent Characteristics Accurately Reflect Targeted Communities?Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026
    Article
  6. Article
  7. Community Acceptance of a Pediatric Prehospital Exception From Informed Consent Trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026
    Article
  8. Article
  9. Measuring the efficacy of community consultation in a pediatric exception from informed consent trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2025
    Article
  10. Article
  11. A call for community-shared decisions.BMJ evidence-based medicine · 2025
    Article
  12. Article
  13. Article
  14. Article
  15. Willingness to participate in an active exception from informed consent trial in the pediatric intensive care unit.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2024
    Article
  16. Review
  17. Article
  18. Article
  19. 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.

Neal W DickertDepartment of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.ORCID 0000-0003-4415-3861
Kathleen MetzDepartment of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Michael D FettersMixed Methods Program and Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Adrianne N HagginsDepartment of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.ORCID 0000-0003-4030-2815
Deneil K HarneyDepartment of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Candace D SpeightDepartment of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Robert SilbergleitDepartment of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.ORCID 0000-0003-4101-2430

Funding

Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Clinical Coordinating Center (CCC)U24NS100659 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI WILLIAM G BARSAN, Clifton W. Callaway · 2017 to 2026
$6.4M
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating CenterU24NS100655 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI VALERIE L DURKALSKI, Sharon Dziuba Yeatts · 2017 to 2026
$4.4M
Central IRB review of local context in emergency research: empirical ethics studyR01HD086676 · NICHD · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SILBERGLEIT, ROBERT · 2015 to 2018
$1.5M
NHLBI NIH HHS U24NS10065502S1NICHD NIH HHS R01 HD086676NINDS NIH HHS U24 NS100655NINDS NIH HHS U24 NS100659NINDS NIH HHS U24NS10065902S1
6 · The paper itself

Abstract

backgroundException from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature.

methodsScoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories.

resultsAmong 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two-way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what "communities" to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy.

conclusionsMultiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.

Indexed as

DisclosureInformed ConsentEmergenciesEmergency Service, HospitalHumansReferral and Consultationclinical trials as topiccommunity-institutional relationscritical caredisclosureemergenciesinformed consent

Identifiers

PMID33872426
PMCPMC8523587

What OpenQuestion holds

Textmetadata
LicenceTDM
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.