Evidence map›Paper›PMID 26707358›Full record

ArticleAnnals of emergency medicine2016

Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.

Neal W Dickert, Jeremy Brown, Charles B Cairns, Aaliyah Eaves-Leanos, Sara F Goldkind, Scott Y H Kim, Graham Nichol, Katie J O'Conor, Jane D Scott, Richard Sinert and 3 more

Abstract read
In one paragraph

Article in Annals of emergency medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

  1. Article
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  3. Article
  4. Article
  5. Observational
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  11. Observational
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  16. Article
  17. Review
  18. Review
  19. Article
  20. Capacity, Vulnerability, and Informed Consent for Research.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2018
    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

13 authors.

Neal W DickertDepartment of Medicine, Emory University School of Medicine, Atlanta, GA; Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA. Electronic address: njr@emory.edu.
Jeremy BrownOffice of Emergency Care Research, National Institute of General Medical Sciences, Bethesda, MD.
Charles B CairnsUniversity of Arizona College of Medicine, Tucson, AZ.
Aaliyah Eaves-LeanosCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD; Albert Gnaegi Center for Health Care Ethics, Saint Louis University, St. Louis, MO.
Sara F GoldkindOffice of the Commissioner, Food and Drug Administration, Silver Spring, MD; Research and Clinical Bioethics Consultant.
Scott Y H KimDepartment of Bioethics, National Institutes of Health, Bethesda, MD.
Graham NicholUniversity of Washington-Harborview Center for Prehospital Emergency Care, University of Washington, Seattle, WA.
Katie J O'ConorJohns Hopkins University School of Medicine, Baltimore, MD.
Jane D ScottNational Heart, Lung, and Blood Institute, Bethesda, MD.
Richard SinertDepartment of Emergency Medicine, State University of New York Downstate Medical Center, New York, NY.
David WendlerDepartment of Bioethics, National Institutes of Health, Bethesda, MD.
David W WrightDepartment of Emergency Medicine, Emory University School of Medicine, Atlanta, GA.
Robert SilbergleitDepartment of Emergency Medicine, University of Michigan Medical School, Ann Arbor, MI.

Funding

ProTECT IIIU01NS062778 · NINDS · EMORY UNIVERSITY · PI WRIGHT, DAVID W · 2009 to 2013
$26.4M
Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hubs....U10NS059032 · NINDS · EMORY UNIVERSITY · PI WRIGHT, DAVID W · 2007 to 2016
$2.5M
Ethics of Standards of Care ResearchZIACL010538 · CLC · CLINICAL CENTER · PI KIM, SCOTT · 2015 to 2025
$0k
NINDS NIH HHS U01 NS062778NINDS NIH HHS U10 NS059032
6 · The paper itself

Abstract

Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available. Most emergency care research, however, involves conscious patients, and surrogates are often available. Unfortunately, there is neither clear regulatory guidance nor established ethical standards in regard to consent in these settings. In this report-the result of a workshop convened by the National Institutes of Health Office of Emergency Care Research and Department of Bioethics to address ethical challenges in emergency care research-we clarify potential gaps in ethical understanding and federal regulations about research in emergency care in which limited involvement of patients or surrogates in enrollment decisions is possible. We propose a spectrum of approaches directed toward realistic ethical goals and a research and policy agenda for addressing these issues to facilitate clinical research necessary to improve emergency care.

Indexed as

ConsciousnessEmergency MedicineEthics, ResearchInformed ConsentHuman ExperimentationHumansUnited States

Identifiers

PMID26707358
PMCPMC7749649

What OpenQuestion holds

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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.