ArticleAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2015
Balancing ethical goals in challenging individual participant scenarios occurring in a trial conducted with exception from informed consent.
Article in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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.
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.
Who cites it
8 citing papers in PubMed.
- Variations in the application of exception from informed consent in a multicenter clinical trial.Resuscitation · 2019Trial
- American College of Medical Toxicology Research Agenda 2024-2030.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2024Article
- Ensuring the Efficacy and Safety of Approved Medications.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2024Article
- Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review.Trauma surgery & acute care open · 2023Review
- Ethical considerations in prehospital ambulance based research: qualitative interview study of expert informants.BMC medical ethics · 2019Article
- Determinants of Patient and Surrogate Experiences With Acute Care Research Consent: A Key Informant Interview Study.Journal of the American Heart Association · 2019Article
- Capacity, Vulnerability, and Informed Consent for Research.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2018Article
- Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.Annals of emergency medicine · 2016Article
Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decision-maker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.
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What OpenQuestion holds
Registered trials
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.