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Related Concept Videos

Ethics in Research01:56

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Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Exception from Informed Consent in Emergency Care Research: Reports from a Workshop Addressing "Edge Cases".

Jeremy Brown1, Neal W Dickert2, Robert Silbergleit3

  • 1Director of the Office of Emergency Care Research at the National Institutes of Health.

Ethics & Human Research
|December 31, 2025
PubMed
Summary

Ethical challenges persist in emergency research without patient consent. Suggestions to improve clinical trials under the exception from informed consent framework were discussed at a National Institutes of Health workshop.

Keywords:
decisional incapacityemergency care researchemergency settinghuman subjects researchlegally authorized representativeresearch ethicssurrogate decision‐maker

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Area of Science:

  • Emergency Medicine
  • Clinical Research Ethics
  • Regulatory Science

Background:

  • Ethical dilemmas persist in enrolling critically ill patients in emergency clinical trials without consent.
  • A 30-year regulatory framework exists for emergency care research, yet challenges remain.
  • The exception from informed consent for emergency research is a complex regulatory area.

Purpose of the Study:

  • To outline suggestions for improving studies conducted under the existing regulatory framework for emergency care research.
  • To address the ongoing ethical challenges of research involving critically ill patients.
  • To foster advancements in clinical trials conducted in emergency settings.

Main Methods:

  • The content is based on suggestions from a workshop sponsored by the National Institutes of Health.
  • Review of the current regulatory framework for exception from informed consent in emergency research.
  • Expert discussions on ethical considerations and practical improvements for emergency research.

Main Results:

  • Identified persistent ethical challenges in emergency research enrollment.
  • Proposed actionable suggestions to enhance studies conducted under the exception from informed consent.
  • Highlighted the need for continued dialogue and improvement in emergency research practices.

Conclusions:

  • Improvements are needed to better navigate the ethical landscape of emergency care clinical trials.
  • The exception from informed consent framework requires ongoing refinement to protect vulnerable populations.
  • Collaborative efforts, like NIH workshops, are crucial for advancing ethical emergency research.