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Updated: Jun 17, 2026

A Saline/Bipolar Radiofrequency Energy Device As an Adjunct for Hemostasis in Solid Organ Injury/Trauma
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A Saline/Bipolar Radiofrequency Energy Device As an Adjunct for Hemostasis in Solid Organ Injury/Trauma

Published on: July 28, 2020

Emergency innovation: implications for the trauma surgeon.

Jennifer L Pretz1, David Magnus, David A Spain

  • 1Stanford Center for Biomedical Ethics, Department of Surgery, Stanford University School of Medicine, Stanford, California, USA.

The Journal of Trauma
|December 17, 2009
PubMed
Summary

Navigating emergency innovation requires clear ethical guidelines. Adhering to principles and protecting subjects are crucial for medical progress in this complex intersection.

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Last Updated: Jun 17, 2026

A Saline/Bipolar Radiofrequency Energy Device As an Adjunct for Hemostasis in Solid Organ Injury/Trauma
04:20

A Saline/Bipolar Radiofrequency Energy Device As an Adjunct for Hemostasis in Solid Organ Injury/Trauma

Published on: July 28, 2020

Area of Science:

  • Bioethics
  • Surgical Innovation
  • Emergency Research

Background:

  • Human subject research requires robust ethical protections, guided by US regulations since the Belmont Report.
  • Distinguishing research, clinical treatment, and innovation is essential for ethical oversight.
  • This study examines the intersection of surgical innovation and emergency research, termed 'emergency innovation'.

Purpose of the Study:

  • To identify and analyze the ethical principles governing surgical innovation and emergency research.
  • To evaluate the ethical considerations of a specific case of emergency surgical innovation.
  • To address the challenges and provide recommendations for ethical conduct in emergency innovation.

Main Methods:

  • Conducted a systematic literature review of emergency research and surgical innovation.
  • Identified core ethical principles within each distinct field.
  • Analyzed a contemporary case study of surgical innovation in emergency care.

Main Results:

  • Informed consent, a key protection in innovation, is often waived in emergencies, posing an ethical challenge.
  • While specific regulations for emergency innovation are lacking, existing ethical principles from both fields are complementary.
  • There is a significant risk of misinterpreting or disregarding ethical principles in emergency innovation due to regulatory ambiguity.

Conclusions:

  • Emergency innovation necessitates unambiguous study purposes and adherence to all applicable ethical principles.
  • Institutional Review Board (IRB) approval is recommended early if publication is a goal.
  • Subtle innovations for patient care may begin with feasibility trials before formal IRB-approved studies, always prioritizing subject vulnerability and ethical conduct.