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Related Experiment Videos

Does the emergency exception from informed consent process protect research subjects?

Nicole M Delorio1, Katie B McClure

  • 1Department of Emergency Medicine, Oregon Health & Science University, Portland, OR 97239, USA. deiorion@ohsu.edu

Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
|November 3, 2005
PubMed
Summary

Protecting subjects in emergency research is challenging, as current methods lack defined success measures. Further research is needed to develop effective subject protection strategies and community engagement processes.

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Area of Science:

  • Medical Ethics
  • Emergency Medicine Research
  • Subject Protection

Background:

  • Subject protection is critical in medical ethics, but its effectiveness in emergency research using exceptions to informed consent is uncertain.
  • Current oversight methods like data safety monitoring boards and community consultation/public notification (CC/PN) have debatable efficacy.
  • There's a lack of defined outcome measures to assess whether subjects are adequately protected.

Purpose of the Study:

  • To discuss challenges in subject protection during emergency research.
  • To recommend improvements for safeguarding research participants and advancing medical knowledge.
  • To highlight the need for validated methods in community consultation and public notification.

Main Methods:

  • Discussion and recommendations from a breakout session at the 2005 Academic Emergency Medicine Consensus Conference.

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  • Review of existing surrogate markers for protection, including data safety monitoring boards and CC/PN.
  • Identification of research gaps and suggested methodologies for future studies.

    • Main Results:

    • No established outcome measures currently define "protection" in emergency research.
    • Existing CC/PN methods have limited empirical support, with few studies specifically designed to assess their success.
    • There is a need for more research, funding, and data sharing on subject protection and CC/PN effectiveness.

    Conclusions:

    • Current rules for subject protection in emergency research require re-evaluation due to a lack of measurable outcomes.
    • Developing and validating effective CC/PN strategies is crucial for ethical emergency research.
    • Prioritizing funding and research into subject protection and community engagement is essential for both individual safety and societal benefit.