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Initial experience using the Food and Drug administration guidelines for emergency research without consent
M S Kremers1, D R Whisnant, L S Lowder
1Mid-Carolina Cardiology, PA, USA.
Annals of Emergency Medicine
|January 29, 1999
Summary
Research without consent is permissible under specific FDA regulations, but requires community consultation. Compliance with these rules for cardiopulmonary resuscitation (CPR) studies proved challenging, highlighting the need for clearer guidelines.
Area of Science:
- Medical Ethics
- Clinical Research Regulation
- Cardiopulmonary Resuscitation
Background:
- The U.S. Food and Drug Administration (FDA) regulation 21 CFR 50.24 permits research without participant consent in limited emergency situations.
- This regulation mandates enhanced patient protections, including community consultation and disclosure.
Purpose of the Study:
- To report the experience of complying with FDA regulation 21 CFR 50.24 in a multicenter investigational device study.
- To assess the practical challenges and acceptance of research without consent in the context of cardiopulmonary resuscitation (CPR).
Main Methods:
- The study involved the Multicenter Vest CPR protocol, an investigational device study conducted under the FDA's exception for consent.
- Community consultation processes were implemented as required by the regulation.
Main Results:
- Interpreting community consultation requirements presented uncertainties.
- While acceptance of research without consent varied, physicians and the public showed minimal reservations.
- The consultation process was resource-intensive, involving significant time, effort, and cost.
Conclusions:
- Clarification of community consultation standards is needed for effective implementation.
- Further dialogue is essential to facilitate research in emergency settings like CPR.
- The study underscores the complexities of balancing research innovation with ethical considerations and patient protection.