Since the ASPIRE Trial will be performed with patients who are in cardiac arrest, it will be impossible to get informed consent from study subjects prior to enrolling them into the study.

The United States Food and Drug Administration has specific rules regarding the use of the emergency exception to informed consent process when performing human subjects research.  The special requirements include consultation with the community regarding the proposed research as well as public disclosure of the results.

This website is intended to inform the public about the proposed study and therefore satisfy part of the requirement for public disclosure of the research study.  In addition to the PowerPoint presentation on this website, the investigators have also developed an information brochure.  This explains the study purpose and methods.  This document is available for viewing or downloading.

All persons (or their next of kin or legal representative) who are treated for cardiac arrest by a participating EMS agency, will be provided formal notification about the research by study personnel.

There is a feedback page on this website where you can provide comments or ask questions to the investigators and the University of Pittsburgh Institutional Review Board (IRB) about the proposed research study.  We encourage you to complete the feedback form so that the IRB will have as much information as possible about the public's opinion of this study.