Food and Drug Administration Public Hearing on the Conduct of Emergency Clinical Research: Testimony of Dr. Pepe-Defending the Rights of All Individuals to Have Access to Potential Life-saving Therapies and Resuscitation Studies

Paul E. Pepe

Research output: Contribution to journalComment/debate

5 Scopus citations

Abstract

In summary, the implementation of well-designed clinical trials in resuscitation medicine using exception from informed consent is crucial to all Americans, particularly young adults and children. Not only is it important to validate promising new interventions, but it is also important to ensure the safety of the public when empirical standards of care have been instituted. In principle, the community consultation concept is sound, but it also has certain limitations and it is not necessarily indicated in all cases of exception from informed consent. In addition to funding community consultation and facilitating certain studies involving exception from informed consent, the scientific community and the federal government need to adopt a new perspective that they are the ultimate stewards of the public trust and should ensure that all Americans are not denied the right to the opportunity to be entered in clinical trials of resuscitation interventions. This is still particularly compelling when recognizing that the implementation of such studies is in itself lifesaving.

Original languageEnglish (US)
Pages (from-to)e51-e56
JournalAcademic Emergency Medicine
Volume14
Issue number4
DOIs
StatePublished - Apr 2007

ASJC Scopus subject areas

  • Emergency Medicine

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