This Article Full Text Full Text (PDF) Data Supplement Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Tisherman, S. A. Search for Related Content PubMed PubMed Citation Articles by Tisherman, S. A. Related Collections AHA Statements and Guidelines CPR and emergency cardiac care

(Circulation. 2008;118:1585-1592.)
© 2008 American Heart Association, Inc.

Special Report

Regulatory Challenges for the Resuscitation Outcomes Consortium

Samuel A. Tisherman, MD; Judy L. Powell, BSN; Terri A. Schmidt, MD, MS; Tom P. Aufderheide, MD; Peter J. Kudenchuk, MD; Julie Spence, MD; Dixie Climer, RN, BSN, MBA; Donna Kelly, RN; Angela Marcantonio; Todd Brown, MD, MSPH; George Sopko, MD, MPH; Richard Kerber, MD; Jeremy Sugarman, MD, MPH, MA; David Hoyt, MD; the Resuscitation Outcomes Consortium Investigators

From the University of Pittsburgh, Pittsburgh, Pa (S.A.T.); University of Washington, Seattle (J.L.P., P.J.K.); Oregon Health and Science University, Portland (T.A.S.); Medical College of Wisconsin, Milwaukee (T.P.A.); University of Toronto, Toronto, Ontario, Canada (J.S.); University of Texas Southwestern Medical Center, Dallas (D.C.); University of California, San Diego (D.K.); University of Ottawa, Ottawa, Ontario, Canada (A.M.); University of Alabama, Birmingham (T.B.); National Heart, Lung and Blood Institute, Bethesda, Md (G.S.); University of Iowa, Iowa City (R.K.); Johns Hopkins University, Baltimore, Md (J.S.); and University of California, Irvine (D.H.).

Correspondence to Samuel A. Tisherman, MD, University of Pittsburgh, Departments of Surgery and Critical Care Medicine, 638 Scaife Hall, 3550 Terrace St, Pittsburgh, PA 15261. E-mail tishermansa@upmc.edu

Key Words: cardiopulmonary resuscitation • hemorrhage • shock • trauma • trials

An extract of the first 250 words of the full text is provided, because this article has no abstract.

	Introduction

 
Resuscitation research is challenging but vital because few effective therapies exist for a number of life-threatening conditions. Cardiovascular disease has been a leading cause of death and morbidity in the United States. Although estimates vary, the American Heart Association estimates >150 000 out-of-hospital cardiac arrests each year in the United States,¹ with little improvement in survival (5%) despite medical advances.² Traumatic injury, resulting in severe hemorrhagic shock or traumatic brain injury, is the leading cause of death in persons 1 to 44 years of age and is a leading cause of morbidity.³ For treatments to be effective in these life-threatening situations, they must be administered immediately, usually at the site of the event.⁴ Consequently, researchers and regulatory agencies find that typical standards for informed consent cannot be applied in the emergency setting.

In 2004, the National Heart, Lung and Blood Institute organized the Resuscitation Outcomes Consortium (ROC) to conduct simultaneous prehospital studies of novel therapies for trauma and cardiac arrest. The consortium consists of 11 regional centers in the United States and Canada and a data coordinating center.

It was anticipated that these trials would require extra effort from a regulatory perspective because of the need to administer treatments during a relatively brief therapeutic window, making the standard practice of obtaining informed consent from the subjects before enrollment impossible. Because of the nature of the medical conditions being studied, the potential subjects would not be competent to consent. In addition, surrogate decision makers are not commonly available at the . . . [Full Text of this Article]