This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

Consensus Statement From the Coalition Conference of Acute Resuscitation and Critical Care Researchers

Michelle H. Biros, MD, MS; Roger J. Lewis, MD, PhD; Carin M. Olson, MD; Jeffrey W. Runge, MD; Richard O. Cummins, MD, MPH; Norman Fost, MD, MPH

JAMA. 1995;273(16):1283-1287.

Abstract
Objective.
—A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research.

Participants.
—Representatives from the Society for Academic Emergency Medicine and the American Heart Association identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patient advocacy groups. The Office for Protection From Research Risks (OPRR), the Food And Drug Administration (FDA), and staff from specific legislative offices were also invited to observe. Forty-three participants attended, including representatives from 12 professional organizations, five medical institutions, and the FDA and OPRR. This was a closed meeting. Participants were self-funded or sponsored by their professional organizations.

Evidence.
—Before the meeting, a draft of a position statement was developed by the conference organizers based on the current literature and discussions with experts in the field. This draft, copies of the current federal research regulations, and supporting articles were distributed before the conference.

Consensus Process.
—Participants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was developed and distributed to each participant and represented organizational board for final review. All comments were considered in the final version of the document.

Conclusions.
—We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.

(JAMA. 1995;273:1283-1287)

Author Affiliations
From the Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minn (Dr Biros); Department of Emergency Medicine, Harbor-UCLA Medical Center, Los Angeles, Calif (Dr Lewis); Emergency Medicine Service, University of Washington, Seattle (Drs Olson and Cummins); Department of Emergency Medicine, Carolinas Medical Center, Charlotte, NC (Dr Runge); and Program in Medical Ethics, University of Wisconsin, Madison (Dr Fost). Dr Olson is a contributing editor, JAMA. At the consensus conference, Drs Biros, Lewis, and Runge represented the Society for Academic Emergency Medicine, and Drs Olson and Cummins represented the American Heart Association.

Footnotes
Dr Cummins has testified as an expert witness in litigation matters involving resuscitation equipment.

Reprint requests to Department of Emergency Medicine, Hennepin County Medical Center, 701 Park Ave S, Minneapolis, MN 55415 (Dr Biros).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Informed Consent for Clinical Research Involving Patients With Chest Disease in the United States
Luce
Chest 2009;135:1061-1068.
ABSTRACT | FULL TEXT  

Parental preferences for neonatal resuscitation research consent: a pilot study
Culbert and Davis
J. Med. Ethics 2005;31:721-726.
ABSTRACT | FULL TEXT  

Prehospital Care of the Multiply Injured Patient: The Challenge of Figuring Out What Works
Lewis
JAMA 2004;291:1382-1384.
FULL TEXT  

Novel consent process for research in dying patients unable to give consent
Rees and Hardy
BMJ 2003;327:198.
ABSTRACT | FULL TEXT  

Conducting Stroke Research With an Exception From the Requirement for Informed Consent
Bateman et al.
Stroke 2003;34:1317-1323.
ABSTRACT | FULL TEXT  

Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?
Agard et al.
Heart 2001;86:632-637.
ABSTRACT | FULL TEXT  

Presumed consent in emergency neonatal research
Manning
J. Med. Ethics 2000;26:249-253.
ABSTRACT | FULL TEXT  

What Makes Clinical Research Ethical?
Emanuel et al.
JAMA 2000;283:2701-2711.
ABSTRACT | FULL TEXT  

Emergency cardiac care: introduction
Ewy and Ornato
J Am Coll Cardiol 2000;35:825-880.
FULL TEXT  

Recommendations for uniform reporting of data following major trauma - the Utstein style
An Iternational Trauma Anaesthesia and Critical Ca et al.
Trauma 2000;2:43-61.
 

Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Severe Traumatic Hemorrhagic Shock: A Randomized Controlled Efficacy Trial
Sloan et al.
JAMA 1999;282:1857-1864.
ABSTRACT | FULL TEXT  

Aspects of Anesthesia for Lung Transplantation
Myles
SEMIN CARDIOTHORAC VASC ANESTH 1998;2:140-154.
ABSTRACT  

Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study
Saugstad et al.
Pediatrics 1998;102:1e-1.
ABSTRACT | FULL TEXT  

Informed Consent for Publication
Fontanarosa and Glass
JAMA 1997;278:682-683.
ABSTRACT  

Emergency Medicine
Marx
JAMA 1997;277:1851-1852.
 

Recommended Guidelines for Reviewing, Reporting, and Conducting Research on In-Hospital Resuscitation: The In-Hospital `Utstein Style' : A Statement for Healthcare Professionals From the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, the Australian Resuscitation Council, and the Resuscitation Councils of Southern Africa
Cummins et al.
Circulation 1997;95:2213-2239.
FULL TEXT  

Informed consent in medical research: Journals should not publish research to which patients have not given fully informed consent–with three exceptions
Doyal
BMJ 1997;314:1107-1107.
ABSTRACT | FULL TEXT  

Ethics of Proxy Consent for Research Involving Patients With Adult Respiratory Distress Syndrome
Wichman
JAMA 1996;276:949-949.
ABSTRACT  

Mentally Disabled Research Subjects: The Enduring Policy Issues
Dresser
JAMA 1996;276:67-72.
ABSTRACT  

Emergency Medicine
Tintinalli
JAMA 1996;275:1804-1805.
ABSTRACT  

Informed Consent for Emergency Research
Merz and Caplan
JAMA 1995;274:1196-1196.
ABSTRACT  

Plungers and Polemics: Active Compression-Decompression CPR and Federal Policy
Olson and Rennie
JAMA 1995;273:1299-1300.
ABSTRACT  

Research in Emergency Situations: The Role of Deferred Consent
Levine
JAMA 1995;273:1300-1302.
ABSTRACT