Studies & Commentaries

These papers discuss the use of "Exception from Informed Consent" in acute care research and emergency care research.

Henry Halperin, MD, MA, FAHA; Norman Paradis, MD; Vincent Mosesso, Jr, MD; Graham Nichol, MD, MPH, FRCPC, FAHA; Michael Sayre, MD; Joseph P. Ornato, MD, FAHA; Michael Gerardi, MD; Vinay M. Nadkarni, MD, FAHA; Robert Berg, MD, FAHA; Lance Becker, MD, FAHA; Mark Siegler, MD; Megan Collins, MD; Charles B. Cairns, MD, FACEP; Michelle H. Biros, MD, MS; Terry Vanden Hoek, MD; Mary Ann Peberdy, MD. Recommendations for Implementation of Community Consultation and Public Disclosure Under the Food and Drug Administration’s "Exception From Informed Consent Requirements for Emergency Research" A Special Report From the American Heart Association Emergency Cardiovascular Care Committee and Council on Cardiopulmonary, Perioperative and Critical Care: Endorsed by the American College of Emergency Physicians and the Society for Academic Emergency Medicine  Circulation. 2007;116:1855-1863

Hsieh M, Dailey MW, Callaway CW. Surrogate consent by family members for out-of-hospital cardiac arrest research. Acad Emerg Med. 2001 Aug;8(8):851-3. 

Kierzek G, Pourriat JL, Rac V, Morrison LJ. Local media influence on opting out from an exception from informed consent trial. Ann Emerg Med. 2010 Sep;56(3):306-7

Biros MH, Sargent C, Miller K. Community attitudes towards emergency research and exception from informed consent. Resuscitation. 2009 Dec;80(12):1382-7.

Morrison CA, Horwitz IB, Carrick MM. Ethical and legal issues in emergency research: barriers to conducting prospective randomized trials in an emergency setting. J Surg Res. 2009 Nov;157(1):115-22.

Nelson MJ, DeIorio NM, Schmidt T, Griffiths D, Daya M, Haywood L, Zive D, Newgard CD. Local media influence on opting out from an exception from informed consent trial. Ann Emerg Med. 2010 Jan;55(1):1-8

Moore PK, Moore EE, Moore FA. Exception from informed consent requirements for emergency research. Surgery. 2009 Jun;145(6):630-5.

Lewis RJ, Duber HC, Biros MH, Cone DC; International Regulatory Status of Emergency Exception to Informed Consent Study Group. International resuscitation research, exception from informed consent, and the European Union Directive 2001/20/EC. Eur J Emerg Med. 2009 Oct;16(5):234-41.

Sugarman J, Sitlani C, Andrusiek D, Aufderheide T, Bulger EM, Davis DP, Hoyt DB, Idris A, Kerby JD, Powell J, Schmidt T, Slutsky AS, Sopko G, Stephens S, Williams C, Nichol G; Resuscitation Outcomes Consortium Investigators. Is the enrollment of racial and ethnic minorities in research in the emergency setting equitable? Resuscitation. 2009 Jun;80(6):644-9.

Jacoby LH, Young B, Watt J. Public disclosure in research with exception from informed consent: the use of survey methods to assess its effectiveness. J Empir Res Hum Res Ethics. 2008 Mar;3(1):79-87.

Schmidt TA, Nelson M, Daya M, DeIorio NM, Griffiths D, Rosteck P. Emergency medical service providers' attitudes and experiences regarding enrolling patients in clinical research trials. Prehosp Emerg Care. 2009 Apr-Jun;13(2):160-8.

Dickert NW, Kass NE. Patients' perceptions of research in emergency settings: a study of survivors of sudden cardiac death. Soc Sci Med. 2009 Jan;68(1):183-91

Nelson M, Schmidt TA, DeIorio NM, McConnell KJ, Griffiths DE, McClure KB. Community consultation methods in a study using exception to informed consent. Prehosp Emerg Care. 2008 Oct-Dec;12(4):417-25.

Bulger EM, Schmidt TA, Cook AJ, Brasel KJ, Griffiths DE, Kudenchuk PJ, Davis D, Bardarson B, Idris AH, Aufderheide TP; ROC Investigators. The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent. Ann Emerg Med. 2009 Mar;53(3):341-50, 350.e1-2.

Goldstein JN, Delaney KE, Pelletier AJ, Fisher J, Blanc PG, Halsey M, Pallin DJ, Camargo CA Jr. A brief educational intervention may increase public acceptance of emergency research without consent. J Emerg Med. 2010 Oct;39(4):419-35.

Merchant RM, Rubright JD, Pryor JP, Karlawish JH. Who can speak for the emergently ill? Testing a method to identify communities and their leaders. Acad Emerg Med. 2008 Jun;15(6):581-3.

Dutton RP, Stansbury LG, Hemlock B, Hess JR, Scalea TM. Impediments to obtaining informed consent for clinical research in trauma patients. J Trauma. 2008 Apr;64(4):1106

Flynn G. Community consultation for emergency exception to informed consent: how much is enough? Ann Emerg Med. 2008 Apr;51(4):416-9.

McRae A, Weijer C. U.S. Federal Regulations for emergency research: a practical guide and commentary. Acad Emerg Med. 2008 Jan;15(1):88-97. Review.

Biros MH. Research without consent: exception from and waiver of informed consent in resuscitation research. Sci Eng Ethics. 2007 Sep;13(3):361-9

Longfield JN, Morris MJ, Moran KA, Kragh JF Jr, Wolf R, Baskin TW. Community meetings for emergency research community consultation. Crit Care Med. 2008 Mar;36(3):731-6.

Robertson CS, McCullough LB, Brody B. Finding family for prospective consent in emergency research. Clin Trials. 2007;4(6):631-7.

Wright DW, Clark PL, Pentz RD, Hertzberg V, Kellermann AL. Enrolling subjects by exception from consent versus proxy consent in trauma care research. Ann Emerg Med. 2008 Apr;51(4):355-60, 360.e1-3.

Deiorio NM, McClure KB, Nelson M, McConnell KJ, Schmidt TA. Ethics committee experience with emergency exception from informed consent protocols. J Empir Res Hum Res Ethics. 2007 Sep;2(3):23-30.

Thompson J. Ethical challenges of informed consent in prehospital research. CJEM. 2003 Mar;5(2):108-14.

McClure KB, Delorio NM, Schmidt TA, Chiodo G, Gorman P. A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent. J Med Ethics. 2007 May;33(5):289-93.

Baren JM, Biros MH. The research on community consultation: an annotated bibliography. Acad Emerg Med. 2007 Apr;14(4):346-52.