Emergency medical service providers' attitudes andexperiences regarding enrolling patients in clinical research trials

Prehospital Emergency Care

Volumn 13, Issue 2, 2009, Pages 160-168

  Schmidt, Terri A ^a,b   Nelson, Maria ^a   Daya, Mohamud ^a   Deiorio, Nicole M ^a   Griffiths, Denise ^a   Rosteck, Pontine ^b  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b American Medical Response ^*  (United States)

Author keywords

Consent in research; EMS research; Paramedic attitudes; Research ethics

Indexed keywords

ADULT; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; FEMALE; HEALTH SURVEY; HOSPITAL; HUMAN; IN SERVICE TRAINING; INFORMED CONSENT; INJURY; MALE; MEDICAL ETHICS; PATIENT; RESCUE PERSONNEL ATTITUDE; ATTITUDE TO HEALTH; DOUBLE BLIND PROCEDURE; EMERGENCY HEALTH SERVICE; HEALTH CARE PERSONNEL; HEALTH CARE SURVEY; HEALTH PERSONNEL ATTITUDE; HEALTH SERVICES RESEARCH; MEDICAL RESEARCH; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; STATISTICS AND NUMERICAL DATA; UNITED STATES;

ATTITUDE OF HEALTH PERSONNEL; BIOMEDICAL RESEARCH; DOUBLE-BLIND METHOD; EMERGENCY MEDICAL SERVICES; HEALTH CARE SURVEYS; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HEALTH PERSONNEL; HEALTH SERVICES RESEARCH; HUMANS; OREGON;

EID: 70350678846     PISSN: 10903127     EISSN: 15450066     Source Type: Journal    
DOI: 10.1080/10903120802708852     Document Type: Article

References (26)

1. Callaham M. Quantifying the scanty science of prehospital emergency care. Ann Emerg Med. 1997;30(6):785-790.
2. Moscati R. Protection of human subjects in prehospital research. Prehosp Emerg Care. 2002;6(2 Suppl):S18-23.
3. Sugarman J. Examining the provisions for research without consent in the emergency setting. Hastings Cent Rep. 2007;37(1):12-13.
4. Weisfeldt ML, Becker LB. Resuscitation after cardiac arrest, a 3- phase time-sensitive model. JAMA. 2002;288:3035-3038.
5. DeMaio VJ, Stiell IG,Wells GA, SpaiteDW. Optimal defibrillation response intervals for maximum out-of-hospital cardiac arrest survival rates. Ann Emerg Med. 2003;42:242-250.
6. Davis DP, Garberson LA, Andrusiek DL, Hostler D, Daya M, Pirrallo R, Craig A, Stephens S, Larsen J, Drum AF, Fowler R. A descriptive analysis of Emergency Medical Service Systems participating in the Resuscitation Outcomes Consortium (ROC) network. Prehosp Emerg Care. 2007;11(4):369-382.
7. Brasel KJ, Bulger E, Cook AJ, Morrison LJ, Newgard CD, Tisherman SA, Kerby JD, Coimbra R, Hata JS, Hoyt DB. Hypertonic resuscitation: Design and implementation of a prehospital intervention trial. J Am Coll Surg. 2008;206(2):220-232.
8. The Pediatric Emergency Care Applied Research Network (PECARN): Rationale, development, and first steps. Acad Emerg Med. 2003;10(6):661-668.
9. Dutton RP, Stansbury LG, Hemlock B, Hess JR, Scalea TM. Impediments to obtaining informed consent for clinical research in trauma patients. J Trauma. 2008;64(4):1106-1112.
10. 21CFR50.24. Protection of human subjects; informed consent- FDA. Final rule. Fed Regist. 1996;61(192):51498-51533.
11. Morris MC. An ethical analysis of exception from informed consent regulations. Acad EmergMed. 2005;12(11):1113-1119.
12. Mosesso VN, Jr., Brown LH, Greene HL, Schmidt TA, Aufderheide TP, Sayre MR, Stephens SW, Travers A, Craven RA, Weisfeldt ML. Conducting research using the emergency exception from informed consent: The Public Access Defibrillation (PAD) Trial experience. Resuscitation. 2004;61(1):29-36.
13. SchmidtTA, Baren JM,MannNC,Richardson LD. Executive summary: The 2005 AEM Consensus Conference on Ethical Conduct of Resuscitation Research. Acad Emerg Med. 2005;12(11):1017-1018.
14. Nichol G, Huszti E, Rokosh J, Dumbrell A, McGowan J, Becker L. Impact of informed consent requirements on cardiac arrest research in the United States: Exception from consent or from research? Resuscitation. 2004;62(1):3-23.
15. Triner W, Jacoby L, Shelton W, Burk M, Imarenakhue S, Watt J, Larkin G, McGee G. Exception frominformed consent enrollment in emergency medical research: Attitudes and awareness. Acad Emerg Med. 2007;14(2):187-191.
16. Smithline HA, Gerstle ML.Waiver of informed consent:Asurvey of emergency medicine patients.AmJ Emerg Med. 1998;16(1):90-91.
17. McClure KB, DeIorio NM, Gunnels MD, Ochsner MJ, Biros MH, Schmidt TA. Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification. Acad Emerg Med. 2003;10(4):352-359.
18. DeIorio N, McClure K, Nelson M, McConnell K, Schmidt T. Institutional review board members' experiences with exception from informed consent protocols. Journal of Empirical Research on Human Research Ethics 2007;2:23-30.
19. McClure KB, DeIorio NM, Schmidt TA, Chiodo GT, Gorman P. A qualitative study of Institutional Review Members' experience with reviewing proposals for exception from informed consent in resuscitation research. J Med Ethics. 2006;33:298-1293
20. Richardson LD. The ethics of research without consent in emergency situations. Mt Sinai J Med. 2005;72(4):242-249.
21. Arias E, Smith BL. Deaths: Preliminary data for 2001. National Vital Statistics Reports. 2003;51:1-48.
22. Zheng ZJ, Croft JB, Giles WH,Mensah GA. Sudden cardiac death in the United States, 1989-1998. Circulation. 2001;104:2158-2163.
23. Nichol G, Huszti E. Design and implementation of resuscitation research: Special challenges and potential solutions. Resuscitation. 2007;73(3):337-346.
24. Conduct of Emergency Clinical Research Public Hearing, Department of Health and Human Services Food and Drug Administration, Proposed Rules Sess. (08/29/2006).
25. Anderson A. Emergency trials of blood substitutes skirt ethical questions. Nat Med. 2007;13(6):652.
26. Vaslef SN, Cairns CB, Falletta JM. Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: From experimental design to institutional review board approval. Arch Surg. 2006;141(10):1019-1023; discussion 1024.