Attitudes of emergency department patients and visitors regarding emergency exception from informed consent in resuscitation research, community consultation, and public notification

Academic Emergency Medicine

Volumn 10, Issue 4, 2003, Pages 352-359

  McClure, Katie B ^a   Delorio, Nicole M ^a   Gunnels, Mary D ^a   Ochsner, Maria J ^a   Biros, Michelle H ^b   Schmidt, Terri A ^a  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b HENNEPIN COUNTY MEDICAL CENTER   (United States)

Author keywords

Community exception; Emergency exception; Informed consent; Public opinion; Resuscitation research

Indexed keywords

ADULT; AGED; ARTICLE; COMMUNITY; EMERGENCY WARD; FEMALE; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; PATIENT ATTITUDE; PRIORITY JOURNAL; PUBLIC OPINION; RESEARCH; RESUSCITATION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ATTITUDE TO HEALTH; BIOMEDICAL RESEARCH; CARDIOPULMONARY RESUSCITATION; EMERGENCY SERVICE, HOSPITAL; FEMALE; HUMANS; INFORMED CONSENT; MALE; MIDDLE AGED; MINNESOTA; OREGON; PATIENTS; VISITORS TO PATIENTS;

EID: 0037387799     PISSN: 10696563     EISSN: None     Source Type: Journal    
DOI: 10.1197/aemj.10.4.352     Document Type: Article

References (26)

1. Final Report of the Tuskegee Syphilis Study, Ad Hoc Advisory Panel. Washington, DC: US Public Health Service, 1973, pp 5-15.
2. Protection of Human Subjects, 45 CFR, part 46, Subpt A.
3. Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Eng J Med. 2001; 20:1473-82.
4. Zipes DP, Wellens HJ. Sudden cardiac death. Circulation. 1998; 98:2334-51.
5. Lewis RJ. Emergency medicine's "illusion of efficacy" and the public perception of resuscitation research. Acad Emerg Med. 1999; 6:771.
6. U.S. Government Food and Drug Administration. Title 21 CFR;(61 FR 51528), Oct. 2, 1996.
7. Alpert SP. Implementing the Final Rule. Acad Emerg Med. 1999; 6:1188-9.
8. Miller BP. Informed consent to research on emergency care. Ann Emerg Med. 1991; 20:1267-9.
9. Passamani ER, Weisfeldt ML. Task Force 3: Special aspects of research conduct in the emergency setting: waiver of informed consent. J Am Coll Cardiol. 2000; 35:862-80.
10. Smithline HA, Gerstle MB. Waiver of informed consent: a survey of emergency medicine patients. Am J Emerg Med. 1998; 16:90-1.
11. Adams JG, Wegener J. Acting without asking: an ethical analysis of the FDA wavier of informed consent for emergency research. Ann Emerg Med. 1999; 33:218-23.
12. Thewes JM, FitzGerald DM, Sulmasy DO. Informed consent in emergency medicine: ethics under fire. Emerg Med Clin North Am. 1996; 14:245-54.
13. Barren JM, Anicetti JP, Ledesma SM, Biros MH, Mahabee-Gittens MM, Lewis RJ. An approach to community consultation prior to initiating an emergency research study incorporation of waiver of informed consent. Acad Emerg Med. 1999; 6:1210-5.
14. Lurie KG, Bennett D. Regulated to death: the matter of informed consent for human experimentation in emergency resuscitation research. PACE. 1995; 18:1443-7.
15. Hsieh MM, Dailey MW, Clifton W, Callaway M. Surrogate consent by family members for out-of-hospital cardiac arrest research. Acad Emerg Med. 2001; 8:851-3.
16. Kremers MS, Whisnant DR, Lowder LS, Gregg L. Initial experience using Food and Drug Administration guidelines for emergency research without consent. Ann Emerg Med. 1999; 33:224-9.
17. Biros MH, Runge JW, Lewis RJ, Doherty C. Emergency medicine and the development of the Food and Drug Administration's final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med. 1998; 5:359-68.
18. Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration's Final Rule for waiver of informed consent in certain emergency research circumstances. Acad Emerg Med. 1999; 6:1272-82.
19. Abramson NS, Meisel AJ, Safa PM. Deferred consent: a new approach for resuscitation research on comatose patients. JAMA. 1986; 255:2466-71.
20. Santora TA, Cowekk V, Trooskin SZ. Working through the public disclosure process mandated by us of CFR 50.24 (Exception to Informed Consent): guidelines for success. J Trauma. 1998; 45:907-13.
21. Spivey WH. Informed consent for clinical research in the emergency department. Ann Emerg Med. 1989; 18:766-71.
22. Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics, Norwalk, CT: Appleton & Lange Publishers, 2001.
23. Smithline HA, Mader TJ, Crenshaw BJ. Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? Acad Emerg Med. 1999; 6:776-80.
24. Sloan EP, Nagy KM, Barrett JM. A proposed consent process in studies that use an exception to informed consent. Acad Emerg Med. 1999; 6:1283-91.
25. Alldredge BK, Gelb AM, Isaacs SM, et al. A comparison of lorazepam and placebo for the treatment of out-of-hospital status epilepticus. N Engl J Med. 2001; 345:631-7.
26. Dorian P, Cass D, Schwartz B, Cooper R, Gelaznikas R, Barr A. Amiodarone as compared with lidocaine for shock-resistant ventricular fibrillation. N Engl J Med. 2002; 346:884-90.