Enrolling Subjects by Exception From Consent Versus Proxy Consent in Trauma Care Research

Annals of Emergency Medicine

Volumn 51, Issue 4, 2008, Pages

  Wright, David W ^a   Clark, Pamela L ^a   Pentz, Rebecca D ^a   Hertzberg, Vicki ^b   Kellermann, Arthur L ^a  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b EMORY UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BRAIN INJURY; CLINICAL RESEARCH; EMERGENCY CARE; INFORMED CONSENT; PRIORITY JOURNAL; THEORETICAL STUDY; TIME; TRAUMATIC BRAIN INJURY;

EID: 40849124048     PISSN: 01960644     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.annemergmed.2007.08.021     Document Type: Article

References (33)

1. Biros M.H. Research without consent: current status, 2003. Ann Emerg Med 42 (2003) 550-564
2. Biros M.H. Development of the multiorganizational document regarding emergency research consent. Acad Emerg Med 3 (1996) 101-105
3. Biros M.H., Fish S.S., and Lewis R.J. Implementing the Food and Drug Administration's Final Rule for waiver of informed consent in certain emergency research circumstances. Acad Emerg Med 6 (1999) 1272-1282
4. Biros M.H., Lewis R.J., Olson C.M., et al. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 273 (1995) 1283-1287
5. Biros M.H., Runge J.W., Lewis R.J., et al. 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 5 (1998) 359-368
6. Protection of human subjects; informed consent-FDA. Final Rule. Fed Reg 61 (1996) 51498-51533
7. Ernst A.A., and Fish S. Exception from informed consent: viewpoint of institutional review boards-balancing risks to subjects, community consultation, and future directions. Acad Emerg Med 12 (2005) 1050-1055
8. Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations-FDA. Final Rule. Fed Reg 56 (1991) 28025-28029
9. Baren J.M., Anicetti J.P., Ledesma S., et al. An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent. Acad Emerg Med 6 (1999) 1210-1215
10. US Food and Drug Administration. 1995S-0158: Community Disclosure of Institutional Review Boards (2006), Department of Health and Human Services, Rockville, MD
11. Sloan E.P., Koenigsberg M., Houghton J., et al. The informed consent process and the use of the exception to informed consent in the clinical trial of Diaspirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. Acad Emerg Med 6 (1999) 1203-1209
12. Lewis R.J., Berry D.A., Cryer III H., et al. Monitoring a clinical trial conducted under the Food and Drug Administration regulations allowing a waiver of prospective informed consent: the Diaspirin Cross-Linked Hemoglobin Traumatic Hemorrhagic Shock Efficacy Trial. Ann Emerg Med 38 (2001) 397-404
13. Mosesso Jr. V.N., Brown L.H., Greene H.L., et al. Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. Resuscitation 61 (2004) 29-36
14. Dix E.S., Esposito D., Spinosa F., et al. Implementation of community consultation for waiver of informed consent in emergency research: one institutional review board's experience. J Investig Med 52 (2004) 113-116
15. Kremers M.S., Whisnant D.R., Lowder L.S., et al. Initial experience using the Food and Drug Administration guidelines for emergency research without consent. Ann Emerg Med 33 (1999) 224-229
16. Shah A.N., and Sugarman J. Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community. Ann Emerg Med 41 (2003) 72-78
17. Valenzuela T.D., and Copass M.K. Clinical research on out-of-hospital emergency care. N Engl J Med 345 (2001) 689-690
18. Mosesso Jr. V.N., and Cone D.C. Using the exception from informed consent regulations in research. Acad Emerg Med 12 (2005) 1031-1039
19. Pape T.L., Jaffe N.O., Savage T., et al. Unresolved legal and ethical issues in research of adults with severe traumatic brain injury: analysis of an ongoing protocol. J Rehabil Res Dev 41 (2004) 155-174
20. Davis A.M. Exception from informed consent for emergency research: drawing on existing skills and experience. IRB 20 (1998) 1-8
21. Prentice E.D., Antonson D.L., Leibrock L.G., et al. An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB 16 (1994) 16-18
22. Prentice E.D., Antonson D.L., Leibrock L.G., et al. IRB review of a phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury. IRB 15 (1993) 1-7
23. McGee G., McErlean M., Triner W., et al. Keynote address: toward a pragmatic model for community consultation in emergency research. Acad Emerg Med 12 (2005) 1019-1021
24. Moler F.W. Resuscitation research and the final rule: is there an impasse?. Pediatrics 114 (2004) 859-861
25. Sayre MR. National EMS research agenda: informed consent. Paper presented at: National EMS Research Agenda. Washington, DC, March 1-2, 2005.
26. Institute of Medicine. Future of Emergency Care in the U.S. Health System. Hospital Based Emergency Care: At the Breaking Point (2006), Institute of Medicine, Washington, DC
27. Wright D.W., Kellermann A.L., Hertzberg V.S., et al. ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med 49 (2007) 391-402 e391-392
28. Wright D.W., Ritchie J.C., Mullins R.E., et al. Steady-state serum concentrations of progesterone following continuous intravenous infusion in patients with acute moderate to severe traumatic brain injury. J Clin Pharmacol 45 (2005) 640-648
29. Saver J.L. Food and Drug Administration public hearing on the conduct of emergency clinical research: testimony of the American Stroke Association. Acad Emerg Med 14 (2007) e57-e58
30. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 333 (1995) 1581-1587
31. Gamble V.N. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health 87 (1997) 1773-1778
32. White R.M. The Tuskegee syphilis study. Hastings Cent Rep 32 (2002) 4-5 author reply 5
33. Schmidt T.A. The legacy of the Tuskegee syphilis experiments for emergency exception from informed consent. Ann Emerg Med 41 (2003) 79-81