Letter to the editor: Emergency research consent waiver - A proper way [3]

American Journal of Bioethics

Volumn 6, Issue 4, 2006, Pages

  Shamoo, Adil ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SUBSTITUTE; HEMOGLOBIN; POLYMERIZED HEMOGLOBIN;

CLINICAL TRIAL; EMERGENCY HEALTH SERVICE; ETHICS; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMED CONSENT; INJURY SCALE; LETTER; METHODOLOGY; STANDARD; UNITED STATES;

BLOOD SUBSTITUTES; CLINICAL TRIALS; EMERGENCY MEDICAL SERVICES; HEMOGLOBINS; HUMANS; ILLINOIS; INFORMED CONSENT; RESEARCH DESIGN; TRAUMA SEVERITY INDICES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33746837602     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265160600843577     Document Type: Letter

References (14)

1. Burton, T. M. 2006. Blood-substitute study is criticized by U.S. agency. The Wall Street Journal March 10: A3.
2. Dalton, R. 2006. Trauma trials leave ethicists uneasy. News@Nature March 26. Published online: 22 March 2006; doi:10.1038/440390b.
3. Food and Drug Administration (FDA). 2005. October 3, 2005, letter (p. 1-8) addressed to Daniel A. Freilich, MD, CDR, MC, USNR, Naval Medical Center.
4. Food and Drug Administration (FDA). 2006. March 2, 2006, letter (p. 1-11) addressed to Daniel A. Freilich, MD, CDR, MC, USNR, Naval Medical Center.
5. Freilich, D. A. 2005. September 6, 2006, letter (p. 1-83) addressed to Alan E. Williams, Food and Drug Administration/CBER.
6. Hallstrom, A. P., J. P. Ornato, M. Weisfeldt, A. Travers, J. Christenson, M. A. McBurnie, R. Zalenski, L. B. Becker, E. B. Schron, M. Proschan, and the Public Access Defibrillation Trial Investigators. 2004. Public Access Defibrillation Trial Investigators. Public access defibrillation and survival after out-of- hospital cardiac arrest. New England Journal of Medicine 351: 637-646.
7. Hicks, T. 2006. Blood substitute study raises concerns. Kingsport Times-News March 2: A1.
8. Holloway, K. F. C. 2006. Accidental communities: Race, emergency medicine, and the problem of PolyHeme®. American Journal of Bioethics 6(3): 4-16.
9. Kipnis, K., N. M. P. King, and R. M. Nelson. 2006a. Trials and errors: Barriers to oversight of research conducted under the Emergency Research Consent Waiver. IRB: Ethics & Human Research March/April: 16-19.
10. Kipnis, K., N. M. P. King, and R. M. Nelson. 2006b. An open letter to IRBs considering Northfield Laboratories' PolyHeme® trial. American Journal of Bioethics 6(3): 17-20.
11. Kierman, V. 1995. Emergency trials "by popular consent." New Scientist November 4: 6.
12. Lewis, R. J., D. A. Berry, H. Cryer 3rd, N. Fost, R. Krome, G. R. Washington, J. Houghton, J. W. Blue, R. Bechhofer, T. Cook, and M. Fisher. 2001. 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. Annals of Emergency Medicine 38: 397-404.
13. Northfield Laboratories. 2003. Press Release: Northfield Laboratories announces patient enrollment in phase III urban ambulance trial to begin Monday, December 22. Available online at: http://phx.corporate-ir.net/phoenix.zhtml?c= 91374&p=irol-newsArticle&ID=599107&highlight.
14. Sloan, E. P., M. Koenigsberg, J. Houghton, D. Gens, M. Cipolle, J. Runge, M. N. Mallory, and G. Rodman Jr. 1999. The informed consent process and the use of the exception to informed consent in the clinical trial of daispirin cross-linked hemoglobin (DCLHb) in severe traumatic hemorrhagic shock. DCLHb Traumatic Hemorrhagic Shock study group. Academic Emergency Medicine 6: 1203-1209.