Protecting research subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community

Annals of Emergency Medicine

Volumn 41, Issue 1, 2003, Pages 72-78

  Shah, Amit Navin ^a   Sugarman, Jeremy ^a  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; COMMUNITY CARE; EMERGENCY HEALTH SERVICE; FOOD AND DRUG ADMINISTRATION; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; PRIORITY JOURNAL;

EID: 0037225183     PISSN: 01960644     EISSN: None     Source Type: Journal    
DOI: 10.1067/mem.2003.14     Document Type: Article

References (13)

1. Department of Health and Human Services/Food and Drug Administration/Office of the Secretary. Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research. Fed Reg. 1996;61(192):51497-51533.
2. Department of Health and Human Services/Food and Drug Administration. Guidance for institutional review boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research. Draft Guidance. Available at: http://www.fda.gov/ora/compliance)_ref/bimo/err_guide.htm. Accessed April 2000.
3. Sharp RR, Foster MW. Involving study populations in the review of genetic research. J Law Med Ethics. 2000;28:41-51.
4. Melton GB, Levine RJ, Koocher GP, et al. Community consultation in socially sensitive research: lessons from clinical trials of treatments for AIDS. Am Psychol. 1988;43:573-581.
5. 45 CFR 46.101.b.4.
6. Sutherland HJ, Till JE. Opinion polling and decision making: a critical appraisal of quality of life assessment. Qual Life Res 1994;3:155-162.
7. Dula A. Bearing the brunt of the new regulations: minority populations. Hasting Center Rep. 1997;27:11-12.
8. 21 CFR 312.54(a).
9. 21 CFR 812.47(a).
10. Sloan EP, Koenigsberg M, Gens D, et al. Diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock: a randomized controlled efficacy trial. JAMA. 1999;282:1857-1864.
11. ICOS Corporation Web site. ICOS announces clinical results of hemorrhagic shock trial. Available at: http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=ICOS& script=460&layout=0&item_id=178159. Accessed October 19, 2002.
12. Longstreth WT, Fahrenbruch CE, Olsufka M, et al. Randomized clinical trial of magnesium, diazepam, or both after out-of-hospital cardiac arrest. Neurology. 2002;59:506-514.
13. Kremers MS, Whisnant DR, Lowder LS, et al. Initial experience using the Food and Drug Administration guidelines for emergency research without consent. Ann Emerg Med. 1999;33:224-229.