Waiver of informed consent: A survey of emergency medicine patients

American Journal of Emergency Medicine

Volumn 16, Issue 1, 1998, Pages 90-91

  Smithline, Howard A ^a   Gerstle, Michael L ^a  

^a BAYSTATE MEDICAL CENTER   (United States)

Author keywords

Emergency medicine; Informed consent; Research ethics

Indexed keywords

ARTICLE; EMERGENCY WARD; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; LAW; PATIENT ATTITUDE; PRIORITY JOURNAL; RISK ASSESSMENT;

EID: 0031963555     PISSN: 07356757     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0735-6757(98)90074-2     Document Type: Note

References (7)

1. Department of Health and Human Services; Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research: Final Rules (21 CFR Part 50, et al., 45 CFR Part 46). Federal Register, October 2, 1996;61 (192):51500-51533
2. Prentice ED, Antonson DL, Leibrock LG, et al: IRB review of a phase II randomized clinical trial involving incompetent patients suffering from severe closed head injury. IRB Rev Hum Subj Res 1993;15:1-7
3. Ellis GB: 'Dear colleague' letter: Human subjects protection. OPRR Rep, August 12,1993; No 93-3
4. Prentice ED, Antonson DL, Leibock LG, et al: An update on the PEG-SOD study involving incompetent subjects: FDA permits an exception to informed consent requirements. IRB Rev Hum Subj Res 1994;16:16-18
5. Biros MH, Lewis RJ, Olsen CM, et al: Informed consent in emergency research: Consensus statement from the coalition conference of acute resuscitation and critical care researchers. JAMA 1995;273:1283-1287
6. FDA/NIH Public Forum on Informed Consent In Clinical Research Conducted in Emergency Circumstances; January 9, 1995; Washington DC.
7. Biros MH, Runge JW, Lewis RJ, Doherty C: Facilitating change: Emergency medicine and the development of the FDA's final rule on informed consent and waiver of informed consent in emergency research circumstances. Acad Emerg Med 1998 (in press)