A proposed consent process in studies that use an exception to informed consent

Academic Emergency Medicine

Volumn 6, Issue 12, 1999, Pages 1283-1291

  Sloan, Edward P ^a,b,c   Nagy, Kimberly ^b   Barrett, John ^b  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b Jr Hospital of Cook County   (United States)

^c UNIVERSITY OF ILLINOIS   (United States)

Author keywords

Consent exception; Diaspirin cross linked hemoglobin; Emergency research; Informed consent; Randomized clinical trial; Traumatic hemorrhagic shock

Indexed keywords

DIASPIRIN CROSSLINKED HEMOGLOBIN;

ARTICLE; CLINICAL TRIAL; COLLAPSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; EMERGENCY MEDICINE; HEMORRHAGIC SHOCK; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MEDICAL DECISION MAKING; MULTICENTER STUDY; PERFUSION; PRIORITY JOURNAL;

EID: 0033405518     PISSN: 10696563     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1553-2712.1999.tb00145.x     Document Type: Article

References (6)

1. Department of Health and Human Services/Food and Drug Administration. Protection of human subjects: informed consent and waiver of informed consent requirements in certain emergency research. Final rules (21 CFR part 50.24 and 45 CFR part 46.408). Fed Reg. 1996; 61:51528-33.
2. Food and Drug Administration. Protection of human subjects; informed consent. Fed Reg. 1996; 61:51498-531.
3. Sloan EP, Koenigsberg M, Gens D, et al. A randomized, controlled efficacy trial of diaspirin cross-linked hemoglobin (DCLHb) in the treatment of severe traumatic hemorrhagic shock. JAMA. 1999; In press.
4. Nelson D, Azari M, Brown R, et al. Preparation and characterization of diaspirin cross-linked hemoglobin solutions for preclinical studies. Biomat Artif Cells Immobil Biotechnol. 1992; 20:423-7.
5. Young B, Runge JW, Waxman KS, et al. Effects of pegorgotein on neurologic outcome of patients with severe head injury. A multicenter, randomized controlled trial [see comments]. JAMA. 1996; 276:538-43.
6. Sloan EP, Koenigsberg MD, Bickell WH, et al. The use of diaspirin crossed-linked hemoglobin (DCLHb) solution in the treatment of hemorrhagic hypovolemic shock [abstract]. Acad Emerg Med. 1995; 2:364-5.