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Volumn 12, Issue 11, 2005, Pages 1134-1137

Minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide

Author keywords

Ethics; Exception from informed consent; IRB; Waiver

Indexed keywords

CONFERENCE PAPER; CONFIDENCE INTERVAL; CONTROLLED STUDY; DEMOGRAPHY; E-MAIL; EMERGENCY MEDICINE; FEMALE; FINANCIAL MANAGEMENT; HEALTH CARE ORGANIZATION; HUMAN; INFORMED CONSENT; LOGISTIC REGRESSION ANALYSIS; MALE; MEDICAL RESEARCH; MEDICAL SCHOOL; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH; RISK ASSESSMENT; STATISTICAL SIGNIFICANCE; TELEPHONE; UNITED STATES;

EID: 27144469480     PISSN: 10696563     EISSN: None     Source Type: Journal    
DOI: 10.1197/j.aem.2005.06.011     Document Type: Conference Paper
Times cited : (14)

References (10)
  • 1
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    • Research without consent: Current status, 2003
    • M.H. Biros Research without consent: current status, 2003 Ann Emerg Med 42 2003 550 564
    • (2003) Ann Emerg Med , vol.42 , pp. 550-564
    • Biros, M.H.1
  • 2
    • 0011166552 scopus 로고    scopus 로고
    • Harrell FE. The Design Library. Available at: http://biostat.mc. vanderbilt.edu/twiki/bin/view/Main/Design. Accessed December 2004.
    • The Design Library
    • Harrell, F.E.1
  • 3
    • 27144493924 scopus 로고    scopus 로고
    • Approval of minimal risk waiver of informed consent and exception from informed consent (Final Rule) studies at IRBs nationwide
    • A.A. Ernst, S.J. Weiss, T.G. Nick, K. Iserson, and M. Biros Approval of minimal risk waiver of informed consent and exception from informed consent (Final Rule) studies at IRBs nationwide [abstract] Acad Emerg Med 11 2004 441
    • (2004) Acad Emerg Med , vol.11 , pp. 441
    • Ernst, A.A.1    Weiss, S.J.2    Nick, T.G.3    Iserson, K.4    Biros, M.5
  • 4
    • 27144443231 scopus 로고    scopus 로고
    • Initial experience using the Food and Drug Administration guidelines for emergency research without consent
    • M.S. Kremers, Dr Whitsnant, and L.S. Lowder Initial experience using the Food and Drug Administration guidelines for emergency research without consent Ann Emerg Med 3 1999 101 105
    • (1999) Ann Emerg Med , vol.3 , pp. 101-105
    • Kremers, M.S.1    Dr, W.2    Lowder, L.S.3
  • 5
    • 0034784681 scopus 로고    scopus 로고
    • 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
    • R.J. Lewis, D.A. Berry, and H. Cryer 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
    • (2001) Ann Emerg Med , vol.38 , pp. 397-404
    • Lewis, R.J.1    Berry, D.A.2    Cryer, H.3
  • 6
    • 0033430288 scopus 로고    scopus 로고
    • An approach to community consultation prior to initiating an emergency research study incorporating a waiver of informed consent
    • J.M. Baren, J.P. Anicetti, S. Ledesma, M.H. Biros, M. Mahabee-Gittens, and R.J. Lewis 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
    • (1999) Acad Emerg Med , vol.6 , pp. 1210-1215
    • Baren, J.M.1    Anicetti, J.P.2    Ledesma, S.3    Biros, M.H.4    Mahabee-Gittens, M.5    Lewis, R.J.6
  • 7
    • 0033453985 scopus 로고    scopus 로고
    • Implementing the Food and Drug Administration's Final Rule for Waiver of Informed Consent in Certain Emergency Research Circumstances
    • M.H. Biros, S.S. Fish, and R.J. Lewis 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
    • (1999) Acad Emerg Med , vol.6 , pp. 1272-1282
    • Biros, M.H.1    Fish, S.S.2    Lewis, R.J.3
  • 8
    • 0032902987 scopus 로고    scopus 로고
    • Acting without asking: An ethical analysis of the Food and Drug Administration Waiver of Informed Consent for Emergency Research
    • J.G. Adams, and J. Wegener Acting without asking: an ethical analysis of the Food and Drug Administration Waiver of Informed Consent for Emergency Research Ann Emerg Med 33 1998 218 223
    • (1998) Ann Emerg Med , vol.33 , pp. 218-223
    • Adams, J.G.1    Wegener, J.2
  • 9
    • 4043181818 scopus 로고    scopus 로고
    • Public access defibrillation and survival after out-of-hospital cardiac arrest
    • Public Access Defibrillation Trial Investigators Public access defibrillation and survival after out-of-hospital cardiac arrest N Engl J Med 351 2004 637 646
    • (2004) N Engl J Med , vol.351 , pp. 637-646
  • 10
    • 16544367953 scopus 로고    scopus 로고
    • Exception from informed consent for pediatric resuscitation research: Community consultation for a trial of brain cooling after in-hospital cardiac arrest
    • M.C. Morris, V.M. Nadkarni, F.R. Ward, and R.M. Nelson Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest Pediatrics 114 2004 776 781
    • (2004) Pediatrics , vol.114 , pp. 776-781
    • Morris, M.C.1    Nadkarni, V.M.2    Ward, F.R.3    Nelson, R.M.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.