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Volumn 141, Issue 10, 2006, Pages 1019-1023

Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: From experimental design to institutional review board approval

Author keywords

[No Author keywords available]

Indexed keywords

COMMUNITY CARE; EMERGENCY CARE; EXPERIMENTAL DESIGN; HEALTH CARE PERSONNEL; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL SOCIETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW;

EID: 33750058249     PISSN: 00040010     EISSN: 15383644     Source Type: Journal    
DOI: 10.1001/archsurg.141.10.1019     Document Type: Review
Times cited : (16)

References (17)
  • 3
    • 33750043248 scopus 로고
    • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: US Government Printing Office
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: US Government Printing Office; 1978. DHEW Publ (OS) 78-0012.
    • (1978) DHEW Publ (OS) 78-0012
  • 4
    • 0030566120 scopus 로고    scopus 로고
    • Protection of human subjects; informed consent; final rule
    • Food and Drug Administration
    • Food and Drug Administration. Protection of human subjects; informed consent; final rule. Fed Regist. 1996;61:51498-51531.
    • (1996) Fed Regist , vol.61 , pp. 51498-51531
  • 5
    • 0001122640 scopus 로고    scopus 로고
    • Waiver of informed consent requirements in certain emergency research
    • National Institutes of Health; Department of Health and Human Services
    • National Institutes of Health; Department of Health and Human Services. Waiver of informed consent requirements in certain emergency research. Fed Regist. 1996;61:51531-51533.
    • (1996) Fed Regist , vol.61 , pp. 51531-51533
  • 6
    • 33750060499 scopus 로고    scopus 로고
    • Exception from informed consent for studies conducted in emergency settings: Regulatory language and excerpts from preamble
    • Accessed February 11, 2005
    • Exception from informed consent for studies conducted in emergency settings: regulatory language and excerpts from preamble. US FDA Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update. http://www.fda.gov/oc/ohrt/irbs/except.html. Accessed February 11, 2005.
    • US FDA Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators 1998 Update
  • 7
    • 0141532235 scopus 로고    scopus 로고
    • Research without consent: Current status, 2003
    • Biros MH. Research without consent: current status, 2003. Ann Emerg Med. 2003;42:550-564.
    • (2003) Ann Emerg Med , vol.42 , pp. 550-564
    • Biros, M.H.1
  • 8
    • 0037906207 scopus 로고    scopus 로고
    • Resuscitation research and consent: Ethical and practical issues
    • Bircher NG. Resuscitation research and consent: ethical and practical issues. Crit Care Med. 2003;31(5)(suppl):S379-S384.
    • (2003) Crit Care Med , vol.31 , Issue.5 SUPPL.
    • Bircher, N.G.1
  • 9
    • 22744458546 scopus 로고    scopus 로고
    • Are US informed consent requirements driving resuscitation research overseas?
    • Cone DC, O'Connor RE. Are US informed consent requirements driving resuscitation research overseas? Resuscitation. 2005;66:141-148.
    • (2005) Resuscitation , vol.66 , pp. 141-148
    • Cone, D.C.1    O'Connor, R.E.2
  • 10
    • 0029649906 scopus 로고
    • Protection of human subjects; informed consent; proposed rule
    • Food and Drug Administration
    • Food and Drug Administration. Protection of human subjects; informed consent; proposed rule. Fed Regist. 1995;60:49086-49103.
    • (1995) Fed Regist , vol.60 , pp. 49086-49103
  • 11
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-145.
    • (1987) N Engl J Med , vol.317 , pp. 141-145
    • Freedman, B.1
  • 12
    • 0034573353 scopus 로고    scopus 로고
    • Defining and describing benefit appropriately in clinical trials
    • King NMP. Defining and describing benefit appropriately in clinical trials. J Law Med Ethics. 2000;28:332-343.
    • (2000) J Law Med Ethics , vol.28 , pp. 332-343
    • King, N.M.P.1
  • 13
    • 0032903073 scopus 로고    scopus 로고
    • Initial experience using the Food and Drug administration guidelines for emergency research without consent
    • Kremers MS, Whisnant DR, Lowder LS, Gregg L. Initial experience using the Food and Drug administration guidelines for emergency research without consent. Ann Emerg Med. 1999;33:224-229.
    • (1999) Ann Emerg Med , vol.33 , pp. 224-229
    • Kremers, M.S.1    Whisnant, D.R.2    Lowder, L.S.3    Gregg, L.4
  • 14
    • 11144355628 scopus 로고    scopus 로고
    • Conducting research using the emergency exception from informed consent: The Public Access Defibrillation (PAD) Trial experience
    • Mosesso VN Jr, Brown LH, Greene HL, et al. Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience. Resuscitation. 2004;61:29-36.
    • (2004) Resuscitation , vol.61 , pp. 29-36
    • Mosesso Jr., V.N.1    Brown, L.H.2    Greene, H.L.3
  • 15
    • 2542444547 scopus 로고    scopus 로고
    • Ethics in public health research: Protecting human subjects: The role of community advisory boards
    • Quinn SC. Ethics in public health research: protecting human subjects: the role of community advisory boards. Am J Public Health. 2004;94:918-922.
    • (2004) Am J Public Health , vol.94 , pp. 918-922
    • Quinn, S.C.1
  • 16
    • 0033453985 scopus 로고    scopus 로고
    • Implementing the Food and Drug Administration's Final Rule for waiver of informed consent in certain emergency research circumstances
    • Biros MH, Fish SS, Lewis RJ. Implementing the Food and Drug Administration's Final Rule for waiver of informed consent in certain emergency research circumstances. Acad Emerg Med. 1999;6:1272-1282.
    • (1999) Acad Emerg Med , vol.6 , pp. 1272-1282
    • Biros, M.H.1    Fish, S.S.2    Lewis, R.J.3
  • 17
    • 33750058910 scopus 로고    scopus 로고
    • Accessed July 21, 2005
    • Resuscitation Outcomes Consortium. https://roc.uwctc.org. Accessed July 21, 2005.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.