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Volumn 118, Issue 15, 2008, Pages 1585-1592

Regulatory challenges for the resuscitation outcomes consortium

(14)  Tisherman, Samuel A a   Powell, Judy L b   Schmidt, Terri A c   Aufderheide, Tom P d   Kudenchuk, Peter J b   Spence, Julie e   Climer, Dixie f   Kelly, Donna g   Marcantonio, Angela h   Brown, Todd i   Sopko, George j   Kerber, Richard k   Sugarman, Jeremy l   Hoyt, David m  


Author keywords

Cardiopulmonary resuscitation; Hemorrhage; Shock; Trauma; Trials

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; EMERGENCY CARE; FLUID RESUSCITATION; HEART ARREST; HEMORRHAGIC SHOCK; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; PRIORITY JOURNAL; RESEARCH SUBJECT; RESUSCITATION; TRAUMATIC BRAIN INJURY; TREATMENT OUTCOME; CANADA; COOPERATION; HEALTH CARE ORGANIZATION; MORTALITY; PRACTICE GUIDELINE; STANDARD; UNITED STATES;

EID: 55249107334     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.107.764084     Document Type: Article
Times cited : (30)

References (40)
  • 1
    • 39749191084 scopus 로고    scopus 로고
    • Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thorn T, Wilson M, Hong Y, for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics - 2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008;117:e25-e146.
    • Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thorn T, Wilson M, Hong Y, for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics - 2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008;117:e25-e146.
  • 2
    • 0037126352 scopus 로고    scopus 로고
    • Defibrillators in public places-one step closer to home
    • Weaver WD, Peberdy MA. Defibrillators in public places-one step closer to home. N Eng J Med. 2002;347:1223-1224.
    • (2002) N Eng J Med , vol.347 , pp. 1223-1224
    • Weaver, W.D.1    Peberdy, M.A.2
  • 3
    • 0037436723 scopus 로고    scopus 로고
    • Deaths: Preliminary data for 2001
    • Arias E, Smith BL. Deaths: preliminary data for 2001. Natl Vital Stat Rep. 2003;51:1-48.
    • (2003) Natl Vital Stat Rep , vol.51 , pp. 1-48
    • Arias, E.1    Smith, B.L.2
  • 4
    • 0037132608 scopus 로고    scopus 로고
    • Resuscitation after cardiac arrest, a 3-phase time-sensitive model
    • Weisfeldt ML, Becker LB. Resuscitation after cardiac arrest, a 3-phase time-sensitive model. JAMA. 2002;288:3035-3038.
    • (2002) JAMA , vol.288 , pp. 3035-3038
    • Weisfeldt, M.L.1    Becker, L.B.2
  • 5
    • 0034910146 scopus 로고    scopus 로고
    • Surrogate consent by family members for out-of-hospital cardiac arrest research
    • Hsieh M, Dailey MW, Callaway CW. Surrogate consent by family members for out-of-hospital cardiac arrest research. Acad Emerg Med. 2001;8:851-853.
    • (2001) Acad Emerg Med , vol.8 , pp. 851-853
    • Hsieh, M.1    Dailey, M.W.2    Callaway, C.W.3
  • 6
    • 34548183619 scopus 로고    scopus 로고
    • Is informed consent in trauma a lost cause? A prospective evaluation of acutely injured patients' ability to give consent
    • Sava J, Ciesla D, Williams M, Street J, White P, Wang D. Is informed consent in trauma a lost cause? A prospective evaluation of acutely injured patients' ability to give consent. J Am Coll Surg. 2007;205:405-408.
    • (2007) J Am Coll Surg , vol.205 , pp. 405-408
    • Sava, J.1    Ciesla, D.2    Williams, M.3    Street, J.4    White, P.5    Wang, D.6
  • 8
    • 0742289910 scopus 로고    scopus 로고
    • Clinical trials in an emergency setting: Implications from the fifth version of the Declaration of Helsinki
    • Vanpee D, Gillet J, Dupuis M. Clinical trials in an emergency setting: implications from the fifth version of the Declaration of Helsinki. J Emerg Med. 2004;26:127-131.
    • (2004) J Emerg Med , vol.26 , pp. 127-131
    • Vanpee, D.1    Gillet, J.2    Dupuis, M.3
  • 9
    • 0026427327 scopus 로고
    • final rule
    • Federal policy for the protection of human subjects
    • Federal policy for the protection of human subjects: final rule. Fed Reg. 1991;56:28003-28018.
    • (1991) Fed Reg , vol.56 , pp. 28003-28018
  • 10
    • 0030566120 scopus 로고    scopus 로고
    • 21CFR50.24: protection of human subjects: informed consent-PDA: final rule. Fed Reg. 1996;61:51498-51533
    • 21CFR50.24: protection of human subjects: informed consent-PDA: final rule. Fed Reg. 1996;61:51498-51533.
  • 11
    • 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
  • 12
    • 0032902987 scopus 로고    scopus 로고
    • Acting without asking: An ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research
    • Adams JG, Wegener J. Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Ann Emerg Med. 1999;33:218-223.
    • (1999) Ann Emerg Med , vol.33 , pp. 218-223
    • Adams, J.G.1    Wegener, J.2
  • 14
    • 55349140653 scopus 로고    scopus 로고
    • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa, Canada: Canadian Institutes of Health Research NSERC, SSHERC; 1998 (with 2000, 2002, and 2005 amendments).
    • Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa, Canada: Canadian Institutes of Health Research NSERC, SSHERC; 1998 (with 2000, 2002, and 2005 amendments).
  • 15
    • 27144469480 scopus 로고    scopus 로고
    • Approval of minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide
    • Ernst AA, Wiess SJ, Nick TG, Iserson KV, Biros MH. Approval of minimal-risk waiver of informed consent and exception from informed consent (Final Rule) studies at institutional review boards nationwide. Acad Emerg Med. 2005;12:1134-1137.
    • (2005) Acad Emerg Med , vol.12 , pp. 1134-1137
    • Ernst, A.A.1    Wiess, S.J.2    Nick, T.G.3    Iserson, K.V.4    Biros, M.H.5
  • 16
    • 3142712328 scopus 로고    scopus 로고
    • Impact of informed consent requirements on cardiac arrest research in the United States: Exception from consent or from research?
    • Nichol G, Huszti E, Rokosh J, Dumbrell A, McGowan J, Becker L. Impact of informed consent requirements on cardiac arrest research in the United States: exception from consent or from research? Resuscitation. 2004;62:3-23.
    • (2004) Resuscitation , vol.62 , pp. 3-23
    • Nichol, G.1    Huszti, E.2    Rokosh, J.3    Dumbrell, A.4    McGowan, J.5    Becker, L.6
  • 17
    • 16544385094 scopus 로고    scopus 로고
    • Resuscitation research and the Final Rule: Is there an impasse?
    • Moler FW. Resuscitation research and the Final Rule: is there an impasse? Pediatrics. 2004:114:859-861.
    • (2004) Pediatrics , vol.114 , pp. 859-861
    • Moler, F.W.1
  • 18
    • 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
    • Morris MC, Nadkarni VM, Ward FR, Nelson RM. Exception from informed consent for pediatric resuscitation research: community consultation for a trial of brain cooling after in-hospital cardiac arrest. Pediatrics. 2004;114:776-781.
    • (2004) Pediatrics , vol.114 , pp. 776-781
    • Morris, M.C.1    Nadkarni, V.M.2    Ward, F.R.3    Nelson, R.M.4
  • 21
    • 55349111029 scopus 로고    scopus 로고
    • Morrison LJ, Dorian P, Long J, Vermeulen M, Schwartz B, Sawadsky B, Frank J, Cameron B, Burgess R, Shield J, Bagley P, Mausz V, Brewer J, Lerman B. A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: PrePACE. Acad Emerg Med. 2004;11:588-a. Abstract.
    • Morrison LJ, Dorian P, Long J, Vermeulen M, Schwartz B, Sawadsky B, Frank J, Cameron B, Burgess R, Shield J, Bagley P, Mausz V, Brewer J, Lerman B. A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: PrePACE. Acad Emerg Med. 2004;11:588-a. Abstract.
  • 22
    • 0033724773 scopus 로고    scopus 로고
    • Resuscitation research and emergency waiver of informed consent
    • Kowey P, Ornato J. Resuscitation research and emergency waiver of informed consent. Resuscitation. 2000;47:307-310.
    • (2000) Resuscitation , vol.47 , pp. 307-310
    • Kowey, P.1    Ornato, J.2
  • 23
    • 0035975404 scopus 로고    scopus 로고
    • Clinical research on out-of-hospital emergency care
    • Valenzuela TD, Copass MK. Clinical research on out-of-hospital emergency care. N Engl J Med. 2001;345:689-690.
    • (2001) N Engl J Med , vol.345 , pp. 689-690
    • Valenzuela, T.D.1    Copass, M.K.2
  • 24
    • 0031795184 scopus 로고    scopus 로고
    • Emergency informed consent
    • Pearson K. Emergency informed consent. Anesthesiology. 1998;89:1047-1049.
    • (1998) Anesthesiology , vol.89 , pp. 1047-1049
    • Pearson, K.1
  • 26
    • 21144431906 scopus 로고    scopus 로고
    • Ethical goals of community consultation in research
    • Dicken N, Sugarman J. Ethical goals of community consultation in research. Am J Public Health. 2005;95:1123-1127.
    • (2005) Am J Public Health , vol.95 , pp. 1123-1127
    • Dicken, N.1    Sugarman, J.2
  • 27
    • 0037225183 scopus 로고    scopus 로고
    • Protecting subjects under the waiver of informed consent for emergency research: Experiences with efforts to inform the community
    • Shah AN, Sugarman J. Protecting subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community. Ann Emerg Med. 2003;41:72-78.
    • (2003) Ann Emerg Med , vol.41 , pp. 72-78
    • Shah, A.N.1    Sugarman, J.2
  • 29
    • 0037387799 scopus 로고    scopus 로고
    • Attitudes of emergency department patients and visitors regarding emergency exception to informed consent in resuscitation research, community consultation and public notification
    • McClure KB. Delorio NM, Gunnels ND, Ochsner MJ, Biros MH, Schmidt TA. Attitudes of emergency department patients and visitors regarding emergency exception to informed consent in resuscitation research, community consultation and public notification. Acad Emerg Med. 2003;10:352-359.
    • (2003) Acad Emerg Med , vol.10 , pp. 352-359
    • McClure, K.B.1    Delorio, N.M.2    Gunnels, N.D.3    Ochsner, M.J.4    Biros, M.H.5    Schmidt, T.A.6
  • 30
    • 55349098127 scopus 로고    scopus 로고
    • Public disclosure in research with exception from informed consent: The use of survey methods to assess its effectiveness
    • Jacoby LH, Young B, Watt J. Public disclosure in research with exception from informed consent: the use of survey methods to assess its effectiveness. J Empir Res Hum Res Ethics. 2008;3:79-87.
    • (2008) J Empir Res Hum Res Ethics , vol.3 , pp. 79-87
    • Jacoby, L.H.1    Young, B.2    Watt, J.3
  • 32
    • 33947402922 scopus 로고    scopus 로고
    • Institutional review board members' experiences with exception from informed consent protocols
    • Abstract
    • Delorio N, McClure K, Nelson M, McConnell K, Schmidt T. Institutional review board members' experiences with exception from informed consent protocols. Acad Emerg Med. 2006;13:520. Abstract.
    • (2006) Acad Emerg Med , vol.13 , pp. 520
    • Delorio, N.1    McClure, K.2    Nelson, M.3    McConnell, K.4    Schmidt, T.5
  • 33
    • 33947424113 scopus 로고    scopus 로고
    • Struggling with the rule: The exception from informed consent in resuscitation research
    • Biros M. Struggling with the rule: the exception from informed consent in resuscitation research. Acad Emerg Med. 2007;14:344-345.
    • (2007) Acad Emerg Med , vol.14 , pp. 344-345
    • Biros, M.1
  • 34
    • 33947371602 scopus 로고    scopus 로고
    • The research on community consultation: An annotated bibliography
    • Baren JM, Biros MH. The research on community consultation: an annotated bibliography. Acad Emerg Med. 2007;14:346-352.
    • (2007) Acad Emerg Med , vol.14 , pp. 346-352
    • Baren, J.M.1    Biros, M.H.2
  • 35
    • 0034538696 scopus 로고    scopus 로고
    • Selection bias from requiring patients to give consent to examine data for health services research
    • Woolf SH RS, Johnson RE, Marsland DW. Selection bias from requiring patients to give consent to examine data for health services research. Arch Fam Med. 2000;9:1111-1118.
    • (2000) Arch Fam Med , vol.9 , pp. 1111-1118
    • Woolf, S.R.1    Johnson, R.E.2    Marsland, D.W.3
  • 36
    • 33745005942 scopus 로고    scopus 로고
    • Barriers of HIPAA regulation to implementation of health services research
    • Shen JJ SL, Washington EL, Johnson P, Edwards C, Malone A. Barriers of HIPAA regulation to implementation of health services research. J Med Syst. 2006;30:65-69.
    • (2006) J Med Syst , vol.30 , pp. 65-69
    • Shen, J.S.1    Washington, E.L.2    Johnson, P.3    Edwards, C.4    Malone, A.5
  • 38
    • 0037077422 scopus 로고    scopus 로고
    • standards for privacy of individually identifiable health information: Final Rule
    • 45 CFR Parts 160 and 164
    • 45 CFR Parts 160 and 164: standards for privacy of individually identifiable health information: Final Rule. Federal Register. 2002;67:53182-53273.
    • (2002) Federal Register , vol.67 , pp. 53182-53273
  • 39
    • 55349131930 scopus 로고    scopus 로고
    • Pub L No. 104-191. Health Insurance Portability and Accountability Act of 1996.
    • Pub L No. 104-191. Health Insurance Portability and Accountability Act of 1996.
  • 40
    • 55349124849 scopus 로고    scopus 로고
    • Canadian Institutes of Health Research. CIHR Best Practices for Protecting Privacy in Health Research. Ottawa, Canada: CIHR: 2005.
    • Canadian Institutes of Health Research. CIHR Best Practices for Protecting Privacy in Health Research. Ottawa, Canada: CIHR: 2005.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.