메뉴 건너뛰기




Volumn 27, Issue 4, 2009, Pages 375-383

Clinical research regulation: challenges to the institutional review board system

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; ADMINISTRATIVE PERSONNEL; ANALYTIC METHOD; CERTIFICATION; CLINICAL RESEARCH; CLINICAL STUDY; CONFLICT OF INTEREST; EDUCATION PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN RIGHTS; INFORMED CONSENT; LICENSING; PRIORITY JOURNAL; RESEARCH ETHICS; RESPONSIBILITY; REVIEW; WELFARE;

EID: 66949159438     PISSN: 0738081X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clindermatol.2009.02.012     Document Type: Review
Times cited : (11)

References (34)
  • 1
    • 66949171130 scopus 로고    scopus 로고
    • Medical laws and ethics of Babylon as read in Hammurabi's code (history)
    • Accessed January 24, 2009
    • Halwani T.M., and Takrouri M. Medical laws and ethics of Babylon as read in Hammurabi's code (history). Internet J Law Healthc Ethics (2007). http://www.ispub.com/ostia/index.php?xmlFilePath=journals/ijlhe/vol4n2/babylon.xml Accessed January 24, 2009
    • (2007) Internet J Law Healthc Ethics
    • Halwani, T.M.1    Takrouri, M.2
  • 3
    • 7944230448 scopus 로고    scopus 로고
    • A survey of IRB process in 68 U.S. hospitals
    • Larson E., Zwanziger J., and Stone P. A survey of IRB process in 68 U.S. hospitals. J Nurs Scholarsh 36 (2004) 260-264
    • (2004) J Nurs Scholarsh , vol.36 , pp. 260-264
    • Larson, E.1    Zwanziger, J.2    Stone, P.3
  • 4
    • 36148939809 scopus 로고    scopus 로고
    • The dysregulation of human subjects research
    • Fost N., and Levine R.J. The dysregulation of human subjects research. JAMA 298 (2007) 2196-2198
    • (2007) JAMA , vol.298 , pp. 2196-2198
    • Fost, N.1    Levine, R.J.2
  • 5
    • 36148951701 scopus 로고    scopus 로고
    • Influence of the HIPAA privacy rule on health research
    • Ness R.B. Influence of the HIPAA privacy rule on health research. JAMA 298 (2007) 2164-2170
    • (2007) JAMA , vol.298 , pp. 2164-2170
    • Ness, R.B.1
  • 6
    • 42349101589 scopus 로고    scopus 로고
    • Eight years after Jesse's death, are human research subjects any safer?
    • Gelsinger P., and Shamoo S.A. Eight years after Jesse's death, are human research subjects any safer?. Hastings Cent Rep 38 (2008) 25
    • (2008) Hastings Cent Rep , vol.38 , pp. 25
    • Gelsinger, P.1    Shamoo, S.A.2
  • 8
    • 14144252850 scopus 로고    scopus 로고
    • A study of warning letters issued to institutional review boards by the United States Food and Drug Administration
    • Bramstedt K.A., and Kassimatis K. A study of warning letters issued to institutional review boards by the United States Food and Drug Administration. Clin Invest Med 27 (2004) 316-323
    • (2004) Clin Invest Med , vol.27 , pp. 316-323
    • Bramstedt, K.A.1    Kassimatis, K.2
  • 14
    • 66949141595 scopus 로고    scopus 로고
    • An ethics primer for institutional review boards
    • Bankert E.A., and Amdur R. (Eds), Jones and Bartlett Publishers Inc, Sudbury (MA)
    • Vanderpool H. An ethics primer for institutional review boards. In: Bankert E.A., and Amdur R. (Eds). Institutional review board: management and function. 2nd ed. (2006), Jones and Bartlett Publishers Inc, Sudbury (MA) 3
    • (2006) Institutional review board: management and function. 2nd ed. , pp. 3
    • Vanderpool, H.1
  • 15
    • 0040144236 scopus 로고    scopus 로고
    • The institutional review board: definition and federal oversight
    • Bankert E.A., and Amdur R. (Eds), Jones and Bartlett Publishers Inc, Sudbury (MA)
    • Bankert E.A., and Amdur R. The institutional review board: definition and federal oversight. In: Bankert E.A., and Amdur R. (Eds). Institutional review board: management and function. 2nd ed. (2006), Jones and Bartlett Publishers Inc, Sudbury (MA) 24-25
    • (2006) Institutional review board: management and function. 2nd ed. , pp. 24-25
    • Bankert, E.A.1    Amdur, R.2
  • 19
    • 0001984825 scopus 로고
    • On the folly of rewarding A while hoping for B
    • Kerr S. On the folly of rewarding A while hoping for B. Acad Manage Exec 9 (1995) 7-14
    • (1995) Acad Manage Exec , vol.9 , pp. 7-14
    • Kerr, S.1
  • 20
    • 4143062563 scopus 로고    scopus 로고
    • Oversight of human participants research: identifying problems to evaluate reform proposals
    • Emanuel E.J., Wood A., Fleischman A., et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med 141 (2004) 282-291
    • (2004) Ann Intern Med , vol.141 , pp. 282-291
    • Emanuel, E.J.1    Wood, A.2    Fleischman, A.3
  • 22
    • 16244385000 scopus 로고    scopus 로고
    • Looking into the institutional review board: observations from both sides of the table
    • Burke G.S. Looking into the institutional review board: observations from both sides of the table. J Nutr 135 (2005) 921-924
    • (2005) J Nutr , vol.135 , pp. 921-924
    • Burke, G.S.1
  • 24
    • 66949174554 scopus 로고    scopus 로고
    • The limits of institutional review board authority
    • Bankert E.A., and Amdur R. (Eds), Jones and Bartlett Publishers Inc, Sudbury (MA)
    • Amdur R.J. The limits of institutional review board authority. In: Bankert E.A., and Amdur R. (Eds). Institutional review board: management and function. 2nd ed. (2006), Jones and Bartlett Publishers Inc, Sudbury (MA) 26-28
    • (2006) Institutional review board: management and function. 2nd ed. , pp. 26-28
    • Amdur, R.J.1
  • 25
    • 60549109061 scopus 로고    scopus 로고
    • Do informed consents really matter?
    • 10.1016/j.cct.2008.10.004 [in press]
    • Resnik D.B. Do informed consents really matter?. Contem Clin Trials (2008) 10.1016/j.cct.2008.10.004 [in press]
    • (2008) Contem Clin Trials
    • Resnik, D.B.1
  • 30
    • 66949152265 scopus 로고    scopus 로고
    • Program DON HRPP: human research certification - is it for you?
    • Accessed January 25, 2009
    • Program DON HRPP: human research certification - is it for you?. Res Prot Update 2 (2007) 1-2. http://www.onr.navy.mil/sci_tech/34/docs/hrp_newsleter_0706.pdf Accessed January 25, 2009
    • (2007) Res Prot Update , vol.2 , pp. 1-2
  • 31
    • 45549090094 scopus 로고    scopus 로고
    • Clinical educators' experiences with institutional review boards: results of a national survey
    • Dyrbye L.N., Thomas M.R., Papp K.K., and Durning S.J. Clinical educators' experiences with institutional review boards: results of a national survey. Acad Med 83 (2008) 590-595
    • (2008) Acad Med , vol.83 , pp. 590-595
    • Dyrbye, L.N.1    Thomas, M.R.2    Papp, K.K.3    Durning, S.J.4
  • 32
    • 0038823787 scopus 로고    scopus 로고
    • Independent institutional review boards
    • Forster D. Independent institutional review boards. Seton Hall Law Rev 32 (2003) 513-523
    • (2003) Seton Hall Law Rev , vol.32 , pp. 513-523
    • Forster, D.1
  • 33
    • 50249121111 scopus 로고    scopus 로고
    • How independent are IRBs?
    • Macklin R. How independent are IRBs?. IRB 30 (2008) 15-19
    • (2008) IRB , vol.30 , pp. 15-19
    • Macklin, R.1
  • 34
    • 66949124771 scopus 로고    scopus 로고
    • A Shared responsibility for protecting human subjects
    • Bankert E.A., and Amdur R. (Eds), Jones and Bartlett Publishers Inc, Sudbury (MA)
    • Peckman S. A Shared responsibility for protecting human subjects. In: Bankert E.A., and Amdur R. (Eds). Institutional review board: management and function. 2nd ed. (2006), Jones and Bartlett Publishers Inc, Sudbury (MA) 16-20
    • (2006) Institutional review board: management and function. 2nd ed. , pp. 16-20
    • Peckman, S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.