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Volumn 10, Issue 4, 2013, Pages 560-567

Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); EMPIRICISM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; INSTITUTIONAL REVIEW; MEDICAL LITERATURE; MEDICAL RESEARCH; MULTICENTER STUDY (TOPIC); PEER REVIEW; PRIORITY JOURNAL; PRODUCTIVITY; PUBLIC OPINION; PUBLICATION; REVIEW; UNITED STATES;

EID: 84881043215     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774513484393     Document Type: Review
Times cited : (46)

References (31)
  • 1
    • 77449109638 scopus 로고    scopus 로고
    • Costs and benefits of the National Cancer Institute central institutional review board
    • Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J. Costs and benefits of the National Cancer Institute central institutional review board. J Clin Oncol. 2010 ; 28: 662-66
    • (2010) J Clin Oncol , vol.28 , pp. 662-666
    • Wagner, T.H.1    Murray, C.2    Goldberg, J.3    Adler, J.M.4    Abrams, J.5
  • 3
    • 84873878033 scopus 로고    scopus 로고
    • 30 April 2010 accessed 6 August 2012
    • MenikoffJ. OHRP correspondence, 30 April 2010. Available at: http://www.hhs.gov/ohrp/policy/Correspondence/mcdeavitt20100430letter.html (accessed 6 August 2012).
    • OHRP Correspondence
    • Menikoff, J.1
  • 4
    • 80052857705 scopus 로고    scopus 로고
    • Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators
    • Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Fed Regist. 2011 ; 76: 44512-31
    • (2011) Fed Regist , vol.76 , pp. 44512-44531
  • 5
    • 84881059158 scopus 로고    scopus 로고
    • The Secretary's Advisory Committee on Human Research Protection SACHRP recommendations on consideration of local context with respect to increasing use of single IRB review accessed 11 January 2012
    • The Secretary's Advisory Committee on Human Research Protection. Presentation Materials October 10, 2012. Revised by SACHRP, 10 October 2012. SACHRP recommendations on consideration of local context with respect to increasing use of single IRB review. Available at: http://www.hhs.gov/ohrp/ sachrp/mtgings/2012%20Oct%20Mtg/revisedlocalconstext.pdf (accessed 11 January 2012).
    • Presentation Materials October 10, 2012. Revised by SACHRP, 10 October 2012
  • 6
    • 4143062563 scopus 로고    scopus 로고
    • Oversight of human participants research: Identifying problems to evaluate reform proposals
    • Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: Identifying problems to evaluate reform proposals. Ann Intern Med. 2004 ; 141: 282-91
    • (2004) Ann Intern Med , vol.141 , pp. 282-291
    • Emanuel, E.J.1    Wood, A.2    Fleischman, A.3
  • 7
    • 84873849027 scopus 로고    scopus 로고
    • Using central IRBs for multicenter clinical trials in the United States
    • Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013 ; 8 (1). e54999
    • (2013) PLoS One , vol.8 , Issue.1 , pp. 54999
    • Flynn, K.E.1    Hahn, C.L.2    Kramer, J.M.3
  • 8
    • 33745662181 scopus 로고    scopus 로고
    • A review finds that multicenter studies face substantial challenges but strategies exist to achieve institutional review board approval
    • Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve institutional review board approval. J Clin Epidemiol. 2006 ; 59: 784-90
    • (2006) J Clin Epidemiol , vol.59 , pp. 784-790
    • Greene, S.M.1    Geiger, A.M.2
  • 9
    • 79954508843 scopus 로고    scopus 로고
    • A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn
    • Abbott L, Grady C. A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. J Empir Res Hum Res Ethics. 2011 ; 6: 3-20
    • (2011) J Empir Res Hum Res Ethics , vol.6 , pp. 3-20
    • Abbott, L.1    Grady, C.2
  • 10
    • 67349264564 scopus 로고    scopus 로고
    • Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial
    • Helfand BT, Mongiu AK, Roehrborn CG, et al. Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial. J Urol. 2009 ; 181: 2674-79
    • (2009) J Urol , vol.181 , pp. 2674-2679
    • Helfand, B.T.1    Mongiu, A.K.2    Roehrborn, C.G.3
  • 11
    • 77949418691 scopus 로고    scopus 로고
    • Local institutional review board (IRB) review of a multicenter trial: Local costs without local context
    • Ravina B, Deuel L, Siderowf A, Dorsey ER. Local institutional review board (IRB) review of a multicenter trial: Local costs without local context. Ann Neurol. 2010 ; 67: 258-60
    • (2010) Ann Neurol , vol.67 , pp. 258-260
    • Ravina, B.1    Deuel, L.2    Siderowf, A.3    Dorsey, E.R.4
  • 12
    • 33646168992 scopus 로고    scopus 로고
    • Regulatory challenges: Lessons from recent West Nile virus trials in the United States
    • Jester PM, Tilden SJ, Li Y, Whitley RJ, Sullender WM. Regulatory challenges: Lessons from recent West Nile virus trials in the United States. Contemp Clin Trials. 2006 ; 27: 254-59
    • (2006) Contemp Clin Trials , vol.27 , pp. 254-259
    • Jester, P.M.1    Tilden, S.J.2    Li, Y.3    Whitley, R.J.4    Sullender, W.M.5
  • 13
    • 0035116519 scopus 로고    scopus 로고
    • Variability among institutional review boards' decisions within the context of a multicenter trial
    • Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med. 2001 ; 29: 235-41
    • (2001) Crit Care Med , vol.29 , pp. 235-241
    • Silverman, H.1    Hull, S.C.2    Sugarman, J.3
  • 14
    • 77649186879 scopus 로고    scopus 로고
    • Variation among institutional review boards in evaluating the design of a multicenter randomized trial
    • Stark AR, Tyson JE, Hibberd PL. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol. 2010 ; 30: 163-69
    • (2010) J Perinatol , vol.30 , pp. 163-169
    • Stark, A.R.1    Tyson, J.E.2    Hibberd, P.L.3
  • 15
    • 0034988768 scopus 로고    scopus 로고
    • Variation in institutional review board responses to a standard protocol for a multicenter clinical trial
    • Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med. 2001 ; 8: 636-41
    • (2001) Acad Emerg Med , vol.8 , pp. 636-641
    • Stair, T.O.1    Reed, C.R.2    Radeos, M.S.3    Koski, G.4    Camargo, C.A.5
  • 16
    • 0038369243 scopus 로고    scopus 로고
    • The effects of local review on informed consent documents from a multicenter clinical trials consortium
    • Burman W, Breese P, Weis S, et al. The effects of local review on informed consent documents from a multicenter clinical trials consortium. Control Clin Trials. 2003 ; 24: 245-55
    • (2003) Control Clin Trials , vol.24 , pp. 245-255
    • Burman, W.1    Breese, P.2    Weis, S.3
  • 17
    • 34250186119 scopus 로고    scopus 로고
    • Institutional review board review of multicenter studies
    • Sobolski GK, Flores L, Emanuel EJ. Institutional review board review of multicenter studies. Ann Intern Med. 2007 ; 146: 759
    • (2007) Ann Intern Med , vol.146 , pp. 759
    • Sobolski, G.K.1    Flores, L.2    Emanuel, E.J.3
  • 18
    • 80051683917 scopus 로고    scopus 로고
    • Who watches the watchmen?
    • Who watches the watchmen?Nature2011; 476: 125. Available at: http://www.nature.com/nature/journal/v476/n7359/full/476125a.html
    • (2011) Nature , vol.476 , pp. 125
  • 19
    • 3042776740 scopus 로고    scopus 로고
    • Medical schools' attitudes and perceptions regarding the use of central institutional review boards
    • Loh ED, Meyer RE. Medical schools' attitudes and perceptions regarding the use of central institutional review boards. Acad Med. 2004 ; 79: 644-51
    • (2004) Acad Med , vol.79 , pp. 644-651
    • Loh, E.D.1    Meyer, R.E.2
  • 20
    • 79959474987 scopus 로고    scopus 로고
    • How local IRBs view central IRBs in the US
    • Klitzman R. How local IRBs view central IRBs in the US. BMC Med Ethics. 2011 ; 12: 13
    • (2011) BMC Med Ethics , vol.12 , pp. 13
    • Klitzman, R.1
  • 21
    • 0242661464 scopus 로고    scopus 로고
    • Local vs central institutional review boards for multicenter studies
    • Rosé CD. Local vs central institutional review boards for multicenter studies. JAMA. 2003 2126 ; 290 :
    • (2003) JAMA , vol.290
    • Rosé, C.D.1
  • 22
    • 0037007688 scopus 로고    scopus 로고
    • A central institutional review board for multi-institutional trials
    • Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med. 2002 ; 346: 1405-08
    • (2002) N Engl J Med , vol.346 , pp. 1405-1408
    • Christian, M.C.1    Goldberg, J.L.2    Killen, J.3
  • 23
    • 77956410562 scopus 로고    scopus 로고
    • Do IRBs protect human research participants?
    • Grady C. Do IRBs protect human research participants?. JAMA. 2010 ; 304 (10). 1122-23
    • (2010) JAMA , vol.304 , Issue.10 , pp. 1122-1123
    • Grady, C.1
  • 24
    • 35348871875 scopus 로고    scopus 로고
    • Moving beyond compliance: Measuring ethical quality to enhance the oversight of human subjects research
    • Taylor HA. Moving beyond compliance: Measuring ethical quality to enhance the oversight of human subjects research. IRB. 2007 ; 29 (5). 9-14
    • (2007) IRB , vol.29 , Issue.5 , pp. 9-14
    • Taylor, H.A.1
  • 25
    • 42549129895 scopus 로고    scopus 로고
    • How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review
    • Coleman CH, Bouesseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics. 2008 ; 9: 6
    • (2008) BMC Med Ethics , vol.9 , pp. 6
    • Ch, C.1    Bouesseau, M.C.2
  • 27
    • 84881050008 scopus 로고    scopus 로고
    • US Department of Veterans Affairs accessed 11 January 2012
    • US Department of Veterans Affairs. VA Central IRB. Available at: http://www.research.va.gov/vacentralirb/#.UPBoMJjc8ng (accessed 11 January 2012).
    • VA Central IRB
  • 28
    • 21244439176 scopus 로고    scopus 로고
    • Central IRBs: Why are some institutions reluctant to sign on?
    • McNeil C. Central IRBs: Why are some institutions reluctant to sign on?. J Natl Cancer Inst. 2005 ; 97 (13). 953-55
    • (2005) J Natl Cancer Inst , vol.97 , Issue.13 , pp. 953-955
    • McNeil, C.1
  • 29
    • 84892442261 scopus 로고    scopus 로고
    • Two roads diverged in a yellow wood: The National Cancer Institute (NCI) Central IRB (CIRB) considers a model change
    • Two roads diverged in a yellow wood: The National Cancer Institute (NCI) Central IRB (CIRB) considers a model change. Presented at: Advancing Ethical Research Conference ; National Harbor, MD ;..
    • Presented At: Advancing Ethical Research Conference
  • 30
    • 84856000206 scopus 로고    scopus 로고
    • NeuroNEXT: Accelerating drug development in neurology
    • NeuroNEXT: Accelerating drug development in neurology. Lancet Neurol. 2012 ; 11: 119
    • (2012) Lancet Neurol , vol.11 , pp. 119
  • 31
    • 78751700368 scopus 로고    scopus 로고
    • The Academy of Medical Sciences January accessed 11 January 2013
    • The Academy of Medical Sciences. A new pathway for the regulation and governance of research, January 2011. Available at: http://www.acmedsci.ac.uk/ p99.html (accessed 11 January 2013).
    • (2011) A New Pathway for the Regulation and Governance of Research


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.