메뉴 건너뛰기




Volumn 67, Issue 2, 2010, Pages 258-260

Local institutional review board (IRB) review of a multicenter trial: Local costs without local context

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA TOCOPHEROL; UBIDECARENONE;

EID: 77949418691     PISSN: 03645134     EISSN: 15318249     Source Type: Journal    
DOI: 10.1002/ana.21831     Document Type: Article
Times cited : (46)

References (16)
  • 1
    • 77958564061 scopus 로고    scopus 로고
    • Advanced notice of proposed rulemaking; request for comments
    • Menikoff J. Advanced notice of proposed rulemaking; request for comments. Fed Regist 2009;74:9578-9583.
    • (2009) Fed Regist , vol.74 , pp. 9578-9583
    • Menikoff, J.1
  • 2
    • 77949396607 scopus 로고    scopus 로고
    • Code of Federal Regulations CFR, Title 45, 1. Part 46.114. Revised as of October 1, 2005. CITE: 45CFR46.114. Title 45. Public Welfare Subtitle A. Department of Health and Human Services. Part 46. Protection of Human Subjects. Subpart A. Basic HHS Policy for Protection of Human Research Subjects. Sec. 46.114 Cooperative Research. Available at: Aug 2009
    • Code of Federal Regulations (CFR). Title 45, Vol 1. Part 46.114. Revised as of October 1, 2005. CITE: 45CFR46.114. Title 45. Public Welfare Subtitle A. Department of Health and Human Services. Part 46. Protection of Human Subjects. Subpart A. Basic HHS Policy for Protection of Human Research Subjects. Sec. 46.114 Cooperative Research. Available at: http://www.gpoaccess.gov/cfr/ retrieve.html. Accessed Aug 2009.
  • 4
    • 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;24:245-255.
    • (2003) Control Clin Trials , vol.24 , pp. 245-255
    • Burman, W.1    Breese, P.2    Weis, S.3
  • 5
    • 0037456358 scopus 로고    scopus 로고
    • Readability standards for informed-consent forms as compared with actual readability
    • Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med 2003;348:721-726.
    • (2003) N Engl J Med , vol.348 , pp. 721-726
    • Paasche-Orlow, M.K.1    Taylor, H.A.2    Brancati, F.L.3
  • 6
    • 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; 346:1405-1408.
    • (2002) N Engl J Med , vol.346 , pp. 1405-1408
    • Christian, M.C.1    Goldberg, J.L.2    Killen, J.3
  • 7
    • 17644372337 scopus 로고    scopus 로고
    • The cost of institutional review boards in academic medical centers
    • Sugarman J, Getz K, Speckman JL, et al. The cost of institutional review boards in academic medical centers. N Engl J Med. 2005; 352:1825-1827.
    • (2005) N Engl J Med , vol.352 , pp. 1825-1827
    • Sugarman, J.1    Getz, K.2    Speckman, J.L.3
  • 8
    • 0035895292 scopus 로고    scopus 로고
    • Breaking the camel's back: Multicenter clinical trials and local institutional review boards
    • Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med 2001;134:152-157.
    • (2001) Ann Intern Med , vol.134 , pp. 152-157
    • Burman, W.J.1    Reves, R.R.2    Cohn, D.L.3    Schooley, R.T.4
  • 9
    • 33646168992 scopus 로고    scopus 로고
    • Regulatory challenges: Lessons from recent West Nile virus trials in the United States
    • Jester PM, Tilden SJ, Li Y, et al. Regulatory challenges: lessons from recent West Nile virus trials in the United States. Contemp Clin Trials 2006;27:254-259.
    • (2006) Contemp Clin Trials , vol.27 , pp. 254-259
    • Jester, P.M.1    Tilden, S.J.2    Li, Y.3
  • 10
    • 0036169297 scopus 로고    scopus 로고
    • Regulatory approvals in a large multinational clinical trial: The ESPRIT experience
    • McNay LA, Tavel JA, Oseekey K, et al. Regulatory approvals in a large multinational clinical trial: the ESPRIT experience. Control Clin Trials 2002;23:59-66.
    • (2002) Control Clin Trials , vol.23 , pp. 59-66
    • McNay, L.A.1    Tavel, J.A.2    Oseekey, K.3
  • 11
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22:151-185.
    • (2003) J Health Econ , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 12
    • 65649102613 scopus 로고    scopus 로고
    • Unabated increases in trial costs reflect evolving research milieu
    • Samson K. Unabated increases in trial costs reflect evolving research milieu. Ann Neurol 2009;65:A9-A11.
    • (2009) Ann Neurol , vol.65
    • Samson, K.1
  • 13
    • 37849047965 scopus 로고    scopus 로고
    • Clinical trials: Rising costs limit innovation
    • Johnston SC, Hauser SL. Clinical trials: rising costs limit innovation. Ann Neurol 2007;62:A6-A7.
    • (2007) Ann Neurol , vol.62
    • Johnston, S.C.1    Hauser, S.L.2
  • 14
    • 77949391438 scopus 로고    scopus 로고
    • Goldberg J. Central Institutional Review Board (CIRB) Initiative: NCRR-CTSA-NICHD Workshop on Comparing IRB Models for Multisite Pediatric Studies; 2009. http://www.ctsaweb.org/uploadedfiles/ CTSA%20Hirshfeld%20workshop%20IRB%20models%20GoldbergFinal1.pdf
    • Goldberg J. Central Institutional Review Board (CIRB) Initiative: NCRR-CTSA-NICHD Workshop on Comparing IRB Models for Multisite Pediatric Studies; 2009. http://www.ctsaweb.org/uploadedfiles/ CTSA%20Hirshfeld%20workshop%20IRB%20models%20GoldbergFinal1.pdf
  • 15
    • 41149177476 scopus 로고    scopus 로고
    • Ontario Cancer Research Ethics Board: Lessons learned from developing a multicenter regional institutional review board
    • Saginur R, Dent SF, Schwartz L, et al. Ontario Cancer Research Ethics Board: lessons learned from developing a multicenter regional institutional review board. J Clin Oncol 2008;26: 1479-1482.
    • (2008) J Clin Oncol , vol.26 , pp. 1479-1482
    • Saginur, R.1    Dent, S.F.2    Schwartz, L.3
  • 16
    • 66749151927 scopus 로고    scopus 로고
    • Dove A. Coast IRB hits treacherous waters. Nat Med 2009;15: 470.
    • Dove A. Coast IRB hits treacherous waters. Nat Med 2009;15: 470.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.