Unique challenges of obtaining regulatory approval for a multicenter protocol to study the genetics of RRP and suggested remedies

Otolaryngology - Head and Neck Surgery

Volumn 135, Issue 2, 2006, Pages 189-196

  Sherwood, Mylaina L ^a   Buchinsky, Farrel J ^a   Quigley, Matthew R ^a   Donfack, Joseph ^a   Choi, Sukgi S ^b   Conley, Stephen F ^c   Derkay, Craig S ^d   Myer III, Charles M ^e   Ehrlich, Garth D ^a   Post, J Christopher ^a  

^a ALLEGHENY GENERAL HOSPITAL   (United States)

^b CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^c CHILDREN S HOSPITAL OF WISCONSIN   (United States)

^d CHILDREN S HOSPITAL OF THE KING S DAUGHTERS   (United States)

^e CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; COHORT ANALYSIS; CORRELATION ANALYSIS; GENETIC ANALYSIS; GENETICS; GOVERNMENT REGULATION; INSTITUTIONAL CARE; MEDICAL DOCUMENTATION; PAPILLOMATOSIS; PEDIATRIC HOSPITAL; RECURRENT DISEASE; RESPIRATORY TRACT DISEASE; RISK ASSESSMENT;

CLINICAL PROTOCOLS; DOCUMENTATION; ETHICS COMMITTEES, RESEARCH; HOSPITALS, PEDIATRIC; HUMANS; MULTICENTER STUDIES; NEOPLASM RECURRENCE, LOCAL; PAPILLOMA; RESPIRATORY TRACT NEOPLASMS; UNITED STATES;

EID: 33746567337     PISSN: 01945998     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.otohns.2006.03.028     Document Type: Article

References (16)

1. Bentsianov B.L., Boruk M., and Rosenfeld R.M. Evidence-based medicine in otolaryngology journals. Otolaryngol Head Neck Surg 126 (2002) 371-376 (Level 3)
2. Buchinsky F.J., Derkay C.S., Leal S.M., et al. Multicenter initiative seeking critical genes in respiratory papillomatosis. Laryngoscope 114 (2004) 349-357 (Level 5)
3. Armstrong L.R., Preston E.J., Reichert M., et al. Incidence and prevalence of recurrent respiratory papillomatosis among children in Atlanta and Seattle. Clin Infect Dis 31 (2000) 107-109 (Level 3)
4. Dal-Re R., Espada J., and Ortega R. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines. [comment]. J Med Ethics 25 (1999) 268-273 (Level 2)
5. Roberts L.M., Bowyer L., Homer C.S., et al. Multicentre research. negotiating the ethics approval obstacle course. [comment] [erratum appears in Med J Aust 2004;180:262]. Med J Aust 180 (2004) 139 (Level 5)
6. Lux A.L., Edwards S.W., and Osborne J.P. Responses of local research ethics committees to a study with approval from a multicenter research ethics committee. [comment]. BMJ 320 (2000) 1182-1183 (Level 2)
7. Thornquist M.D., Edelstein C., Goodman G.E., et al. Streamlining IRB review in multisite trials through single-study IRB Cooperative Agreements. experience of the Beta-Carotene and Retinol Efficacy Trial (CARET). Control Clin Trials 23 (2002) 80-86 (Level 5)
8. Randal J. Growing pains. central review board project still developing. J Natl Cancer Inst 95 (2003) 636-637 (Level 5)
9. National Cancer Institute. The Central Institutional Review Board Initiative. http://www.ncicirb.org/accessed December, 2004.
10. McWilliams R., Hoover-Fong J., Hamosh A., et al. Problematic variation in local institutional review of a multicenter genetic epidemiology study. [comment]. JAMA 290 (2003) 360-366 (Level 4)
11. Rose C.D. Local vs central institutional review boards for multicenter studies. [comment]. JAMA 290 (2003) 2126-2127 (Level 5)
12. Silverman H., Hull S.C., and Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 29 (2001) 235-241 (Level 2)
13. Rogers A.S., Schwartz D.F., Weissman G., et al. Adolescent medicine HIVARN. A case study in adolescent participation in clinical research. eleven clinical sites, one common protocol, and eleven IRBs. IRB 21 (1999) 6-10 (Level 2)
14. 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 24 (2003) 245-255 (Level 2)
15. Burman W.J., Reves R.R., Cohn D.L., et al. Breaking the camel's back. multicenter clinical trials and local institutional review boards. [comment]. Ann Intern Med 134 (2001) 152-157 (Level 5)
16. Continued Vigilance Critical to Protecting Human Subjects. Statement by Sarah F. Jaggar, Director of Health Financing and Public Health Issues. Committee on Governmental Affairs, US Senate. Washington, DC: United States General Accounting Office, 1996. p 6.