Institutional review board variability in minimal-risk multicenter urogynecology studies

Female Pelvic Medicine and Reconstructive Surgery

Volumn 18, Issue 2, 2012, Pages 89-93

  Harvie, Heidi S ^a   Lowenstein, Lior ^b   Omotosho, Tola B ^c   Sanses, Tatiana ^d   Molden, Stephanie ^e   Hardy, Janet ^f   Brubaker, Linda ^g  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b Department of Obstetrics and Gynecology Rambam Medical Center Health Care Campus ^*  (Israel)

^c UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF MARYLAND   (United States)

^e Institute for Female Pelvic Medicine   (United States)

^f UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^g LOYOLA UNIVERSITY CHICAGO   (United States)

Author keywords

Bioethics; Institutional review board; IRB variability; Multicenter studies; Research standards

Indexed keywords

RESEARCH; UROLOGY;

ACADEMIC INSTITUTIONS; BIOETHICS; CASE-CONTROL STUDY; INSTITUTIONAL REVIEW BOARD; IRB VARIABILITY; MULTICENTER STUDY; PROSPECTIVE STUDY; RESEARCH NETWORKS; REVIEW PROCESS; STANDARD FORMAT; STUDY DESIGN;

SOCIETIES AND INSTITUTIONS;

ARTICLE; CLASSIFICATION; CLINICAL PROTOCOL; ETHICS; GYNECOLOGY; HUMAN; INFORMED CONSENT; LEGAL ASPECT; METHODOLOGY; MULTICENTER STUDY (TOPIC); ORGANIZATION; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RISK ASSESSMENT; STANDARD; UROLOGY;

ACADEMIES AND INSTITUTES; CLINICAL PROTOCOLS; CONSENT FORMS; ETHICS COMMITTEES, RESEARCH; GUIDELINE ADHERENCE; GYNECOLOGY; HUMANS; MULTICENTER STUDIES AS TOPIC; RESEARCH DESIGN; RISK ADJUSTMENT; UROLOGY;

EID: 84860610253     PISSN: 21518378     EISSN: None     Source Type: Journal    
DOI: 10.1097/SPV.0b013e318249bd40     Document Type: Review

References (26)

1. Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med 2001;29(2):235-241. (Pubitemid 32171764)
2. Burman W, Daum R. Infectious Disease Society of America. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Regulation and Research and Quality Improvement. CID 2008:49328-49335.
3. Ravina B, Deuel L, Siderowf A, et al. Local institutional review board (IRB) review of a multicenter trial: local costs without local context. Ann Neurol 2010;67:258-260.
4. Newgard CD, Hui SJ, Stamps-White P, et al. Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research. Health Serv Res 2005;40: 1247-1258. (Pubitemid 41040672)
5. Stair TO, Reed CR, Radeos MS, et al, on behalf of the MARC Investigators. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med 2001;8(6):636-641. (Pubitemid 32522205)
6. McWilliams R, Hoover-Fong J, Hamosh A, et al. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 2003;290(3):360-366. (Pubitemid 37430522)
7. Ness R. Influence of the HIPAA privacy rule on health research. JAMA 2008;298(18):2164-2170.
8. Goldman J, Katz MD. Inconsistency and institutional review boards. JAMA 1982;248(2):197-202. (Pubitemid 12078157)
9. Bennett CL, Sipler AM, Parada JP, et al. Variations in institutional review board decisions for HIV quality of care studies: a potential source of study bias. 2001;26(4):390-391.
10. Hirshon JM, Krugman SD, Witting MD, et al. Variability in institutional review board assessment of minimal-risk research. Acad Emerg Med 2002;9(12):1417-1420. (Pubitemid 35416537)
11. Dziak K, Anderson R, Sevick MA, et al. Variations among institutional review board reviews in a multisite health services research study. Health Serv Res 2005;40(1):279-290. (Pubitemid 40229360)
12. Green LA, Lowery JC, Kowalski CP, et al. Impact of institutional review board practice variation on observational health services research. Health Serv Res 2006;41(1):214-230.
13. Mansbach J, Acholonu U, Clark S, et al. Variation in institutional review board responses to a standard, observational, pediatric research protocol. Acad Emerg Med 2007;14(4):377-380. (Pubitemid 46464032)
14. Stark AR, Tyson JE, Hibberd PL. Variation among institutional review boards in evaluating the design of a multicenter randomized trial. J Perinatol 2010;30(3):163-169.
15. Vick CC, Finan KR, Kiefe C, et al. Variation in institutional review processes for a multisite observational study. Am J Surg 2005;190(5):805-809. (Pubitemid 41446509)
16. Greene SM, Geiger AM, Harris EL, et al, from the Group Health Cooperative Center for Health Studies. Impact of IRB requirements on a multicenter survey of prophylactic mastectomy outcomes. Ann Epidemiol 2006;16(4):275-278.
17. Tu JV, Willison DJ, Silver FL, et al, for the Investigators in the Registry of the Canadian Stroke Network. Impracticability of informed consent in the registry of the Canadian Stroke Network. N Engl J Med 2004;350:1414-1421. (Pubitemid 38419995)
18. Lowenstein L, Olivera C, Harvie H, et al. The Fellows Pelvic Research Network (FPRN). Int Urogynecol J 2008;19(7):895-897. (Pubitemid 351772618)
19. Lowenstein L, Gamble T, Deniseiko Sanses TV, et al. Sexual function is related to body image perception in women with pelvic organ prolapse. J Sex Med 2009;6(8):2286-2291.
20. Lowenstein L, Gamble T, Sanses TV, et al. Changes in sexual function after treatment for prolapse are related to the improvement in body image perception. J Sex Med 2010;7(2 Pt 2):1023-1028.
21. Sanses TVD, Shahryarinejad A, Molden S, et al. Anatomic outcomes of vaginal mesh procedure (Prolift, Gynecare) compared to uterosacral ligament suspension and abdominal sacrocolpopexy for pelvic organ prolapse. Am J Obstet Gynecol 2009;201(5):519.e1-519.e8.
22. Schimpf MO, Harvie HS, Omotosho TB, et al, for the SGS Fellows' Pelvic Research Network. Do vaginal length and caliber impact sexual activity and function? Int Urogynecol J 2010;21(4):447-452.
23. Molden S, Bracken J, Nguyen A, et alfor the SGS Fellows' Pelvic Research Network. A retrospective multicenter study on outcomes after midurethral polypropylene sling revision for voiding dysfunction. Female Pelvic Med Reconstr Surg 2010;16(6):340-344.
24. Molden S, Bracken J, Nguyen A, et alFor the SGS Fellows' Pelvic Research Network. Risk factors leading to midurethral sling revision: a multicenter case-control study. Int Urogynecol J 2010;21(10):1253-1259.
25. American Hospital Directory. Data from AHA annual survey database. Available at: http://www.ahd.com/freesearch.php3. Accessed Jan 2010.
26. National Institutes of Health Office of Extramural Research. NIH extramural awards by state and foreign site. 2007. Available at: http://report.nih.gov/award/state/state.cfm. Accessed Jan 2010.