FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1996361420> ?p ?o ?g. }

• W1996361420 endingPage "2679" @default.
• W1996361420 startingPage "2674" @default.
• W1996361420 abstract "No AccessJournal of UrologyAdult Urology1 Jun 2009Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Randomized, Controlled Surgical Trial Brian T. Helfand, Anne K. Mongiu, Claus G. Roehrborn, Robert F. Donnell, Reginald Bruskewitz, Steven A. Kaplan, John W. Kusek, Laura Coombs, Kevin T. McVary, and MIST Investigators Brian T. HelfandBrian T. Helfand Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Equal study contribution. More articles by this author , Anne K. MongiuAnne K. Mongiu Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Equal study contribution. More articles by this author , Claus G. RoehrbornClaus G. Roehrborn University of Texas Southwestern Medical Center, Dallas, Texas More articles by this author , Robert F. DonnellRobert F. Donnell Medical College of Wisconsin, Milwaukee, Wisconsin More articles by this author , Reginald BruskewitzReginald Bruskewitz University of Wisconsin Clinical Science Center, Madison, Wisconsin More articles by this author , Steven A. KaplanSteven A. Kaplan Weill Cornell Medical College, New York, New York More articles by this author , John W. KusekJohn W. Kusek Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland Financial interest and/or other relationship with Pfizer and Lilly. More articles by this author , Laura CoombsLaura Coombs American College of Radiology, Reston, Virginia More articles by this author , Kevin T. McVaryKevin T. McVary Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Financial interest and/or other relationship with Sanofi Aventis Medical, GlaxoSmithKline, Lilly-ICOS, Beckman-Coulter and National Institutes of Diabetes and Digestive and Kidney Diseases. More articles by this author , and MIST Investigators More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2009.02.032AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: The primary responsibility of institutional review boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of institutional review boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various institutional review boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol. Materials and Methods: We obtained the institutional review board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an institutional review board at another participating institution and analyzed that review of these protocols. Results: We found that the number and type of responses required for institutional review board approval of an identical study protocol varied significantly among participating institutions. We also found that institutional review board responses were inconsistent in the second review, although all protocols were ultimately approved. Conclusions: The current system of local institutional review board review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise for overseeing surgical trials. Based on these results a central surgical institutional review board may be needed to improve the ethical review process in multicenter trials. References 1 : Variation in institutional review processes for a multisite observational study. Am J Surg2005; 190: 805. Google Scholar 2 Title 45 Code of Federal Regulations (CFR), Part 46: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D. C: Office of Human Research Protection, United States Department of Health and Human Services1979. Google Scholar 3 : A protocol review guide to reduce IRB inconsistency. IRB1987; 9: 9. Google Scholar 4 : Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med2001; 8: 636. Google Scholar 5 : Inconsistency and institutional review boards. JAMA1982; 248: 197. Google Scholar 6 : Variations among institutional review board reviews in a multisite health services research study. Health Serv Res2005; 40: 279. Google Scholar 7 : Impact of institutional review board practice variation on observational health services research. Health Serv Res2006; 41: 214. Google Scholar 8 : Variability in institutional review board assessment of minimal-risk research. Acad Emerg Med2002; 9: 1417. Google Scholar 9 : Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA2003; 290: 360. Google Scholar 10 : Medical education research and IRB review: an analysis and comparison of the IRB review process at six institutions. Acad Med2007; 82: 654. Google Scholar 11 : Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research. Health Serv Res2005; 40: 1247. Google Scholar 12 : Variation in institutional review board responses to a standard, observational, pediatric research protocol. Acad Emerg Med2007; 14: 377. Google Scholar 13 : Lessons learned from a failed multi-institutional randomized controlled study. J Pediatr Surg2002; 37: 431. Google Scholar 14 Institutional Review Boards: A Time for Reform. Department of Health and Human Services Contract No. OEI-01-97-00193 ed. Washington, D. C.: Department of Health and Human Services, Office of Inspector General June 1998; vol 2008. Google Scholar 15 Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subject. Bethesda: Office of Extramural Research, National Institutes of Health1998. Google Scholar 16 : A central institutional review board for multi-institutional trials. N Engl J Med2002; 346: 1405. Google Scholar 17 : Surgical innovation: too risky to remain unregulated?. Ann Thorac Surg2006; 82: 1957. Google Scholar 18 : Randomized, controlled trials in surgery: perceived barriers and attitudes of Australian colorectal surgeons. Dis Colon Rectum2001; 44: 1413. Google Scholar 19 : Development and perspectives of randomized controlled trials in surgery. Am J Surg2007; 194: 148. Google Scholar 20 : A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature. J Urol2007; 177: 1090. Link, Google Scholar 21 : Randomized controlled trials in pediatric urology: room for improvement. J Urol2006; 176: 306. Link, Google Scholar 22 : http://www.ncicirb.org/. Accessed October 10, 2008. Google Scholar 23 : The Ontario Cancer Research Ethics Board: a central REB that works. Curr Oncol2008; 15: 49. Google Scholar 24 : Ontario Cancer Research Ethics Board: lessons learned from developing a multicenter regional institutional review board. J Clin Oncol2008; 26: 1479. Google Scholar 25 : Growing pains: central review board project still developing. J Natl Cancer Inst2003; 95: 636. Google Scholar © 2009 by American Urological AssociationFiguresReferencesRelatedDetails Volume 181Issue 6June 2009Page: 2674-2679 Advertisement Copyright & Permissions© 2009 by American Urological AssociationKeywordsminimally invasiveresearch subjectsethics committeessurgical proceduresrandomized controlled trials as topicprostateresearchMetricsAuthor Information Brian T. Helfand Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Equal study contribution. More articles by this author Anne K. Mongiu Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Equal study contribution. More articles by this author Claus G. Roehrborn University of Texas Southwestern Medical Center, Dallas, Texas More articles by this author Robert F. Donnell Medical College of Wisconsin, Milwaukee, Wisconsin More articles by this author Reginald Bruskewitz University of Wisconsin Clinical Science Center, Madison, Wisconsin More articles by this author Steven A. Kaplan Weill Cornell Medical College, New York, New York More articles by this author John W. Kusek Division of Kidney, Urologic and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland Financial interest and/or other relationship with Pfizer and Lilly. More articles by this author Laura Coombs American College of Radiology, Reston, Virginia More articles by this author Kevin T. McVary Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois Financial interest and/or other relationship with Sanofi Aventis Medical, GlaxoSmithKline, Lilly-ICOS, Beckman-Coulter and National Institutes of Diabetes and Digestive and Kidney Diseases. More articles by this author MIST Investigators More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
• W1996361420 created "2016-06-24" @default.
• W1996361420 creator A5001689326 @default.
• W1996361420 creator A5002446975 @default.
• W1996361420 creator A5040913447 @default.
• W1996361420 creator A5047934585 @default.
• W1996361420 creator A5049019006 @default.
• W1996361420 creator A5073389579 @default.
• W1996361420 creator A5075996085 @default.
• W1996361420 creator A5081214299 @default.
• W1996361420 creator A5087921119 @default.
• W1996361420 date "2009-06-01" @default.
• W1996361420 modified "2023-09-29" @default.
• W1996361420 title "Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Randomized, Controlled Surgical Trial" @default.
• W1996361420 cites W1903966615 @default.
• W1996361420 cites W1991532240 @default.
• W1996361420 cites W1998648694 @default.
• W1996361420 cites W2003442882 @default.
• W1996361420 cites W2009610549 @default.
• W1996361420 cites W2017717106 @default.
• W1996361420 cites W2024500962 @default.
• W1996361420 cites W2035716019 @default.
• W1996361420 cites W2036397172 @default.
• W1996361420 cites W2071029366 @default.
• W1996361420 cites W2099916637 @default.
• W1996361420 cites W2139623473 @default.
• W1996361420 cites W2150519706 @default.
• W1996361420 cites W2161193035 @default.
• W1996361420 cites W2162341425 @default.
• W1996361420 cites W2167741645 @default.
• W1996361420 cites W2474005940 @default.
• W1996361420 cites W2792869253 @default.
• W1996361420 cites W4233390441 @default.
• W1996361420 cites W4241312034 @default.
• W1996361420 cites W4250126373 @default.
• W1996361420 doi "https://doi.org/10.1016/j.juro.2009.02.032" @default.
• W1996361420 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/4720253" @default.
• W1996361420 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/19375101" @default.
• W1996361420 hasPublicationYear "2009" @default.
• W1996361420 type Work @default.
• W1996361420 sameAs 1996361420 @default.
• W1996361420 citedByCount "35" @default.
• W1996361420 countsByYear W19963614202012 @default.
• W1996361420 countsByYear W19963614202013 @default.
• W1996361420 countsByYear W19963614202014 @default.
• W1996361420 countsByYear W19963614202015 @default.
• W1996361420 countsByYear W19963614202017 @default.
• W1996361420 countsByYear W19963614202018 @default.
• W1996361420 countsByYear W19963614202019 @default.
• W1996361420 countsByYear W19963614202020 @default.
• W1996361420 countsByYear W19963614202021 @default.
• W1996361420 countsByYear W19963614202022 @default.
• W1996361420 countsByYear W19963614202023 @default.
• W1996361420 crossrefType "journal-article" @default.
• W1996361420 hasAuthorship W1996361420A5001689326 @default.
• W1996361420 hasAuthorship W1996361420A5002446975 @default.
• W1996361420 hasAuthorship W1996361420A5040913447 @default.
• W1996361420 hasAuthorship W1996361420A5047934585 @default.
• W1996361420 hasAuthorship W1996361420A5049019006 @default.
• W1996361420 hasAuthorship W1996361420A5073389579 @default.
• W1996361420 hasAuthorship W1996361420A5075996085 @default.
• W1996361420 hasAuthorship W1996361420A5081214299 @default.
• W1996361420 hasAuthorship W1996361420A5087921119 @default.
• W1996361420 hasBestOaLocation W19963614202 @default.
• W1996361420 hasConcept C121332964 @default.
• W1996361420 hasConcept C141071460 @default.
• W1996361420 hasConcept C142724271 @default.
• W1996361420 hasConcept C168563851 @default.
• W1996361420 hasConcept C204787440 @default.
• W1996361420 hasConcept C2777106319 @default.
• W1996361420 hasConcept C2778334786 @default.
• W1996361420 hasConcept C2780385302 @default.
• W1996361420 hasConcept C2992435398 @default.
• W1996361420 hasConcept C44870925 @default.
• W1996361420 hasConcept C71924100 @default.
• W1996361420 hasConceptScore W1996361420C121332964 @default.
• W1996361420 hasConceptScore W1996361420C141071460 @default.
• W1996361420 hasConceptScore W1996361420C142724271 @default.
• W1996361420 hasConceptScore W1996361420C168563851 @default.
• W1996361420 hasConceptScore W1996361420C204787440 @default.
• W1996361420 hasConceptScore W1996361420C2777106319 @default.
• W1996361420 hasConceptScore W1996361420C2778334786 @default.
• W1996361420 hasConceptScore W1996361420C2780385302 @default.
• W1996361420 hasConceptScore W1996361420C2992435398 @default.
• W1996361420 hasConceptScore W1996361420C44870925 @default.
• W1996361420 hasConceptScore W1996361420C71924100 @default.
• W1996361420 hasIssue "6" @default.
• W1996361420 hasLocation W19963614201 @default.
• W1996361420 hasLocation W19963614202 @default.
• W1996361420 hasLocation W19963614203 @default.
• W1996361420 hasLocation W19963614204 @default.
• W1996361420 hasOpenAccess W1996361420 @default.
• W1996361420 hasPrimaryLocation W19963614201 @default.
• W1996361420 hasRelatedWork W1586374228 @default.
• W1996361420 hasRelatedWork W2003938723 @default.
• W1996361420 hasRelatedWork W2009610549 @default.
• W1996361420 hasRelatedWork W2047967234 @default.
• W1996361420 hasRelatedWork W2118496982 @default.

• next