Literature DB >> 28412874

Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.

Pankaja Desai1, Priyanka Nasa2, Jackie Soo2, Cunhui Jia2, Michael L Berbaum2, James H Fischer2, Timothy P Johnson2.   

Abstract

We evaluated how regulatory support services provided by University of Illinois at Chicago's Center for Clinical and Translational Science may reduce Institutional Review Board (IRB) turnaround times. IRB applications were categorized by receipt of any regulatory support and amount of support received. Turnaround time included total turnaround time, time for IRB review, and time for investigators to modify protocols. There were no differences in any turnaround times for supported versus nonsupported applications. However, for supported applications, those receiving more intensive support had total turnaround times 16.0 days ( SE 7.62, p < .05) faster than those receiving less intensive support. Receiving higher regulatory support may be associated with faster approval of IRB submissions.

Entities:  

Keywords:  CTSA evaluation; Institutional Review Boards; clinical research; evaluation research; translational research

Mesh:

Year:  2017        PMID: 28412874      PMCID: PMC5546085          DOI: 10.1177/1556264617704294

Source DB:  PubMed          Journal:  J Empir Res Hum Res Ethics        ISSN: 1556-2646            Impact factor:   1.742


  12 in total

Review 1.  A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.

Authors:  Sarah M Greene; Ann M Geiger
Journal:  J Clin Epidemiol       Date:  2006-03-15       Impact factor: 6.437

2.  Medical education research and IRB review: an analysis and comparison of the IRB review process at six institutions.

Authors:  Liselotte N Dyrbye; Matthew R Thomas; Alex J Mechaber; Anne Eacker; William Harper; F Stanford Massie; David V Power; Tait D Shanafelt
Journal:  Acad Med       Date:  2007-07       Impact factor: 6.893

Review 3.  The impact of escalating regulatory requirements on the conduct of clinical research.

Authors:  B G Gordon; A Kessinger; S L Mann; E D Prentice
Journal:  Cytotherapy       Date:  2003       Impact factor: 5.414

4.  Evaluating translational research: a process marker model.

Authors:  William Trochim; Cathleen Kane; Mark J Graham; Harold A Pincus
Journal:  Clin Transl Sci       Date:  2011-06       Impact factor: 4.689

Review 5.  Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature.

Authors:  Devon K Check; Kevin P Weinfurt; Carrie B Dombeck; Judith M Kramer; Kathryn E Flynn
Journal:  Clin Trials       Date:  2013-05-10       Impact factor: 2.486

Review 6.  Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.

Authors:  George Silberman; Katherine L Kahn
Journal:  Milbank Q       Date:  2011-12       Impact factor: 4.911

Review 7.  A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn.

Authors:  Lura Abbott; Christine Grady
Journal:  J Empir Res Hum Res Ethics       Date:  2011-03       Impact factor: 1.742

8.  Time required for institutional review board review at one Veterans Affairs medical center.

Authors:  Daniel E Hall; Barbara H Hanusa; Roslyn A Stone; Bruce S Ling; Robert M Arnold
Journal:  JAMA Surg       Date:  2015-02       Impact factor: 14.766

9.  Latent variable modeling and its implications for institutional review board review: variables that delay the reviewing process.

Authors:  Dong-Sheng Tzeng; Yi-Chang Wu; Jane-Yi Hsu
Journal:  BMC Med Ethics       Date:  2015-08-27       Impact factor: 2.652

10.  Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.

Authors:  Mary Dixon-Woods; Chris Foy; Charlotte Hayden; Rustam Al-Shahi Salman; Stephen Tebbutt; Sara Schroter
Journal:  BMJ Open       Date:  2016-08-31       Impact factor: 2.692

View more
  5 in total

1.  Operational Characteristics of Institutional Review Boards (IRBs) in the United States.

Authors:  Genevieve L Nesom; Iraklis Petrof; Tyler M Moore
Journal:  AJOB Empir Bioeth       Date:  2019-10-16

2.  Evaluating IACUCs: Previous Research and Future Directions.

Authors:  Madeline L Budda; Stacy L Pritt
Journal:  J Am Assoc Lab Anim Sci       Date:  2020-09-14       Impact factor: 1.232

3.  The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.

Authors:  Ryan Spellecy; Ann Marie Eve; Emily R Connors; Reza Shaker; David C Clark
Journal:  J Empir Res Hum Res Ethics       Date:  2018-06-14       Impact factor: 1.742

4.  A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months.

Authors:  Zainab Abedin; Alan Teller; Brenda Ruotolo; Kawthar Muhammad; Deborah F Stiles; Rui Ferreira; Nancy Green
Journal:  Int J Acad Med       Date:  2020-06-29

5.  A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.

Authors:  Holly A Taylor; Kimberley Serpico; Holly Fernandez Lynch; John Baumann; Emily E Anderson
Journal:  J Clin Transl Sci       Date:  2021-09-13
  5 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.