Literature DB >> 32976069

Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Alexandra Murray1, Ekaterina Pivovarova1, Robert Klitzman2, Deborah F Stiles3, Paul Appelbaum4, Charles W Lidz5.   

Abstract

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.

Entities:  

Keywords:  Electronic IRB systems (eIRB); institutional review boards (IRB); interoperability; research ethics; single IRB (sIRB)

Mesh:

Year:  2020        PMID: 32976069      PMCID: PMC9035281          DOI: 10.1080/23294515.2020.1818877

Source DB:  PubMed          Journal:  AJOB Empir Bioeth        ISSN: 2329-4515


  11 in total

1.  Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment.

Authors:  Fran Turisco; Diane Keogh; Connie Stubbs; John Glaser; William F Crowley
Journal:  J Investig Med       Date:  2005-12       Impact factor: 2.895

Review 2.  Computerized information management for institutional review boards.

Authors:  Maureen N Hood; Brian Gugerty; Richard Levine; Vincent B Ho
Journal:  Comput Inform Nurs       Date:  2005 Jul-Aug       Impact factor: 1.985

Review 3.  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

4.  A Measure of Effectiveness Is Key to the Success of sIRB Policy.

Authors:  Holly A Taylor; Ann Margret Ervin
Journal:  Am J Bioeth       Date:  2017-07       Impact factor: 11.229

5.  How closely do institutional review boards follow the common rule?

Authors:  Charles W Lidz; Paul S Appelbaum; Robert Arnold; Philip Candilis; William Gardner; Suzanne Myers; Lorna Simon
Journal:  Acad Med       Date:  2012-07       Impact factor: 6.893

6.  NIH Policy on Single-IRB Review - A New Era in Multicenter Studies.

Authors:  Ann-Margret Ervin; Holly A Taylor; Stephan Ehrhardt
Journal:  N Engl J Med       Date:  2016-12-15       Impact factor: 91.245

7.  A domain analysis model for eIRB systems: addressing the weak link in clinical research informatics.

Authors:  Shan He; Scott P Narus; Julio C Facelli; Lee Min Lau; Jefferey R Botkin; John F Hurdle
Journal:  J Biomed Inform       Date:  2014-06-11       Impact factor: 6.317

8.  The silent majority: who speaks at IRB meetings?

Authors:  Philip J Candilis; Charles W Lidz; Paul S Appelbaum; Robert M Arnold; William Gardner; Suzanne Myers; Albert J Grudzinskas; Lorna J Simon
Journal:  IRB       Date:  2012 Jul-Aug

9.  CLARA: an integrated clinical research administration system.

Authors:  Jiang Bian; Mengjun Xie; William Hogan; Laura Hutchins; Umit Topaloglu; Cheryl Lane; Jennifer Holland; Thomas Wells
Journal:  J Am Med Inform Assoc       Date:  2014-04-28       Impact factor: 4.497

Review 10.  Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.

Authors:  Charles W Lidz; Ekaterina Pivovarova; Paul Appelbaum; Deborah F Stiles; Alexandra Murray; Robert L Klitzman
Journal:  AJOB Empir Bioeth       Date:  2018-10-04
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  2 in total

1.  Pediatric specific challenges of the single institutional review board mandate.

Authors:  Andrew Hu; Jane L Holl; Mehul V Raval
Journal:  Trials       Date:  2022-03-21       Impact factor: 2.279

2.  Using single IRB consultations to meet the educational needs of investigative teams.

Authors:  Ann R Johnson; Mary Pautler; Jeri S Burr; Nael Abdelsamad; John M VanBuren; Lisa M Rigtrup; J Michael Dean; Erin Rothwell
Journal:  Contemp Clin Trials Commun       Date:  2022-08-11
  2 in total

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