Skip to main content Accessibility help
×
Home

The SMART IRB platform: A national resource for IRB review for multisite studies

  • Nichelle Cobb (a1), Elizabeth Witte (a2), Maria Cervone (a2), Aaron Kirby (a2), Douglas MacFadden (a2), Lee Nadler (a2) (a3) and Barbara E. Bierer (a2) (a4)...

Abstract

Single institutional review board (IRB) review of multisite research increased in frequency over a decade ago with a proliferation of master IRB reliance agreements supporting statewide and regional consortia and disease- and population-specific networks. Although successful, the increasing number of agreements presented significant challenges and illuminated potential benefits of a single, nationwide agreement. Anticipated changes in federal regulations highlighted the need to systematize and simplify IRB reliance. To address these challenges, the NIH National Center for Advancing Translational Sciences funded a project to establish a national IRB reliance network that would support national adoption of single IRB (sIRB) review. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform launched in July 2016 to facilitate dissemination, adoption, and implementation of a collaboratively developed master IRB reliance agreement and supportive tools and resources. More than 580 institutions have joined SMART IRB’s Master Common Reciprocal Institutional Review Board Authorization Agreement and begun using the SMART IRB platform to support sIRB arrangements. Here, we describe the tenets of the agreement and operational benefits and challenges of its use. SMART IRB’s early success affirms the utility of collaborative, flexible, and centralized approaches to supporting sIRB review while highlighting the need for further national harmonization.

  • View HTML
    • Send article to Kindle

      To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

      Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

      Find out more about the Kindle Personal Document Service.

      The SMART IRB platform: A national resource for IRB review for multisite studies
      Available formats
      ×

      Send article to Dropbox

      To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

      The SMART IRB platform: A national resource for IRB review for multisite studies
      Available formats
      ×

      Send article to Google Drive

      To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

      The SMART IRB platform: A national resource for IRB review for multisite studies
      Available formats
      ×

Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

Address for correspondence: B. E. Bierer, MD, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115, USA. Email: bbierer@bwh.harvard.edu

References

Hide All
1. Menikoff, J. The paradoxical problem with multiple IRB review. New England Journal of Medicine 2010; 363: 15911593.
2. Silberman, G, Kahn, K. Burdens on research imposed by Institutional Review Boards: the state of the evidence and its implication for regulatory reform. Milbank Quarterly 2011; 89(4): 599627.
3. Winkler, SJ, et al. The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight. Clinical and Translational Science 2015; 8(1): 5766. doi: 10.1111/cts.12202.
4. Cola, PA, Reider, C, Strasser, JE. Ohio CTSAs implement a reliant IRB model for investigator-initiated multicenter clinical trials. Clinical and Translational Science 2013; 6(3): 176178. doi: 10.1111/cts.12074.
5. National Institutes of Health National Center for Advancing Translational Sciences (NCATS). IRB reliance: A new model for accelerating translational science [Internet]. 2014. Retrieved from https://ncats.nih.gov/pubs/features/irb-reliance. Accessed October 1, 2018.
6. National Institutes of Health National Center for Advancing Translational Sciences (NCATS). CTSA program hubs [Internet]. 2018. Retrieved from https://ncats.nih.gov/ctsa/about/hubs. Accessed October 18, 2018.
7. National Institutes of Health National Center for Advancing Translational Sciences (NCATS). NCATS SMART IRB platform [Internet]. 2016. Retrieved from https://ncats.nih.gov/ctsa/projects/smartirb. Accessed October 18, 2018.
8. National Institutes of Health. Final NIH policy on the use of a single institutional review board for multi-site research. NOT-OD-16-094. 2018. Retrieved from https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html. Accessed October 18, 2018.
9. Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB). Master Common Reciprocal Institutional Review Board Authorization Agreement [Internet]. 2016. Retrieved from https://smartirb.org/agreement/. Accessed October 18, 2018.
10. Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB). SMART IRB agreement implementation checklist and documentation tool [Internet]. 2018. Retrieved from https://smartirb.org/sites/default/files/SMART_IRB_Agreement_Implementation_Checklist_FORM.pdf. Accessed October 18, 2018.
11. Health and Human Services Office for Human Research Protections. OHRP QA self assessment tool [Internet]. 2018. Retrieved from https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals/ohrp-self-assessment-tool/index.html. Accessed October 18, 2018.
12. Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB). SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement Standard Operating Procedures [Internet]. 2016. Retrieved from https://smartirb.org/sites/default/files/SMART_IRB_SOP-090816.pdf. Accessed October 18, 2018.
13. Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB). Inserting “Local Context” language in informed consent documents [Internet]. 2017. Retrieved from https://smartirb.org/sites/default/files/Local_Context_Language_Guidelines.pdf. Accessed October 18, 2018.

Keywords

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 0
Total number of PDF views: 0 *
Loading metrics...

Abstract views

Total abstract views: 0 *
Loading metrics...

* Views captured on Cambridge Core between <date>. This data will be updated every 24 hours.

Usage data cannot currently be displayed