WIC Transition to SMART IRB

Version Date: July 2017

This FAQ addresses the transition from WIC to SMART IRB, which will be effective August 1, 2017. If you have additional questions about this transition, please contact the HS IRBs Reliance Team (irbreliance@wisc.edu) for assistance.

When will WIC transition to SMART IRB?

The effective date for the transition is August 1, 2017. Any WIC requests under review at that time or received in early August will be processed under the WIC agreement and procedures. Studies currently approved under the WIC agreement will NOT be affected.

Why is WIC transitioning to SMART IRB?

Each WIC institution has signed on to the SMART IRB agreement, along with over 230 other institutions across the United States. The WIC institutions have agreed that transitioning to the SMART IRB agreement now would ensure the IRB reliance process continues to go as smoothly as possible for researchers and IRBs alike. While the WIC agreement and process were critical to development of IRB reliance arrangements in the state and across the country, the time has come to retire WIC as a separate process.

Will the former WIC institutions continue to allow IRB reliance among each other?

Absolutely. All four participants in WIC remain committed to streamlining the IRB review process for researchers conducting studies at multiple sites. This will now be accomplished through the SMART IRB agreement and procedures rather than through WIC.

What else does this mean for researchers?

Researchers should experience little to no disruption resulting from this transition. The main impacts are:

  • For studies already approved under the WIC agreement, no changes will be needed, including to any consent and authorization documents.
  • For new studies involving former WIC sites after August 1st, the WIC process will no longer be in place and researchers will instead follow the same processes used for any study team seeking to cede review to another IRB or ask UW-Madison to serve as IRB of record. Information on both of those processes can be found on the Single IRB Basics page of the HS IRBs website.

Do I need to submit an application in ARROW if a former WIC institution will serve as my IRB of record?

Yes. This is the biggest change for researchers at UW-Madison since ceding review to another WIC IRB previously did not require an application in ARROW. An application to request ceding review to another IRB will now be required for these studies. This change is being made to allow the university to better track the studies being conducted here and to be consistent with how ceded review are being handled for SMART IRB and other agreements. The ceded review application is very short.

What will happen to the WIC request form and consent/authorization templates? Do these still need to be used?

No. All WIC documents will be retired as of August 1st, including the request form, protocol template, and consent and authorization template. While a protocol and consent and authorization form may still be required depending on the nature of the study, WIC-specific versions of these documents will no longer be required. This should simplify the document development process for study teams, particularly for studies involving sites outside of WIC.

What consent template should study teams use for studies enrolling subjects at multiple sites that were part of WIC?

Studies enrolling subjects at multiple sites should generally use the consent and authorization template for the institution that will be serving as IRB of record for that study. The template will generally need to be customized for each enrolling site to include institutionally required language (e.g., compensation for injury, information on who to contact, etc.). If you have questions about which consent and/or authorization template is appropriate for your study, please contact the Reliance Team (irbreliance@wisc.edu).

Keywords:WIC, SMART IRB, multisite   Doc ID:74689
Owner:Monica E.Group:Health Sciences IRBs
Created:2017-07-20 10:26 CSTUpdated:2017-07-21 08:27 CST
Sites:Health Sciences IRBs
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