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Interim Guidelines for Use of Commercial IRBs Participating in SMART IRB

The HS IRBs are seeing an increasing number of requests from researchers to use commercial IRBs with which the UW does not yet have a contract and/or for studies that are not industry-sponsored. Although the UW is in the process of establishing contracts with a range of commercial IRBs, these arrangements will take some time to finalized. Consistent with its support for researchers to take advantage of single IRB review models, however, the HS IRBs will allow expanded use of commercial IRBs in limited situations. These interim guidelines will be in place until contractual arrangements between the UW and additional commercial IRBs are complete and revised criteria for use of these IRBs are finalized.

During this interim period, studies that are NOT industry-sponsored and for which the UW is NOT the lead site or coordinating center may be reviewed by a commercial IRB if ALL of the following criteria are met:

  1. The study is federally funded or is funded by a private, non-profit entity such as a foundation or professional association;
  2. Use of a specific commercial IRB is mandated by the sponsor and the UW may not participate as a study site unless IRB review is provided by the specified commercial IRB;
  3. The commercial IRB participates in the SMART IRB agreement;
  4. The commercial IRB agrees to use the SMART IRB agreement and SOPs to allow the commercial IRB to serve as IRB of record for the UW for a specific study; and
  5. The UW study team and/or its department agrees to being held solely responsible for any IRB fees charged by the commercial IRB for participation in the study.

These interim guidelines do NOT apply to any industry-sponsored studies and, as with all requests to rely on a non-UW IRB, the UW reserves the right to decline to cede IRB review in accordance with UW policies and procedures. If you have any questions about these guidelines, please contact the Reliance Team (irbreliance@wisc.edu).



Keywords:reliance, SMART IRB, commericial   Doc ID:73489
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2017-05-23 16:26 CSTUpdated:2017-05-24 10:57 CST
Sites:Health Sciences IRBs
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