This section of the Reliance Manual provides information on other reliance considerations including guidance for conducting research with UW-Madison’s various partners and joint ventures. The status, scope, and reliance process for each of these partnerships differ. Please review any sections of interest and contact RELIANT (irbreliance@wisc.edu) with any questions.
UWHC Partners/Affiliates
UW-Madison has agreements in place to serve as IRB of record for the following entities, therefore no additional agreements need to be in place for UW-Madison IRBs to serve as IRB of record for studies involving personnel from these entities:
- University Hospital and Clinics
- University of Wisconsin Medical Foundation
- Morgridge Institute for Research
In addition, research conducted at the following Joint Ventures (JV) with UnityPoint Health – Meriter do not need additional agreements to be in place (personnel at these JVs are UW, UWHC, or UWMF employees and the records are held be UW Health):
- Madison Surgery Center at 1 S. Park
- Generations Fertility Clinic
- Transformations Surgery Center
- Wisconsin Sleep Clinic and Laboratory
Please contact RELIANT (irbreliance@wisc.edu) for additional information.
UnityPointHealth – Meriter
For studies involving UnityPointHealth – Meriter, please review the Meriter Submission Guidance page. If you have any questions about the submission guidance, reach out to RELIANT.
UW Health in Northern Illinois (formerly SwedishAmerican)
While UW Health has a partnership agreement with SwedishAmerican, this agreement does not encompass human research and SwedishAmerican still has its own IRB. If you are interested in conducting research at SwedishAmerican (including using or accessing medical records), please contact RELIANT (irbreliance@wisc.edu) for help.
VA Research Requirements
While the UW-Madison HS IRB is the affiliate IRB for the Madison VA, UW Madison does not have the authority to cede IRB review of VA Research to another IRB. In addition, the UW-Madison IRB cannot serve as the reviewing IRB for external sites involved with a VA study, and no VA sites can be added to a non-VA study. Please contact the Madison VA Research Office first for assistance in determining whether single IRB review can be used for your VA Research.
Sending or Receiving Specimens
When UW-Madison sends, the first step is to determine if the receiving institution is engaged in human research. The study team receiving specimens from UW-Madison will need to consult with their own IRB regarding an engagement determination. If the IRB at the recipient site determines that it is engaged in human research, then a reliance agreement may be appropriate if the study falls within the parameters for when UW-Madison will cede or serve (See Appendix A and B).
For UW-Madison study teams receiving specimens from other sites, similar assessments will need to be made to determine whether UW-Madison is engaged in human research and, if so, what kind application is needed, including whether IRB review can be ceded to another institution.
For more information on sending or receiving specimens, see HRP-103-Investigator Manual.
Data Transfer and Material Use Agreements
Study teams are responsible for ensuring required agreements for data or biospecimen transfer (e.g., data use agreements, material transfer agreements) are in place prior to the UW-Madison receiving or transferring data or biospecimens. Data Transfer and Material Use Agreements (DTUA and MTA) are separate from IRB review. The need for a DTUA and/or MTA is not affected by using a single IRB; these are institutional requirements that apply regardless of reviewing IRB. For more information, see HRP-103-Investigator Manual and HRP-309-WORKSHEET-Ancillary Review Matrix. Also see the Guidance on External Sharing of Human Subjects Research Data page or Guidance on Receiving Human Subjects Research Data from an External Entity.