Unusual Circumstances: Serving

It may be appropriate for UW-Madison (when engaged) to serve as the reviewing IRB for circumstances not described in the sIRB decision tree or Appendix B of this manual. Examples and considerations include:

  • Community partners: Regardless of whether a study is funded, it may be appropriate for UW-Madison to serve as the reviewing IRB for community organizations or individuals.Considerations include:
    • Type of research activities that will be performed
    • Qualifications of the community partner to conduct human subjects research (i.e., resources and any necessary study/role specific tasks)
    • Location of study sites (e.g., outside of Wisconsin)
    • Ability to meet UW-Madison training and conflict of interest requirements
  • SBIR/STTR funded studies: It may be appropriate for the UW-Madison to serve as the reviewing IRB for studies funded via SBIR/STTR grants.Considerations include:
    • Role of the external entity in the study
    • Qualifications of external personnel to conduct human subjects research
    • Time-frame for obtaining IRB approval
    • Appropriate mechanism for conflict of interest review as well as human subjects research training
  • Sites with an IRB but without AAHRPP accreditation or a robust HRPP: It may be appropriate for the UW-Madison to serve as the reviewing IRB for sites that are not accredited and do not have a robust HRPP in limited circumstances.Considerations include:
    • Role of the external entity in the study
    • Overall study is minimal risk
    • Qualifications of external personnel to conduct human subjects research
    • Appropriate mechanism for conflict of interest review as well as human subjects research training
    • Staff at the site who provide dedicated support to their IRB and are knowledgeable about single IRB arrangements. Staff also must be responsive to queries from the UW-Madison HRPP

Unusual Circumstances: Ceding

It may be appropriate for the UW-Madison to cede IRB review for circumstances not described in the sIRB decision tree or Appendix B of this manual. Examples and considerations include:

  • Sites with an IRB but without AAHRPP accreditation or a robust HRPP: It may be appropriate for the UW-Madison to cede review to IRBs that are not accredited and do not have a robust HRPP in limited circumstances.Considerations include:
    • Role of UW-Madison in the study
    • Overall study is minimal risk
    • The site holds a federal-wide assurance (FWA)
    • The site has policies that address how IRB review is conducted, including those that are most applicable to the study (e.g., enrollment of children or other vulnerable populations)
    • The IRB has appropriate expertise and qualifications to review the study
    • Staff at the site who provide dedicated support to their IRB and are knowledgeable about single IRB arrangements. Staff also must be responsive to queries from the UW-Madison HRPP.