When the institution agrees to serve as the reviewing IRB for external sites or personnel, the UW-Madison study team must follow relevant UW-Madison requirements and assume several responsibilities, including, but not limited to:
- Contacting RELIANT (irbreliance@wisc.edu) to:
- Discuss whether UW-Madison can act as the single IRB for all or some institutions or personnel participating in this study or whether another external IRB would be appropriate.
- Consultation with RELIANT is required before study teams submit a grant or other funding application when UW-Madison is being proposed as the single IRB. If study teams have not consulted with RELIANT, UW-Madison cannot guarantee it will agree to serve as the single IRB.
- Identify who will act in the role of the Lead Study Team (e.g., your own study team, a coordinating center). Due to the additional responsibilities that a Lead Study Team assumes, an IRB liaison may need to be hired. To review a sample job description language, please see Appendix C: IRB Liaison Job Description.
- Provide RELIANT with details about the study, including the study-wide protocol and template consent document(s), which will help facilitate the discussion of single IRB review options.
- Discuss whether UW-Madison can act as the single IRB for all or some institutions or personnel participating in this study or whether another external IRB would be appropriate.
- Identify all sites that will be engaged in human research.
- If the institution agrees to serve as the sIRB, the UW-Madison study team must:
- Include the relevant reliance request in the IRB application and protocol.
- Work with the IRB and RELIANT to determine specific roles and responsibilities for communicating key information to relying sites, including developing a communication plan (i.e. regular conference calls, site initiation). For template communication plans, see HRP-830-WORKSHEET-Communication and Responsibilities or SMART IRB template communication plan.
- Promptly respond to questions from relying site study teams and IRB/Human Research Protection Program personnel.
- When preparing the UW-Madison IRB application, the UW-Madison study team must:
- Obtain from the relying site study team information regarding how the study will be
conducted at that site if different from the study-wide protocol (e.g., recruitment processes may differ among sites). See HRP-811-FORM-Basic Site Information. This form does not need to be submitted to the IRB; rather it is a tool to assist you in collecting and tracking information for relying sites. - Assist relying site study teams in ensuring consent documents for that site use the approved UW-Madison template and is revised to include applicable site-specific required language for that site.
- Obtain from the relying site study team information regarding how the study will be
- Provide relying sites with links to UW-Madison HRPP policies.
- Provide relying site study teams with the IRB-approved versions of all study documents (e.g., consent and authorization forms, protocol, recruitment materials).
- Notify site investigators of all IRB determinations.
- In coordination with the IRB and RELIANT, promptly notify the relying site study team of any unanticipated problems involving risks to subjects or others or significant subject complaints that may affect subjects at the relying site, including potential impact on willingness to continue study participation.
- If the study requires continuing review, the UW-Madison study team must notify relying site study teams of any lapse in IRB approval and, if applicable, any resulting corrective action plans.
- Promptly notify relying site study teams of any change in the continuing review requirement for the study.
- Provide access, upon request, to study records for audit by relying sites.