Appendix B: sIRB Review Requirements

Certain criteria must be met for UW-Madison to serve as the reviewing IRB (sIRB) or to cede IRB review to an external IRB. If your study does not meet the criteria below, RELIANT will assist you in determining whether sIRB review is the best option for your study and, if so, which IRB can provide oversight. (See also the Unusual Cases section.)

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Appendix C: IRB Liaison Job Description

Working Position Title: IRB Liaison

Estimated Full Time Equivalent (FTE): Depends upon the complexity of the study and the number of sites. It is estimated that most studies with 10 or more sites will require 1.0 FTE dedicated to this role. Smaller studies may be able to combine this role with another role such as general study coordination.

Summary of job duties:

The IRB Liaison will work directly with the overall study/lead UW PI as part of the lead site team in order to facilitate and coordinate IRB review and other compliance requirements across all participating
sites of a multi-site clinical trial. The IRB Liaison will serve as a central hub for communication among sites as well as between the sites, the IRB and other compliance offices. This liaison will serve as the primary point of contact between the reviewing IRB and the overall study.

Primary duties may include:

• Understand and communicate the policies and processes of the reviewing IRB, and be familiar with the research and the sites
• Work with the sites and their research compliance or IRB offices to establish reliance agreements with the reviewing IRB
• Coordinate the timing of initial review and modifications across all sites
• Assist the participating sites with completing and submitting materials to the reviewing IRB, which may include preparing and submitting all materials on their behalf
• Facilitate the continuing IRB review for the entire study by collecting information from all sites and submitting it to the reviewing IRB
• Serve as an intermediary between the reviewing IRB and the participating sites
• Obtain local context considerations (e.g., a state’s age of majority) for each site and ensure that the information is provided to the reviewing IRB
• Assist the participating sites with responding to IRB requests
• Plan IRB and other regulatory approval timelines and troubleshoot challenging situations
• Coordinate the payment of IRB fees by the lead site
• May require travel in order to accomplish job duties, e.g., when assisting a participating site in responding to an inspection request from the reviewing IRB

Qualifications:

Because this is a crucial role that requires a complex set of skills, the most qualified individuals will have significant regulatory experience related to multi-site studies and/or clinical trials. This person needs a strong knowledge of the regulatory requirements for single IRB review and must be able to nimbly respond to changes in the implementation of this new policy across many different institutions. They also need to have enough scientific and regulatory background to understand the study and anticipate other regulatory and institutional requirements that may apply at each site and affect the IRB process (e.g., Radiation Safety review, Institutional Biosafety Committee review, etc.). The IRB liaison will need to establish relationships and maintain close communications with a wide variety of people and offices quickly. Outstanding demonstrated ability to communicate quickly and effectively with a wide range of stakeholders is strongly recommended.

Suggested Additional Qualifications:

• Specific education or training in biomedical regulatory affairs
• Project management experience or certification for grant applications

Grant Budget Justification Example:

TBN, Research Study Coordinator/IRB Liaison
Effort = 12.0 months calendar (100% FTE) in Years 1-5 [adjust FTE & years to match the study]
A Research Study Coordinator will be hired to serve as the IRB Liaison for all participating sites in order to facilitate the complex and time-sensitive communications among sites, and between the participating sites and the single IRB (sIRB). Under the direction of the Lead PI, the IRB Liaison will facilitate and coordinate IRB approval and related regulatory compliance activities for all participating sites. This includes serving as an intermediary between the sIRB and the sites in order to: (1) establish reliance agreements; (2) facilitate timely initial review, modifications, and continuing review; and (3) establish and maintain communication plans among all stakeholders to ensure consistency among IRB-approved consent forms, other materials, and procedures among all sites.

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Appendix D: Unusual Circumstances, Serving and Ceding

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

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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.

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