Table of Contents

  1. Scope
    1. Purpose
    2. Reliance and Navigation Team (RELIANT)
  2. UW-Madison as Reviewing IRB or Single IRB
    1. Single IRB Review
      1. Single IRB Review Requirements
      2. Single IRB Plan Template
      3. Using the Single IRB Application
    2. Selecting the Best Reviewing IRB Option
      1. Factors to Consider
      2. Engagement Determination
      3. Exemptions & International Research
      4. Community-Based Research Requirements
      5. When UW-Madison Will Review for External Sites
      6. When UW-Madison Will Review for External Individuals
      7. UW-Madison Serving as HIPAA Privacy Board
      8. Fees and Budget Considerations
    3. How Tos When UW is Reviewing IRB
      1. Write a Protocol or Application for Studies Involving External Sites
      2. Write a Protocol or IRB Application for Studies Involving External Individuals
      3. Write a Consent Template
      4. Prepare and Submit Site-Specific Documents
      5. How and When to Submit Requests for UW-Madison to Serve as the Reviewing IRB for Other Sites
      6. Submit a Request for UW-Madison to Review for External Individuals
    4. How You Can Help with the Reliance Process
      1. Choosing Collaborating Sites
      2. After You Select Your Sites
      3. After the Study is Approved
    5. Reliance Agreements
      1. Types of Reliance Agreements
      2. Reliance Agreement Process
      3. Approval Process for Reviewing IRB Requests
      4. Single IRB Review Platforms
    6. Follow-On Submissions
      1. Follow-On Submissions for UW-Madison and/or the Study-wide Protocol
      2. Follow-On Submissions for Relying Sites
    7. Investigator Responsibilities
      1. UW-Madison PI & Study Team Responsibilities
      2. Relying Site Investigator Responsibilities
      3. Letters of Cooperation
      4. Lines of Communication
      5. Training Requirements
  3. UW-Madison Relying or Ceding IRB Review
    1. When UW-Madison Will Rely on an External IRB
      1. Criteria for Relying on External IRB
      2. Engagement
      3. Exemptions
      4. International Ethics Boards
    2. Additional Cede Considerations
      1. Types of External IRBs
      2. HIPAA Privacy Board Considerations
      3. Fee and Budget Considerations
      4. Institutional Requirements
    3. How Tos for Relying or Ceding IRB Review
      1. Prepare Study Protocol and Site Supplement
      2. Write UW-Madison Consent Documents
      3. Write UW-Madison Authorization Documents
    4. Cede Agreements
      1. Overview of Agreement Process
      2. How and When to Submit a Request to Cede IRB Review
    5. How You Can Help with the Cede Process
    6. Follow-On Submissions for Cede Applications
      1. To Reviewing IRB
      2. To UW-Madison
    7. PI Responsibilities
      1. Principal Investigator Responsibilities & Requirements
      2. Lines of Communication
  4. Other Reliance Considerations
    1. UWHC Partners/Affiliates
    2. UPH-Meriter
    3. Swedish American
    4. VA Requirements
    5. Sending or Receiving Specimens
    6. Data Transfer and Material Use Agreements
  5. Appendices
    1. Appendix A: Q&A When UW will Cede or Serve
    2. Appendix B: sIRB Review Requirements
    3. Appendix C: IRB Liaison Job Description
    4. Appendix D: Unusual Circumstances, Serving and Ceding