Principal Investigator (PI) Status Policy and Request Form

Health Sciences IRBs Principal Investigator (PI) Signature Policy

Forms

• Submission Cover Sheet for Initial and Ongoing Studies
• Initial Review Applications (for submission of new protocols to the IRB)
• Initial Application for Full Review
  • Elements of a Protocol Guidance
  • Potential Conflict of Interest Form (required for all Applications for Initial Review by Full IRB)
  • Request for UW-Madison to Defer IRB Oversight
  • Request for UW-Madison to Serve as IRB of Record
• Initial Review Application for Non-Exempt Medical Records Research
• Exemption Application
• Humanitarian Use Device (HUD) Application
• Emergency or One-Time Use Application
• Protocol Development Activities (PDA)
• Continuing Review Protocol Progress Report (for the reapproval of protocols)
  
• Change of Protocol (for revisions to IRB-approved materials)
  • Full Review Change of Protocol
  • Expedited Change of Protocol
  • Investigator Drug Brochure (IDB) Change of Protocol
• Adverse Event Reporting
• Unanticipated Problems/Incident Reporting
• NCI Central IRB Forms
• Noncompliance Reporting Form
• Protocol Closure Report
• Request to Re-Open Form
• Other Forms
  • HIPAA: Preparatory to Research Activities
  • HIPAA: Data Use Agreement
  • Tissue Collection Form
  • Clinical and Translational Research Core (CTRC)
  • VA Research Policies & Forms

Initial Review Application

Several applications have been developed to meet the various needs of researchers. Please call the IRB Office at 608-263-2362 if you have questions about the best application for your project.

Continuing Review

Federal regulations require that ongoing research must be reviewed by the IRB at least once a year, except in the case of exempt research. Most protocols are approved for a period of one year, although an IRB may require a shorter review period. The IRB Office recommends the submission of a Continuing Review Protocol Progress Report at least 2 IRB meetings before the study is due to expire to allow enough time to resolve any questions that may arise during the review process. The IRB Office will determine whether a progress report can be reviewed under expedited procedures.

When a research project is complete, a Protocol Closure Report should be submitted to the IRB Office. If you have questions about whether you should close a protocol, link to the guidance below. If you close a study and need to re-open it within a short period of time after the closure, submit a “Request to Re-Open a Closed Study” form.

Change of Protocol

All changes of protocol, except those needed to eliminate an apparent immediate hazard to subjects, require prior IRB approval before they can be implemented. A change in protocol can be submitted to the IRB by using the appropriate change of protocol form available below.

Adverse Events, Unanticipated Problems, and Other Incident Reporting

Click here for forms and guidance.

National Cancer Institute (NCI) Central IRB Approved Protocol

The University of Wisconsin-Madison has agreed to defer IRB review of some protocols to the National Cancer Institute Central IRB (CIRB). Currently, this agreement is in place only protocols approved by the NCI CIRB involving adults. Further information about this process is included below. Please note that even when the UW has deferred IRB review to the NCI CIRB, local adverse events, noncompliance, and unanticipated problems that occur on these protocols must still be reported to the Health Sciences IRB using the UW-Madison forms.

Other Forms

Tissue Collection Form

• Guidelines for Genetic Research and Use of Storable Tissues

HIPAA Forms and Guidance

• Data Use Agreement
• Certification for Activities Preparatory to Research Application
• Planning a Project: Preparatory to Research Activities Guidance

Clinical and Translational Research Core (CTRC) Forms