Health Sciences Institutional Review Boards

Policies and Guidance

All UW-Madison IRBs follow policies and guidance established by the campus Human Research Protection Program (HRPP). Each IRB also has its own policies and guidance to address specific issues its investigators encounter. This page provides links to some of the most frequently referenced policies and guidance from the HRPP and the Health Sciences IRBs. For a complete list of HRPP policy and guidance documents please use the 'UW-Madison HRPP Policies Index' link below.

UW-Madison Health Sciences IRBs Guidance and Policies

• Adverse Event Reporting Guidelines (for studies with devices)
• Adverse Event Reporting Guidelines (for studies without devices)
• Case Report Guidance
• Changes to Eliminate Immediate Hazards to Subjects Guidance
• Expedited Change Guidance
• FAQs About Pre-Review for Research Teams
• Genetic Research and the Use of Storable Tissues Guidelines
• Gene Transfer Protocols Guidance
• International Research Guidance
• Multisite Research Checklist (Investigator Initiated Studies)
  
• Principal Investigator (PI) Signature Policy
• Protocol Closure Guidance
• Protocol Exceptions and Deviations for Clinical Trials Guidance
• Re-Consenting Subjects Guidance
• Scientific Review Guidance
• Self-Experimentation Guidance
• Summary of Investigator Responsibilities
• Telephone Screening Guidance
• Treatment of Subjects at Other Institutions Policy

UW-Madison Human Research Protection Program Guidance and Policies By Topic

• Step by Step Instructions for Protocol Submission (Guidance and Forms)
• Index of HRPP and IRB Policies and Procedures
• Confidentiality/Privacy
  • Certificates of Confidentiality Guidance
  • Research with Vulnerable Subjects Policy
  • Protecting Privacy & Confidential Data Policy
• Conflict of Interest
  • Investigator Conflict of Interest Policy
• Datasets
  • Existing Datasets Policy
• Exemption
  • Exempt Research Policy
• Human Subjects Training
  • Education and Training Policy
• IRB Review Of Protocols
  • Data Safety & Monitoring Plans Policy
  • Change of Protocol Review by Full IRB Policy
  • Continuing Review by Full IRB Policy
  • Defining Human Subjects Research Policy
  • Expedited Review Policy
  • Five Year Renewal Policy
  • Health Sciences IRBs Exception to Five Year Renewal Policy
  • Initial Review by Full IRB Policy
  • Review of Prisoner Research Policy
  • Scientific & Scholarly Review Policy
• Multisite Research
  • IRB Authorization Agreements Policy
  • Multisite Research Policy
• Subject Selection, Recruitment, Enrollment, & Consent Process
  • Emergency Exceptions to Informed Consent Policy
  • Equitable Selection of Subjects Policy
  • Informed Consent Policy
  • Monitoring Consent Policy
  • Participant Recruitment Policy
  • Research with Adults Lacking Consent Capacity Policy
  • Research with Vulnerable Subjects Policy
• Noncompliance & Unanticipated Problems
  • Noncompliance Policy
  • Suspension & Termination of Research Policy
  • Unanticipated Problems Policy
• Student Research
  • Student Research: Policies & Guidance
• Test Article Research
  • Control of Test Articles Policy
  • Review of Test Articles Research Policy
• Use of Tissue & Specimens
  • Coded Information & Specimens Policy
  • Fetal Tissue Policy
• Wisconsin Law
  • Applying State Law in Human Subjects Research Policy