Human Research Policies
The HRPP maintains the human subjects research protection policies utilized by all UW-Madison Institutional Review Boards (IRBs) and campus officials. These policies are reviewed by the Cross-Campus HRPP Committee and approved by the Institutional Official. Additionally, researchers and study teams should review the documentation specific to the IRB office they are working with.
HRPP policies and Health Sciences IRB policies are found below. All links to the policies on this page now take you directly to those policies in the UW–Madison Policy Library at policy.wisc.edu. The policy library brings all university-wide policies together in one place so you can quickly locate the most accurate, up-to-date version of a policy. Visit the Policy Library to search for a specific policy by topic or key word(s).
Additional guidance and resources can be found here: HRPP Guidance, Forms, and Resources page, Health Sciences IRBs Policy and Guidance, and Education and Social/Behavioral Sciences IRB Guidance .
HRPP and IRB Operations
- Application of Federalwide Assurance (FWA) Terms to UW-Madison Human Participants Research Policy
- Compliance with Human Research Protections in Sponsored Research
- Creation and Dissemination of Policies and Related Documentation
- Cross-Campus Human Research Protection Program (HRPP) Committee Charter
- HRPP and IRB Resources
- Institutional Official in Charge of HRPP
- IRB Authority and Independence
- IRB Composition and Quality Performance
- IRB Consultants Use and Conflict of Interest
- IRB Meeting Minutes and Regulatory Documentation
- IRB Meetings
- IRB Members’ Conflicts of Interest
- IRB Purview
- IRB Reliance
- Maintenance of IRB Records
- Retention of IRB Records
- Scientific, Scholarly, and Other Expertise Review Policy
- Single Institutional Review Board (IRB) for Multi-Site Federal Grants Policy
IRB Submissions and Reviews
- Changes in Research Activities: Submission and Review
- Continuing Review: Submission and Review
- Exempt Research Policy
- Initial Review: Submission and Review Policy
- IRB Review of Study Resources
- Review of Data and Safety Monitoring in Research
- Review of FDA-Regulated Research Policy
- Review of Research Involving Vulnerable Participants
- VA Research: Health Sciences IRBs Policy for IRB Review of Human Subjects Research that Falls Under VA Purview
Monitoring, Quality Assurance, and Reporting
Study Conduct Considerations
- Control of Test Articles Used in Research Policy
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- Exceptions to Informed Consent Requirements in Emergency Situations
- Humanitarian Use Device Policy
- Noncompliance
- Obtaining and Documenting Informed Consent
- Protecting Research Participants Privacy Interests and Confidentiality of Data
- Research with Adult Participants Lacking Capacity to Consent
- Study Closure
- Suspension and Termination of Approved Research
- Unanticipated Problems
- Use of Human Fetal Tissue in Research