HRPP Policies, Guidance, and Forms
HRPP Policies
HRPP
Application of Federalwide Assurance (FWA) Terms to UW-Madison Human Participants Research Policy
Cross-Campus Human Research Protection Program (HRPP) Committee Charter
Creation and Dissemination of Policies and Related Documentation
Institutional Officials in Charge of HRPP
HRPP and IRB Resources
Reporting of Suggestions and Concerns Regarding HRPP Performance and Function
Reporting of Suggestions and Concerns Regarding the Protection of Research Participants
Reporting to Institutional and External Authorities
Monitoring and Quality Assurance
Compliance Monitoring and Quality Improvement
Monitoring the Consent Process
IRB Operation and Responsibilities
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
IRB Review of Study Resources
Expert Review
Evaluating the Scientific or Scholarly Merits of Proposed Research
Maintenance of IRB Records
Retention of IRB Records
Review of Data and Safety Monitoring in Research
Education and Training
HRPP Education and Training
Principal Investigator and Personnel Requirements
Principal Investigator Status for UW-Madison Studies Involving Human Participants
Engagement in Human Participants Research at UW-Madison
Conflicts of Interest of Non-UW-Madison Key Personnel
Review Types
Exempt Research (due to delayed implementation of the Revised Common Rule, there are two versions of this policy)
Federally supported, VA-regulated, or FDA-regulated research
Non-federally funded/FDA-regulated/VA-regulated research
Initial Review: Submission and Review Policy
Changes in Research Activities: Submission and Review
Continuing Review: Submission and Review
Noncompliance
Unanticipated Problems
Informed Consent
Obtaining and Documenting Informed Consent
Exceptions to Informed Consent Requirements in Emergency Situations
Confidentiality
Protecting Research Participants Privacy Interests and Confidentiality of Data
Closure or Suspension/Termination
Study Closure
Suspension and Termination of Approved Research
Guidance, Forms, & Federal Regulations
NEW: Upcoming Changes to Human Subjects Regulations
Certificate of Confidentiality (CoC) Guidance
Considerations for Accepting or Ceding IRB Review Guidance
De-Identified Publicly Available Datasets Guidance
Equitable Selection of Research Participants Guidance
IRB Analysis of Risks and Benefits of Research Guidance
List of Approved De-Identified Publicly Available Datasets
NIH Genomic Data Sharing Policy for Human Data Guidance
Recruitment of Research Participants Guidance
Reportable Abuse and Neglect Guidance
Preventing Noncompliance Guidance
Developing an Internal Quality Assurance (QA) Program Guidance
Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans Guidance
Consent Form Wizard
Declaration to Researchers
HIPAA Authorization Wizard
HIPAA Authorization and Consent Form Wizard (Combined)
A Minor’s Right to Consent to Treatment and Authorize Disclosure of PHI
Parent/Guardian Authorization Form Wizard
Power of Attorney for Research
Request for PI Status Form
Request for Personally Identifiable Information from Student Education Records for Research Form
Statement to Activate Power of Attorney for Research
Consent Form Wizard
Declaration to Researchers
HIPAA Authorization Wizard
HIPAA Authorization and Consent Form Wizard (Combined)
A Minor’s Right to Consent to Treatment and Authorize Disclosure of PHI
Parent/Guardian Authorization Form Wizard
Power of Attorney for Research
Request for PI Status Form
Request for Personally Identifiable Information from Student Education Records for Research Form
Statement to Activate Power of Attorney for Research