HRPP Guidance, Forms and Resources
Guidance:
- Accessing ARROW and the NetID Process
- Application of Good Clinical Practice at UW-Madison
- 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
- Guidance on External Sharing of Human Subjects Research Data
- 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
Forms:
- 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 Purposes
- Statement to Activate Power of Attorney for Research
Agencies, Regulations, and Laws Governing Human Participants Research:
- Common Rule and Subparts
- Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
- Food and Drug Administration (FDA) and FDA Regulations
- Issues in Human Subjects Research When State Law May Apply
- National Science Foundation (NSF)
- Office for Human Research Protection (OHRP)
- UW–Madison Federalwide Assurance (FWA) & IRB Registration Numbers
- VA Research - Overview
Communications:
UW–Madison Resources:
- HIPAA at UW–Madison
- Lab Close-Out Checklist
- Payments to Research Participants Policy and Procedure
- Data Security, Management, and Retention
- Misconduct in Scholarly Research
- Quality Assurance Committees
UW–Madison Research Services:
- Clinical Research Toolkit (includes checklists and templates for study conduct)
- UW Institute for Clinical & Translational Research (ICTR) Clinical Research Services
- Pharmaceutical Research Center (PRC)
- Research Data Services
- University of Wisconsin Survey Center