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
• Guidance on Receiving Human Subjects Research Data from an External Entity
• 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:

• Advance Directive for Research Participation Form
• A Minor’s Right to Consent to Treatment and Authorize Disclosure of PHI
• Parent/Guardian Authorization Form Wizard
• Request for PI Status Form

• Request for Personally Identifiable Information from Student Education Records for Research Purposes

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 HRPP Newsletter

UW–Madison Resources:

• HIPAA at UW–Madison
• Research Close-Out Checklist
• Payments to Research Participants Policy
• 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

Ethical Guidelines:

• Belmont Report
• Declaration of Helsinki

Keywords: human subjects research resources forms guidance hrpp dod epa doe doj fda ictr coc