Table of Contents

1. Introduction
   1. Purpose
   2. HRPP Toolkit Library
   3. Human Research Protection Program
   4. Defining Human Participant Research
   5. Self Experimentation of Researchers
   6. Getting Help & Answers to Questions
2. Researcher Requirements
   1. Study Team Member Engagement
   2. Who Can Serve as a Principal Investigator
   3. Principal Investigator Responsibilities
   4. Study Team Member Responsibilities
   5. Student Research, Advisor, & Course Instructor Responsibilities
   6. Training Requirements
   7. Financial Interests and Disclosures
3. IRB Review Requirements and Application Types
   1. When IRB Review May Not Be Required
      1. Program Evaluation/Quality Improvement or Assurance Projects
      2. Case Reports
      3. Oral History
      4. Analysis of Publicly Available Datasets
   2. Human Research Requiring a Protocol
      1. Protocol Templates
      2. Studies Requiring Review by the ICTR Scientific Review Committee (SRC)
      3. Non-Exempt Studies for Which UW-Madison Will Serve as the Reviewing IRB for Other Sites
      4. Protocol Guidelines
   3. Human Research Not Requiring a Protocol
      1. Exempt Projects (including health care records research and not human research)
      2. Non-Exempt Minimal Risk Research (including community-based participatory research)
      3. International Research
   4. Other Types of Applications
      1. Umbrella Protocols, Training Grants, & Core Grants
      2. Analysis Center Applications
      3. Emergency/One-Time/Compassionate Use
      4. Expanded Access of Investigational Medical Products (non-emergency)
      5. Humanitarian Use Device (HUD/HDE)
      6. Protocol Development Activities
   5. Institutional Requirements
4. Preparing Supporting Documents
   1. Writing a Consent Document
   2. Writing a HIPAA Authorization Form
   3. Preparing Recruitment Materials
   4. Other Subject-Facing Materials Requiring IRB Review
   5. Supporting Documents That Do NOT Require IRB Review
5. Submitting IRB Applications
   1. Scientific Review Requirements
   2. General Submission Information
6. IRB Review Process
   1. Regulatory Classifications for Human Participant Research
   2. IRB Approval Criteria
   3. IRB Review Decisions
      1. Types of Decisions
      2. Communication of IRB Decisions
      3. Disagreeing with IRB Decisions
   4. Accessing IRB Records & Rosters
7. Conducting Human Participant Research
   1. Recruitment Guidelines
      1. General Recruitment Guidelines
      2. Initial Contact Guidelines
      3. Email Recruitment Guidelines
      4. Clinical Recruitment Guidelines
      5. MyChart Recruitment Guidelines
      6. Social Media Recruitment Guidelines
      7. Eligibility Screening
   2. Participant Remuneration & Compensation
   3. Consent Processes and Documentation
      1. Informed Consent Document
      2. Assent Process and Documentation
      3. Remote Consent Processes
      4. Documenting Consent Electronically
      5. Waivers of Signed Consent
      6. Enrolling Participants with Limited English Proficiency
      7. Other Consent Considerations
   4. HIPAA Processes & Documentation
      1. HIPAA Authorization Document
      2. Remote Authorization
      3. Preparatory to Research Activities
      4. Partial and Full Waivers of Authorization
      5. Altered Authorization
      6. Data Use Agreements
      7. Accounting for Disclosures
      8. Authorization & Participants with Limited English Proficiency
   5. Research with Special Populations
      1. Participants with Impaired Decision-Making
      2. Prisoners
      3. Children
      4. Pregnant Persons and/or Neonates
      5. Other Special Populations
   6. Translation & Interpreter Requirements
   7. Privacy & Confidentiality
      1. Protecting Participant Privacy & Confidentiality
      2. Certificates of Confidentiality
   8. Identifiability
   9. Data Safety Monitoring Plans (DSMP)
   10. Communicating with Participants
       1. General Communication Guidelines
       2. Use of Personal Cell Phones for Research
   11. Special Procedures
       1. Use of Video or Audio Recording
       2. Deception
       3. Radiation
       4. Controlled Substances
   12. Regulatory Information
       1. HIPAA Privacy & Security Rules
       2. Federal Educational Privacy Act (FERPA)
       3. FDA Regulations and IRB Review
   13. Conducting VA Research
       1. General Information about VA Research
       2. VA Requirements
       3. Use of Preparatory to Research
       4. Special Populations in VA Research
       5. Certificates of Confidentiality in VA Research
       6. Collaborative VA Research
       7. Photography, Video and/or Audio Recording for VA Research
       8. VA International Research
       9. Posting VA Clinical Trial Consent Forms
   14. Different Types of Research
       1. Research in K-12 Settings
       2. Tribal Research
       3. Analysis Center Projects
       4. Research Registries and Repositories
       5. Decedent Research
       6. Technology & New Media Research
       7. Biomedical Interventions Conducted in Non-Clinical Settings
       8. Fetal Tissue Research
       9. Biospecimen and Data Research
          1. Biospecimens & Data: IRB Review Requirements
          2. Biospecimen & Data Research: Informed Consent Requirements
          3. Biospecimen & Data Research: Storage
          4. Sharing Data, Specimens, or Images
       10. Study Personnel Training and Preparatory Activities
8. Post-Approval Responsibilities
   1. Researcher Responsibilities After IRB Approval
   2. Changes of Protocol
      1. General Change Requirements
      2. Editorial Changes to Subject-Facing Materials
      3. Changes to Research Determined to be Exempt
      4. Changes to Analysis Center Protocols
      5. Changes in Principal Investigator
   3. Continuing Reviews
   4. Reportable Events
      1. Reporting Requirements
      2. Reporting Requirements for VA Studies
      3. Guidance on what does not need to be reported
      4. Subject Deviations from the Study Protocol
      5. Changes to eliminate an apparent immediate hazard to subjects
      6. Corrective Action Plans
      7. Study Suspension or Termination
      8. IRB Reporting Obligations
   5. Reporting Clinically Relevant Information to Participants
   6. “Souvenir” Radiology Images
   7. Communicable Disease (Including HIV)
9. Other Issues & Considerations
   1. Complaints or Concerns About a Study
   2. Record Retention
   3. Clinicaltrials.gov
   4. Sharing Data in Repositories
   5. Institutional Certification for NIH Genomic Data Sharing
   6. General Data Privacy Regulation (GDPR)
   7. Investigator Responsibilities When Leaving UW-Madison
10. Appendix A: Additional Research Requirements
    1. DHHS-Regulated Research
    2. FDA-Regulated Research
    3. Clinical Trials and ICH-GCP
    4. DOD Research
    5. DOE Research
    6. DOJ Research
    7. ED Research
    8. EPA Research
    9. Single IRB Basics
    10. EU GDPR
11. Appendix B: Additional Resources
    1. Recruitment Elements & Scripts