1. Human Subjects Research Protection Program (HRPP) Policy Index
  2. Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans Guidance
  3. Review of Research Involving Vulnerable Participants
  4. Recruitment of Research Participants Guidance
  5. Instructions for Linking Previous CITI Training to Your NetID
  6. Research with Adult Participants Lacking Capacity to Consent
  7. Good Clinical Practice (GCP) Training Guidance and Instructions
  8. Instructions for Completing CITI Human Participants Research Training
  9. HRPP Guidance, Forms and Resources
  10. Principal Investigator Status for UW–Madison Studies Involving Human Participants
  11. Research Participants
  12. Cross-Campus Human Research Protection Program (HRPP) Committee Charter
  13. Post-Approval Monitoring Program
  14. Issues in Human Subjects Research When State Law May Apply
  15. Retention of IRB Records
  16. Continuing Review: Submission and Review
  17. Study Closure
  18. UW–Madison Federalwide Assurance (FWA)
  19. Contact Information for Reporting Suggestions and Concerns
  20. Changes in Research Activities: Submission and Review
  21. Noncompliance
  22. HRPP Education and Training
  23. IRB Reliance
  24. HRPP Newsletter - Spring 2018
  25. Human Research Protection Program Newsletter
  26. Institutional Officials in Charge of HRPP
  27. Protecting Research Participants Privacy Interests and Confidentiality of Data
  28. Engagement in Human Participants Research at UW–Madison
  29. Evaluating the Scientific or Scholarly Merits of Proposed Research
  30. Equitable Selection of Research Participants Guidance
  31. Exempt Research
  32. Certificate of Confidentiality (CoC) Application Help
  33. Instructions for Completing CITI Refresher Training
  34. IRB Members’ Conflicts of Interest
  35. Obtaining and Documenting Informed Consent
  36. Clinical Trials Registration & Results Reporting
  37. Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support
  38. Creation and Dissemination of Policies and Related Documentation
  39. Application of Federalwide Assurance (FWA) Terms to UW-Madison Human Participants Research Policy
  40. Exempt Research (for non-federally funded, non-FDA-regulated, non-VA research)
  41. De-Identified Publicly Available Datasets Guidance
  42. IRB Composition and Quality Performance
  43. Reporting to Institutional and External Authorities
  44. Review of Data and Safety Monitoring in Research
  45. Maintenance of IRB Records
  46. ED/SBS IRB Principal Investigator Responsibilities
  47. Good Clinical Practice (GCP) Refresher Instructions
  48. UW HRPP Quality Assurance
  49. Suspension and Termination of Approved Research
  50. Reportable Abuse and Neglect Guidance
  51. OHRP Continuing Review Guidance
  52. Common Rule (45 CFR 46)
  53. Use of Human Fetal Tissue in Research
  54. IRB Meeting Minutes and Regulatory Documentation
  55. Use of Human Fetal Tissue in Research Policy Links
  56. OPRR Guidance on 45 CFR 46.101(b)(5): Exemption for Research and Demonstration Projects on Public Benefit and Service Programs
  57. Reporting of Suggestions and Concerns Regarding HRPP Performance and Function
  58. IRB Analysis of Risks and Benefits of Research Guidance
  59. IRB Consultants Use and Conflict of Interest
  60. Developing an Internal Quality Assurance (QA) Program Guidance
  61. OHRP & FDA Expedited Review Guidance
  62. OHRP Guidance on Engagement of Institutions in Human Subjects Research
  63. IRB Meetings
  64. IRB Authority and Independence
  65. IRB Purview
  66. Student Research
  67. Compliance Monitoring and Quality Improvement
  68. Exceptions to Informed Consent Requirements in Emergency Situations
  69. Unanticipated Problems
  70. Considerations for Accepting or Ceding IRB Review Guidance
  71. Expert Review
  72. Compliance with Human Research Protections in Sponsored Research
  73. HRPP and IRB Resources
  74. Office for Human Research Protections (OHRP) - IRB Knowledge of Local Research Context
  75. IRB Review of Study Resources
  76. ED/SBS IRB Office Guidance Index
  77. List of Approved De-Identified Publicly Available Datasets
  78. Conflicts of Interest of Non-UW-Madison Key Personnel
  79. NIH Genomic Data Sharing Policy for Human Data Guidance
  80. Initial Review: Submission and Review Policy
  81. FDA IRB Regulations (21 CFR 56)
  82. Monitoring the Consent Process
  83. UW-Madison HIPAA Program
  84. Campus IT Policies
  85. Preventing Noncompliance Guidance
  86. Single Institutional Review Board (IRB) for Multi-Site Federal Grants Policy
  87. Reporting of Suggestions and Concerns Regarding the Protection of Research Participants
  88. Quality Assurance Committees
  89. Post Approval Monitoring Program Services
  90. UW Post-Approval Monitors
  91. Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
  92. Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
  93. Human Research Protection Program (HRPP) Newsletter - Spring 2017
  94. Human Research Protection Program (HRPP) Newsletter - Fall 2016
  95. Human Research Protection Program (HRPP) Newsletter - Spring 2016
  96. Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
  97. Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
  98. UW Human Research Protection Program Newsletter - Fall 2015