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