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