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