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