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