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