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