1. Principal Investigator Status for UW–Madison Studies Involving Human Participants
  2. Post Approval Monitoring Program Services
  3. Clinical Trials Registration & Results Reporting
  4. Engagement in Human Participants Research at UW–Madison
  5. UW Human Research Protection Program Newsletter - Fall 2015
  6. Good Clinical Practice (GCP) Training Guidance and Instructions
  7. Human Research Protection Program (HRPP) Newsletter - Spring 2016
  8. Human Research Protection Program (HRPP) Newsletter - Fall 2016
  9. Human Research Protection Program Newsletter
  10. Good Clinical Practice (GCP) Refresher Instructions
  11. Certificate of Confidentiality (CoC) Application Help
  12. Human Subjects Research Protection Program (HRPP) Policy Index
  13. IRB Meeting Minutes and Regulatory Documentation
  14. Changes in Research Activities: Submission and Review
  15. HRPP Guidance, Forms and Resources
  16. Instructions for Completing CITI Refresher Training
  17. Instructions for Linking Previous CITI Training to Your NetID
  18. Use of Human Fetal Tissue in Research
  19. Compliance with Human Research Protections in Sponsored Research
  20. Monitoring the Consent Process
  21. Exceptions to Informed Consent Requirements in Emergency Situations
  22. IRB Meetings
  23. Contact Information for Reporting Suggestions and Concerns
  24. Reporting of Suggestions and Concerns Regarding the Protection of Research Participants
  25. UW–Madison Federalwide Assurance (FWA) & IRB Registration Numbers
  26. Initial Review: Submission and Review Policy
  27. IRB Purview
  28. Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support
  29. Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
  30. Application of Federalwide Assurance (FWA) Terms to UW-Madison Human Participants Research Policy
  31. Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
  32. Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
  33. Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
  34. Compliance Monitoring and Quality Improvement
  35. Research with Adult Participants Lacking Capacity to Consent
  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. Post-Approval Monitoring Program
  58. Issues in Human Subjects Research When State Law May Apply
  59. Retention of IRB Records
  60. Continuing Review: Submission and Review
  61. Study Closure
  62. IRB Reliance
  63. HRPP Newsletter - Spring 2018
  64. Protecting Research Participants Privacy Interests and Confidentiality of Data
  65. Evaluating the Scientific or Scholarly Merits of Proposed Research
  66. Equitable Selection of Research Participants Guidance
  67. Creation and Dissemination of Policies and Related Documentation
  68. De-Identified Publicly Available Datasets Guidance
  69. Reporting to Institutional and External Authorities
  70. Review of Data and Safety Monitoring in Research
  71. Maintenance of IRB Records
  72. ED/SBS IRB Principal Investigator Responsibilities
  73. List of Approved De-Identified Publicly Available Datasets
  74. NIH Genomic Data Sharing Policy for Human Data Guidance
  75. IRB Consultants Use and Conflict of Interest
  76. FDA IRB Regulations (21 CFR 56)
  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. Preventing Noncompliance Guidance
  80. IRB Analysis of Risks and Benefits of Research Guidance
  81. Reportable Abuse and Neglect Guidance
  82. Common Rule (45 CFR 46)
  83. UW-Madison HIPAA Program
  84. Student Research
  85. Developing an Internal Quality Assurance (QA) Program Guidance
  86. OHRP Guidance on Engagement of Institutions in Human Subjects Research
  87. Expert Review
  88. Office for Human Research Protections (OHRP) - IRB Knowledge of Local Research Context
  89. IRB Review of Study Resources
  90. Considerations for Accepting or Ceding IRB Review Guidance
  91. Conflicts of Interest of Non-UW-Madison Key Personnel
  92. Campus IT Policies