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