1. Recruitment Registry, Data Repository, and Tissue Repository Guidance
2. Documenting Consent Electronically or for Remote Subjects Guidance
3. Control of Test Articles Used in Research Policy
4. Review of FDA-Regulated Research Policy
5. Emergency Use of Test Articles and of Humanitarian Use Devices Policy
6. Humanitarian Use Device Policy
7. VA Research: Policy for IRB Review of Human Subjects Research that Falls Under VA Purview
8. Policy and Guidance
9. Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes
10. Remote Study Activities Guidance
11. Do I need to get consent for my exempt study?
12. Guidance on Research vs. Quality Improvement and Program Evaluation
13. Sending or Receiving Specimens/Data/Images Guidance
14. Guidance on Exemption: Not Human Subjects Research
15. Application Type Guidance
16. Emergency Use/Expanded Access
17. Expanded Access of Investigational Medical Product Requests (Non-emergency)
18. Emergency, Expanded Access for an Investigational Medical Product (One Patient)
19. Information for New Investigators
20. Expedited Change of Protocol Guidance
21. Principal Investigator Changes and Personnel Updates Guidance
22. Release of Grant Funds When IRB Review for a Study is Ceded to an External IRB
23. Processing the Departure of a Principal Investigator Guidance
24. Understanding the NIH Genomic Data Sharing (GDS) Policy
25. Protocol Guidance
26. Guidance on Making Editorial Changes to Subject-Facing Study Materials
27. Scientific Review Requirement
28. VA Research - Policy and Guidance
29. Identification of Suicidality or Major Depression Guidance
30. Training Grant, Umbrella Grant or Core Grant
31. Case Reports and Case Series Guidance
32. Letters of Cooperation for Non-UW Institutions/Organizations
33. Family Education Rights and Privacy Act (FERPA) Guidance
34. Scientific Review: UW Comprehensive Cancer Center (UWCCC) Protocol Review Monitoring Committee (PRMC)
35. Clinically Relevant Information and Reporting Guidance
36. Summary of Investigator Responsibilities
37. Guidance on Exemption Categories under the Revised Common Rule
38. Guidance for Completing IRB Applications for Recruitment Registries or Repositories that Store Data and/or Tissue
39. Guidance on Research Involving Surveys, Interviews, and Focus Groups
40. IRB QI/Program Evaluation Self-Certification Tool Guidance
41. International Research Guidance
42. Children as research participants: Pregnancy Status
43. Key Personnel Guidance
44. Using Specimens/Information from Decedents: The Common Rule and FDA Regulations
45. Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts
46. Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW
47. Use of Email for Research Purposes Guidance
48. Identifiability Guidance
49. Recruitment of Subjects with Status Relationship with the Research Team
50. Guidance on FDA Regulation of Medical Mobile Apps
51. Protocol Closure Guidance
52. Guidance on Presenting Changes of Protocol to IRB
53. Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval
54. Continuing Review: UW-Madison Purview Enrollment Guidance
55. Investigational Software Guidance
56. Genetic Information and Nondiscrimination Act (GINA) Guidance
57. HIV Testing in Research Guidance
58. Communicable Disease Guidance
59. Vulnerable Populations Guidance
60. MRIs and Pregnancy Status Guidance
61. Audio Recordings, Video Recordings, Photographs Guidance
62. What Happens After an Application Is Submitted to the Health Sciences or Minimal Risk IRB: Scientific Review
63. Guidance Regarding Drug Shortages and Substitutions that Occur During the Conduct of Research Studies
64. Data Safety Monitoring Plans (DSMP) Guidance
65. Guidance Regarding Research that Involves the Collection of Information about Illegal Substance or Alcohol Abuse
66. Outline of the Endorsement Process
67. Guidance for Analysis Centers
68. What Happens After a New Application Is Submitted to the Health Sciences or Minimal Risk IRB: IRB Administrative Review and IRB Pre-Review
69. Timeframe for Submission of Changes of Protocol to the IRB
70. Endorsement and Approval of VA Research
71. Changes to Eliminate Immediate Hazards to Subjects Guidance
72. Protocol Development Activities (PDA) Guidance
73. Deception in Research Guidance
74. Registry-Repository Overview Table
75. Devices Implanted or Applied to Subjects Guidance