The following protocol and consent templates are used by researchers in preparation for IRB submission (see Investigator Manual (download) for additional guidance on completing these documents). Additional IRB templates are provided to promote transparency of IRB operations. HIPAA and data use agreements are not part of the Toolkit and can be found in the Contracts Library.
Download Frequently Accessed Forms & Templates:
- 503: Human Research Determination Form
- 590: Medical Template Protocol
- 580: Social Template Protocol
- 595: Data or Specimen-Only Protocol
- 592: Consent Form Template for Medical Research
- 588: Combined HIPAA and Consent
- 582: Consent Form Template for Social/Behavioral Research
- 507: Consent Short Form Template (English)
- 216: External Team Member Form
Protocols
| Number | Title | Updated |
|---|---|---|
| 503 | Human Research Determination Form (download) | March 2023 |
| 508 | Local Protocol Addendum - With Instructions (download) Local Protocol Addendum - No Instructions (download) |
May 2023 |
| 580 |
Social Template Protocol - With Instructions (download) |
March 2023 |
| 590 | Medical Template Protocol - With Instructions (download) Medical Template Protocol - No Instructions (download) |
March 2023 |
| 591 | HUD Template Protocol (download) | August 2019 |
| 595 | Data or Specimen-Only Protocol (download) | March 2023 |
| 597 | Database, Registry, and Biospecimen Repository Protocol (download) | March 2023 |
Consent
Other Templates
| Number | Title | Updated |
|---|---|---|
| 504 | School Permission to Conduct Research | August 2019 |
| 537 | Business and Industry Funded Study Fee (download) | March 2021 |
| 538 | Scientific Review (download) | April 2019 |
| 574 | Certification of Attestation of Translation | June 2018 |
| 5000 | HIPAA Authorization Forms: | June 2021 |
| 5001 | Data Use Agreements (download) | June 2021 |
IRB Operations
| Number | Title | Updated |
|---|---|---|
| 501 | Minutes (download) | October 2022 |
| 515 | Letter—Suspension or Termination (download) | December 2018 |
| 519 | Letter—Information Item (download) | October 2022 |
| 520 | Letter - External Report (download) | January 2019 |
| 543 | CoC Assurance Letter (download) | December 2018 |
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.
Forms
IRB staff and members use these documents as a reference when reviewing IRB submissions.
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.