The following protocol and consent templates are used by researchers in preparation for IRB submission (see Investigator Manual 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 | August 2024 |
| 508 | Local Protocol Addendum - With Instructions Local Protocol Addendum - No Instructions | August 2024 |
| 580 | Social Template Protocol - With Instructions Social Template Protocol - No Instructions | August 2024 |
| 590 | Medical Template Protocol - With Instructions Medical Template Protocol - No Instructions | August 2024 |
| 591 | HUD Template Protocol | August 2019 |
| 595 | Data or Specimen-Only Protocol | August 2024 |
| 597 | Database, Registry, and Biospecimen Repository Protocol | August 2024 |
Consent
Other Templates
| Number | Title | Updated |
|---|---|---|
| 504 | School Permission to Conduct Research | August 2019 |
| 537 | Business and Industry Funded Study Fee | March 2021 |
| 538 | Scientific Review | April 2019 |
| 574 | Certification of Attestation of Translation | June 2018 |
| 988 | Referral Information Sheet for Research Participants | December 2023 |
| 5000 | HIPAA Authorization Forms: | June 2021 |
| 5001 | Data Use Agreements | June 2021 |
IRB Operations
| Number | Title | Updated |
|---|---|---|
| 501 | Minutes | June 2024 |
| 515 | Letter—Suspension or Termination | August 2024 |
| 519 | Letter—Information Item | October 2022 |
| 520 | External Report - All Agencies Not Including OHRP | August 2024 |
| 520a | External Report - All Agencies w/OHRP | August 2024 |
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.