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 | April 2026 |
| 508 | Local Protocol Addendum - With Instructions Local Protocol Addendum - No Instructions | April 2026 |
| 580 | Social Template Protocol - With Instructions Social Template Protocol - No Instructions | April 2026 |
| 590 | Medical Template Protocol - With Instructions Medical Template Protocol - No Instructions | April 2026 |
| 591 | HUD Template Protocol | April 2026 |
| 595 | Data or Specimen-Only Protocol | April 2026 |
| 597 | Database, Registry, and Biospecimen Repository Protocol | April 2026 |
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 2026 |
| 574 | Certification of Attestation of Translation | June 2018 |
| 988 | Referral Information Sheet for Research Participants | December 2023 |
| 5000 | HIPAA Authorization Forms: Go to the HIPCO Forms web page to find the most current forms. | October 2025 |
| 5001 | Data Use Agreements | June 2021 |
IRB Operations
| Number | Title | Updated |
|---|---|---|
| 501 | Minutes | April 2026 |
| 515 | Letter—Suspension or Termination | April 2026 |
| 519 | Letter—Information Item | May 2026 |
| 520 | External Report - All Agencies Not Including OHRP | April 2026 |
| 520a | External Report - All Agencies w/OHRP | April 2026 |
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.