Templates & Forms

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:



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

Social Template Protocol - With Instructions (download)
Social Template Protocol - No 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


Number Title Updated
506 Consent Form Template for Emergency Use (download) August 2019

Consent Short Form Template (English)

Consent Short Form Template Translations:

Certificates of Translation


November 2022
582 Consent Form Template for Social/Behavioral Research (download) March 2023
583 Assent Form Template (download) March 2023
584 Assent Script Template (download) March 2017
585 Parental Permission Document (download) March 2023
586 Certificate of Confidentiality Information Sheet (download) February 2018
587 Information Sheet for Exempt Research (download) June 2022
588 Combined HIPAA and Consent (download) March 2023
589 Consent Collection After Withdrawal (download) August 2019
592 Consent Form Template for Medical Research (download) March 2023
593 Multi-Site Master Consent Form (download) November 2021


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.


IRB staff and members use these documents as a reference when reviewing IRB submissions.

Number Title Updated
203 IRB Member Evaluation Form (download) March 2018
204 IRB Chair Evaluation Form (download) March 2018
210 Expert Consult (download) June 2017
215 Ombudsman Report Form (download) January 2020
216 External Team Member Form (download) October 2022
223 Confidentiality Agreement for Attendance (download) March 2018
226 MacCAT-CR Assessment Form (download) Jan 2018
227 UBACC Interview Form Jan 2018
229 Request to Transfer (download) August 2019
230 HRPP Education Session Evaluation Form (download) August 2019
503 Human Research Determination Form (download)  June 2021
815 Institutional Profile (download) June 2021
821 Participating Site List (download) June 2021
822 Participating Site Local Context and Institutional Requirements (download) January 2020
823 ADVARRA Institution Cover Page (download) March 2023
824 Participating Site Modification Request (download) January 2020
825 Participating Site Reportable New Information (download) January 2020
826 Participating Site Progress Report for Continuing Review (download) January 2020
827 Participating Site Closure Form (download) January 2020
828 Attestation of PI Responsibilities when UMN IRB Serves as sIRB (download) March 2022
829 PI Attestation Form for Reliance on an External IRB (download) June 2021
855 Individual Investigator Agreement for Federally Funded Research (download) October 2022
856 Individual Investigator Agreement for Non-Federally Funded Research (download) October 2022

Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.