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:

 
 

Protocols

NumberTitleUpdated
503Human Research Determination Form (download)March 2023
508Local Protocol Addendum - With Instructions (download)
Local Protocol Addendum - No Instructions (download)
December 2023
580Social Template Protocol - With Instructions (download)
Social Template Protocol - No Instructions (download)
December 2023
590Medical Template Protocol - With Instructions (download)
Medical Template Protocol - No Instructions (download)
December 2023
591HUD Template Protocol (download)August 2019
595Data or Specimen-Only Protocol (download)December 2023
597Database, Registry, and Biospecimen Repository Protocol (download)December 2023

 

NumberTitleUpdated
506Consent Form Template for Emergency Use (download)August 2019
507

Consent Short Form Template (English)

Consent Short Form Template Translations: Certificates of Translation

March 2024
582Consent Form Template for Social/Behavioral Research (download)December 2023
583Assent Form Template (download)December 2023
584Assent Script Template (download)March 2017
585Parental Permission Document (download)December 2023
586Certificate of Confidentiality Information Sheet (download)February 2018
587Information Sheet for Exempt Research (download)June 2022
588Combined HIPAA and Consent (download)December 2023
589Consent Collection After Withdrawal (download)August 2019
592Consent Form Template for Medical Research (download)December 2023
593Multi-Site Master Consent Form (download)December 2023

 

Other Templates

NumberTitleUpdated
504School Permission to Conduct ResearchAugust 2019
537Business and Industry Funded Study Fee (download)March 2021
538Scientific Review (download)April 2019
574Certification of Attestation of TranslationJune 2018
988Referral Information Sheet for Research Participants (download)December 2023
5000

HIPAA Authorization Forms:

June 2021
5001Data Use AgreementsJune 2021

 

IRB Operations

NumberTitleUpdated
501Minutes (download)January 2024
515Letter—Suspension or Termination (download)December 2018
519Letter—Information Item (download)October 2022
520Letter - External Report (download)January 2019


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.

NumberTitleUpdated
203IRB Member Evaluation Form (download)March 2018
204IRB Chair Evaluation Form (download)March 2018
210Expert Consult (download)June 2017
215Ombudsman Report Form (download)January 2020
216External Team Member Form (download)October 2022
223Confidentiality Agreement for Attendance (download)March 2018
226MacCAT-CR Assessment Form (download)Jan 2018
227UBACC Interview FormJan 2018
229Request to Transfer (download)August 2019
230HRPP Education Session Evaluation Form (download)August 2019
815Institutional Profile (download)June 2021
821Participating Site List (download)June 2021
822Participating Site Local Context and Institutional Requirements (download)January 2020
823ADVARRA Institution Cover Page (download)March 2023
824Participating Site Modification Request (download)January 2020
825Participating Site Reportable New Information (download)January 2020
826Participating Site Progress Report for Continuing Review (download)January 2020
827Participating Site Closure Form (download)January 2020
828Attestation of PI Responsibilities when UMN IRB Serves as sIRB (download)March 2022
829PI Attestation Form for Reliance on an External IRB (download)June 2021
833Local Compliance Assessment (download) December 2023
855Individual Investigator Agreement for Federally Funded Research (download)October 2022
856Individual Investigator Agreement for Non-Federally Funded Research (download)October 2022
1899Sponsor Investigator ResponsibilitiesJune 2023


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