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.
Protocols
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503Biomedical Protocol January 2025
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503aRegistries and Repositories Protocol April 2024
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508Site Supplement January 2022
Additional protocol template resource:
- UW ICTR Protocol Template page:
Protocol templates for prospective clinical trials evaluating drugs, devices, biologics, or behavioral or clinical interventions can be found at the link above. Both oncology and non-oncology options are available.
Consent & Authorization
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502Consent Document March 2025
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502aExempt Consent Document July 2023
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502cInstitutional Consent Language March 2025
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502d
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506Emergency, Single Patient, or Compassionate Device Use February 2024
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507Short Form Consent Document September 2024
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507Short Form Consent Document – Spanish Translation September 2024
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507Short Form Consent Document – Vietnamese Translation October 2021
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511Self Experimentation Consent Document February 2024
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512HIPAA Authorization Form (Stand-alone) September 2024
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512
Additional consent resource:
- ED/SBS Consent Form Wizard
For educational and social-behavioral studies, you can use the Consent Form Wizard. The Wizard does not include HIPAA authorization language
Other Templates
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504School Permission to Conduct Research Letter January 2021
IRB Operations
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501Minutes July 2021
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509VA Minutes Supplement January 2021
*VA Consent Form and HIPAA Authorization Form templates for VA researchers can be found on IRBNet.
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.