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Medical Research: Forms & Consent Templates

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This section contains all of the forms and consent templates that apply to investigators from:  

  • School of Medicine (SoM) 
  • Veteran's Affairs (VA) Hospital 

*Please note that when creating a protocol for IRB submission, these investigators need to select the Medical eProtocol Application category.

If you have questions or are having trouble accessing these forms, please contact IRB Education (email or call 650-724-7141).

The consent/assent form should be in a language that is understandable to someone without a medical or scientific background. Please use the Microsoft Readability Statistics tool as needed when writing your consent form.

See consent template updates for recent changes.

Consent template typeDescription

Stanford

[rev. date]

Stanford – Spanish

[rev. date]

VA

[rev. date]

RegularFor greater than minimal risk researchdoc
[03/2024]
doc
[03/2024]
VA doc
[01/2024]
Regular without HIPAAUse with VA Form 10-0493N/AN/AVA doc
[01/2024]
ExpeditedFor minimal risk research (e.g., blood draws, non-invasive specimen collection, interviews, surveys, behavioral interventions, etc.)doc
[03/2024]
doc
[03/2024]
VA doc
[01/2024]
Expedited without HIPAAUse with VA Form 10-0493N/AN/AVA doc
[01/2024]
Somatic cell donationFor stem cell researchdoc
[09/2023]
doc
[09/2023]
N/A
Assent template typeDescriptionStanfordStanford – SpanishVA
Adults (18+) unable to provide consentUse with legally authorized representative (LAR) consent for adults (18+)doc
[01/2023]
doc
[01/2023]
N/A
Children, age 13-17 yearsUse for children age 13-17doc
[04/2024]
doc
[04/2024]
N/A
Children, age 7-12 yearsUse for children age 7-12doc
[04/2024]
doc
[04/2024]
N/A
Information Sheets and Screening ScriptsDescriptionStanfordStanford – SpanishVA
Expedited research information sheetUse for waiver of documentation (i.e., waiver of signature) for minimal risk proceduresdoc
[09/2023]
doc
[09/2023]
N/A
Exempt research information sheetFor exempt researchdoc
[09/2023]
doc
[09/2023]
N/A
Screening script, level 1aUse for waiver of documentation for screeningdoc
[01/2023]
doc
[01/2023]
N/A
Screening script, level 1bUse for waiver of documentation for screening and retaining contact information for future researchdoc
[01/2023]
doc
[01/2023]
N/A
Other form typesDescriptionStanfordStanford – SpanishVA
VA HIPAA Authorization (VA Form 10-0493)Use with regular or expedited consent without HIPAAN/AN/AVA doc
[09/2015]
Schedule of Procedures tableUse with or insert into consent when standard of care procedures overlap with research proceduresdoc
[10/2017]
doc
[10/2017]
N/A
General Data Protection Regulation (GDPR) consent form languageInsert into consent when study takes place in the European Union/European Economic Area (EU/EEA)doc
[01/2023]
doc
[01/2023]
N/A

Other Forms:

HS Research determination; IND & IDE forms; Other
Human Subject Research (HSR) Determination Form
Initial Submission Checklist for Investigators (Medical)
Letter of Agreement - for research in cooperation with other organizations
IND Forms and Instructions:  
  - FDA 1571 Investigational New Drug Application  
  - FDA 1572 Statement of Investigator 
  - Instructions for completing FDA forms 1571 and 1572
IDE application
FDA forms & submission requirements (drugs)
SIR Self-Assessment Checklist - IND/IDE
Emergency Use of a Test Article - Notification to the IRB
NIH Genomic Data Sharing (GDS) Consent Checklist
Scientific Review
Review of Scientific and Scholarly Validity, and Oversight (by Academic Sponsor)
Review of Scientific and Scholarly Validity (by Dept Chair or School Dean)
Scientific Review Protocol - for projects not otherwise undergoing scientific review

eProtocol Forms:

Required Attachments
DOE-supported research: Protection of Personally Identifiable Information (PII)    [Form APP-14]
Gene Transfer Protocol Application Supplemental Questions
HIPAA Supplemental Questions for Single IRB
International Research Supplemental Questions – research outside the US
Blank eProtocol Application Forms

  Requires Stanford SUNetID Login to view

      New, Modification, Continuing Review

   (These are for informational purposes only)

 

• Medical: 
   -Regular 
   -Expedited 
   -Exempt 
   -Chart Review 
   -sIRB 
   -HSR 
• Mod 
• Continuing Review 
• Report 
• Final Report 
• Non-Medical:  
   -Regular 
   -Expedited 
   -Exempt 
   -sIRB

eProtocol is used to submit: 
  • New Protocol applications - see examples above. 
      - Complete and attach supplemental required attachments as needed (see above) 
  • Modifications to approved protocols (need prior IRB approval to implement). 
  • Continuing Review applications. 
  • Reports unanticipated problems, events/information requiring prompt reporting. 
  • Final Reports (not required for Exempt research).