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Medical Research: Forms & Consent Templates

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

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

*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.

 

    Consents 
        See consent template updates for recent changes
VA
[rev. date]
Stanford
[rev. date]
Consent (HIPAA embedded)
 
w/HIPAA
2/4/19
doc
w/HIPAA 
5/25/19
Consent without HIPAA
Note: For separate VA HIPAA, use FORM 10-0493.
VA doc
no HIPAA
2/4/19
doc
no HIPAA 
5/25/19
Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.) 
 
w/HIPAA 
2/4/19

doc 
w/HIPAA 
7/31/19

Minimal Risk Consent without HIPAA
Note: For separate VA HIPAA, use FORM 10-0493.

no HIPAA 
2/4/19
 
Minimal Risk Consent - MRI for research (e.g., for fMRI use in behavioral research; HIPAA included)
doc
5/25/19
HIPAA Authorization   -  VA Form 10-0493 - standalone document
VA pdf
09/2015
doc
02/23/16
VA Header & Footer 10-1086
VA doc
11/02/11
 
Short Form Consent Process & Templates
 
Somatic Cell Donation for Stem Cell Research (HIPAA included)
 
doc
04/12/18
Radiation Consent Language
 
NIH Certificate of Confidentiality (Spanish)
pdf
02/23/16
General Data Protection Regulation (GDPR) Consent Form Language
doc
10/22/18
   Assents, scripts, phone screens, info sheet 
        See consent template updates for recent changes
Assent – under 18
doc
1/07/15
Assent – adults (18+) unable to provide consent i.e., LAR provides consent
doc
1/07/15
Telephone Screening of Potential Subjects
  • Sample Phone Screen Level 1a
  • Sample Phone Screen Level 1b
• Guidance
• Screen1a
• Screen1b
Research Information Sheet - Use for Waiver of Documentation & Exempt applications
doc
09/18
Schedule of Procedures Table
doc
10/05/17

 

Other Forms:

    HS Research determination; IND & IDE forms; Other
Human Subject Research (HSR) Determination Form
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
Required Questions - VA Research
International Research Supplemental Questions – research outside the US
Gene Transfer Protocol Application Supplemental Questions
DOE-supported research: Protection of Personally Identifiable Information (PII)    [Form APP-14]
  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
• 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).