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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 (MRI studies)

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

For questions, please contact IRB Education

    Consents
        See consent template updates for recent changes
VA
[rev. date]
Stanford
[rev. date]
Consent (HIPAA embedded)
doc
w/HIPAA
02/23/16
Consent
Note: VA requires participants to sign a separate HIPAA   (FORM 10-0493)
VA doc
11/24/15
doc
no HIPAA
02/23/16
Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.) Note: VA requires participants to sign a separate HIPAA   (FORM 10-0493)
VA doc 12/16/13

doc
w/HIPAA
02/23/16

Minimal Risk Consent - MRI for research (e.g., for fMRI use in behavioral research; HIPAA included)
doc
02/23/16
HIPAA Authorization   -  VA Form 10-0493 - standalone document
VA pdf 09/15
doc
02/23/16
VA Header & Footer 10-1086
VA doc 11/2/11
Sample consent - Blood draws only (HIPAA included)
doc
02/23/16
Sample consent - Data collection only (HIPAA included)
doc
02/23/16
Sample consent - Use of leftover specimens only (HIPAA included)
doc
02/23/16
Short Form Consent Process & Templates
Somatic Cell Donation for Stem Cell Research (HIPAA included)
doc
02/23/16
Sample consent language for particular situations:
  • Diagnostic Use of Ionizing Radiation
doc
10/11
Video Use Consent
doc
02/23/16
   Assents, scripts, phone screens, info sheet
        See consent template updates for recent changes
Assent – under 18
doc
1/7/15
Assent – adults (18+) unable to provide consent i.e., LAR provides consent
doc
1/7/15
Telephone Screening of Potential Subjects
  • Sample Phone Screen Level 1a
  • Sample Phone Screen Level 1b
Oral Consent Script
doc
12/16/13
Research Information Sheet - Use for Waiver of Documentation
doc
1/7/15

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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 Form - IND
SIR Self-Assessment Form - 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
Gene Transfer Protocol Report Form
DOE-supported research: Protection of Personally Identifiable Information (PII)    [Form APP-14]
   Sample eProtocol Application Forms



      New, Modification, Continuing Review

   (These are for informational purposes only)


New:
   -Regular
   -Expedited
   -Chart Review
   -Exempt
Mod
ContRev
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).

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