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.
| VA [rev. date] |
Stanford
[rev. date] |
|
|---|---|---|
|
Consent (HIPAA embedded)
|
w/HIPAA
04/2021
|
|
 |
|
|
|
Consent without HIPAA
Note: For separate VA HIPAA, use FORM 10-0493. |
VA doc
no HIPAA 04/2021
|
doc
01/2023no HIPAA |
|
Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.)
|
VA doc
w/HIPAA 12/2/19
|
doc
w/HIPAA 01/2023 |
|
|
|
doc
w/HIPAA 01/2023 |
|
Minimal Risk Consent without HIPAA
Note: For separate VA HIPAA, use FORM 10-0493. |
no HIPAA
04/2021 |
|
|
Research Information Sheet with HIPAA - Use for Waiver of Documentation & Exempt applications
|
doc
01/2023 |
|
|
Minimal Risk Consent - MRI for research (e.g., for fMRI use in behavioral research; HIPAA included)
|
01/2023 | |
|
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
01/2023 |
|
|
Radiation Consent Language
|
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|
NIH Certificate of Confidentiality (Spanish)
|
pdf
02/23/16 |
|
|
General Data Protection Regulation (GDPR) Consent Form Language
|
doc
01/2023 |
|
|
Assent – under 18
|
doc
02/2023 |
|
|
Assent – adults (18+) unable to provide consent i.e., LAR provides consent
|
doc
01/2023 |
|
|
Telephone Screening of Potential Subjects
• Sample Phone Screen Level 1a • Sample Phone Screen Level 1b |
||
|
Schedule of Procedures Table
|
doc
10/05/17 |
|
Other Forms:
|
Human Subject Research (HSR) Determination Form
|
|
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Initial Submission Checklist for Investigators (Medical)
|
|
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Letter of Agreement - for research in cooperation with other organizations
|
|
|
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
|
|
|
Review of Scientific and Scholarly Validity, and Oversight (by Academic Sponsor)
|
|
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Review of Scientific and Scholarly Validity (by Dept Chair or School Dean)
|
|
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Scientific Review Protocol - for projects not otherwise undergoing scientific review
|
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eProtocol Forms:
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Required Questions - VA Research
|
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International Research Supplemental Questions – research outside the US
|
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Gene Transfer Protocol Application Supplemental Questions
|
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DOE-supported research: Protection of Personally Identifiable Information (PII) [Form APP-14]
|
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Blank eProtocol Application Forms
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Requires Stanford SUNetID Login to view New, Modification, Continuing Review (These are for informational purposes only)
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• Medical: -Regular -Expedited -Exempt -Chart Review -sIRB -HSR • Mod • Continuing Review • Non-Medical: -Regular -Expedited -Exempt -sIRB |
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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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