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
*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 type | Description | Stanford [rev. date] | Stanford – Spanish [rev. date] | VA [rev. date] |
|---|---|---|---|---|
| Regular | For greater than minimal risk research | doc [03/2024] | doc [03/2024] | VA doc [01/2025] |
| Regular without HIPAA | Use with VA Form 10-0493 | N/A | N/A | VA doc [01/2024] |
| Expedited | For minimal risk research (e.g., blood draws, non-invasive specimen collection, interviews, surveys, behavioral interventions, etc.) | doc [03/2024] | doc [03/2024] | VA doc [01/2025] |
| Expedited without HIPAA | Use with VA Form 10-0493 | N/A | N/A | VA doc [01/2024] |
| Somatic cell donation | For stem cell research | doc [09/2023] | doc [09/2023] | N/A |
Short Form Consent Templates can be found HERE.
| Assent template type | Description | Stanford | Stanford – Spanish | VA |
| Adults (18+) unable to provide consent | Use with legally authorized representative (LAR) consent for adults (18+) | doc [01/2023] | doc [01/2023] | N/A |
| Children, age 13-17 years | Use for children age 13-17 | doc [04/2024] | doc [04/2024] | N/A |
| Children, age 7-12 years | Use for children age 7-12 | doc [04/2024] | doc [04/2024] | N/A |
| Information Sheets and Screening Scripts | Description | Stanford | Stanford – Spanish | VA |
| Expedited research information sheet | Use for waiver of documentation (i.e., waiver of signature) for minimal risk procedures | doc [09/2023] | doc [09/2023] | N/A |
| Exempt research information sheet | For exempt research | doc [09/2023] | doc [09/2023] | N/A |
| Screening script, level 1a | Use for waiver of documentation for screening | doc [01/2023] | doc [01/2023] | N/A |
| Screening script, level 1b | Use for waiver of documentation for screening and retaining contact information for future research | doc [01/2023] | doc [01/2023] | N/A |
| Other form types | Description | Stanford | Stanford – Spanish | VA |
| VA HIPAA Authorization (VA Form 10-0493) | Use with regular or expedited consent without HIPAA | N/A | N/A | VA doc [09/2015] |
| Schedule of Procedures table | Use with or insert into consent when standard of care procedures overlap with research procedures | doc [10/2017] | doc [10/2017] | N/A |
| General Data Protection Regulation (GDPR) consent form language | Insert 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 | ||
| Waiver of HIPAA Authorization for VA Studies | doc | |
| Blank eProtocol Application Forms | ||
Requires Stanford SUNetID Login to view New, Modification, Continuing Review (These are for informational purposes only)
| • Medical: -Regular -Regular SCRO -Expedited -Exempt -Chart Review -sIRB -HSR • Mod • Continuing Review • Report • Final Report • Non-Medical: -Regular -Expedited -Exempt -sIRB | |
eProtocol is used to submit: | ||