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 05/2023 | |
 Spanish Consent (HIPAA embedded) | ||
Consent without HIPAA Note: For separate VA HIPAA, use FORM 10-0493. | VA doc no HIPAA 05/2023 | doc no HIPAA 05/2023 |
Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.) | VA doc w/HIPAA 05/2023 | doc w/HIPAA 06/2023 |
Spanish Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.) | doc w/HIPAA 06/2023 | |
Minimal Risk Consent without HIPAA Note: For separate VA HIPAA, use FORM 10-0493. | no HIPAA 05/2023 | |
Research Information Sheet with HIPAA - Use for Waiver of Documentation | doc 06/2023 | |
Exempt Medical Research Information Sheet | 06/2023 | |
Minimal Risk Consent - MRI for research (e.g., for fMRI use in behavioral research; HIPAA included) | 06/2023 | |
HIPAA Authorization - VA Form 10-0493 - standalone document | VA pdf 09/2015 | doc 04/2023 |
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 06/2023 | |
Radiation Consent Language | ||
NIH Certificate of Confidentiality (Spanish) | pdf 02/23/16 | |
General Data Protection Regulation (GDPR) Consent Form Language | doc 01/2023 | |
Assents, scripts, phone screens, info sheet See consent template updates for recent changes | ||
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:
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: | ||