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.

Stanford

[rev. date]

Stanford – Spanish

[rev. date]

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:

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