Where Do I Get A Template To Write An Irb Protocol Stanford

Medical Inquiry: Forms & Consent Templates

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This section contains all of the forms and consent templates that apply to investigators from:

• School of Medicine (SoM)
• Veteran'south Affairs (VA) Hospital
• Psychology (fMRI studies)

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

If y'all take questions or are having trouble accessing these forms, delight contact IRB Instruction (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 every bit needed when writing your consent form.

Consents Run across consent template updates for contempo changes	VA [rev. engagement]	Stanford [rev. date]
Consent (HIPAA embedded)	VA medico w/HIPAA 04/2021	doc west/HIPAA 10/2021
Consent without HIPAA Note: For split up VA HIPAA, apply FORM x-0493.	VA physician no HIPAA 04/2021	doc no HIPAA 10/2021
Minimal Risk Consent (east.g., blood draws, information collection, leftover specimens, interviews, surveys, behavioral interventions.)	VA physician due west/HIPAA 12/2/xix	doc westward/HIPAA 10/2021
Minimal Take chances Consent without HIPAA Note: For carve up VA HIPAA, apply Form 10-0493.	VA doc no HIPAA 04/2021
Minimal Risk Consent - MRI for research (due east.g., for fMRI utilise in behavioral research; HIPAA included)		doc 10/2021
HIPAA Authorisation - VA Form ten-0493 - standalone document	VA pdf 09/2015	medico 02/23/16
VA Header & Footer 10-1086	VA doctor eleven/02/11
Brusk Form Consent Procedure & Templates		shortform
Somatic Cell Donation for Stem Prison cell Research (HIPAA included)		doctor 11/2021
Radiation Consent Language		EH&Due south Website
NIH Certificate of Confidentiality (Castilian)		pdf 02/23/xvi
General Data Protection Regulation (GDPR) Consent Class Linguistic communication		physician 05/12/21
Assents, scripts, phone screens, info sheet See consent template updates for contempo changes
Assent – under 18		doc 01/07/fifteen
Assent – adults (18+) unable to provide consent i.e., LAR provides consent		doctor 01/07/15
Telephone Screening of Potential Subjects • Sample Phone Screen Level 1a • Sample Phone Screen Level 1b		• Guidance • Screen1a • Screen1b
Research Information Canvass with HIPAA - Use for Waiver of Documentation & Exempt applications		doc ten/2021
Schedule of Procedures Tabular array		doc ten/05/17

Other Forms:

HS Enquiry determination; IND & IDE forms; Other
Homo Subject area Inquiry (HSR) Determination Course	VA doc \| doc
Letter of Agreement - for inquiry in cooperation with other organizations	doc
IND Forms and Instructions: - FDA 1571 Investigational New Drug Awarding - FDA 1572 Statement of Investigator - Instructions for completing FDA forms 1571 and 1572	FDA/CDER website
IDE application	FDA website
FDA forms & submission requirements (drugs)	FDA website
SIR Self-Assessment Checklist - IND/IDE	Assist-58m
Emergency Apply of a Test Commodity - Notification to the IRB	pdf
NIH Genomic Data Sharing (GDS) Consent Checklist	pdf

Scientific Review
Review of Scientific and Scholarly Validity, and Oversight (past 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 Enquiry		doc
International Inquiry Supplemental Questions – enquiry outside the US		doc
Gene Transfer Protocol Application Supplemental Questions		doc
DOE-supported enquiry: Protection of Personally Identifiable Information (PII) [Form APP-fourteen]		doc
Blank eProtocol Application Forms
Requires Stanford SUNetID Login to view New, Modification, Continuing Review (These are for advisory purposes only)	• Medical: -Regular -Expedited -Exempt -Chart Review -sIRB -HSR • Modernistic • Standing Review • Not-Medical: -Regular -Expedited -Exempt -sIRB
eProtocolis used to submit: •New Protocolapplications - 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. •Terminal Reports (not required for Exempt research).