This section contains all of the medical and nonmedical forms and consent templates that researchers need to submit for IRB review. The IRB recommends the use of the consent templates to help researchers meet the legal requirements for consent.

Consent:

Medical - consent templates, minimal risk samples, short forms

Nonmedical - consent templates, parental permission

Medical & Nonmedical - assent, scripts, phone screens, video, information sheet

Short Form - consent process and templates

• Consent Form Do's & Don'ts (a practical guide)
• Downloading your protocol's latest IRB-approved consent form

See consent template updates for recent changes.

 

Other Forms:

Determination of Human Subject Research

IND and IDE Forms and Instructions

Scientific review

 

eProtocol Forms:

Required Attachments - for VA, international research, etc.

Samples of eProtocol Applications

 

MEDICAL - Consent         See consent template updates for recent changes	VA [rev. date]	Stanford [rev. date]
Consent (HIPAA embedded)		doc w/HIPAA 11/24/15
Consent Note: VA requires participants to sign a separate HIPAA   (FORM 10-0493)	VA doc 11/24/15	doc no HIPAA 11/24/15
Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.) Note: VA requires participants to sign a separate HIPAA   (FORM 10-0493)	VA doc 12/16/13	doc w/HIPAA 1/17/15
Minimal Risk Consent - MRI for research (e.g., for fMRI use in behavioral research; HIPAA included)		doc 11/24/15
HIPAA Authorization   -  VA Form 10-0493 - standalone document	VA pdf 09/15	doc 12/16/13
VA Header & Footer 10-1086	VA doc 11/2/11
Sample consent - Blood draws only (HIPAA included)		doc 12/16/13
Sample consent - Data collection only (HIPAA included)		doc 12/16/13
Sample consent - Use of leftover specimens only (HIPAA included)		doc 12/16/13
Short Form Consent Process & Templates		shortform
Somatic Cell Donation for Stem Cell Research (HIPAA included)		doc 1/7/15
Sample consent language for particular situations:   • Diagnostic Use of Ionizing Radiation		doc 10/11
NONMEDICAL - Consent         See consent template updates for recent changes
Consent		doc 1/7/15
Parent or Legally Authorized Representative Permission		doc 1/7/15
MEDICAL & NONMEDICAL - assent, scripts, phone screens, info sheet         See consent template updates for recent changes
Assent – under 18		doc 1/7/15
Assent – adults (18+) unable to provide consent i.e., LAR provides consent		doc 1/7/15
Telephone Screening of Potential Subjects   • Sample Phone Screen Level 1a   • Sample Phone Screen Level 1b		• Guidance • Screen1a • Screen1b
Oral Consent Script		doc 12/16/13
Video Use Consent		doc 1/7/15
Research Information Sheet - "online consent form"		doc 1/7/15

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Other Forms:

HS Research determination; IND & IDE forms; Other
Determination of Human Subject Research - Application to the IRB	doc
Letter of Agreement - for research in cooperation with other organizations	doc
IND Forms and Instructions:   - FDA 1571 Investigational New Drug Application   - 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 Form - IND	AID-40m
SIR Self-Assessment Form - IDE	AID-41m
Emergency Use of a Test Article - Notification to the IRB	doc

 

Scientific Review
Review of Scientific and Scholarly Validity, and Oversight (by Academic Sponsor)	doc
Review of Scientific and Scholarly Validity (by Dept Chair or School Dean)	doc
Scientific Review Protocol - for projects not otherwise undergoing scientific review	doc

 

eProtocol Forms:

Required Attachments
Required Questions - VA Research		doc
International Research Supplemental Questions – research outside the US		doc
Gene Transfer Protocol Application Supplemental Questions		doc
Gene Transfer Protocol Report Form		doc
DOE-supported research: Protection of Personally Identifiable Information (PII)    [Form APP-14]		doc
Samples of eProtocol Applications (submitted online via eProtocol)
Sample Medical applications:       New, Modification, Continuing Review	• New:    -Regular    -Expedited    -Chart Review    -Exempt • Mod • ContRev
Sample Nonmedical applications:       New, Modification, Continuing Review		• New:     -Regular     -Expedited     -Exempt • Mod • ContRev
eProtocol is used to submit:   • New Protocol applications - see Samples 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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