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  Forms & Templates

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

Other Forms:

Determination of Human Subject Research

IND and IDE Forms and Instructions

Scientific review

eProtocol Forms:

Required Attachments - for VA, international research, etc.

Sample eProtocol Applications

    MEDICAL - Consent
VA
[rev. date]
Stanford
[rev. date]
Consent (HIPAA embedded)
doc
w/HIPAA
3/21/14
Consent (VA doc contains ICF, followed by a HIPAA Authorization)
VA doc
3/21/14
doc
no HIPAA
3/21/14
Minimal Risk Consent (e.g., blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions.)
VA doc 12/16/13

doc
w/HIPAA
12/16/13

Minimal Risk Consent - MRI for research (e.g., for fMRI use in behavioral research; HIPAA included)
doc
3/21/14
HIPAA Authorization - standalone document
VA doc 7/24/13
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
Somatic Cell Donation for Stem Cell Research (HIPAA included)
doc
12/16/13
Sample consent language for particular situations:
  • Diagnostic Use of Ionizing Radiation
doc
10/11
   NONMEDICAL - Consent
Consent
doc
12/16/13
Parent or Legally Authorized Representative Permission
doc
12/16/13
    MEDICAL & NONMEDICAL - assent, scripts, phone screens, info sheet
Assent – under 18
doc
1/7/13
Assent – adults (18+) unable to provide consent i.e., LAR provides consent
doc
1/7/13
Telephone Screening of Potential Subjects
  • Sample Phone Screen Level 1a
  • Sample Phone Screen Level 1b
Oral Consent Script
doc
12/16/13
Video Use Consent
doc
12/16/13
Research Information Sheet - "online consent form"
doc
12/16/13

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Other Forms:

    HS Research determination; IND & IDE forms; Other
Determination of Human Subject Research - Application to the IRB
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 Form - IND
SIR Self-Assessment Form - IDE
Emergency Use of a Test Article - Notification to the IRB

 

    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;   Sample Applications
Required Questions - VA Research
International Research Supplemental Questions – research outside the US
Gene Transfer Protocol Application Supplemental Questions
Gene Transfer Protocol Report Form
DOE-supported research: Protection of Personally Identifiable Information (PII)    [Form APP-14]

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 must be used to submit:
  • New Protocol applications - see Samples above.
      - For VA research also complete and attach Required Questions - VA Research
        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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