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IRB Home > For Researchers

  For Researchers           

Quick links:
   Forms & Consent Templates
   Determination of Human Subject Research (HSR) Application for decision whether project is HSR

The IRB’s primary concerns in the review of research are that:

Do I need an IRB Submission?

Does My Project Need IRB Review? (pdf)

Determination of Human Subject Research Application (Word doc)

IRB Review Type: What is it and why do I need to know?

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Forms and Processes

Forms & Consent Templates

Consent

Recruitment

Emergency Use of a Test Article

Extended Approval Period for some Research (Triennial review)
The approval period is extended for qualifying non-federally sponsored research, involving no more than minimal risk (as defined by 45 CFR 46.102), to researchers conducting:

  • Nonmedical studies, (effective10/1/2011)
  • Medical human subject chart review studies, (effective 3/1/2013)

as long as certain conditions are met.  Certain changes in these studies may change the triennial IRB review requirement to annual review. See Extended Approval Policy.

 

Medical Research

Medical Application Process

Filling out the Medical Protocol Application

Sample Medical eProtocol applications

 

Clinical trial documents: The following checklists are from the FDA E6 Consolidated Guidance for Good Clinical Practice:

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Nonmedical Research 

Nonmedical Application Process

Information about eProtocol Sections for Nonmedical Applications

Sample Nonmedical eProtocol applications



Working with Central and External IRBs (CIRB)
In some cases, Stanford researchers may rely on an external (non-Stanford) IRB to review their human subject research. Stanford has a memorandum of understanding (a written agreement) with the external IRBs listed below, who may be relied upon to conduct IRB review for certain types of research:

NCI CIRB - the NCI Central IRB Initiative

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