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:

• risks are minimized for participants and are reasonable when compared to benefits to the individual and/or to society;
• participant selection is equitable so that the benefits and burdens of research are equitably shared;
• privacy and confidentiality are protected (see SoM Privacy Office tips); and
• participants are adequately informed of what their participation will entail so that they can make an informed decision about whether to participate. 
  
  

  • What’s New at the IRB

  • Do I need an IRB Submission?
    
    
  • Research at non-Stanford facilities: Can Stanford human subject, animal subject or human stem cell studies be conducted at non-Stanford facilities?
    
    
  • Forms and Processes
    
    
  • Medical Research
    
    
  • Nonmedical Research
    
    
  • Training - what does the IRB require?
    
    
  • Working with Central and External IRBs (CIRB)
    
    
  • FAQs
    
    
  • Presentations (education) provided to the research community
    
    
  • IRB Contacts
    
    

     

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:

• Checklist: Before the Clinical Phase of the Trial Commences (section 8.2) - Documents on file before the trial formally starts
• Checklist: During the Clinical Conduct of the Trial (section 8.3) - Documents added to the files during the trial

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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

Protocols Qualifying for CIRB Review
The Adult and Pediatric CIRBs are the IRBs of record for certain adult and pediatric national multi-center cooperative oncology group cancer treatment trials.

• Life Cycle of an NCI CIRB protocol at Stanford (flowchart)
• Working with the CIRB (FAQs)
• Instruction Manual for Worksheet Completion in IRBManager
• CIRB Informed Consent Checklist
  

Quick links

• NCI CIRB website
• IRBManager login

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