UA Forms

New!  "Checklist - Attachments to Include with IRB Proposals"

The “Attachments for IRB Submission” checklist includes a detailed listing of documents required for New Projects, Continuing Review, or Amendment applications. Completed checklists are intended only for guidance and organization of materials, and do not need be included with application packets submitted to the HSPP Office.

 New Project

  • Project Review Form
    (Version 10/08)
    For projects involving questionnaires/surveys, records review. No drugs, devices, or medical intervention involved. 

Application for UA-ASU-NAU Projects

This form is to be used for studies in which the PI of the overall project represents either ASU or NAU, but a co-investigator represents The University of Arizona. PI's must submit this completed form accompanied by the ASU or NAU IRB approval letter to our office. In the event that the UofA- IRB does not act as the lead institution for the project, oversight will be deferred to either the ASU-IRB or NAU-IRB.   

Changes to a Project

Continuing Review

 
 
 

 

 
 
 
 
 
 

 

  

 


Study Related Problems

  1. Unanticipated or unexpected in nature, frequency or severity, AND
  2. Related or possibly related to participation in the research (there is a reasonable possibility that it is related), AND
  3. The event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (not already referenced in existing study documents, such as the protocol, consent form or Investigator’s Brochure) 
Reportable events include one or more of the following: 
  1. Protocol Deviation: non-compliance with the protocol (typically does not significantly affect subject’s rights,
    safety, welfare or integrity of data). 
  2. Protocol Violation: accidental or unintentional changes to the IRB approved protocol procedures without prior sponsor AND IRB approval (generally affects subject’s rights, safety, welfare or integrity of data).  
  3. Non-Compliance: failure to comply with Federal regulations, state or local laws, HSPP policy, determinations or requirements of the IRB, or requirements of VA guidance (if applicable).   

Responding to IRB Committee