Can an IRB ask for changes to my application for waiver of authorization or altered authorization?
Yes. If an IRB finds the information regarding the waiver or alteration inadequate, it may ask for clarifications or modifications. Also, IRBs may not approve requests that do not meet the criteria for waiver or altered authorization. For example, applications that would not usually fulfill the waiver criteria are research that 1) involves the collection of sensitive PHI (unless adequate precautions are in place to protect the identifiers); 2) involves plans to re-contact the person whose PHI would be used for research purposes; or 3) involves the disclosure of PHI outside the University of Wisconsin Health Care Component (HCC) and outside the Affiliated Covered Entity (ACE).
Related Questions
- What information do I need to include in my IRB application, renewal or revision to request a Waiver of Authorization?
- Can an IRB ask for changes to my application for waiver of authorization or altered authorization?
- What is the difference between a waiver of authorization and an altered authorization?
