Documents

Purpose

The IRB evaluates the proposed number of subjects when it reviews the risks and benefits of the proposed research.  When the IRB grants approval, the approval is for the specific number (or range) of subjects described in the IRB application.  This number cannot be increased without prior approval from the IRB.  Data or specimens collected from or about “extra” subjects without prior IRB approval cannot be described in publications or presentations as having been obtained with IRB approval.  This policy applies to all UW human subjects research, regardless of funding.

Further information on definitions, consequences, and researcher responsibilities can be found in the document.