IRB Updates: Changes to Tissue Banking Policy

The IRB requires investigators to indicate in the consent document whether or not it is mandatory to participate in a tissue bank if the participant wants to be in another larger or primary study.  Some studies require participation in the tissue bank as a condition of participation and this must be stated in the consent form.  Other studies are designed only for the purpose of tissue banking.  If tissue banking is the purpose of the study, this must be made clear to the participant.

Due to changes in HIPAA regulation released in March 2013, investigators may not condition participation in a treatment/interventional trial upon participation in a tissue bank.  Participation in the tissue bank must be an optionalsub-component for treatment/intervention trials.  Currently approved treatment and intervention trials with mandatory tissue banking described in the consent document must be corrected at next continuing review.  

Summary of Document and Website Changes

Help with Tissue Banking

For additional help with tissue banking requirements, you are highly encouraged to attend the following RATS classes: