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
- The Tissue Banking Consent Language document has been updated to reflect this policy change and can be viewed online at Tissue Banking Consent Language 091513
- In addition to this change, the Tissue Banking Consent Language document has also been updated for clarity, as well as to shorten verbatim language included in the document. A tracked copy of the document can be viewed online at Tissue Banking Consent Language TRACKED Sep 2013. If you are using language from the past version, your consent document is still compliant and does not need revision. If you choose to revise the language, an amendment is required.
- A new index for the IRB’s existing tissue banking guidance is now available online at Creating and Managing Tissue Banks for Research.
Help with Tissue Banking
For additional help with tissue banking requirements, you are highly encouraged to attend the following RATS classes:
- Tissue Banking in Research
- Best Practices Roundtable - Troubleshooting Tissue Banking Issues