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
- The Tissue Banking Consent Language document has been updated to reflect this policy change and can be viewed online at http://irb.utah.edu/_doc/Tissue%20Banking%20Consent%20Language%20091513.docx
- 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 http://irb.utah.edu/_pdf/Tissue%20Banking%20Consent%20Language%20TRACKED%20Sep%202013.pdf. 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 http://irb.utah.edu/guidelines/index-tissue-banking.php.
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: https://education.research.utah.edu/class_details.jsp?offeringId=193
- Best Practices Roundtable - Troubleshooting Tissue Banking Issues: https://education.research.utah.edu/special_events.jsp
The VA administrative review has been incorporated into ERICA's new study review process.
The IRB has updated a number of consent and parental permission document templates.
Due to changes in HIPAA regulation released in March 2013, participation in the tissue bank must be optional for treatment/intervention trials.
The IRB has reviewed studies where the sponsor section of the application is blank, even when the study has a sponsor.
This policy change proposes one additional non-federal exemption category, and outlines the new Exemption Umbrella Protocol procedures.
Effective Monday, April 29, 2013, the ERICA system will be updated.
The IRB is pleased to announce two new Coordinators have been selected!
There will be several IRB staff changes in the coming weeks.