New repository policy: how it affects your annual IRB continuing review

OHSU’s new Research Repository Policy requires all data or specimens being stored for future research to have Institutional Review Board (IRB) approval.

As you know, one mission of the OHSU Institutional Review Board (IRB) is to protect the rights and welfare of research participants at OHSU.  Managing repositories is an important step in protecting their privacy once the study ends. Remember, a collection of human tissue, specimens, or data is considered a repository when there is no explicit plan to destroy the materials when the research study ends.

So how does the new repository policy impact your continuing study?

The electronic IRB system was updated on August 19, 2010, to guide investigators through this policy change. You can now enter new repository information for your current studies at your continuing review.

Here is what you need to know during continuing review:

CRQs are due to the IRB six to ten weeks before the study approval expiration date. This requirement is even more important now that we have additional information to review.

• If your study has no intention to save data or samples for future research uses, then the CRQ will be processed as usual. The analyst will check all study documents including the initial review questionnaire to see if there are any indications of repository banking or saving activities that are in conflict with what has been indicated in the CRQ. You may receive questions from the analyst to confirm the study’s intentions NOT to save samples or data for future uses.

• If your study includes research repository activities, your responses on the CRQ and the study documents will be reviewed for repository descriptions.

• The study may bank its own samples or data. In this case, the analyst will request that these activities are covered in your protocol or that a new document called a Repository Protocol is created. You will be given instructions for creating this document and for revising any existing study documents if necessary.

• The study may send its samples or data to another OHSU repository. If this occurs, the analyst may request revisions to current study documents but a Repository Protocol will not be requested. If the other OHSU repository has not yet been created, this information should be included in the CRQ.

• The study may send its samples or data to a non-OHSU repository. In this case, the analyst will send you a simple form to complete with information about the repository. This form may be sent to you through the eIRB or by email, and is used to update the study’s initial review questionnaire.

Please note that late CRQ submissions may result in expiration of IRB approval, especially if the study requires revisions to meet new repository requirements. Once it’s clear that your study intends to store samples or data, this information must be included in the consent and HIPAA documents as well as in the protocol. If you’d prefer to update your studies before your CRQ is due, you are welcome to submit a modification request with the information.

The IRB tries very hard to avoid expirations of approval. This may mean that your study is approved WITHOUT the repository information included and with those requirements STILL pending.  If this happens, you may see an “IMPORTANT MESSAGE” added to the approval memo indicating that a modification request must be created to bring the study into compliance with the new repository policy as soon as possible.

Our goal is to bring all studies into compliance with the new repository policy by the end of August 2011. Thank you for your help in achieving this goal!

If you have any questions about this policy, please contact the OHSU IRB.