Changes to the Procedure for Re-Approval of Questionnaires/Instruments During IRB Continuing Review
As of January 7, 2014, Continuing Review Applications no longer need to include a copy of the previously –approved study instruments if no changes have been made to these documents. Study instruments include but are not limited to the following documents: questionnaires, surveys, focus group question, instructions, etc.
In place of submitting the actual instruments, you should submit a separate Word document that lists the names of all of the previously-approved instruments that are currently being used in the study. The IRB will review the list to ensure that all instruments on the list have been previously reviewed and approved by the IRB. The IRB will apply an approval stamp to the list once the continuing review application has been approved. We will send this approved list to you along with your IRB Approval Letter. Going forward, you will use un-stamped versions of the instruments.
If, however, changes are being proposed to any instrument or if any instrument is being removed or added, please submit an amendment to reflect the changes. Additionally, submit a list to document all of the non-changed instruments.
Please note that this procedural change only applies to instruments and questionnaires being reviewed at the time of continuing review. All other study documents such as flyers, recruitment brochures, recruitment letters, etc. should be submitted as attachments to your annual continuing review application. In addition, when submitting a New Application or an Amendment to add a new instrument, you must submit the actual instrument for review and approval.
Please contact the IRB office if you have questions or concerns.