If you are submitting a memo with your Institutional Review Board submission, it should be written to give the IRB staff and reviewers a brief overview of the initial, modification, continuing review or reportable event. Memos are not required with submissions but are helpful if the changes are extensive, complicated, or potentially confusing.
If you are submitting a modification or continuing review that includes changes to the protocol and/or Investigator’s Brochure, it is important that a summary of the changes be provided. For example, the IRB must know if the risk profile of the drug/device/study has changed and if the inclusion/exclusion criteria have changed and why. If the sponsor does not provide this information it is up to the OHSU researcher to make this information clear to the IRB and the best way to do so is in a memo. Not providing the IRB with this information can delay review and approval of the revisions.
If you have questions, feel free to call our help desk at 503 494-7887, option 1.