Change may be good, but it needs to be reported to the IRB

Recognizing when to submit an amendment is crucial. An amendment is viewed as ANY change to what was previously approved to an existing approved Institutional Review Board (IRB) protocol. Some examples for when to submit an amendment are, but not limited to change in: document content/format, study personnel, recruitment material, tests, consent form language, survey questions, and inclusion/exclusion criteria. All changes must be approved by the IRB through an amendment prior to implementation, except when necessary to eliminate apparent immediate hazards to the human subjects. After the decision has been made to implement change in an already approved protocol, it is important to address: what steps need to be followed? What must the amendment contain? What other information should be noted?

To submit an amendment with Solutions IRB start by choosing the application you would like to amend by logging into your Axiom account and selecting “My Applications” within the IRB tab. Scroll to the amendments section at the bottom of the application and use the grey “Create New Amendment” button. Once you have chosen the appropriate sections to modify click the “Create Amendment” button. Next, you will need to click on the button, “Post Modification Form” and select “Add/Edit Answer.” Choose the type of changes you are making and provide detail for the changes. While in the amendment section, upload the documents needed by clicking the top red and white striped context menu. All modified protocols, consent forms, recruitment materials, and any other items that may have been added or modified for the study should be uploaded. Corresponding track changes versions of these documents will need to be provided for our records to aid in the review, along with clean copies for final approval. Lastly, be sure to hit the grey “Submit” button on the left-hand side of the amendment.

It is important to note, failure to report any changes within an amendment will result in a protocol deviation with additional fees to follow. Depending on level of risk or seriousness in failure to report, there is the possibility for an investigation, suspension or even termination. If implementation without approval occurs and is later found during an annual check-in, it could delay continuation of the protocol. Once submitted it is important to wait for the IRB Approval Notice before implementing any proposed modifications, unless as described above and the amendment is needed for patient safety. Keep in mind, it is acceptable to continue with the currently approved protocol during the review process of an amendment.