NOTE: No changes may be implemented to your study until you receive a response from the IRB stating that your proposed changes have been approved.

If your study has received full IRB approval (not conditional IRB approval) and you need to make changes to your approved procedures or materials, then you should submit those changes in IRB Manager using an IRB Modification Form, with the following exception:

Learners who received a review designation of “not human subjects research” (e.g. most capstone learners) and need to make revisions to their procedures or materials should contact the IRB Office for further guidance. This applies to learners who completed the Doctoral Capstone Screening Form and received a determination of Not Human Subjects Research from the Capella IRB Office.

Your proposed changes may also require you to submit additional documents as attachments to your IRB Modification Form. For instance, if you wish to add a new recruitment site to your study, you will likely need to provide a permission document from that site. (Contact the IRB Office if you are unsure about site permission materials.) Or if you need to make changes to your recruitment and informed consent procedures or materials (including alterations to your inclusion/exclusion criteria), then you will need to attach updated copies of those revised materials to your IRB Modification Form in the designated section on the form.

For the majority of studies, amendment/modification requests are approved quickly. However, proposed changes that alter the risk determination for a study, or introduce a new conflict of interest, or involve significant changes to previous procedures or materials may require additional review and a lengthier approval process.

To locate and submit the IRB Modification Form in IRB Manager, use the attached step-by-step guide