March 2020 - Changes in Protocol after Approval
To soften a well-known adage:
stuff happens. Whether it’s discovering a new way to gather data, a realization that you forgot something in your application, or large unforeseen issues that restrict contact with participants, like a pandemic, sometimes our research design changes.
When your new design might introduce concerns to confidentiality, issues about someone’s willingness to participate, requirements for additional efforts for participants, or anything else that fundamentally changes the study, you must first submit these changes to the IRB before continuing your study with those changes.
To submit changes, use the following form:
https://www.stcloudstate.edu/irb/_files/documents/irb-protocol-revision-modification-form.docx
Will this slow down my study?
Usually, no, but that depends on the risk to participants the new changes bring. When new risk might be introduced, additional precautions might be needed, like a modification to the consent form to alert participants to the new risks. Additional approvals might also be required (e.g., when the change alters the protocol from expedited to full board [see:
https://www.stcloudstate.edu/irb/review.aspx]).
As always, please let us know if you have any questions over these or other IRB-related topics.
Happy researching!
