Guidance on when to submit amendments versus new project applications

New project or modification? That is the question. Whether ‘tis nobler to change an existing study in AURA or ‘tis better to start fresh? If you engage in research long enough, at some point you face this quandary. While there is no absolute rule to follow, here are a few questions that can help guide your decision.

Does the revision alter my research hypothesis?

If the basic research question remains intact, then a new application might not be warranted. If the new aspect involves a new focus or research question, even if it builds on the knowledge learned in an existing study, a new application may be needed.

How substantially will my procedures change?

The more your new procedure(s) deviate from the original research plan, the more you should consider submitting a new application. Don’t let your study become unwieldy with multiple add‐ons that blur the focus of your
research and prevent others from comprehending study procedures.

How long has my study been open?

If your application was approved by the IRB 5 or more years ago, it may include outdated aspects, and in this case, a new application would allow you to refresh your hypothesis, your procedures, and ensure that all aspects of the application align.

Will I utilize a new grant?

New funding may point to new directions for your research, and a new application will cleanly delineate this new focus.

It is a fallacy to think that adding an amendment  to an existing study will always be easier than submitting a new application. In fact, an amendment that results in an overly long application with many inconsistencies and inclusion of information and documents that are no longer relevant, can be much more confusing to reviewers than a new, shorter “clean” application which is current and consistent. The IRB will scrutinize a major revision to an existing study with the same diligence that a new application receives, and we
tell investigators who submit major changes to their study that a new application is needed instead. The new application can reference the “parent” study, and can utilize the same subjects (when appropriate).
If in doubt, call us -- the SBS IRB staff would be happy to discuss proposed changes with you!

With thanks to Becka Simpson of the University of Iowa IRB, who wrote the article from which this was adapted.  Our thanks to the University of Iowa IRB for allowing us to adapt this article.