Ongoing Actions Post Approval

Once IRB approval has been granted for a human participant research study, the study must be conducted exactly as described to and approved by the IRB. Additionally, approval of the study is granted for a defined period of time, which varies per the level the review. The resources below will describe how to make modifications to your study, obtain renewed approval from the IRB, and handle unanticipated problems that may occur during the study. Information regarding what constitutes noncompliance and how it is addressed by the IRB is also available.

The ORP's Human Participant Protections Quality Management pages offer tips, tools, and self-assessment guides for conducting your study or for preparing for a post-approval review.

 Next: When your study has completed, you will need to close your study with the Office for Research Protections. Please see Closing the Study for more information.

Getting Started → Preparing a New eSubmission Application → The Review Process → Ongoing Actions Post Approval → Closing the Study