Umbrella Research Projects
- Always require FSU IRB review
- May include separate sub-studies
- Streamlines IRB review
Submissions accepted for IRB review AFTER August 1, 2024
WHAT IS AN UMBRELLA PROJECT?
An umbrella project is a general and overarching human research framework within which multiple, separate and more discrete sub-studies may later be carried out, simultaneously or asynchronously to answer multiple research questions of shared interests. As such, an umbrella project is not in itself a study; however, as an umbrella project's organizational objective includes future human research sub-studies, an umbrella project is subject to IRB review and oversight. After initial FSU IRB review and approval of a new umbrella project application, later sub-studies may be reviewed as modifications to the initial application, foregoing the need to submit a new IRB application.
Once the umbrella project is approved by the FSU IRB, the umbrella project PI or sub-study PIs (as proxies for the umbrella study PI) may then submit a study modification to add sub-studies and materials related to their sub-study studies. These team members and sub-study materials are removed via a study modification when the sub-study is complete.
Additional Features and Aspects of Umbrella Projects
- Sub-studies usually share key design components or operational aspects under an umbrella project
- Sub-studies may be conducted by multiple researchers (referred to as sub-study Principal Investigators), who are responsible to the umbrella project Principal Investigator
- If the IRB deems use of an umbrella project as not appropriate for a sub-study, the sub-study modification submission will be returned for revision or submission as a new stand-alone IRB submission
- Umbrella projects generally do not expire and are not required to obtain continuing review from the IRB; thus, continuing review applications are not required
- When a sub-study is complete, then via a study modification: (1) sub-study team members are removed IF the members are not conducting other sub-studies under the FSU IRB-approved umbrella project or do not serve as the umbrella project's PI, primary contact or PI proxy, and (2) sub-study materials are removed
- When the umbrella project is complete (e.g., no further sub-studies are planned and the objectives of the umbrella project have been achieved), the umbrella project should be closed via a continuing review submission
Plans to submit an Umbrella project for FSU IRB review should first be discussed with OHSP in advance of submission to ensure the planned activity aligns with an umbrella project model and related IRB submission requirements. Contact Julie Haltiwanger or Brian Brotzman to schedule a discussion.
Contact information for the FSU IRB and OHSP (bottom of OHSP home page). The garnet ribbon below is information for the FSU Office of Research or FSU generally, and does not include any information for the IRB or OHSP.