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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

Find out more! 

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.

Find out more: see a panel below about key requirements, examples and templates.

Key Requirements for Umbrella Projects:

  • Discuss your plan to submit an umbrella project with OHSP staffers; email Julie Haltiwanger, Brian Brotzman or Howard Stone to schedule a discussion, or register for one of our virtual IRB office hours (every Wednesday from 10-11AM ET (more details))
  • Umbrella projects should not at this time be submitted for basic, medical and clinical research studies that involve health-related interventions (experimental or standard of care), including use of pharmaceutical or controlled drugs, devices (including any software that may be considered as a device), biologics, nutritional supplements or combination products
  • Umbrella projects and their sub-studies always require some level of FSU IRB review, although expedited review or limited IRB review may be suitable under certain conditions (check here for the different IRB review pathways and review turn-around time)
  • Requests for IRB review of any new or revised umbrella projects or sub-studies must be submitted in RAMP IRB
  • Umbrella projects and their sub-studies submitted for FSU IRB review require use of specific protocol templates tailored to those types of studies
    • umbrella project templates are intended to collect more general information about the overall research framework while sub-study protocol templates require submision of much more specific information and related study materials 
    • check the templates panel below for information about and RAMP IRB links to those templates 
  • Adding a sub-study under an existing FSU IRB-approved umbrella project, or modifying an approved sub-study, requires submission to the IRB of a study modification (NOT a new study) to the umbrella project in RAMP IRB

Umbrella projects and their sub-studies may cover a wide range of research frameworks and their specific research objectives and activities. These may include education research examining more in-depth issues such as graduate student supports; health care research into primary care access or post-treatment outcomes; and social science research about foster care placement or criminal justice.

The essential feature of umbrella projects is that their sub-studies explore or acquire more focused knowledge that contribute to the overarching umbrella project's general research interests and objective. In many cases, study design components and research operations may be shared among the umbrella project's sub-studies.

Check out our examples of common umbrella projects, related sub-studies and sub-study activities. The examples are intended for illustration only.

Umbrella projects and their sub-studies submitted for FSU IRB review require use of protocol templates specifically tailored to those types of studies. Umbrella project templates are much more streamlined than the typical IRB study protocol, and are intended to collect general information about the overall research framework; sub-study protocol templates are more similar to the typical IRB study protocol, requiring information and related study materials (study measures; consent forms; etc.) that are specific to the planned sub-study. 

For the umbrella project, use only HRP-503u - TEMPLATE UMBRELLA PARENT PROTOCOL

For a sub-study, use only HRP-503uss - TEMPLATE UMBRELLA SUBSTUDY PROTOCOL; however, IF your umbrella (parent) project has already been determined exempt, use only the more abbreviated HRP-503dss - Template Sub-study Determination Form.

Be certain to use only the current IRB-approved templates. If your study's protocol does not conform to a template, your submission will be returned to you for correction and resubmission, resulting in needless delay in the review of your project. Required study-related materials, such as consent forms, must also follow the FSU approved templates, and these may be uploaded together with research protocols in the applicable RAMP IRB submission workspace sections. 

These and all other templates are accessible by logging into RAMP IRB, and navigating to the IRB, Library and Templates tabs. Instructional videos on how to submit your study in RAMP IRB are available at this link.

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.

Questions? Click for FAQs!