As a flexibility initiative, the UI IRB allows the creation of Umbrella projects. An umbrella project is a type of HawkIRB application that seeks approval for sub-projects that follow a common pattern or paradigm and are conducted by multiple researchers.  The umbrella project Principal Investigator (PI) must be faculty or staff actively engaged in oversight. They create a HawkIRB New Project application outlining the parameters and providing template documents for the sub-projects. Once the project is approved, the PI can submit HawkIRB Modification forms to add team members, abstract forms and other documents related to new sub-projects. These team members and materials are removed via a HawkIRB Modification form when studies under an umbrella application are complete.

Overall umbrella project approval is at the discretion of the IRB.  Contact the Human Subjects Office for assistance with establishing a new umbrella project or managing an existing one.

Umbrella Project Policy

The IRB Standard Operating Procedures & Researcher Guide (Section I, Part 17) outlines the conditions that apply to umbrella projects.

Umbrella Project Application Guidance

See the Umbrella Project Educational Tool for step-by-step instructions to prepare New Project, Modification and Continuing Review or Biennial Review forms for an Umbrella Project.

Examples of Umbrella Projects

Umbrella Projects can involve retrospective review, secondary data analysis or prospective data collection. Here are some example Umbrella Projects:

Retrospective medical records reviews in Radiology

Many trainees (students, residents, postdoctoral fellows/scholars) conduct retrospective medical record reviews with a standard and consistent research question. Example: how well does a particular imaging test perform in predicting specific disorders, as confirmed by later clinical course or other diagnostic studies? If submitted after the new HawkIRB form was released in January 2022, retrospective record reviews or secondary data analysis may qualify for Exempt Status, with waiver of consent and waiver of HIPAA authorization. As individual trainees develop sub-projects, they complete an abstract form which provides specific details for the sub-project, including a hypothesis/research question, the date the review of records will begin and end, and the earliest and latest date of the data being accessed. All records reviewed for the sub-project must exist at the time the HawkIRB Modification Form to add the sub-project is submitted, to be consistent with the regulatory requirements for waiver of consent for the review of “retrospective” data.  Note: Unlike individual HawkIRB applications for retrospective record review, it is acceptable for the latest date that data will be accessed for a sub-project to be after the date of submission for the Umbrella Project New Project form.

Marketing research in the College of Business

A professor in the College of Business has an umbrella project primarily for students to conduct research about consumer behavior and decision-making. Subjects come from a pool of students in the College who receive course credit for participating in research studies. Subjects complete surveys on paper, in a computer lab or online. Depending on the nature of the questions, studies like this may qualify for a waiver of documentation of consent (no subject signature required on the consent document) or exempt status (subjects receive an exempt information sheet prior to participating in the survey). The exact questions posed to the students vary, but the general theme is that students are given certain choices from which to choose. No personal information is sought, and individual results are not linked to the student’s identity.

[Note: It is not an umbrella project when the Principal Investigator (PI) plans to conduct variations of the study design in separate waves by making slight changes to stimuli or other study procedures. The UI IRB also does not use this term for multi-site projects.]