The University of Iowa Community-Based Research (CBR) Program was established by The UI Institutional Review Board (IRB) and the Human Subjects Office (HSO) to address the needs of UI researchers involved in research collaborations or affiliations with non-University organizations or independent individuals. CBR Program staff provide support to UI researchers and their Community Partners’ (community-based organizations or independent individuals) who are “engaged” in research activities to ensure regulatory compliance.
Program Eligibility Guidelines
A study must meet the following requirements to be reviewed under the CBR Program:
First, the project must meet the federal regulatory definition of human subjects research. The definition of human subjects research, as outlined by the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46), is split into two separate definitions. The project must meet both of these definition
"Research" is defined by the Office for Human Research Protections (OHRP) as: "a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" [45 CFR 46.102(l)].
“Human Subject” is defined by the OHRP as: “a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." [45 CFR 46.102(e)(1)]
Engaged in Research:
The UI Principal Investigator who is overseeing the project must be determined to be “engaged” in research. Defined by the OHRP as: “an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain:
- Data about the subjects of the research through intervention or interaction;
- Identifiable private information about the subjects of the research; OR
- Informed consent of human subjects for the research [45 CFR 46.116]”
The project’s Community Partners’ must be determined to be “engaged” in research. Defined by the OHRP as listed in item 3 above.
To assist in determining if your project is considered Human Subjects Research you may complete a “Human Subjects Research Determination” form via the UI HawkIRB system.
If you are unsure about the status of “engagement” of the PI or Community Partners, you can schedule an appointment to discuss your project with the Education & Outreach Program Manager.