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If a proposal meets the definition of ‘research’ and ‘human subjects’, IRB review and approval is required.
When Do You Need RSRB (IRB) Approval?
OHSP policy requires all human subject research conducted or supported by employees or agents of the University of Rochester to undergo Institutional Review Board (IRB) review. The University’s IRB is called the Research Subjects Review Board (RSRB).
What is ‘human subject research’?
To be considered ‘human subject research’, a proposal needs to meet the definition of ‘research’ and involve ‘human subjects’ (as defined by Department of Health and Human Service regulation, 45 CFR 46.102):
- Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subject: A living individual about whom an investigator conducting research: a) obtains information or biospecimens through intervention or interactions with the individual and uses, studies, or analyzes the information or biospecimens or b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Note: The Food & Drug Administration’s (FDA) definition of ‘research’ and ‘human subject’ differs from the Department of Health and Human Service, based on the involvement of a test article. Reference our definitions FAQ for more information.
RSRB (IRB) scope FAQs
It depends on who you’re speaking with and the context of the conversation… Consider the following regulatory definitions:
- Research (HHS): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l))
- Clinical Trial (HHS): A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes (45 CFR 46.102(b))
- Clinical Investigation (FDA – Part 50 Protection of Human Subjects): Any experiment that involves a test article and one or more human subjects… (21 CFR 50.3(c))
- Clinical Investigation (FDA – Part 312 Investigation New Drug): Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects (21 CFR 50.312.3(b))
- Clinical Investigation (FDA – Part 812 Investigational Device Exemption): A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device (21 CFR 50.812.3(b))
Generally, the term ‘clinical’ relates to the observation of a patient in a health-related setting. And the term ‘trial’, in the context of research, relates to the use of an intervention. So, ‘clinical research’ commonly refers to research that is patient or health-oriented and ‘clinical trial’ commonly refers to a type of clinical research that involves some type of intervention (e.g., a drug, device or behavioral intervention).
That said, these terms are often used interchangeably. Definitions may depend on the context, funding agency, and applicable regulations/policies.
(Determination Checklist for reference)
Consult with your IRB Coordinator. Verify whether your project requires IRB review prior to initiating the project.
If a study sponsor or funding agency requires formal IRB review and determination, submit the proposal for IRB review via Click IRB.
Yes. It is the responsibility of the RSRB (IRB) to determine whether a proposal qualifies for IRB exemption. For more information on this process, visit our IRB Exemptions page.