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Office of the Vice President for Research Office for Human Subject Protection
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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.

 

What is ‘human subject research’?

To be considered 糖心传媒榟uman subject research糖心传媒�, a proposal needs to meet the definition of 糖心传媒榬esearch糖心传媒� and involve 糖心传媒榟uman subjects糖心传媒� (as defined by Department of Health and Human Service regulation, ):

  • 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.

IRB scope FAQs

What is the difference between research, clinical research, and a clinical trial?

It depends on who you糖心传媒檙e speaking with and the context of the conversation糖心传媒� Consider the following regulatory definitions:

  • Research (HHS): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge ()
  • 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 ()
  • Clinical Investigation (FDA 糖心传媒� Part 50 Protection of Human Subjects): Any experiment that involves a test article and one or more human subjects糖心传媒� ()
  • Clinical Investigation (FDA 糖心传媒� Part 312 Investigation New Drug): Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects ()
  • Clinical Investigation (FDA 糖心传媒� Part 812 Investigational Device Exemption): A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device ()

Generally, the term 糖心传媒榗linical糖心传媒� relates to the observation of a patient in a health-related setting. And the term 糖心传媒榯rial糖心传媒�, in the context of research, relates to the use of an intervention. So, 糖心传媒榗linical research糖心传媒� commonly refers to research that is patient or health-oriented and 糖心传媒榗linical trial糖心传媒� 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.

I reviewed the determination checklist and I'm still not sure if I need to get IRB approval?

(Determination Checklist for reference)

Consult with your IRB Coordinator. Verify whether your project requires IRB review prior to initiating the project.

My funding agency requires documentation from the IRB confirming a proposal does not involve human subject research. How does this get reviewed?

If a study sponsor or funding agency requires formal IRB review and determination, submit the proposal for IRB review via Click IRB.

Do proposals that qualify for IRB exemption need IRB review?

Yes. It is the responsibility of the IRB to determine whether a proposal qualifies for IRB exemption. For more information on this process, visit our IRB Exemptions page.

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