Frequently Asked Questions    ​

What is an IRB? What does IRB stand for?
An IRB (Institutional Review Board) is a group of medical, ethical and research experts that review and monitor biomedical and social/behavioral research involving human subjects. 

How would you describe the role of an IRB?
An IRB is tasked with ensuring that human-subject research meets high ethical and regulatory standards. They are established to protect the rights and welfare of human research subjects and they have the authority to approve, monitor, and require modifications in research activities to ensure they adhere to federal regulations.

What types of studies require an IRB review?
All federally-funded, human-subject research, or research into drugs and devices under the jurisdiction of the Food and Drug Administration (FDA)  must go through an IRB review or be formally determined to meet a category for exemption. Exempt research may include, for example, reviews of records or surveys where the subjects can’t be identified and aren’t at risk for civil or criminal liability or damage to their reputation. However, even if IRB review is not required by regulation, review may be required by journals, and an IRB review can be helpful for ensuring the study can withstand outside scrutiny.

What is IRB approval? And how does a study get approved?
IRB approval is the determination that the study in question meets all current ethical and regulatory standards. In order to receive IRB approval, a study must adhere to federal ethical and regulatory guidelines in regards to the safety of human research subjects. 

What is an IRB charged with?
An IRB is charged with reviewing federally-funded human-subject research to ensure subjects aren’t being put at risk. The IRB will determine whether a study is properly designed, meets the highest ethical standards and doesn’t threaten the welfare, rights or privacy of the participants. They have the authority to approve, disapprove or require modifications in order to ensure the study adheres to ethical standards and federal regulations.

How long does IRB approval take?
IRB approval times can vary greatly. A well-designed study that meets high ethical and regulatory standards and has broad medical application can be approved in 2-3 weeks. Reviews take longer if the IRB asks the researcher to resolve any shortcomings of the research design.

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