What Needs Institutional Review Board (IRB) Review? Questions/Answers
Investigators understand the definition of human research and seek guidance when determining if an activity requires IRB review.
Answers
Could a Human Subject not have a heart beat?
We aren't talking zombies, but the answer is yes.
Even though the regulatory definition of human subject specifies “living individual,” identifiable private information or identifiable biospecimens are also considered to be “Human Subjects.”
Under the definition of human subject, obtaining identifiable private information or identifiable specimens for research purposes constitutes human subjects research and requires IRB review.
"A Human Subject is a living individual about whom an investigator 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)]
Private information is considered a human subject if any study personnel or collaborators:
- can see identifiers;
- have access to a code linking identifiers;
- know who provided the private information; or
- can readily figure out who provided the private information.
For more guidance, see the brief video What Needs IRB Review? [HTML Video, 05:10 minutes]
When does secondary research with specimens or data require IRB Review?
Activities that meet the federal regulatory definition of “research” with a “human subject” require IRB review. Secondary Research involves “re-using identifiable information and identifiable biospecimens that are collected for some other ‘primary’ or ‘initial’ activity.”
The following guidance provides a series of questions and a flow chart for determining whether secondary research requires IRB review. Considering only whether the data or specimens is “identifiable” may result in a wrong determination.
ORI also offers an interactive tool to point you to the most likely level of review based on responses to a series of questions.
UK ORI Secondary Use Research Tool [HTML Interactive Tool]
