November 2023

The IRB Review

A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.

For research to be eligible for Exempt IRB Review, all research activities must fall into one or more of the regulatory exemption categories and the IRB must agree the level of review is appropriate based on ethical principles.

ORI has created a new interactive decision tool to guide researchers in determining if a study might qualify for Exempt IRB Review Interactive Tool. Researchers can use the tool to explore exempt categories and answer a series of questions to determine if their research might qualify for Exempt IRB Review.

Minimal risk research qualifying for Exempt IRB Review is excused from the requirement for annual or continuing review.

Exempt Interactive Tool

Holiday Closure - Dates & Deadlines

The Office of Research Integrity (ORI) will be closed Monday, December 25, 2023, through Monday, January 1, 2024, and will reopen on Tuesday, January 2, 2024. If you have received an Institutional Review Board (IRB) continuation review reminder, please check your approval end date and submit materials to ORI as soon as possible to prevent expiration of approval.

In 1947 the Nuremburg Code set the course for voluntary consent in human research as a response to Nazi experiments on concentration camp prisoners during WWII. Documentaries in the early 1970s also pushed prison research to the forefront of public consciousness.

In 1973, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created as means to address ethical concerns in human research. To inform their understanding of research using prisoners as subjects, the National Commission visited four prison facilities. They spoke with prisoners and prison administrators and incorporated what they learned into the ethical framework for research involving prisoners.

On This Day In Human Research History: November 16, 1978, Subpart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subject established federal regulations for conducting prison research.

45 CFR 46 Subpart C

True or False

Research involving prisoners will not fit into any of of the exemption categories.

***Keep Reading for the Answer***

Upcoming ORI Office Hours

Wednesday, November 21, 1:00pm - 2:00 pm

Join Here

Click Here for All Office Hours Dates/Times

The Office of Research Integrity offers consultations by phone, Zoom, or in-person. Consultations are offered for studies in development (with or without an E-IRB submission) as well as approved research projects.

Click Here to Request a Consult

Answer to the Trivia Question:

True. None of the exemption categories in the HHS regulations for research involving human subjects at 45 CFR 46.101(b) apply to research involving prisoners (45 CFR 46.101(i), Footnote 1) For more information on IRB review and research safeguards for research involving prisoners, see the prisoner category of the IRB Survival Handbook.