The Common Rule is a set of ethics regulations governing biomedical and behavioral research on human
subjects.1 Adherence to the Common Rule
is mandatory for federally funded proj-
ects involving research on human subjects
where the sponsoring agency has adopted
the Common Rule. Some agencies that
have adopted the Common Rule are the
Department of Agriculture, Department of
Education, Department of Transportation,
Department of Justice, National Science
Foundation, and NASA. Agencies that have
not adopted the Common Rule are the Social
Security Administration, the Department
of Homeland Security, and the Central
Intelligence Agency (CIA). The changes, as
stated in the Notice of Proposed Rulemaking
(NPRM), issued January 19, 2017, may
require changes in the grant review pro-
cess of Institutional Review Boards (IRBs)
and Offices of Integrity (ORIs). The updated
changes required by the federal rules may
also result in higher costs and
Furthermore, communicating these new changes to principal
investigators (PIs), project directors, and others results in questions
regarding how projects can be
reviewed efficiently and effectively
and still maintain compliance.
Thus, the University of Kentucky’s
Internal Audit department, in
response to the recent changes to the
Common Rule, undertook a survey
to attempt to answer some of the
· How will the Common Rule
changes affect the operations of
ORIs and IRBs?
· What changes will ORIs make in
reaction to the new requirements
in the Common Rule?
· Will the changes to the Common
Rule necessitate significant
modifications in procedures
Major changes to the Common Rule
The changes to the Common Rule encompass
new definitions, new interpretations, and
by Urton Anderson, CIA, CCEP; Ralph Kimbrough, Jr., CPA, CIA; and Sean Liao
Research: Institutional Review
Boards and the Common Rule
» Challenges ahead for adopters of Common Rule revisions encompass new definitions, new interpretations, and new rules.
» Offices of Research Integrity face structural changes due to revisions.
» External IRB reviews are on the rise, requiring greater oversight responsibility.
» Costs and workloads of IRB reviews will most likely increase.
» IRB reviews will have to be tailored by institutional size and complexity.
Urton Anderson ( firstname.lastname@example.org) is Director of the Von Allmen
School of Accountancy at the University of Kentucky. Ralph B. Kimbrough, Jr.
( email@example.com) is Audit Manager for the University of Kentucky.
Sean Liao ( firstname.lastname@example.org) is a Research Intern for Dr. Ralph Kimbrough at
the University of Kentucky in Lexington, KY.