2018 Common Rule Update
Major Regulatory Changes
Exemptions
Categories have been updated, mostly to expand the type of research qualifying for
exemption. New categories have been added.
Expedited Continuing Review
Continuing review is no longer required for minimal risk research, including research
originally reviewed by the convened IRB that now qualifies for expedited categories
8 or 9.
Informed Consent
Consent forms are now required to include a “Key Elements” section and new elements
of informed consent are required in some circumstances.
Single IRB of Record
Beginning January 20, 2020, most federally-funded multi-site/collaborative research
projects occurring in the U.S. will be required to use a single IRB.
Minor Regulatory Changes
Human Subject Research
The definition of what qualifies as human subject research has been updated to include
identifiable biospecimens and to specifically exclude particular types of non-research
activities.
Waiver of Informed Consent
In order to approve a waiver of informed consent, in addition to previously existing
waiver criteria, the IRB must now also determine: If the research involves using identifiable
private information or identifiable biospecimens, the research could not practicably
be carried out without using such information or biospecimens in an identifiable format.