Research Insights

Substantial revisions to the federal Policy for the Protection of Human Research Participants, also known as the Common Rule, will take place on Jan. 21, 2019. These changes will apply to all new studies submitted for IRB determination or review on or after Jan. 21, 2019. Please note that the revised Common Rule does NOT apply to FDA-regulated or human subjects research supported by the Department of Justice.

What does this mean for UGA researchers?
The Common Rule changes were designed to reduce administrative burden and to enhance the protection of human subjects. The UGA Human Research Protection Program is working to implement the revised regulations. The revisions will include changes to the IRB Portal, policies, and some procedures. There are some specific changes that may be of interest to many UGA researchers. These changes are described below and on the IRB website.

New Exempt Categories
The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The revised Common Rule broadens the types of research that may be determined to be exempt from IRB review. For example, starting January 21, benign behavioral interventions conducted with adults may be determined to be exempt. Also, the collection of identifiable, sensitive information from adults may be determined to be exempt; however, this new category requires a limited IRB review to determine that appropriate privacy and confidentiality protections are in place. Submission to the IRB office to obtain the Exempt determination is still required.

Continuing Review Changes
Some minimal-risk research will no longer require continuing review (renewal). A general progress report will be requested at a period determined by the IRB during initial review, but research activities can continue as approved without waiting for the IRB to acknowledge the report. Such projects will not be assigned an expiration date.

Consent Form Changes
Consent forms must begin with a concise and focused presentation of the key information that is most likely to assist in understanding why one might or might not want to participate in the research. Consent forms must now include information regarding the potential for future use of de-identified data and biospecimens.

Learn More
Additional information is available at the links below.

• UGA Human Research Protection Program website: https://research.uga.edu/hrpp/
• CITI training basic information: https://about.citiprogram.org/en/final-rule-resources/#irbimpact
• Department of Health and Human Services revised Common Rule educational materials: https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html

Contact the Human Subjects Office to schedule in-person group sessions (irb@uga.edu or 706-542-3199)