Human Research Protection Program

Human Subjects Office

The Human Subjects Office (HSO) assists UGA faculty, staff, and students in meeting the highest ethical and professional standards when conducting research with human subjects.

Our Vision is to enable UGA to become a global leader in human subjects research.

Our Mission is to ensure the UGA research community has practical, accessible resources and tools to ensure the ethical protection of human subjects in research.  We do this work by:

  • convening, engaging, and supporting a diverse and inclusive Institutional Review Board (IRB); and
  • ensuring that policies and educational programs both advance a culture of compliance and safety and elevate the integrity and quality of research in order for the UGA research community to achieve the highest professional standards.

We want the UGA research community to view the Human Subjects Office as a partner in compliance and as a group of dedicated professionals who believe in UGA’s research mission and care about the way we do our work.
Our core Values are:

  • Continuous quality improvement
  • Lifelong learning
  • Problem solving
  • Flexibility
  • Responsiveness

Final Rule Changes: Compliance Delayed until January 21, 2019

Substantial revisions to the federal regulations for the protection of human participants in research (Common Rule) will be effective on January 21, 2019.  These changes will apply to all new studies submitted for IRB determination or review on or after January 21, 2019.  Please note:  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 regulatory 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.

New Exempt Categories

The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The new 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

Possible delay and exceptions:

The revised Common Rule can be found at

Additional resources can be found on the CITI site at

Attention NIH Investigators

Investigators who will be seeking NIH support of clinical trial should review the new and pending NIH policies including: the NIH Definition of a Clinical Trial the Requirements for Registering & Reporting NIH-funded Clinical Trials in requirements for Good Clinical Practice Training, and the Single IRB Policy for Multi-site Research. Please contact the Human Subjects Office ( or 706-542-3199) for more information.

How Do I Report an Adverse Event?

The Principal Investigator (PI) bears direct responsibility for the implementation and conduct of the research and for ensuring the protection of human research participants. The PI must promptly report any unanticipated problems or incidents involving risks to subjects or others to the IRB.

Reportable events include any harm or injury (physical, psychological, social or economic) or other unexpected events occurring as a result of participation in a research study. Such events, unless considered serious (see below), must be reported to the IRB by submitting a Report of New Information in the e-portal ( within 72 hours of any member of the investigative team becoming aware of the event. You also should notify the chair of the department.

If you have any questions, please contact the HSO at 542-3199.