Human Research Protection Program

Develop & Submit

Obtain
Training

Plan &
Collaborate

Develop &
Submit

Review &
Respond

Post Approval
& Reporting

Be prepared to provide the UGA IRB with a description of your project purpose and procedures, and all materials that will be provided to participants and used to collect information.
Policies and Procedures
Many common questions can be answered by reviewing the Human Research Protection Program Policies and Procedures. Search by keyword or view an alphabetical list. Many policies contain links to templates and other helpful resources.
IRB Portal Library
UGA employees and students can also access policies and procedures, templates, and worksheets in the IRB portal.
IRB Portal
All submissions to the IRB must be through the IRB Portal. Submission forms are interactive; new pages will open and some may close depending on your response to certain trigger questions. Therefore, it is difficult to provide a sample submission since the content may vary considerably.

Protocols eligible for review by expedited procedure or for exempt determination are processed in the order received by the Human Subjects Office.  Expedited review takes an average of 40 days and exempt determinations take an average of 20 days.
New protocols, modifications, and continuing reviews must be submitted for Full Board review by the submission deadline posted in the meeting schedule.

Certain grant applications and proposals lacking definite plans for involvement of human subjects may qualify for Developmental Review. This determination is only granted by the Human Subjects Office to satisfy the funding agency’s requirements or to allow investigators to have access to funding to begin aspects of the project that do not involve human subjects. These applications need not be reviewed by an IRB before an award may be made. However, no human subjects may be involved in any project supported by these awards until the IRB has reviewed and approved the human research activities in the project.

Activities must meet the DHHS or FDA definition of “research” involving “human subjects” for the activity to fall under IRB oversight. Activities that do not meet the definition of “Research involving Human Subjects” are not subject to IRB oversight or review. Review the policy for Determination of Human Subjects Research and contact the Human Subjects Office in cases where it is unclear whether an activity meets the regulatory definition of Human Research for additional assistance.

The IRB Portal will send an email confirmation to the Principal Investigator and selected Contacts for each successfully submitted project. Also the project status for the submission will transition to the appropriate review state. Submissions in state “Pre-Submission” or “Draft” have not been submitted for review and are editable by the study team.