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.
HSO performs professional and administrative functions in support of the Institutional Review Board (IRB), the research oversight committee charged with ensuring that human subjects research is conducted in compliance with the applicable federal, state, and institutional policies and procedures.
External IRB Review of Clinical Trials/Research
UGA OVPR has engaged Western IRB (WIRB), a commercial IRB, to specifically conduct full-board reviews of clinical research or trials that involve drugs/biologics or devices, as well as research involving bio-medical procedures and/or interventions related to the treatment or management of disease or physical condition. Full board review of other types of protocols will be conducted by the UGA IRB.
This limited use of WIRB review services will enable the UGA IRB to focus on major initiatives that will ultimately strengthen the University’s human subjects protections program. These initiatives include enhancing the use of the e-Research Portal for IRB and achieving accreditation of the human subject protection program, which requires the review and/or development of policies and procedures.
For research involving clinical trials, use of an FDA-regulated drug/biologic or device, or bio-medical procedures and/or interventions, please contact the Human Subjects Office at email@example.com or 706-542-3199 for further information.
The University Policy on activities involving Human Subjects is to fully comply with regulations and follow guidelines defined by the Office for Human Research Protections and to implement principles outlined in the Belmont Report. Any research activity that involves human subjects, whether such activity is undertaken on a large or small scale, whether it is preliminary or fully designed, whether it is conducted by students or faculty, whether it is externally funded or not, and whether it involves minimal risk or more than minimal risk, is subject to the IRB review.
Sample Consent Documents:
Consent Form with Signature
Consent Form for Use of Data Already Collected (Artifacts)
Consent Cover Letter (no signature)
Parental Permission Form Guidance and Template
Minor Assent Script/Form
Telephone Eligibility Screening Consent Script
Debriefing Form Template (for Deception or Incomplete Disclosure)
HIPAA Authorization Form Template
How Do I Report an Adverse Event?
The Principal Investigator (PI) bears direct responsibility for the implementation 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 contacting the Human Subjects Office at (706) 542-3199 or by e-mail to firstname.lastname@example.org 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 concerns or are uncertain about what constitutes a violation, please contact the HSO at 542-3199 For more information read IRB Policies and Guidelines, Responsibility of the Principal Investigator.