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.

For additional information regarding UGA Human Subjects policy and procedures see the IRB Guidelines for Investigators.

The IRB is the University of Georgia's committee that reviews and approves protocols for the use of human subjects in research. Federal regulations require that the IRB membership represent a variety of backgrounds, training and experience. At least one IRB member must have no formal or family connection with the University. At least one member must be a non-scientist.

The IRB reviews research protocols to ensure that the rights and welfare of subjects are protected and that the proposed use of human subjects is in compliance with Federal regulations, state laws, and the UGA policy.

The Board meets monthly. Meetings are typically held on the second Friday of each month. Board approval requires a majority vote of a quorum of members. The Board may require additional information or modifications as conditions for approval. The Board may also "table" the application until more information is provided or until significant changes are made. You will be notified of the Board's decision.

The HSO is an administrative office, provides support for the IRB and is responsible for the review and approval of applications for certain categories or research with human subjects/participants. The IRB is a committee of researchers and community members that review human subjects research.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

Intervention includes both physical procedures, by which data are gathered (for example, venipuncture), and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between researchers and subjects.

Private information includes information about behavior that occurs in a context, in which an individual can reasonably expect that no observation or recording is taking place, and information, which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, client or medical records or information obtained in an interview).

Research is defined as a systematic investigation that contributes to the larger body of knowledge of any given discipline. This includes collection of scholarly materials for theses and dissertations done by students, and investigations carried out by faculty and staff for publication and/or presentation.

Examples include psychological experiments, questionnaires, in-person and telephone surveys, interviews and focus groups, educational and behavioral tests, review of medical or other records, observation of public or private behavior, including classroom observations, and taste tests. Also included are physical procedures like blood tests, MRIs, DEXAs and X-rays. Please refer to Section 1 of the Guidelines for further information.

"Practice" consists of interventions designed to enhance the well being of a patient or client.

"Research" is designed to test hypotheses, permit conclusions to be drawn and thereby develop or contribute to the larger body of knowledge. Research and practice can be carried out together. However, as a general rule, if there is any element of human subject research in an activity, then that activity should be described in an application for submission to the IRB.

By anonymous, the IRB means that the researcher cannot link the data to the participant. Confidential means that the researcher may be able to identify a participant’s data but will not reveal the participant’s identity to anyone else. Person-to-person interviews, for instance, are never anonymous.

Yes. The IRB has the authority to disapprove, suspend or terminate research that is not carried out according to its requirements or may be associated with unexpected serious harm to subjects. Any such step shall include a statement of the IRB's reasons for its action and will be reported promptly to the principal investigator, the Vice President for Research, and the funding agency.

No, but if a proposed project appears to lack scientific merit or rigor, or duplicate existing work with more than minimal risk to subjects, the Board is required to consider whether the benefits to individual subjects and society outweigh the potential for harm to them.

Yes. All research that involves human subjects/participants must be reviewed and approved by the HSO or the IRB. For more information on UGA policy and procedures for research with human subjects/participants read the IRB Guidelines.

Yes. The federal regulations allow six specific categories of human subjects research to be exempt from continuing IRB review. However, the UGA IRB requires that such activities be reviewed and approved.  Only the IRB/HSO can make a determination if any of the exemption categories may apply. Approval is granted for five years; any modifications must be submitted through an Amendment Form, reviewed, and approved prior to implementation.

Course instructors who assign human subjects related class projects receive a research exemption from the HSO/IRB. For additional information please read the "Class Projects Exemption" Section XII of the Guideliness.

Yes. Master’s thesis or a Doctoral dissertation research is considered research and must be approved by the IRB. Failing to obtain approval may result in disqualification of these activities in application towards a degree program.

Yes, the Human Subjects Office staff is available to discuss the importance of protecting human subjects/ participants and the procedures with any group on campus.

Researchers and Department Heads are responsible for reporting promptly to the IRB any serious or continuing noncompliance with federal regulations, or university policies, or injuries to subjects, unanticipated problems, and changes proposed in research activities. Research related problems should be reported to the IRB Chair at 542-3199 or e-mail at IRB@uga.edu

You should notify the chair of the department and/or the Human Subjects Office. If you have any concerns or are uncertain about what constitutes a violation, please contact the HSO at 542-3199 or e-mail at IRB@uga.edu. For more information read Section XI of the Guidelines.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Contact the Human Subjects Office at 542-3199 or e-mail at IRB@uga.edu