The Human Subjects Office is a group of dedicated professionals who provide UGA faculty, staff, and students support in meeting the highest ethical and safety 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.
- Continuous quality improvement
- Lifelong learning
- Problem solving
If you are interested in scheduling a training session for your group or class, call the Human Subjects Office at 706-542-3199 or e-mail email@example.com.
Note: For planning purposes, the following dates are scheduled.
|Human Subjects Outreach and Training||Dates|
|Harklau - LLED 8000||9/21/2020|
|Knight - EPID 7800||9/21/2020|
|Engelhard - Educational Research||9/28/2020|
|King - GRSC 8550||10/14/2020|
|Reukov - TXMI 8050||10/19/2020|
|Walcott - GRSC 8550||11/3/2020|
|Happe - Intro to Graduate Studies||11/16/2020|
Graduate Student Open House sessions are open to all graduate students. No registration required.
In response to limitations on in-person meetings related to COVID-19, the Human Subjects Office is offering Virtual Open House sessions via Zoom. Sessions will be held every other Tuesday at 2pm beginning May 19, 2020 and are open to everyone, no registration required. Each session will include time for questions following a short IRB information presentation. *Virtual Open House sessions will be cancelled if no attendees are present 20 minutes after the start time. Click to join: Zoom Virtual Open House
Substantial revisions to the federal regulations for the protection of human participants in research (Common Rule) became effective on January 21, 2019. These changes applied 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.
New Exempt Categories The Common Rule defines three levels of review for human subjects research: exempt, expedited, and full (committee). The new Common Rule broadened the types of research that may be determined to be exempt from IRB review. For example, 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 no longer requires 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.
- Final Common Rule:
- Additional resources:
- Contact HSO (firstname.lastname@example.org or 706-542-3199 if you are interested in face-to-face training for your class or group.
The primary purpose of the quality improvement program (QIP) is to increase the quality, performance, and efficiency of UGA’s Human Research Protection Program (HRPP). One goal is to strengthen the HRPP by working with investigators to evaluate and improve ethical research conduct through education and training.
The Quality Improvement program can also provide a confidential consultation for study start-up or any other research activity documentation needs.
We can provide any educational outreach training needs. We would be happy to speak with you and/or a class. If you would like to schedule an educational outreach training, please email the Human Subjects Office email@example.com
Concerns, Comments, Suggestions?
Before a program can be improved, an assessment of the program’s strengths and weaknesses should be completed.
The UGA Human Subjects Office would like to hear from you to help us assess what we are doing right and what we should work on improving. Your input is appreciated. Satisfaction Survey Link
If you have a concern that requires immediate assistance, please contact the Human Subjects Office directly at firstname.lastname@example.org or 706-542-3199.
The Human Subjects Office will be conducting post-approval assessments of active projects in order to ensure that we are meeting the educational outreach needs of our investigators as well as to ensure research is compliant with institutional policies, regulations, and best practices for human subjects research protections.
Projects that will be assessed are identified through the IRB Portal. Post-approval monitoring will be conducted on non-Exempt federally funded studies. Our goal is to assess up to 10% of active federally-sponsored projects each quarter. Projects will be randomly selected from the database of active studies or based on previous reports of new information.
In order to prepare for a post-approval assessment, the Human Subjects Office recommends that you complete the Post Approval Monitoring PI Self-Assessment. The principal investigator and/or study team member should locate the informed consent documents, HIPAA Authorization forms (if applicable), and any other protocol documentation that may be applicable to your research activities and have them accessible.
To find the continuing review progress report, under the Active tab, select the parent study. Once the parent study is open, you will see a tab titled: Follow-on Submissions of Parent.
In the follow-on submission to the parent, you will see several columns including the created date, type, and state. The last column is titled Last Snapshot. Find the specific continuing review that you are looking for by looking under the columns Type and Created Date.
Once you have found the continuing review, click on Last Snapshot link.
Once opened, you will be able to see the continuing review progress report.
If you have further questions, please contact the Humans Subjects Office; email@example.com or 706-542-3199
When a modification is created, the system copies the approved study to create a draft study. When the modification is approved, the changes are published into the approved study. To find each modification submission, under the Active tab, select the parent study. Once the parent study is open, you will see a tab titled: Follow-on Submissions of Parent.
In the follow-on submission tab, you will see several columns including the created date, type, and state. The last column is titled Last Snapshot. Find the specific modification that you are looking for by looking under the columns type and created date.
Once you have found the modification, click on Last Snapshot.
Once opened, you will be able to see the modification information summary as well as any other applicable pages for that modification submission.
If you further questions, please contact the Human Subjects Office firstname.lastname@example.org or 706-542-3199.
To find continuing review and/or modification approval letters, under the Active tab, select the parent study.
In the follow-on submission of parent, you will see several columns including the name, ID, type, state, created date. Once you have located the modification and/or continuing review of interest, click on the ID link. Once opened, look at the submission history.
You will see the IRB approval letter underneath the heading Letter Sent.
You may print and/or save the approval letter. If you further questions, please contact the Human Subjects Office email@example.com or 706-542-3199.