Human Subjects

Quality Improvement Program

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 Human Subjects Office will be conducting post-approval assessments 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.

Studies are identified through our eResearch Portal for IRB. 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 year.

In order to prepare for a post-approval assessment, the Human Subjects Office recommends that you complete the Self-Assessment Checklist. 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.

Follow-on submissions tab
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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.

Type of submission
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Once you have found the continuing review, click on Last Snapshot link.

last snapshot
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Once opened, you will be able to see the continuing review progress report.

continuing review progress report
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If you have further questions, please contact the Humans Subjects Office; irb@uga.edu 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.

Follow-on submissions tab
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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.

 

Type of submission
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Once you have found the modification, click on Last Snapshot.

last snapshot
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Once opened, you will be able to see the modification information summary as well as any other applicable pages for that modification submission.

 

Modification Summary
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If you further questions, please contact the Human Subjects Office irb@uga.edu or 706-542-3199.

To find continuing review and/or modification approval letters, under the Active tab, select the parent study.

Follow-on submissions tab
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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.

History tab
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You will see the IRB approval letter underneath the heading Letter Sent.

 

Letter Sent[1]
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You may print and/or save the approval letter. If you further questions, please contact the Human Subjects Office irb@uga.edu or 706-542-3199.

Additional Services

 

  • 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 irb@uga.edu
  • Identify areas of improvement and achievement by conducting a Root Cause Analysis.

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 irb@uga.edu or 706-542-3199