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Announcements Compliance, Integrity & Safety

Beginning in January, the review of human subjects protocols that typically require review by the convened UGA IRB (Full Board) will be delegated to Western IRB (WIRB), a commercial IRB.  This review arrangement is temporary and will last for the next four to six months.

Very few studies will be affected by this change since only about 3 percent of IRB protocols require Full Board review.

The OVPR has engaged WIRB review services to allow the IRB to advance major initiatives that will strengthen the University’s human subjects protections program.  These initiatives include enhancing the e-Research Portal for IRB, training two new employees, developing policies and procedures, and taking definitive steps to achieve accreditation of the human subjects protection program.  Since Full Board reviews are lengthy, rigorous and time-consuming, this review arrangement will enable the IRB to focus on these initiatives and, more importantly, ensure the review of the majority of the submissions is done expeditiously.

Please contact the Human Subjects Office at irb@uga.edu or 706.542.3199 for questions or WIRB submission details.

Categories
Announcements Compliance, Integrity & Safety

The University of Georgia Institutional Review Board (IRB) has instituted new procedures that streamline the review of human subjects research qualifying for exempt review.  UGA recently joined the Flexibility Coalition, a group consisting of major U.S. research institutions and medical centers that has a major goal of identifying “flexibility” measures that institutions can implement in the IRB review to reduce regulatory burden for researchers and/or workload for IRBs without diminishing human subject protections.  This flexibility is permitted for an institution that has limited the scope of its Federalwide Assurance (FWA) for the Protection of Human Subjects to federally sponsored research.  UGA is one of those institutions, which means that it is allowed a degree of flexibility in the review and oversight of unfunded research involving no risk or no greater than minimal risk to the participants.

As its first flexibility initiative, UGA IRB has approved the addition of two new “Flex” Exempt categories for non-federally funded studies.  Also, only certain modifications to exempt research will now require IRB review and approval.  These changes are all embodied in the new Policies and Procedures for Exempt Review available at https://research.uga.edu/docs/policies/compliance/hso/IRB-Exempt-Review.pdf.

The Human Subjects Office (HSO) and the IRB are committed to continuously improving our human research protection program and identifying opportunities for flexibility within the IRB review process.  If you have any questions or suggestions, please feel free to contact the HSO Director, Dr. Benilda Pooser at bpooser@uga.edu or 706.542.3199, or the IRB Chair, Dr. Larry Nackerud, at nackerud@uga.edu.

 

Categories
Announcements Compliance, Integrity & Safety

The University of Georgia Institutional Review Board (IRB) has approved the following new Policies & Procedures and form templates:

These are also available in the eResearch IRB Portal Library .

We encourage you to peruse these new policies/procedures and form templates.  If you have any questions, please feel free to contact the HSO Director, Dr. Benilda Pooser at bpooser@uga.edu or 706.542.3199, or the IRB Chair, Dr. Larry Nackerud, at nackerud@uga.edu.

 

Categories
Compliance, Integrity & Safety

Effective January 1, 2014, projects or activities involving human subjects that will be conducted by students to satisfy the requirements for a course and are only being carried out for teaching or training purposes (e.g., research methodology courses) will no longer need to be submitted to the Human Subjects Office (HSO).

These projects do not meet the federal definition of human subjects research and are outside the purview of the University of Georgia Institutional Review Board (IRB).  As with any instructional activity, the course instructor is responsible for providing the oversight and guidance to students for these types of class projects.  It is, however, expected that all these activities will uphold the principles of ethical treatment and respect, and ensure the safety and protection, of the individuals who will be involved in these projects.  When a class project meets the definition of human subjects research, this activity must be reviewed by the IRB.  Masters or doctoral theses involving human participants meet the definition of human research and must be submitted for IRB review.

The new policy, including relevant definitions and faculty/student responsibilities for the conduct of class projects, is described in detail at IRB Guidelines XII.

The HSO professional staff, upon request, can provide educational seminars/training sessions for faculty, staff, and students on this topic or other IRB matters.  For questions or guidance related to this policy change or to schedule an educational seminar/training session, please call 706.542.3199 or email irb@uga.edu.

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Announcements

The first two modules of UGA’s integrated electronic research administration system, Grants and IRB, went live this summer.  The integrated system will simplify and streamline administrative processes, ease the burden these processes place on faculty, and serve the University community better via transparency and better communication.

The new eResearch Grants and Awards Portal (“Grants portal”) went live on June 11.  As of this date, users must login to this new system with MyID  to submit proposals of all types to Sponsored Programs.  This new portal will also handle all electronic  grants.gov submissions to federal sponsors. Weekly training sessions are offered. Find out more.

The new eResearch Portal for Institutional Research Board (“IRB portal”) went live on May 30. UGA researchers users must login to this new system with MyID  to submit new Human Subjects proposals, amendments and continuing reviews. Training is available online.  Find out more.

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Announcements

As of Mon., July 29 at 11 a.m. U.S. Eastern Daylight Time, the CITI Program website will be unavailable for approximately two to three days to complete a major software upgrade.

This software change will update many internal features of the CITI Program platform, and provide a changed user interface across the site designed to improve the experience of both learners and administrators. Learners will find all their familiar links and tools, but in a format that is easier to navigate. In particular, the main learner menu and other learner sections will be divided into areas that expand and contract on a click, to allow easier focus on particular information.
Please plan on completing your IRB training accordingly to avoid any delay in submitting your IRB Applications through Click IRB; you are also advised to log off prior to this time.  If you have any questions, please contact the Human Subjects Office at irb@uga.edu or 706.542.3199.

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