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Announcements Compliance, Integrity & Safety

Due to recent staff turnover, the turnaround times for IRB reviews are currently, unfortunately, longer than we’d like them to be. 

The current review timelines below are a general guide only. Submissions that are incomplete or do not adhere to IRB submission guidelines may require additional time. Time to final approval depends on meeting the regulatory criteria, institutional policy requirements, and cooperation of the investigator(s) in responding to the IRB’s requests for modifications promptly. Please submit early whenever possible.

In general, the submissions are reviewed in the order in which the Human Subjects Office receives them. Investigators who believe that their submission requires immediate processing should contact the IRB Office and justify and describe the specific circumstances. Funded studies and submissions to support graduate student theses and dissertations may be given priority when justification is provided.

New Study

The IRB receives approximately 80 new studies each month. Generally, studies are reviewed within four weeks of submission. The exact timing depends on whether or not there are conflicting demands and the volume of submissions.

For 2021, the average days from submission to Exempt determination is 42 calendar days. The average days from submission to approval for research eligible for Expedited review (review by one or more IRB members) is 83 days. Studies that require full board review and approval are placed on the next available agenda after the submission is determined to be complete via pre-review by IRB staff. 

Modifications and Continuing Reviews

It is our priority to facilitate ongoing research, so modifications to active studies often receive priority review. The IRB receives approximately 80 follow-on submissions each month. The average days from submission to approval follow-ons to Exempt research and Expedited research is 17 days.

The HSO has put in place several interim measures to help mitigate this problem until new staff are hired. The Office of Research understands how these extended throughput times affect your research, and we are committed to addressing the current staffing issues as quickly as possible.

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Announcements Compliance, Integrity & Safety

Airgas is the State of Georgia’s mandatory supplier for liquid nitrogen, liquid helium and other gases. Some labs have recently reported concerns with Airgas’ service levels and quality control. We have created this short form to provide feedback related to Airgas’ service. Please use this form to share comments and/or photos related to your ongoing experiences or those experienced over the past 12 months. Your feedback will help to strengthen UGA’s position in quickly remediating recurring issues related to this mandatory statewide contract.

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Announcements Compliance, Integrity & Safety

Before engaging in an international shipment, UGA personnel should contact the Office of Export Control to request review of the shipment. This review will ensure an export license is not needed for the equipment or research material (including pathogens, toxins and biologicals, for example) and a due diligence review of the end-use and end-user at the foreign destination.

The Department of Commerce has taken export enforcement actions, including monetary settlements, against U.S. academic institutions for unlicensed export of strains and recombinants of animal pathogens to non-U.S. research institutions, as well as for shipments of basic research equipment to embargoed non-U.S. research institutions.

Please contact Dan Runge (drunge@uga.edu) to begin any international shipment review.

Further detailed information about International Shipping is available here and a list of export controlled items, software, and technology is available here. Any export classification process should include review by the Office of Export Control.

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Announcements Compliance, Integrity & Safety

This module is for University of Georgia faculty, staff and students who have the potential to be exposed to human blood or other potentially infectious materials. This training provides a basic understanding of common human bloodborne pathogens and their transmission paths, exposure control and prevention, and procedures for responding to accidents and potential exposures.

This course takes the place of the previous Bloodborne Pathogen Training course provided by USG. This course is required annually and can now be accessed through PEP (https://pep.uga.edu) by searching UGA Right to Know:  Bloodborne Pathogens Training. Once the course is completed it will be credited automatically in PEP.

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Announcements Compliance, Integrity & Safety

NIH’s Office of Laboratory Animal Welfare (OLAW) has notified institutions that the new 2020 AVMA Guidelines on Euthanasia of Animals are to be implemented October 1, 2020. After October 1, 2020, grant applications and contract proposals must be consistent with the AVMA 2020 Guidelines.

The main change that will affect the most researchers is the method of CO2 exposure for rodents. The new required CO2 displacement rate is 30-70% of the chamber volume/minute.

Note that the UGA IACUC Policy on Rodent Euthanasia Using Carbon Dioxide has already been updated to reflect the new requirements.

Instructions posted at CO2 euthanasia stations should no longer reflect the old flow rate range, and must reflect the new required flow rate range.

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Announcements Compliance, Integrity & Safety

The Office for Human Research Protections (OHRP) has posted on its website a set of decision charts that are consistent with the 2018 Requirements (i.e. the revised Common Rule). The decision charts are necessarily generalizations and may not be specific enough for particular situations. The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, the National Institutes of Health, other sponsors, or state or local governments. These decision charts can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html.

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Announcements Compliance, Integrity & Safety

The Human Research Protection Program (HRPP) has developed a Toolkit for researchers who are planning to resume in-person research activities involving human participants. Please look for forms and materials on the HRPP website or in the IRB Portal Library. Contact IRB@uga.edu if you have any questions.

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Announcements Compliance, Integrity & Safety

Attention human research investigators: We recognize and value UGA investigators’ experience and expertise in conducting research projects. Further, we understand the demands on researchers’ time, and we strive to create systems and infrastructure that provide a high level of research project management support. However, the PI is ultimately accountable for ensuring that individual research projects meet all reporting and approval requirements. While the IRB portal is programmed to send courtesy reminders at 90, 60, and 30 days prior to a study’s expiration date, this system does not replace the responsibility of PIs to be aware of the approval period for research studies.

We strongly urge investigators to have multiple tools and safeguards to ensure that they meet regulatory and institutional requirements pertaining to continuing review and maintaining approval of human research projects. Setting up calendar reminders for 30 days prior to study expiration is one possible method.

Please remember that all human research procedures related to the approved project must stop when approval expires until a new approval period is granted. When research activities are complete, the PI is responsible for closing the project in the IRB portal, even if the project was for a student’s thesis or dissertation.

Please contact the Human Subject Office at IRB@uga.edu or 706-542-3199 if you have any questions about continuing review and expiration of IRB approval. More information is available in our Policies and Procedures and on the Human Research Protection Program website https://research.uga.edu/hrpp/.

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Announcements Compliance, Integrity & Safety

In order to improve animal welfare and research outcomes, the IACUC will require specific online training, beginning July 1, 2019, for all persons on protocols that involve rodent surgery and/or general anesthesia.

What researchers need to know about this mandatory training:

  • Starting July 1, 2019, training will be required for all personnel on Animal Use Protocols (AUPs) that include survival surgical procedures on rodents and/or general anesthesia of rodents.
    • Training validation will be required for approval of new AUPs and Annual Renewals.
    • For amendments adding new personnel, the new personnel will need to complete this training to be added to the AUP.
  • The required training is the online training module, “LAT 13: Aseptic Technique and Surgical Support and Anesthesia”, in the Professional Education Portal (PEP).
  • Individuals only need to complete this training module one time. There will be no expirations or repeat expectations for this course.

This course is already available via PEP for anyone that would like to take this training proactively. You can find the course by searching for “LAT 13” or “surgical support” from the search bar in the upper right corner of the PEP dashboard. Principal investigators can assign this course in PEP to personnel on their AUPs effective immediately. For assistance with assigning training to your personnel, please contact the Office of Research Integrity and Safety Support Services at pep@uga.edu.

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Announcements Compliance, Integrity & Safety

The Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services released a new informational video that describes social and behavioral health research (SBER) and explains how it is different from biomedical research. The video is for potential participants and is designed to help them consider whether or not they want to participate in research. Researchers may also find this helpful when designing consent processes and materials. View the SBER in English. Watch video: www.youtube.com/watch?v=CGOYerqfsNc&feature=youtu.be