Starting Jan. 25, 2022, Investigators identified as senior/key personnel on new National Institutes of Health projects and renewals will need to provide expanded disclosures of other support including third party contracts and agreements.
Other Support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes but is not limited to:
- Resources and/or financial support from all foreign and domestic entities, that are available to the researcher. This includes but is not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.). Institutional resources, such as core facilities or shared equipment that are made broadly available, should not be included in Other Support, but rather listed under Facilities and Other Resources.
- Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities. Non-research consulting activities are not Other Support.
- Honoraria in support of an individual’s research endeavors must be reported.
- In-kind contributions, e.g. office/laboratory space, equipment, supplies, or employees or students supported by an outside source. If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates.
NIH will require the following:
- Supporting documentation, which includes copies of contracts/agreements specific to senior/key-personnel foreign appointments and/or employment with a foreign institution for all foreign activities and resources that are reported in Other Support. If the contracts/agreements are not in English, recipients must provide translated copies.
- Immediate notification of undisclosed Other Support. When a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, the recipient must submit updated Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known.
The information required by NIH should also be disclosed to UGA via the Grants Portal. In addition, an Investigator may need to disclose the significant financial interest on UGA’s Compensated Outside Activities Approval Form. See UGA’s Conflicts of Interest, Conflicts of Commitment, and Outside Activities Policy.
NIH- Upcoming Changes to the Biographical Sketch and Other Support
Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components
NIH Other Support FAQs
Updated NIH Biosketch instructions
NIH Disclosure table
Protecting U.S. Biomedical Intellectual Innovation (NIH)
IACUC has instituted the Guidelines for Ferret Housing in T2000 Containment Caging, outlining the standards for housing ferrets in that type of caging system.
IACUC has also revised the guidelines for ferret inhalant anesthesia, renamed Guidelines for Ferret Inhalant Anesthesia for Brief, Non-Painful Procedures. The guidelines were revised to apply more specifically to only brief anesthetic events for which food restriction is not necessary, and which represent the typical anesthesia experience for ferrets under study at UGA.
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.
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.
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.
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.
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.
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.
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.
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/.
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 email@example.com.