Category: Compliance, Integrity & Safety

The National Science Foundation (NSF) released an updated Proposal and Award Policies and Procedures Guide (PAPPG) on June 22, 2021. The new PAPPG is effective on October 4, 2021. NSF requires the use of an NSF-approved format to prepare Current and Pending Support.

Current and pending support information must be separately provided through use of an NSF-approved format, for each individual designated as senior personnel on the proposal.  Current and pending support includes all resources made available to an individual in support of and/or related to all of his/her research efforts, regardless of whether or not they have monetary value.  Current and pending support also includes in-kind contributions (such as office/laboratory space, equipment, supplies, employees, students. In-kind contributions not intended for use on the project/proposal being proposed that have associated time commitments also must be reported.

Current and pending support information must be provided for the proposed project, for ongoing projects, and for any proposals currently under consideration from whatever source irrespective of whether such support is provided through the proposing organization or is provided directly to the individual.  This includes, for example, Federal, State, local, foreign, public, or private foundations, non-profit organizations, industrial or other commercial organizations, or internal funds allocated toward specific projects.

NSF updated Proposal and Award Policies and Procedures Guide

FAQs on Current & Pending Support (nsf.gov)

https://www.nsf.gov/bfa/dias/policy/disclosures_table/jan2022.pdf

NSF-Approved Formats for Current and Pending Support

On Dec. 20, 2021, the Department of Energy issued an interim conflict of interest (COI) policy that addresses both financial and organizational conflicts of interest, which will be incorporated in and made enforceable through the Special Terms and Conditions for DOE financial assistance awards. The interim COI policy establishes standards that provide a reasonable expectation that the design, conduct, and reporting of projects wholly or in part funded under DOE financial assistance awards (e.g., a grant, cooperative agreement, or technology investment agreement) will be free from bias resulting from financial conflicts of interest or organizational conflicts of interest. As used in this announcement, reference to DOE includes both DOE and the National Nuclear Security Administration (NNSA).

The interim policy requires each Investigator who is planning to participate in the DOE award to disclose the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) to UGA no later than the time of proposal for the DOE award.  Disclosures must be made at least annually, thereafter, and within 30 days of acquiring a new significant financial interest.  Disclosures of significant financial interests should be made 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.

Finally, the DOE interim policy requires Investigator complete COI training prior to engaging in projects related to any DOE financial assistance award and at least every four years.  Investigators can complete the CITI COI training module through UGA’s Professional Educational Portal (PEP).

More information

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

More information

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.

More information

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.

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.