Impact of COVID-19 on Research and Sponsored Programs


COVID-19 is a significant challenge that will continue to impact research on campus and across the state in the weeks ahead. UF Research is coordinating efforts to maintain essential research administration functions and the research infrastructure while minimizing human interactions that could contribute to the spread of the virus.

Overview

  • UF has reduced on-campus personnel to those identified as essential, as determined by their managers and university leadership
  • UF Research business support units, including grant submission, award management and billing, are open but operating remotely. We continue to process all proposals, agreements and awards. 
  • Face-to-face human subject research is paused, except for therapeutic studies involving drugs or devices, or those critical to the health and safety of patients or study participants.
  • Animal research is suspended, effective 12 p.m. on Thursday, March 26, unless explicitly approved by the Vice President for Research.

The links on this site provide internal guidance, FAQs, and policies related to COVID-19 from offices supporting the UF research enterprise. The site also includes links to guidance and information from the federal government and other research sponsors.

Specific questions about operations should be directed staff in the relevant research administration offices. You may also submit questions to the DSP email address We will provide further guidance and direction as more information becomes available.

UF Research staff are here to help you navigate this challenging terrain. We encourage you to look out for one another and those in your communities. If you have any questions or concerns, please don’t hesitate to reach out.

University-wide updates are posted on UF’s COVID-19 Updates page and UF Human Resources Guidance is available at the Working Through COVID-19 page.

UF Research Update on March 23, 2020

COVID-19 is a significant challenge that will continue to impact our research on campus and across the state in the weeks ahead. Given the progression of impact on campus and across the state, please take the following actions immediately:

  • Research activities that can be accomplished remotely should move to that modality now.
  • Make all necessary preparations now in the event that campus and other UF facilities are restricted to essential functions and personnel.
    • UF facility on-site research support functions that are deemed essential need to be identified now, with approvals by the relevant Dean and Vice President for Research required. These could include maintaining basic animal and plant care, maintenance of cell lines, and maintenance of equipment or building infrastructure that cannot be shut down during this pause in on-site research. Deans would need to provide list of requests that they support to the VPR for his approval.
    • For the period during which such restrictions to campus are imposed, subject to the authority imposing campus restrictions, only mission-critical, essential research should continue on campus and other UF research sites. Approvals to continue on-campus research will be quite limited.  Research activities deemed essential include projects addressing the COVID-19 crisis, as well as human-subjects research that would endanger research participant lives if stopped. Designation of other research as mission-critical and essential would require written approvals by the investigator’s Dean and the UF Vice President for Research.  Again, Deans would need to provide list of requests that they support to the VPR for his approval.
    • Activities within Animal Care Services would be limited to animal care functions by ACS staff and those investigators associated with research deemed mission-critical and essential as stated above. ACS will communicate regularly with researchers.
    • Identify critical equipment (including computers) that must remain in service, then plan for how to manage or shut down this equipment if necessary.
  • Effective immediately, all face-to-face human subjects research interactions are paused, except for therapeutic studies involving drugs or devices, or those critical to the health and safety of patients or study participants. Additional guidance forthcoming.
  • With the exception of animals needed for mission-critical, essential research as defined above, orders and shipment of animals for research have already been suspended. Researchers should consider reduction of animal census, including agricultural animals and USDA-covered species.
  • Research computing resources are expected to remain remotely accessible to investigators working at home. Identify individuals who can access remote or on-campus computing resources in case of the need to ‘restart’, or provide other emergency service, to a computer/server.
  • Some federal agencies are revising grant policies. UF Research is tracking updates to be posted on the UF Research COVID-19 webpage.
  • All UF-affiliated facilities and labs, whether on-campus or off-campus, are subject to this notice.
  • Please also note that all research business support units, including grant submission, award management and billing, are open and operating remotely as this time.   
  • Please know that we are here to help you navigate this challenging terrain. We ask that each of you look out for one another and those in your communities. If you have any questions or concerns, please don’t hesitate to reach out.

Animal Care (ACS & IACUC)

Updated March 25, 2020

As announced yesterday, the University of Florida is reducing on-campus personnel to those identified as essential, effective March 24. Animal Care Services has already begun moving to a modality that best ensures maintaining the health and care of our research animals, particularly those animals deemed ESSENTIAL to rebooting our animal research once we emerge from the COVID-19 epidemic. Please note the following:

You have already been asked by ACS to identify those animals within your portfolio that you deem essential for the future date when we resume normal research operations. Please do this immediately per instructions from ACS.

With few exceptions, animal experiments within the ACS facility will be suspended effective 12:00 PM on Thursday, March 26. Most activity should have already ramped down or ceased. This suspension will remain in effect until we emerge from the COVID-19 crisis. IF FOR ANY REASON YOU NEED TO ENTER ACS FACILITIES PRIOR TO 12 PM ON THURSDAY, PLEASE NOTE THAT SOCIAL DISTANCING OF AT LEAST 6 FEET IS MANDATORY.

If you believe that your animal experiments should be deemed MISSION CRITICAL and exempt from this suspension of animal research, you must secure written approval from your Dean and the UF Vice President for Research. The most likely justification for this exemption will be research directly addressing COVID-19. While I can confidently state that the research each is doing is important and highly valued by the institution, at this specific time and place, designation as MISSION CRITICAL will very much be the exception. For the health science colleges, Dr. Steve Sugrue is collecting and reviewing all such requests for possible submission to the UF Vice President for Research to consider. Others should submit through your respective Dean. All requests submitted through the proper channels that pertain to animal studies will be reviewed no later than 5 pm Monday, March 30.

In order to manage the needs of our animal population for many weeks ahead, access to the ACS facilities will be restricted to ACS staff and researchers with studies that have been provided the above- referenced exemption to this suspension. The rationale for this action is simple: as COVID-19 moves through our community in the coming weeks, it is imperative that person-to-person transmission of COVID-19 within our ACS staff population and facility be aggressively minimized. If a significant fraction of ACS staff are simultaneously required to self-quarantine due to illness, the consequences on ACS operations would be remarkably negative. We are taking multiple steps to keep our ACS workspace and staff as safe and dispersed as possible. If during this period you require access to ACS facilities, please contact Denisse Cancel (dcancel@ufl.edu; 352-246-9983) or Mike Riley (mpriley@ufl.edu; 352-246-5227).

Additional ACS-specific guidance and instruction over the coming days and weeks will be provided by the ACS leadership.

Human Subjects Research and Clinical Trials (IRB, OCR & CTSI)

Updated March 24, 2020

Effective immediately, the University will use the following guidelines when assessing whether specific human subject research projects may continue at UF.  These guidelines are for human subject research only, pertinent only during the current COVID-19 epidemic, and will be in place until removed by the UF Vice President for Research.  Since this crisis is fluid, these recommendations may change over time:

Tier

Potential Health Benefit to Participants

Activities

Enrollment

Alternatives

1

COVID-19 research

Activities may continue.    

May continue

NA

2

Direct health benefit, serious risk to subjects if study interventions stopped

Activities may continue. 

Paused/halted

May request exception to enroll new subjects, see below.

3

Low to no direct health benefit, no face to face interactions with study subjects or between study staff.

Activities may continue, however any on-campus research activities must have prior approval by your appropriate Dean and UF Vice President for Research (VPR).

May continue

NA

4

Low to no direct health benefit, with face to face interactions with study subjects or between study staff.

All activities that involve face to face interaction with subjects or between study staff must be halted.*

Paused/halted

*See COVID-19 Investigator Guideline 


Based on the above table:

Tier 1 – COVID-19 Research

Activities may continue. As part of the submission, you must describe safeguards you are taking to protect human subjects and researchers engaged in research that may come into contact with known or unknown infected individuals or materials in the conduct of the research.

Tier 2 – Direct Health Benefit to Research Participants

All protocols in which serious or immediate harm could be caused to the research participants if research activities are stopped.

For example:

  • Research protocols involving treatments for acute, life threatening health conditions (e.g. some treatment trials for cancers)
  • Protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful to the subjects

For FDA governed clinical trials, please refer to the FDA guidance at https://www.fda.gov/media/136238/download

Research in Tier 2 can continue if the PI ensures the research can be conducted in a safe manner that protects subjects, researchers and staff, and the community.

Enrollment of new subjects must be paused.
  • A compelling reason to continue enrollment must be a matter of potential life or limb saving over the next 2 months.
  • PIs may petition the IRB if they have a compelling reason for not following this pausing enrollment policy.
    • Requests are made via a miscellaneous reportable event submission within myIRB. Please complete and upload this request form:  http://irb.ufl.edu/wp-content/uploads/tier2exception.docx​.
    • Requests will be reviewed by the IRB. The IRB may involve appropriate senior level staff to assist in the determinations.
    • Requests will be reviewed in order of priority.
  • These guidelines must be followed for studies seeking an appeal until such time as an appeal is granted. 

Tier 3 – Low to No Direct Health Benefit to Research Participants

Research that has no face-to-face interaction or intervention with subjects.

  • Chart review studies
  • Research interactions conducted online or over the phone
  • Analysis of previously collected data/tissue

Research activities in Tier 3 may continue conducting all activities and enrolling subjects provided there is never any face to face interaction with subjects. If this involves on-campus activities, this will also require prior review and approval by the appropriate Dean and the UF VPR.

Tier 4 – Low to no Direct Health Benefit to Research Participants

Research in these categories that include face to face interaction with subjects. 

  • Cohort and natural history studies where delays in data collection have limited impact on scientific objectives
  • Protocols in which delays to starting or pausing of research does not substantively impact on research objectives of the research protocol
  • Protocols in which risks to research participants are higher (e.g., potentially exposing elderly vulnerable individuals to COVID) and benefits of the study to the participants remain minimal
  • Research with healthy volunteers
  • Any minimal risk studies that require research subjects to travel, that involve students, or that are in a community setting and require direct interaction with researchers

Research activities in Tier 4 must not enroll new participants in studies requiring face to face interaction nor continue to conduct face to face visits. Activities that do not require participant interaction may continue. Researchers may also submit a revision to the IRB to conduct interactions online or via phone.

Items to consider:

  • OTHER RESTRICTIONS: UF Health, CTSI, UF Cancer Center, and/or other units may set or change restrictions that impact human research.  It is imperative that researchers comply with all applicable restrictions/requirements as we respond to the COVID-19 pandemic.  Please see the UF Health Updates page http://www.ufl.edu/health-updates/.
  • Reduce Study Visits: To the extent reasonable and appropriate, researchers should propose to replace in-person study visits with virtual study visits, using phone, email, and internet- based video technology. Please refer to the UF IRB Investigator Guideline http://irb.ufl.edu/wp-content/uploads/Temporary-Guideline-COVID-19-Related-Protocol-Revisions.pdf or contact the UF IRB promptly for guidance on submitting protocol amendments to address proposed changes to study procedures. If you are uncertain about whether a change requires IRB approval prior to implementation, please contact the IRB office immediately.
  • Research Contracting Issues: Should your study be placed on hold by UF, you may need to consult with an appropriate funding agency.  If you have questions, please contact the following:
  • Consult Travel Advisory: Given the University’s restrictions on international and essential-only domestic travel, researchers should consult the UF COVID-19 website (http://www.ufl.edu/health-updates/) for up to date information.  Please also refer to the CDC page on their link under travel information https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html
  • Develop a Script for Participants: Research teams should consider developing a script outlining for research participants how UF is making the environment as safe as possible when they come in for their research visit. Please make sure to determine if the study subject wants to remain in the study, and if not, what their options are.
  • Multi-site studies where UF is serving as the sIRB for other institutions: The restrictions of this guidance must be communicated to all of the relying site investigators by the overall lead PI of the study. Relying site investigators must also ascertain if their institution has implemented more restrictive requirements. Relying site investigators need to comply with whatever requirements are most restrictive and communicate same to the lead PI.
  • sIRB Studies ceded to another IRB: If oversight for your study is ceded to an external IRB, communicate UF’s guidance to the overall lead PI and the reviewing IRB, especially if your research is placed on hold by UF, per the tier system spelled out above.

Develop Contingency Plans:

Study teams should immediately prepare contingency plans for their active research protocols. These changes may require IRB approval prior to implementation (see: http://irb.ufl.edu/wp-content/uploads/Temporary-Guideline-COVID-19-Related-Protocol-Revisions.pdf). Consider whether disruption of a research protocol will impact the safety of your research participants, and how you can manage that disruption:

  • Investigational Drugs – If you have specific questions related to investigational drugs, please contact the Investigational Drug Service at IDS@shands.ufl.edu or call 352-294-5894.  Currently the IDS is open regular business hours Monday to Friday 7:30am to 4:00pm at both locations, Shands North Tower and CTSI. If research participants are on investigational drugs, work with the IDS to determine what the plan would be if the investigational drug could not be dispensed to your research participants. You might find a way to deliver investigational drugs to their home. If the investigational drugs cannot be dispensed to our research participants, you should make plans to transition research participants back onto their most appropriate clinically available medications. This transition should include consultations with the investigation drug service and the clinical team caring for the research participants. Where the investigational drug is administered under an external, sponsor-held IND, the sponsor should be proposing any protocol changes needed to the FDA protocol and IRB protocol to the FDA and responsible IRB.
  • Consider Pausing Study Procedures: For studies where appropriate, individual investigators may choose to temporarily pause enrollment. PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures. Even routine research interventions might not be easy or safe if experienced staff are not available.
  • Timely review of research data – If research team members are not available, integration of research care such as reviewing lab results in a timely manner might not be possible and will require special attention under the direction of the study PI. Study teams should consider the availability of appropriate back-ups to the PI to make safety assessments.
  • Utilization of alternate visit options: including telephone or Zoom visits for participants who are unable or unwilling to come to on-site visits. Remember, you must use IT Security approved methods.
  • Home visits: Some essential research visits may require blood draws or simple measurements like BP and BMI assessments that could be accomplished with a home visit. Before moving to home visits, research teams need to consider: can the activity be done safely in the home, as PI do you acknowledge that the research staff doing the home visits have been appropriately trained, does the research staff member have any health conditions or current symptoms related to the coronavirus, and does the research participant or other individuals in the home have symptoms that would indicate a high risk of coronavirus transmission. Up-to-date screening questions should be utilized to make the assessment about risk of coronavirus transmission. Research teams should follow the current policy that two members of the research team be present for home visits.
  • For investigators with Epic access: The research visit must be documented in Epic and include the following information: did the research participant pass the screening questions about risk for infection, what times did the research team enter and leave the house, and who else was present in the home during the visit.

Proposal Submission, Award Management & Expenses on Grants (DSP & C&G)

DSP

Updated March 23, 2020

DSP services are currently all operating remotely.  We continue to process all proposals, agreements and awards. 

As you identify impacts to your active awards (reporting, changes in ongoing or planned experiments, project timelines, ability to meet deliverables, etc.) contact DSP at ufawards@ufl.edu  for guidance.  Sponsors are inviting communications but please make sure ufawards@ufl.edu is copied or contacted first. Assuming you are unable to get prior approval for changes, we suggest you document the impacts and load this information into UFIRST.  If you need assistance, email ufawards@ufl.edu and we will ensure this information is loaded for you.

The federal-wide grant policy organization, OMB, has announced that federal agencies are allowed to be flexible during this time. See: https://www.whitehouse.gov/wp-content/uploads/2020/03/M-20-17.pdf.  Please note that each agency now has to extend these flexibilities in their own systems and procedures.  Please follow: https://research.ufl.edu/covid-19-updates.html#fedagencies where we will load updates as we are made aware.   

Proposal Deadlines: While we have been hearing of flexibility from some sponsors, don’t assume any extension or deviations from posted deadlines.  Double check sponsor site directly for confirmation.  Email ufproposals@ufl.edu with any specific questions on pending proposals.

We caution you that each sponsor is different.  Each will make determinations about proposal deadline extensions, reporting extensions and other flexibilities different than the next.  Please review the sponsor websites and guidance.  If you are unsure, please email Stephanie Gray at slgray@ufl.edu whose team can assist with navigating your needs relative to the sponsors situation.   

Frequent Questions:  

Can I pay my research staff during this time? 

As long as there is benefit to the project, then regardless of the location where those duties are performed, salaries can be charged.  Some allowable activities may include data analysis, preparation of articles and papers based on the analysis of the research findings, monitoring subrecipients, updating protocols, etc. Our primary federal guidance at 200.430(h)(I) states: “…writing reports and articles, developing and maintaining protocols (human, animals, etc.), managing substances/chemicals, managing and securing project-specific data, coordinating research subjects, participating in appropriate seminars, consulting with colleagues and graduate students, and attending meetings and conferences.”   

Do I still need prior approval for changes in scope, rebudgeting, and other changes?  

Yes. While agencies will grant flexibility, don’t assume the process. Email ufawards@ufl.edu with your project id, impact and questions. 

See UF-wide guidance regarding accessing UF locations, travel and more.

See Clinical Research guidance.

C&G

Updated March 18, 2020

Contracts and Grants (C&G) continues to be operational and our main line (352-392-1235) continues to be answered as normal. Please leave a message if not answered and a C&G representative will return your call as soon as possible. Most of our business is electronic and we discourage hard copies. However, if you have hard copy documents please route them via campus mail or US Postal Service at this time.

If you have difficulty reaching us by phone during this time, please send an e-mail to the following address BA-CFO-CG-Mgmt@mail.ufl.edu and a representative from C&G leadership will respond as soon as possible.

Guidance from Federal Agencies

Please visit the Council of Governmental Relations to receive up-to-date information on Institutional and Agency Responses to COVID-19 and Additional Resources.

Research Integrity

Updated March 12, 2020

All UF research projects that have been deemed subject to export-controlled restrictions must adhere to the Technology Control Plan (TCP) that has been reviewed and approved by UF Research Integrity.   If specific challenges arise that generate a need to consider changes to the TCP, please contact Marsha Pesch to submit a request for TCP modification.  Any alterations or modifications to individual TCP protocols must be pre-approved by UF Research Integrity. 

If you have specific concerns regarding your current TCP as written, please reach out to UF Research Integrity at exportcontrol@research.ufl.edu or 352-392-9174.

Frequent Questions:  

How do I report Research Misconduct or other incidents of Research Non-Compliance?

Please continue report all allegations of research misconduct or research non-compliance to the UF Research Integrity Officer (RIO), Cassandra Farley at cfarley@ufl.edu or 352-273-3052. You may also report research misconduct or research non-compliance anonymously anytime by calling the UF Compliance Hotline at 1-877-556-5356 or navigating to the Compliance Hotline website.

What if I need to work in a remote location for my export-controlled project?

All export-controlled work shall continue in the manner dictated in the Technology Control Plan (TCP) unless a modification is pre-approved by UFRI. Addendums to TCPs will only be approved on a very limited basis for projects utilizing ResVault. If specific challenges arise which generate a need to consider changes to the TCP, please contact Marsha Pesch at mpesch@ufl.edu.

Is it currently allowable to use ResVault from a location for export-controlled projects?

The widely approved locations that faculty and staff may use to access ResVault for export-controlled work are the locations identified within each individual TCP. Unless remote access to ResVault is approved prior to use, via written addendum to the TCP, all export-controlled work must continue in the manner specified in the TCP. No TCP security changes may occur without written prior approval from the UF Export Control Officer, Marsha Pesch. Requests for remote work access may be made via email to mpesch@ufl.edu.

Program Development & Funding Opportunities

Please visit the UF Emerging Pathogen’s funding webpage to see the latest opportunities.