UF Research Resumption

Like so much of the world, the University of Florida suffered significant disruptions when the COVID-19 pandemic reached our shores in March 2020. Earlier memos on this page are a reminder of how quickly the situation changed. We went from “there are currently no restrictions or limitations on research activities,” on March 12^th to “perform situational planning in the event that access to your research space is restricted,” on March 16^th to “research activities that can be accomplished remotely should move to that modality now,” on March 23^rd. For the next six weeks, most research on campus was halted.

But as the stories in this Sustaining Science compilation illustrate, the pursuit of knowledge continued. Faculty, staff and students did whatever they could to keep science moving forward. Some focused on the disease itself, from understanding it to preventing it to treating it. Others used their expertise to address shortages of personal protective equipment and medical devices.

And still others focused on the countless research projects under way. They brought samples home, they wrote new software, they published papers, and they applied for grants. They also sewed masks for health care workers and mixed hand sanitizer in vacant chemistry labs.

UF Research Resumption Plan

Almost as soon as the shutdown began, we started thinking about how to reopen. We established a task force of research leaders from throughout the university with a goal of securing a fully reconstituted research enterprise, akin to that which existed prior to the onset of the pandemic, while minimizing the risks of coronavirus transmission in the workplace through the deployment of PPE, social distancing, screening and other workplace practices.

The result of their efforts was a Research Resumption Plan with a phased reentry strategy that balances the need to resume research activities, the type of research environment and the density of research personnel, while keeping the health and safety of faculty and staff paramount.

We entered Stage 1 of that plan on May 18 and began the process of clearing faculty, staff and students to return to their research facilities. Since then we have authorized more than 7,000 people to return, as we moved to Stage 2 on June 1 and Stage 3 on June 18.

Much has changed in the world and at our university, but COVID-19 did not change the need for solutions to medical, environmental, social and other challenges that are immune to the demands of the coronavirus. Faculty are returning to their research labs because they know that science delayed is opportunity lost for people who could benefit from their discoveries, whether it’s a new medical treatment or a breakthrough technology.

The pace of change documented on this page has slowed, but whenever there is new information to share, this is where you will find it.

Stay well.

David Norton, Vice President for Research, University of Florida.

UF Research Resumption Plan: Stage 3

It has been four weeks since we started the process of bringing UF researchers back on campus through the UF Research Resumption Plan. I want to thank everyone for their incredible efforts. Research activities of over 4000 UF faculty, staff, post-docs and graduate students were successfully reviewed and approved though the Research Activity Approval Portal. These efforts to reengage activities that were disrupted due to the COVID-19 pandemic are remarkably important to the research mission and objectives of our enterprise. Again, thank you for your resiliency, patience, and dedication.

UF Research Resumption Plan

Beginning today, June 18 2020, we are progressing to Stage 3 of the resumption plan. For most activities, the significant change will be an increase in the allowed density of people per laboratory, an increase to 1 per 150 sq. ft. For human subject research, please see specific guidance at the Clinical and Translational Science Institutes’ page on resuming health-related human subjects research during COVID-19.

In order to assist researchers as we move to Stage 3 of the plan, we are providing the following guidance:

• For activities approved in Stage 1 or 2 that require no additions in personnel or facility location, no additional approval is needed for Stage 3. Researchers may proceed within the Stage 3 limitation.
• For Stage 1 and Stage 2 approved activities that simply require the addition of personnel or facility location, a Stage 3 Activity Request must be submitted through the portal for review. To the extent possible, please reference the previously approved Stage 1 case number so as to avoid re-inputting all information.
• For Stage 3 activities that are significantly modified relative to a Stage 1 or 2 approval, or for researchers who did not have approved Stage 1 or 2 activity plans, please submit all information requested. As with the Stage 1 and Stage 2 activities, please work with the associate dean for research within your college for submission of new or modified activities through the Research Activity Approval Portal.

The COVID-19 Screen/Test process being administered by UF-HR / UF Health continues, and as a reminder, note that all UF employees must successfully complete this process before returning to UF facilities. After being cleared by UF-HR / UF Health, employees should coordinate with their department chair or facility administrator to establish a schedule for return.

As we progress through this stage, our success will remain dependent on our adherence to the UF Health Screen/Test/Protect program which include:

• Face covering – required within all UF building
• Social distance – Keep 6 feet between people inside or outdoors
• Hand and surface hygiene – Wash hands and disinfect surfaces often
• If sick, stay home – Seek medical assistance if experiencing COVID-19 symptoms.

Together, we can accelerate the mission of UF research discovery that impacts our state, nation, and world.

Stay well.

David Norton, Vice President for Research, University of Florida.

I want to thank everyone for their incredible efforts in bringing our researchers back on campus through the initial stage of the UF Research Resumption Plan.  Research activities of over 3000 UF faculty, staff, post-docs and graduate students were successfully reviewed and approved though the Research Activity Approval Portal.  These efforts to reengage activities that were disrupted due to the COVID-19 pandemic are remarkably important to the research mission and objectives of our enterprise.  Again, thank you to all for your resiliency, patience, and dedication.

UF Research Resumption Plan

Beginning today, June 1, 2020, we are progressing to Stage 2 of the resumption plan.  For many, the most significant change will be an increase in the allowed density of people per laboratory, an increase from 1 per 500 sq. ft. to 1 per 250 sq. ft.  For human subject research, the allowed resumption of diagnostic, screening and interventional studies will expand activities as we move to Stage 2.  Specific guidance for human subject researchers can be found at the Clinical and Translational Science Institutes’ page on resuming health-related human subjects research during COVID-19.

In order to assist researchers as we move to Stage 2 of the plan, we are providing the following guidance:

• For activities approved in Stage 1 that require no additions in personnel or facility location, no additional approval is needed for Stage 2.  Researchers may proceed within the Stage 2 limitation.
• For Stage 1 approved activities that simply require the addition of personnel or facility location, a Stage 2 Activity Request must be submitted through the portal for review.  To the extent possible, please reference the previously approved Stage 1 case number so as to avoid re-inputting all information. 
• For Stage 2 activities that are significantly modified relative to a Stage 1 approval, or for researchers who did not have approved Stage 1 activity plans, please submit all information requested.  As with the Stage 1 activities, please work with the associate dean for research within your college for submission of new or modified activities through the Research Activity Approval Portal.

We are aware that the COVID-19 Screen/Test process being administered by UF-HR / UF Health is ongoing, and as a reminder, note that all UF employees must successfully complete this process before returning to UF facilities.”  After being cleared by UF-HR / UF Health, employees should coordinate with their department chair or facility administrator to establish a schedule for return.

As we progress through this and future stages, our success will remain dependent on our adherence to the UF Health Screen/Test/Protect program which include:

• Face covering – required within all UF building
• Social distance – Keep 6 feet between people inside or outdoors
• Hand and surface hygiene – Wash hands and disinfect surfaces often
• If sick, stay home – Seek medical assistance if experiencing COVID-19 symptoms.

Together, we can accelerate the mission of UF research discovery that impacts our state, nation, and world.

Stay well.

David Norton, Vice President for Research, University of Florida.

The research we do here at the University of Florida is important, really important. Across disciplines and colleges, we are making discoveries that solve the challenges of today and tomorrow, form the basis of future economies, and create opportunities for a better life for current and future generations. Many of our efforts in research, in particular our experimental enterprise, were disrupted by COVID-19. While some of our research pursuits continued, the bench laboratory activities have suffered significantly during the pandemic. Despite the challenges, it is critically important that we find modalities to reengage the full breadth of our endeavors in pursuit of the UF research mission.

UF Research Resumption Plan

With this objective, the University of Florida is beginning the process for reengaging on-campus research activities which have been interrupted by the COVID-19 pandemic. The goal is to secure a fully reconstituted research enterprise, akin to that which existed prior to the onset of the pandemic, while minimizing the risks of coronavirus transmission in the workplace through the deployment of personal protective equipment (PPE), social distancing, screening, and other workplace practices. The UF Research Resumption Plan employs a phased reentry strategy that balances the need to resume research activities, the type of research environment and the density of research personnel, while keeping the health and safety of faculty and staff paramount. Efforts to reengage on-campus activities are designed so as to minimize the risk of workplace exposure to or transmission of COVID-19.

Beginning on Monday May 18, faculty members whose research activities require on-site UF facilities should begin working with their department chairs and deans to create individual program plans that fit within the conditions set forth in Stage 1 of the Research Resumption Plan. After consultation planning with the chairs and deans, and with their approval, faculty members will be directed to submit the information necessary for university review and approval of their plan through a Research Resumption Request Portal. The information that will be required in the entries is indicated in the plan. The departments and colleges are responsible for the pre-submission screening process prior to granting approval to proceed with Request Portal entry. The colleges will also provide instructions for accessing the portal. The online system is designed to elicit critical information from faculty researchers so as to allow for review and approval by the department, the college and Vice President for Research. Ancillary reviews will also be required for research involving animals or human subjects.

Once the individual research resumption plans have been approved, researchers identified with each plan will need to be cleared for return to UF facilities by UF Human Resources through the UF COVID-19 screening/testing process. The names of these researchers will be forwarded to HR to receive information for the screening process. Once cleared by HR, they should coordinate with their departments to return to their labs.

At present, we are proceeding with the restrictions outlined in Stage 1. In coming weeks, we anticipate progressing through Stages 2, 3 and 4, arriving at a sustainable steady-state level of on-campus research activity within the context of the pandemic.

Questions regarding the pre-screening process should be directed to your department chair or college associate dean for research. Questions about the overall process can be directed to Dr. Rob Ferl, assistant vice president for research, or Dr. David Norton, vice president for research.

Stay well.

David Norton, Vice President for Research, University of Florida.

One of the things that characterizes our university and its academic health center is a shared spirit of compassion and innovation. That has never been more evident than in the midst of this history-making pandemic.

We applaud your ingenuity and understand your desire to make an impact, using your expertise, energy and enthusiasm for the greater good.

We are already aware of many novel ideas, prototypes and devices being generated at the departmental, college and/or center and institute levels that are rapidly being produced for possible use in an effort to address crucial needs that have arisen from this global public health emergency.

But to make sure we’re not missing anything, the UF Clinical and Translational Science Institute has put together this survey to help gather information about projects related to COVID-19 across campus. Your responses will help us get a better idea of the broader picture, so we’ll be able to help fill in the gaps, speed research along, direct supporting efforts where they are most needed, and perhaps even suggest collaborations among teams that didn’t know they were working in similar or complementary areas.

The survey will also serve as a resource for intellectual property, legal and liability, compliance and communications teams. These are all areas where we need to make sure we check all the boxes before we share our ideas widely.

Never has the University of Florida demonstrated its strength as Florida’s land-grant university more clearly than during this crisis. We look forward to seeing all of the ways UF researchers are responding to the pandemic.

Thank you again for your dedication and enterprising spirit.

David Norton, Ph.D, Vice President for Research
Stephen P. Sugrue, Ph.D., Associate Vice President for Research, UF Health
Duane Mitchell, M.D./Ph.D, Director, Clinical and Translational Science Institute

The University of Florida continues to work through the challenges presented by the COVID-19 pandemic. Despite these challenges, most of our sponsored projects have continued, many by temporarily transitioning to remote workplace, some with modifications to work plans, while others have been allowed to maintain some on-campus effort as a designated essential activity. As we continue to support the research objectives in specific sponsored projects, it will prove helpful to keep sponsors accurately informed on the status of university operations and of specific sponsored projects, including modifications of work plans.

If your project is affected in any way, please consider providing your sponsor with a short update. In addition, many program managers are interested to hear how their sponsored projects are continuing under the current work conditions. Please consult your Notice of Award to identify reporting contact and reporting cycle, considering whether it is prudent to provide the contact with an interim update. These updates can take the form of short memos or bulleted lists and are intended to let agency contacts assess the impacts on their programs. In order to assist Principal Investigators in this process of updating sponsors, we are providing the following template as a framework for these communications.

Status of University of Florida Operations:

• During the COVID-19 pandemic, the University of Florida remains deeply committed to the health and safety of the people involved in research at our institution, while continuing to pursue the objectives of our research sponsors.
• The University of Florida remains open with the majority of operations temporarily transitioned to teleworking from home. All UF|Research administrative operations are fully functional and available via this modality.
• On-campus activities are currently limited to those identified and approved as essential by UF managers and leadership.
• Residents within the Gainesville community are currently under an emergency Stay as Home order from the state and local county.
• The University of Florida continues to monitor the impacts of the epidemic, and in coordination with local, state and national authorities, will assess changes to campus status as conditions warrant.

Sponsored Project Activity Update (enter project number and title):

• Despite the current challenges, we continue to pursue the objectives of this project. Activities that have continued with little or no interruption include:
  • (Insert that which is appropriate for your project. This might include computational studies; data analysis; reports and manuscript preparation; literature review; online dissemination of research; laboratory activities deemed essential and continuing; laboratory maintenance; etc)
• Sponsored project activities that have been temporarily impacted include:
  • (Insert that which is appropriate for your project. This might include experimental laboratory activities; travel; field work; etc)
• Tentative plans for work on this project in the next 60 days
  • (Insert short paragraph describing tentative research plans for the next 2 months of activity. Consider including work that is continued or modified. If there are unanticipated costs going forward, you may wish to include this as well.)
• Additional information or requests to consider if needed or applicable include:
  • Inability to meet deliverables or reporting timelines
  • Need to extend the final budget period for 12 months due to project suspension
  • Request carryforward of unobligated balances from prior year to current year for immediate effort to support activities related to or affected by COVID-19
  • Sponsored project related travel, conferences, seminars, or other assemblies that were delayed or canceled, and their associated costs
  • Affected personnel (please include name, role, and impact such as unable to perform work functions remotely or reduced % from predicted)
    • Note that any personnel who are working now from foreign locations that were previously working from US locations may now qualify as foreign components and should be communicated to DSP.
  • Other: please describe in detail

Please note that a change in scope from approved aims is typically not permitted.  If you believe a change in scope (rather than change in methods or timelines) is necessary, please contact the Division of Sponsored Programs at ufawards@ufl.edu.

If you have any questions or concerns, please contact the Division of Sponsored Programs at ufawards@ufl.edu.

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.

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.

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:

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:
  • Contractual issues:  Brian Sevier  bjse@ufl.edu.
  • Federally funded issues: Stephanie Gray  slgray@ufl.edu.
• 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.

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.

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

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.

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

• Supervisors are encouraged to determine what functions can be migrated to remote workplace (e.g. home), and begin implementation. While we don’t anticipate all functions will migrate off campus, moving some functions now makes implementation of social distancing throughout the on-campus UF workspace more readily achievable. 
• Implement recommended practices for on-campus operations that minimize the potential person-to-person transmission of COVID-19. If an employee is or feels sick, they should stay home.  At work, frequent hand-washing, social distancing (maintaining at least 6-feet of separation from others), and migrating meetings to calls or Zoom are good practices and are strongly encouraged. 
• Perform situational planning in the event that access to your research space is restricted, or the availability of laboratory personnel is curtailed.
• Formulate research plans in the event that extended absence from laboratory is required for one or more individuals. For critical functions that must be performed on campus, such as research animal care, develop a plan for how these will be handled.  Discuss now with your group who will be designated as research continuity personnel to maintain ongoing experiments and receive essential supplies, should access to campus be restricted. 
• Primary consideration is the health and safety concerns of your group members and their families. Individuals in high-risk groups or with high-risk family members should significantly limit exposure to other co-workers, who may be asymptomatic. 
• Consider what supplies and reagents you will need to maintain ongoing laboratory experiments and human subject data collection projects in the event of a shortage or restricted campus access.
• Prioritize ongoing laboratory activities that are critically important in the event that on-campus efforts are disrupted. Consider postponing new experiments that require significantly long timelines of uninterrupted on-campus activities.
• Discuss with your research group the types of research activities that could be performed if access to campus is impaired. This could include data analysis, documentation of procedures, developing manuscripts, and writing reports.  The university recognizes that such disruption may impair progress for certain research endeavors.  While the university will seek to maintain on-campus research operations, these could become unavailable.
• In light of disruptions due to COVID-19, federal funding agencies are providing flexibility to awardees and applicants. Agency-specific guidance will be posted at https://research.ufl.edu/covid-19-updates.html  as it becomes available.  Please contact Stephanie Gray or [tcasi@ufl.edu]Tiffany Schmidt for specific guidance.
• Establish a communication plan (or review existing plan) for your group, including both students and staff. This should include emergency contact phone numbers for all group members, and a strategy for how you will communicate essential information rapidly, if necessary. This information should be shared with all members of your group. Plan to stay in good communication via virtual lab meetings to provide scientific as well as emotional support to your research team.

Many of these recommended actions represent prudent preparation for what might occur going forward. The local situation with COVID-19 could evolve rapidly.  Our goal is to keep research laboratories open and available for UF researchers, but we to need to prepare now for various scenarios so as to protect UF personnel and families, and to preserve the remarkable entity that is the UF research enterprise. 

Additional updates specific to the research community will be posted at https://research.ufl.edu/covid-19-updates.html. University-wide updates are posted at http://www.ufl.edu/health-updates/.

UF Research is committed to supporting the research community as our institution addresses COVID-19.
While the university is requiring that all classes be moved online, there are currently no restrictions or limitations on research activities. Access to research facilities remains unchanged for faculty, staff, graduate students and others who are engaged in these activities.

UF Research will continue to provide existing research support services for proposal submission, award management, compliance, animal care, and other functions.

Sponsored research should continue, with the understanding that some activities may need to be modified or performed at alternate workplace locations at some point. For individuals paid through a grant or contract, the expense allocation should continue so long as the individual continues to work on the project, either from campus or elsewhere. If challenges related to COVID-19 prevent the execution of activities supported on a grant or contract, please contact Stephanie Gray or Tiffany Schmidt for guidance.

Researchers are encouraged to institute recommended practices that minimize potential exposure to COVID-19 within the research workspace environment. Additional updates specific to the research community will be posted at https://research.ufl.edu/covid-19-updates.html. University-wide updates are posted at http://www.ufl.edu/health-updates/.

Stay Home If Sick: 

Personnel should stay home if they experience any symptoms, including fever, cough, or difficulty breathing. Limit physical contact with others, such as hand-shaking (substitute elbow bumps or bows) and sharing of food. Finally, the most effective prevention measure is frequent, thorough hand-washing.

Prepare for Restricted Campus Access:

At this time, there are no plans to restrict access to university research spaces, but every research group is encouraged to plan ahead in the event that full access is not possible for some time period. If campus operations are suspended, additional instructions will be provided.

Develop a Communications Plan:

If a communications plan for your research group is not already in place, designate points of contact to ensure everyone receives timely information.

Plan for Extended Absence of Key Personnel:

Principal investigators and research group leads should discuss approaches now in the event that some personnel are unable to come to work. Such advanced planning will make future decisions straightforward and minimize disruption to research activities.

Prepare to Work Remotely:

All faculty, staff, postdocs and students involved in research projects should ensure they have access to the information they need to carry out work remotely. This might include, for example, access to literature, to existing datasets and research-related files, and to meeting software (such as Zoom). Principal Investigators should prepare to carry out meetings remotely, just as they would to teach classes remotely. Examples of the types of research work that can be done remotely are data analysis, literature reviews, writing of proposals, research papers, and background sections of theses, computational work, meetings, discussions, etc.

Prioritize Critical On-Campus Work:

Depending upon the nature of your research, consider prioritizing work that can only be carried out in your research facility, and put off work that can be done remotely, such as data analysis. Stockpiling results and data now that could be analyzed remotely in the future is a potential option that might create future flexibility.

Save Samples Along the Way:

If you are carrying out a long-term experiment and if it is feasible to freeze or otherwise capture samples at specific steps, you might consider doing this more often.