COVID-19 Response

Table of Contents


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UF|Research Resumption Plan

Overview

Guiding Principles

This section was updated on 05/19/21 to emphasize that UF human subjects research will continue to follow masking guidance provided by UF Health.
  • These guidelines are intended to gradually increase the number of research studies conducted in clinical areas at UF and UF Health.
  • The reduced number of studies will allow the university to begin operations in a highly controlled environment and will maintain agility in handling emergent issues resulting from an unpredictable situation.
  • Decisions on staging will be made considering community transmission of COVID-19, the availability of appropriate protective equipment and the safety of research participants and staff.
  • These guidelines are subject to frequent review and revision as the situation is closely monitored.
  • Pursuant to guidance from UF regarding a transition to normal campus operations, all clinical research encounters with research participants being conducted in clinical settings (or non-clinical e.g. CTSI CRC, AMRIS, study team labs, etc) will continue to follow masking and PPE guidelines published on the UF Health Bridge.
  • Additionally, Human Subjects Research being conducted in the community setting will also continue to follow UF Health patient care and PPE guidelines with respect to masking policies.  It is absolutely paramount that we continue to care for the participants we engage.

UF Clinical Research Resumption Plan

Stage 1 Activated 05/20/2020

Stage 2 Activated 06/01/2020

Stage 3 Activated 06/18/2020

UF clinical research teams must continue to follow current UF Health PPE and masking guidance.

Click image to enlarge

UF Clinical Resumption Plan Table

Requests to Start or Resume Research During COVID-19

This section was updated on 05/04/21 to remove resumption approval requirement, 01/27/21 to add info about SRCWG, 11/13/20 to add details for the approval process, and 06/18/20 for Stage 3.

Studies That Require Approval from UF|Research

  • On May 4, 2021, UF Research Results Newsletter announced that the Research Resumption Portal for submitting research resumptions during COVID-19 has been closed. Resumption reviews are no longer required at this time.

COVID-19 Exposure – Important Safety Resources for UF Faculty & Staff

This section was updated on 05/19/21 to emphasize that UF human subjects research will continue to follow masking guidance provided by UF Health.

When study teams engage in approved direct physical interaction with human subjects, appropriate steps must be taken to minimize the potential spread of COVID-19.


COVID-19

UF Health Command Center

For coordinated management of the overall COVID-19 response in the hospital and a general resource for all UF faculty and staff.

COVID-19

UF Health Health Care Worker (HCW) Hotline

Guidance for UF faculty and staff who are symptomatic or have been exposed to a COVID-19 positive patient. The hotline is operational from 7 a.m. to 7 p.m., seven days a week.

COVID-19

UF Health Screen, Test & Protect

Guidance for UF faculty and staff who have questions about the screening or testing process and return-to-workplace initiative. This includes questions about exposures outside of the hospitals across UF. The phone line is operational Monday through Friday from 8 a.m. to 6:30 p.m., and on weekends from 8:30 a.m. to 6 p.m.

COVID-19

UF Health Telehealth Triage Center

Health care guidance for UF faculty and staff with questions about possible illness. The triage center is open from 8 a.m. – 5 p.m., seven days a week.


Personal Protection Equipment (PPE) Guidance

This section was updated on 05/19/21 to emphasize that UF human subjects research will continue to follow masking guidance provided by UF Health, 01/07/21 to remove CTSI as PPE resource, 11/10/20 to add phasing out CTSI as PPE resource, and 08/28/20 to address changes in PPE requirements.

General Information

  • For all UF Health and UF research patient-care areas, research staff must continue to follow the most stringent PPE requirements or recommendations applicable as outlined in any current patient care clinical guidance on the UF Health Bridge.
  • Proper hand hygiene is an important infection prevention and control measure. Wash hands with soap and water for at least 20 seconds after putting on, touching or removing PPE.
  • To ensure that your PPE lasts as long as possibe, please refer to the CDC guidance on Strategies to Optimize the Supply of PPE and Equipment.

Respiratory Protection Policy

Per the UF Environmental Health & Safety Respiratory Protection Policy, prior to using a respirator at UF, an individual MUST complete the following:

PPE Sources

  • UF departments and researchers can purchase PPE for their research teams and labs through UF Procurement Services.
  • Ordering information can be found at https://procurement.ufl.edu/covid19ppe/.
  • If you need something that is not listed, please contact Procurement@ufl.edu providing specific information (part numbers and quantities) of what’s needed and they will try to assist.
  • If you have an urgent need for clinical research PPE and have not been able to obtain it through your department or UF Procurement, the UF CTSI will attempt to assist. Please contact Matt Alday walday@ufl.edu.

COVID-19 Screening for Visitors

This section has been added for Stage 3
  • The UF CTSI Clinical Research Center Screening for COVID-19 SOP provides guidance on COVID-19 screening for all research participants, study monitors, and external visitors (Gatorlink login and VPN required to access the PDF).
  • Study monitoring visits should continue to be conducted remotely whenever possible. If an in-person visit is necessary, the monitor must be screened and cleared for COVID-19 per the UF CRC SOP above (or a similar SOP that has been established for your specific clinical/research area). Study teams can refuse access if the monitor fails the screening or refuses to participate.
  • In addition to following COVID-19 screening, PPE, and social distancing guidance, all study participants, monitors, and external visitors must also follow any applicable State of Florida travel restrictions.

Additional COVID-19 Resources

Alachua County

Centers for Disease Control and Prevention

FDA

Florida Department of Health

National Institutes of Health

University of Florida

UF Clinical Research Forum

COVID-19 Scientific Review Committee and Peer Assistance Working Group

UF Emerging Pathogens Institute

UF Health

UF Human Resources

UF IRB

UF Health IT

UF OnCore

UF Screen, Test, & Protect

UF | Research

World Health Organization (WHO)


FAQs

Do you have a question not listed below? Contact OCR.

Question Answer
1. How will COVID-19 related studies be reviewed?Studies involving COVID-19 patients must still be reviewed by the COVID-19 Scientific Review Committee to evaluated and prioritized. Protocols that are then sent to the IRB will be prioritized.

If you are submitting via IRB01 or IRB02, an ancillary review will route automatically to the COVID-19 Scientific Review Committee.

If you are using a ceded or WIRB submission, send an email request to COVID_SRCWG@ahc.ufl.edu
to be added to the next COVID-19 Scientific Review Committee agenda.
2. Will there be any prioritization of of non-COVID related new studies vs restarting existing studies?No. Any study that falls within the guidelines based on staging will be allowed to start operations. Keep in mind that in-person site initiation visits are not allowed until Stage 3, so this may prevent your ability to start a new study that would otherwise be eligible to begin enrollment.
3. What is the difference between therapeutic intent (life threatening), therapeutic intent (all) and interventional research (all)? Therapeutic intent (life threatening) signifies that the study has a potential direct benefit to research participants (including placebo-controlled trials) and has been approved by the Institutional Review Board. Studies with direct benefit for patients with life-limiting/threatening conditions are allowed in Stage 0.

Therapeutic intent (all) includes studies with direct benefit regarding other conditions, which are allowed in Stage 1, provided that research visits are conducted during clinical encounters.

Interventional (all) research includes studies with therapeutic intent (potential for direct benefit), screening and diagnostic studies, and any other study that manipulates the participant or participant’s environment to examine the impact on health outcomes.
4. I have a study that meets the criteria for inclusion in Stage 1, but not all the visits on the study calendar are designed to take place during a clinical visit (i.e. research-only clinic visits). Am I allowed to enroll participants into this study?Yes, but while UF is in “Stage 1”, all research-only visits must be changed to either remote visits or be rescheduled to coincide with clinical encounters. Once UF moves to Stage 2, research-only visits for these participants will be allowed.

If a study visit needs to be rescheduled and would result in a study deviation, a revision can be submitted to the IRB ahead of time to acknowledge the delayed visit window ahead of time. See http://irb.ufl.edu/wp-content/uploads/Temporary-Guideline-COVID-19-Related-Protocol-Revisions.pdf.
5. Is there anything specific we should tell study subjects as we contact them to re-start their research involvement?Yes, the IRB has provided template language that can be adjusted to fit any research protocol. This should be used regardless of the type of contact (eg. phone, email, letter). See IRB's Contacting Template.
6. What if I am allowed to resume my research and subjects who have already consented want to delay their involvement?If a study subject does not want to come on site, and there cannot be an accommodation that allows them to continue (e.g. remote visits, further delay in restarting for an individual subject), then the PI should inform the study subject that he/she will be withdrawn from the protocol.
7. What changes to my protocol must require pre-approval from the IRB before the change is made?For changes resulting from the COVID crisis to already approved protocols, any research activity that can be changed to a remote activity does not require approval from the IRB.

Any change to a research activity that cannot be conducted remotely must have pre-approval from the IRB before the change can be made.

Also, any change to the informed consent process must be submitted and approved by the IRB prior to making the change.
8. I have a participant visit scheduled for early June. Should I reschedule?Staging is based on environmental factors outside of the control of UF/UF Health. There are no dates that can be associated with the beginning or end of the stages.

UF/UF Health will monitor the situation closely, update the staging as appropriate, and communicate changes with the research community through established communication channels.
9. What if my study is able to restart but the laboratory where I process, ship, and store samples is closed?If the laboratory is closed per the laboratory guidelines, then delaying enrollment/resumption of study activities will be necessary.
10. I have an observational or diagnostic study that does not have direct patient benefit but the study visits align with clinical care, and much of the data collection can be done remotely, can I restart?These studies, while relatively safe, are not permitted until Stage 3. The intent of this guidance is to control the number of studies that are being conducted at one time in order to maintain safe management of space densities and inventories of available PPE.
11. What if my research study is included in the “research allowed” category, but I am not able to comply with all of the guidelines related to allowable visits, PPE, and maximum occupancy?Research must be included in the allowable category AND all safety guidelines must be met in order to begin operations. This includes, but is not limited to, the COVID-19 specific guidelines for clinical research safety.

For example, if you have a diagnostic study that is allowed to reopen in Stage 2, you will need to ensure that all staff have access to surgical masks and can follow social distancing practices. In addition, you will need to follow guidelines for opening laboratories and office spaces as applicable.

If your team needs to be physically on campus to begin working on a study, but you do not have sufficient space to follow maximum capacity guidelines, your study will not be able to resume/start.
12. Can my research team return to work in the office?Please see guidance for laboratory and office locations in the UF|Research Resumption Plan.

As long as your team can comply with the space and mask requirements, you should be able to have the team resume work on campus / in campus office space.
13. Is it necessary to register/get approval for studies that intend to restart? Do the teams have to submit a skeleton plan for managing the applicable guidelines?Requests to Resume Research Activities must be submitted to via the following website: https://researchtools.ifas.ufl.edu/apps/essentialActivities/.

14. If my research is allowed to restart, what are my options if I do not feel it is safe to start at this time?On May 18, 2020, UF HR released the following policy statement specifically addressing Institutional Recovery and COVID-19 Return to Workplace. The policies and guidance in that document must be adhered to.
15. How will my staff access needed PPE for allowable activities?PPE will be available to all allowable research through a request to the CTSI. See the CTSI Personal Protective Equipment (PPE) Order Form.

Industry sponsors will be asked to reimburse the CTSI/UF for PPE used to conduct this research. Reimbursement for other funded and internally funded studies is TBD.

PPE is not expected to be rationed at this time, but the availability of PPE must be considered as you think about beginning your research during all stages, as appropriate.

Also, please see CDC Guidance on Strategies to Optimize the Supply of PPE and Equipment and EH&S COVID-19 PPE Guidance and Instructions.
16. My study qualifies under stage 1 or 2 but the patient needs to travel from out of state. Are there any travel restrictions for patients?Travel restrictions will follow the current State of Florida travel restrictions.
17. Is COVID-19 testing being required for study teams or patients?The UF|Research Resumption Plan offers guidance on the requirements for testing of UF faculty, staff, and students.
18. Once my research resumes, can I enroll subjects who may experience worse outcomes if they contract COVID-19 (e.g. diabetics, people 65 and older, people with cardiovascular or pulmonary conditions, etc.)?Protecting subject welfare is always paramount.

Principal Investigators should give additional consideration to individuals who may be at higher risk of experiencing a worse outcome should they contract COVID-19, and evaluate if this additional risk can be appropriately mitigated through protective measures like PPE or if the potential benefits of participating in the research are insufficient to proceed with enrollment.

Most significantly, if your study involves experimental drugs or devices you should carefully evaluate if the intervention has any impact on cardiovascular or pulmonary function.

The IRB can also be consulted for guidance before proceeding with enrollment.
19. If my study qualifies for a particular resumption stage, do I have to resume the study? What must I do to justify a delayed onset of my study?The answer will depend on if your project is externally funded or not.

Federal awards will be guided by institutional practice. The UF approach at this time is that a delayed restart is an unapproved reduction in effort and reduced performance towards project goals. You would need to work with DSP if you are seeking an exemption.

Industry awards failing to restart potentially put us in breach. You would have to work with the sponsor to get permission to delay.

Internal projects "unfunded" are at the discretion of the PI.
20. I deal with a vulnerable patient population, and I believe the risks of bringing them back outweigh the benefits. What must I do to justify a delayed onset of my interventional study?The IRB is best positioned to determine if it is safe for a certain population, and if additional precautions should be taken, including delayed resumption. Also see question 19 above.


21. I’m a stage 2 study, but my lab space is not 250 square feet. There is *no way* for me to have even a single tester and participant pair and be compliant. What should I do?For research-only spaces where you interact with participants, the Maximum Occupancy Limits for clinical research is "Social Distancing". This means both in the pair must wear a mask and keep a 6 foot distance whenever possible.

Do you have a question not listed above? Contact OCR.