Resuming Health-Related Human Subjects Research During COVID-19

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Overview

  • On May 15, 2020, UF Vice President for Research David Norton issued the UF|Research Resumption Plan, which presents the framework for resuming all research activities throughout the University of Florida during the next phases of the COVID-19 pandemic.
  • On May 18, 2020, UF Human Resources issued the policy statement addressing Institutional Recovery and COVID-19 Return to Workplace.
  • On May 20, 2020, the Office of Clinical Research (OCR) issued the following additional guidance for UF clinical research projects, which applies to all UF health-related human subjects research.
  • In the event of a conflict, the UF|Research Resumption Plan shall take precedence.
  • Questions? See FAQs section below or Contact OCR.

Guiding Principles

  • 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.

UF Clinical Research Resumption Plan Stages

Stage 1 Activated 05/20/2020

Stage 2 Activated 06/01/2020

Stage 3 Activated 06/18/2020

Click image to enlarge

UF Clinical Resumption Plan Table

Resuming Research

This section has been updated for Stage 3
  • The objective is to facilitate the resumption of human research while protecting research participants and UF researchers during the COVID-19 pandemic.
  • Requests to resume research must be submitted via Request to Resume Research Activities Submission Form.
  • Multiple studies can be now combined into one submission by PI/research team with a description of the resumption of research plans and implementation of safety precautions for all distinct research areas where contact with human subjects will occur.
  • Human Subjects Research that must be submitted via the Resume Research Activities Submission Form includes:
    • Clinical trials
    • Direct interaction with human subjects
    • Use of UF lab space or other UF facilities
  • Human Subjects Research that does not have to be submitted via the Resume Research Activities Submission Form includes:
    • Research that (a) does not include direction physical interaction with human subjects and (b) does not use UF lab space / facilities such as:
      • Research activities that can be conducted remotely via REDcap, Zoom, Qualtrics, etc.
      • Chart reviews
      • Analysis of pre-existing data
  • If it has been longer than one week since you submitted a HSC College request and you would like to check its status, please email your request # to UFH-Research-Continuity-l@lists.ufl.edu  for an update.

Staying Safe

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 including:

  • Ensuring that both researchers and subjects wear surgical/cloth masks 
  • Maintaining at least 6 feet social distancing whenever possible 
  • Properly disinfecting surfaces or items before subjects come in contact with them
  • Ensuring research staff disclose any symptoms to the PI
  • Ensuring that staff do not have contact with subjects if they feel ill or have been exposed to someone who has tested positive for COVID-19 unless they have been cleared by a medical professional (e.g. have a negative COVID-19 test)
  • Directing subjects to disclose before or during study participation if they
    • Have tested positive for COVID-19 or
    • Have been exposed to someone who has tested positive for COVID-19 or
    • Are experiencing symptoms consistent with a COVID-19 infection (fever, difficulty breathing, etc.). 

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

This section was added 09/28/20

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.


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 the State of Florida’s travel restrictions.

Personal Protection Equipment (PPE) Guidance

This section was updated on 08/28/20 to address changes in PPE requirements

General Information

  • At a minimum, research staff are required to wear surgical masks and eye protection in ALL patient-facing areas.
  • In addition, for all UF Health and UF research patient-care areas, research staff must follow the most stringent PPE requirements or recommendations applicable as outlined in any current Patient Care Clinical Guidance on the UF Health Bridge.
  • Please note that in patient-care areas, research staff should not be wearing cloth masks alone. Cotton masks may be worn under the 3-ply ear loop for those who are allergic to procedural masks. To prolong the life of procedural masks, you can also wear cotton mask over the procedural mask and then launder.
  • 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.
  • 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:

  • An online Review for Respirator Use form must be completed and submitted to EH&S.
  • Individuals who wear a respirator must be medically evaluated by the UF Occupational Medicine Program before it is used. For individuals who wear a tight-fitting respirator, medical evaluation is required annually.
  • Once the medical clearance is established, required respirator training must be completed.
  • After the medical clearance and training have been completed, contact EH&S for a required respirator fit test.
  • Every time there is a change in respirator manufacturer, a new fit testing will be required.

UF CTSI PPE Kits

ItemsQuantityReplacement Frequency / Notes
Kit 1: For Personnel Working in an Office or Lab-based Setting *
Procedural masks per person per week5 per person per weekReplace every 2 – 3 weeks (more frequently if dirty or misshapen).
Cotton masks that can be laundered2 per personReplace when worn out.
Kit 2: For Personnel who are Patient-facing (Non-COVID-19 or Non-aerosol Producing Procedures)
FDA surgical mask (for all patient-facing activities)5 per person per weekReplace every 2 – 3 weeks (more frequently if dirty or misshapen).
Cotton masks (to be worn over or under the surgical masks as needed).2 per personReplace when worn out.
Eye protection (face shields, full-length visors, goggles or safety glasses)TBATBA
Kit 3: For Personnel who are Patient-facing (Working with COVID Patients and/or Aerosol Producing Procedures)
N95/KN95 (for all patient facing activities, COVID-19 or aerosol producing procedure) ***2 – 5 per person Replacement will depend on frequency of use. **
Face shield1 per personReplacement will depend on frequency of use and ability to clean. Resupply only if damaged or unable to safely clean.
Gloves ****1 – 6 pairs per day depending on the setting or number of patient visitsDepending on the study, the burn rate will vary.
Gowns ****Varies Depending on the study, the burn rate will vary - either one per day per person or one per study visit.

* Please refer to the EH&S guidelines regarding use of PPE when working with hazardous materials.

** Frequency of resupply depends on the study as well as type and frequency of visits. Would recommend at least one re-use if possible.

*** Fit testing for N95 or KN95 required. See http://www.ehs.ufl.edu/programs/ih/respirator/. Every time there is a change in manufacturer, a new fit testing will be required.

**** Gown and gloves are available depending on the study and location of study visits.


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.


Content Last Updated 09/28/20