These are some guidelines for conserving PPE during this time;

• OACM asks that you limit entering the animal facility even if you have approval to do essential research. This is in an effort to maintain social distancing standards as well as save PPE—multiple lab members should not gown up to go into animal rooms if your work can be completed by one lab member.
• If you are working in HSRF and then in Given, save your PPE from HSRF to wear in Given (remove before walking through corridors).
• Limit your visits to the animal facility by clustering your duties on specific days (e.g., every other day visits) when possible; if you need to enter the facility multiple times in the same day, please save and re-wear your PPE (not gloves).
• Limit the number of lab members
• If you find a damaged PPE item (especially masks with broken ear-loops) please set aside for OACM to repair. Ear loops can be re-glued.
• DO NOT cover cages on carts with new gowns; cages should be covered with your used gown or a sheet/towel.
• DO NOT take PPE from the Animal Facility for use elsewhere; there has been an increase in “missing” PPE in recent weeks.
• Enlist OACM to help—we are already in the facility and will work with a representative from your lab to assist with some tasks (weaning, separating, breeding, etc.) for a reduced fee.
• If you are entering a room just to retrieve a cage or quickly check something, please ask Animal Care for help—someone who is already gowned up can likely assist you.

If you have an animal in need of immediate attention, the quickest means to get in touch with on-call veterinary staff is to locate an Animal Care staff member in your facility.

If you are unable to locate someone in your facility:

• During business hours (Tuesday-Thursday 7 a.m. – 4:00 p.m.), call the Veterinary Technician office at 802-656-8708
• Outside of business hours, call Dr. Ida Washington at 425-592-2397 or Alyssa Frizzell at 802-528-9460.

• Effective immediately, no additional studies/experiments or breedings may begin, unless specifically approved by your Dean and the VPR, so that we may minimize the number of animals requiring daily care (Note that IACUC approval processes remain intact for protocol changes and reviews).
• Orders for acquiring additional animals, as well as imports and exports, are no longer being accepted.

If you are suspending breeding of commercially-available animals, try to conserve the fewest number of animals needed to maintain the strain or line.

Specifically:

• Remove male breeders from breeding cages and identify the male.
• Ideally, save the youngest weanlings of a strain (~3-5 weanlings, male and female in separate cages).
• Save one cage of female weanlings (3-5 weanlings, ideally 6-8 weeks old or youngest available) and label the cages with a “Save for Breeding” note.
• Save one cage of male weanlings (2-3 weanlings, ideally 6-8 weeks old or youngest available) and label the cages with a “Save for Breeding” note.
• If possible, recombine females into socially-housed cages (up to 5 per cage); females from different strains may be combined if socially compatible. Consider euthanatizing males if there are several of the same strain to reduce the number of singly-housed animals.

For strains that need to be maintained by breeding:

• It is recommended that you reduce the number of breeding cages to 2-3 cages and allow mice to continue to breed.
• Pups should be euthanized prior to weaning except in cases in which breeder cages are being replaced due to age or poor breeding.

• OACM’s primary focus is to continue the provision of critical life support services that ensure animal welfare. This includes continuing veterinary medical care; assessment of animal health and well-being; provision of food, water, clean cages, and maintenance of appropriate environmental conditions.
• While OACM staff may be able to perform some research support services on an emergency, case-by-case basis, our commitment and priority focus must remain with critical standard care services.

Accordingly, laboratories should take the following actions:

• Do not bring animals to laboratories with the idea of maintaining them overnight;
• If you have IACUC approval to house animals outside of the animal facility, ensure that OACM staff are aware of their location;
• At the end of each day (i.e., before leaving) monitor your animals closely and euthanize those that are nearing endpoints (i.e., do not plan to euthanize them first thing the next morning); and
• Maintain vigilant communication with your research team to ensure that each team member monitors his or her animals according to the duties and assignments outlined in your protocol.

• OACM will continue to provide special diets if appropriate arrangements have been made with OACM staff. We will continue to do our best to provide special diets for which we have ready access.
• If the diets are for clinical care (e.g., required to maintain animal welfare) OACM will continue to provide these as a priority.

• While 2 dogs (Hong Kong) and 2 cats (one in Belgium and one in Hong Kong) living with people diagnosed with COVID-19 have been reported to have been infected with SARSCoV-2, infectious disease experts and multiple international and domestic human and animal health organizations continue to agree that there is no evidence at this point to indicate that, under natural conditions, pets spread COVID-19 to people. – Source: American Veterinary Medical Association (link is external) (AVMA)
• The USDA National Veterinary Services Laboratories has confirmed the presence of SARS-CoV-2 in one tiger at a zoo in New York. Public health employees believe the large cats became ill after being exposed to a zoo employee who was actively shedding virus. No other animals in other areas of the zoo are exhibiting similar clinical signs. The USDA and CDC are monitoring this situation. – Source: AVMA (link is external)
• Out of an abundance of caution, it is recommended that those ill with COVID-19 limit contact with animals until more information is known about the virus.
• Although several new research articles have been disseminated showing that some domestic animals can be experimentally infected with SARS-CoV-2 and may transmit the virus to other animals in an experimental setting, it is important to note that:
  • Reported data is preliminary,
  • Studies include a very small number of animals in an experimental setting and, therefore,
  • Results from these studies should not be extrapolated to the potential for SARS-CoV-2 to naturally infect or be transmitted by companion animals kept as pets. – Source: AVMA (link is external)

The RPO and its Committees are operating through modified procedures. RPO staff are working remotely and are conducting regularly scheduled and ad hoc meetings via online conferencing.

On-site educational programs have been cancelled until further notice.

In response to the COVID-19 pandemic that is impacting public health worldwide, the "call" has gone out to the scientific research community to develop screening tests and therapeutics, as well as studies to better understand the virus itself.

If you are planning to work with COVID-19 clinical specimens or SARS-CoV-2 associated materials, it is important to obtain Vice President of Research approval, have a risk assessment completed and an IBC registration approved prior to accepting any of these materials in the laboratory

The RPO and its Committees are operating through modified procedures. RPO staff are working remotely and are conducting regularly scheduled and ad hoc meetings via online conferencing. On-site educational programs have been cancelled until further notice, however a request for for a specific educational session may be scheduled with Melanie.Locher@uvm.edu.

As of February 1, 2021, the institutions are at Research Activity Level 3.  See latest notices in the Quick Link under UVM Notices.  The Research Activities Level Table can be viewed here.

The rollout has been in phases. The current phase, Phase III, is the last phase of resumption. Because of the phased rollout, different departments have different requirements to restart.

Larner College of Medicine (LCOM)

1. Ensure that your department has obtained approval from UVM to return to work. Ensure all staff have completed UVM VOSHA training and the recommended spring refresher training.  
2. Develop protocol-specific plan to address COVID-19 federal and state requirements.  This plan should be entitled “COVID Mitigation Plan for Resumption of Research” and must be appended to the end of your currently approved protocol. 
3. Obtain LCOM Dean’s office approval of your COVID-19 reopening plan, Safety Plan.
4. Submit a modification to the IRB with the modified protocol and/or a mitigation appendix.
   1. If COVID-19 mitigation processes will result in changes to your protocol or processes you must submit a modification (MOD) related to these changes for IRB review and approval.  Please identify within the modification if the changes are specific to COVID-19 and whether the planned changes are temporary or permanent.
5. Once you receive IRB approval of this modification, you are ready to resume your research.

Agriculture and Life Sciences, Arts and Sciences, Business, Education and Social Services, Engineering and Mathematical Sciences, Environment and Natural Resources, Nursing and Health Sciences, Honors College, Graduate College

1. Ensure that your department has obtained approval from UVM to return to work. Ensure all staff have completed UVM VOSHA training and the recommended spring refresher training.  
2. Develop protocol-specific plan to address COVID-19 federal and state requirements.  This plan should be entitled “COVID Mitigation Plan for Resumption of Research” and must be appended to the end of your currently approved protocol. 
   Note:  You do not need to revise text within your protocol, the appendix is sufficient and hopefully temporary. 
3. Obtain chair/dean approval of this plan.
4. Submit a modification to the IRB with the protocol and the new mitigation appendix and documentation of chair/dean approval.  The approval could be their signature on the plan or it can be an email. 
5. Once you receive IRB approval of this modification, you are ready to resume your research.

Required CDC and State requirements for screening must be completed prior to any in-person research visits. The screening procedures do not need IRB approval. For non-LCOM departments, we would expect that the screening is part of an overall mitigation plan. If a participant endorses answers that may indicate exposure or symptoms, instruct them to contact their primary care physician.

Though the IRB has determined that researchers are not required to submit modifications to their protocols or consents to include COVID-19 screening, it is important that the participant be informed of these requirements and any changes prior to coming to campus.

The IRB has developed an information sheet to be sent to potential new or ongoing participants whose research visits have been paused. The information sheet informs the individual as to how they will be treated during their research visits as well as how study procedures may be postponed to further alleviate safety concerns to both the individual participant as well as others. The sheet also has an editable area to inform participants, as applicable, if they will be required to undergo a nasal swab testing for COVID-19 as this is now a requirement for many hospital procedures. Hospital PIs/coordinators must educate themselves as to which procedures require a COVID-19 test and the timing required prior to the procedure. Required COVID-19 testing should be part of the discussion with the participant during their pre-visit COVID-19 screening phone call.

Yes, switching to remote follow up requires a modification to your approved protocol.

The IRB developed guidance on virtual research visits which can be found in the Policy and Procedure Manual under 9.10 Virtual Research Visits and 9.11 Technical Guidance for Virtual Research Visits, Electronic Consent, Electronic Data Capture, and Communications.

In appropriate situations, a remote consenting process may be used.  You will need to submit a modification to your protocol for review and approval.  In certain minimal risk situations, it may be appropriate to request a waiver of consent documentation.  Work with your IRB Analyst for appropriate options.  The IRB completed guidance on electronic consent which can be found in the Policy and Procedure Manual under sections 9.9 Obtaining Electronic Written Consent and 9.11 Technical Guidance for Virtual Research Visits, Electronic Consent, Electronic Data Capture, and Communications.

References include:

• FDA Guidance on Use of Electronic Informed Consent
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

You may need to notify the reviewing IRB of the resumption of research activities. Researchers should contact those IRBs for guidance.

If the Overall Recruitment Status and/or Individual Site Status of a UVM investigator-initiated clinical study registered on ClinicalTrials.gov is changing due to the COVID-19 situation, you should update the study record as you normally would, within 30 days of the change. If enrollment and/ or other study activities are "on pause" rather than under an official IRB suspension, consider still selecting Suspended, which will populate the Why Study Stopped data element, where you may then more clearly explain the status. Additional information regarding study record maintenance requirements is available on the Office for ClinicalTrials.gov website.

If you had updated ClinicalTrials.gov with the pause information, once you have begun your research again, you must update with this new information within 30 days.

If your sponsor requires notification, you may provide the institutional policy and or this set of frequently asked questions.

Develop and submit a protocol for review and approval. Address within the submission why the proposed research does not increase risk to participants, does not increase risk to non-clinical research staff, and does not require additional use of PPE resources necessary for clinical purposes. To help us prioritize incoming submissions, please include "COVID-19" in UVMClick project full and short title fields.

Yes, you can amend your protocol to add COVID activities. Address within the submission why the proposed amendment does not increase risk to participants, does not increase risk to non-clinical research staff, and does not require additional use of PPE resources necessary for clinical purposes. To help us prioritize incoming submissions, please include "COVID-19" in UVMClick amendment name.

The IRB is ready to assist researchers and clinical care providers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or FDA emergency authorizations for diagnostics. In some cases, IRB approval will not be required. The IRB can assess the circumstances, provide advice, and issue determination letters. Please contact your assigned IRB Analyst for more information.

For information regarding activities that are not considered Human Participant Research, please see the IRB site.

Hospital information regarding PPE is updated regularly. To find out whether COVID-19 testing is required and what PPE requirements are associated with certain procedures, please contact Travis.BeebeWoodard@uvmhealth.org.

It depends upon whether the COVID-19 test is being completed for clinical purposes or research purposes only.

If participants are coming in for a clinically related procedure that requires COVID-19 testing, are currently a study participant or will be enrolled in a research study, the cost of the test would be considered standard of care and billed to the patient or their insurance. If participants are coming in for a research-specific procedure (e.g. not clinically necessary for care or for a test that is being completed more often than what is standard) that requires COVID-19 testing, the cost of the test is not standard of care and must be billed to the research study. The billing plans for these protocols must be revised to include this testing. To update billing plans please contact Denise Quint in UVM Medical Center Compliance, Denise.Quint@uvmhealth.org.

If a COVID-19 test must be completed prior to study enrollment, this must be paid for by the study. PIs/coordinators must contact UVMMC Billing after the regular clinical order has been placed to ensure that the test is appropriately billed to the study and not billed to the participant.

• Larner College of Medicine
• UVM Return to Campus
• FDA COVID-19 Landing Page
• OHRP Guidance on COVID-19
• FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
• FDA Emergency Use Authorization

Caring for You During Your Research Visit