Guidelines for Safely Ramping Down On-Campus Research Activities During COVID-19

This section outlines our process for decreasing on-campus research-related activities. In general, ramping down research to 50% and 25% of current capacity reflects a reversal of our campus ramp-up phases (i.e., COM phases 3 and 2, respectively).

Triggers for ramping down research to approximately 50% of capacity will be those outlined by the University’s COVID-19 Operations Control Center (COCC) and correspond to Off-Ramp 3 as well as others presented below that are highly pertinent to College of Medicine.

Specific triggers for ramping down research will include, but are not limited to:

• Increase in COVID-19 hospitalizations at Hershey Medical Center (HMC) for three consecutive weeks, when compared to a running average of the previous four weeks
• Limited availability of ICU beds within PSH system (i.e., “yellow” on the HMC COVID-19 Patient Placement and Surge Plan (available in the policy portal; Penn State Health ePass login required).
• COVID-19 testing at 80% of hospital capacity
• Increase in the average turnaround time to obtain test results, compared to the average of the previous two consecutive weeks
• Quarantine rooms at local hotels more than 75% of capacity
• PPE inventory of less than 4 weeks
• Gradual increase in number of persons under investigation (PUIs) and/or COVID-19 positive individuals within the College of Medicine over three consecutive weeks, compared to a running average of the 3 previous weeks
• Restrictions in activities imposed by state and federal agencies

In situations where research activities need to be scaled back, each department or institute at the COM will develop a plan for operating and prioritizing on-campus research activities. Such plans for ramping down research at COM will include:

• An enhanced strategy for preventing virus transmission that will be developed with the input of Departmental Safety Officers (DSO) and Laboratory Safety Officers (LSO) as well as the Pandemic Safety Officer (PSO).
• An increase in physical distancing in the research environment, as needed, from 150 to 300 square feet per person.
• A decrease in the time-averaged laboratory and department/institute research capacity to 50% of that approved on the date the ramp-down is announced.
• Open and frequent communication with lab members to coordinate and adjust schedules as circumstances dictate so personal interactions are minimized.
• A flexed work schedule (e.g., alternating days, and platooning of research personnel to take advantage of 24/7 laboratory access) to accommodate both research activity and any non-research office staff who cannot work remotely.
• Criteria used to prioritize research within departments/institutes and the COM when on-site research exceeds capacity, while still maintaining appropriate safety precautions.
• Strategies for maintaining laboratory safety during times of low staff density so as to avoid situations where it may be potentially unsafe to have a single employee carrying out the work in isolation (e.g., buddy system or other mechanism).
• A plan to accommodate any vulnerable individuals and persons at high-risk or those individuals who do not wish to be in the laboratory setting as a result of COVID-19.
• Details on the process by which departments/institutes will rapidly reduce the number of research teams when a cluster of PUIs or COVID-positive test results arise.
• A listing of pre-approved personnel that will be permitted on-site during a specific phase. Compliance of individual laboratories in submitting and adhering to their weekly research personnel and activity schedule will be done at the level of department chair or institute director. Labs will identify operations they wish to maintain and those than can be temporarily curtailed. Weekly work schedules will, as is currently done, be posted on lab doors and confirmed by DSO/LSOs.
• A statement by the PI that graduate students cannot be required to work on site.
• Re-evaluation of all safety precautions by DSOs and LSOs. Safety officers will review with faculty, staff and students policies and procedures related to campus and university/college safety guidance, physical distancing, wearing of face masks and other public health guidance.
• Increased frequency of DSO and LSO meetings, with the exact number being dictated by the severity of the ramp down. During these meetings, SOPs for shared facilities and equipment as well as SOPs related to other safety precautions and cleaning will be reviewed.
• DSO and LSOs will evaluate and post new signage, as needed, to ensure all new research personnel are appropriately aware of and trained regarding safety protocols.
• Implementation of additional measures for risk mitigation, as necessary.
• A moratorium on any research and large group in-person meetings that have been restarted during the ramp-up phase; depending on the severity of the ramp-down small (two- to three-person) in-person meetings with protective face masks may be permitted.
• A clear communication plan for each laboratory for all faculty, staff and students so that critical work and activities can be maintained during illnesses and absences.
• Limiting departmental/institute common spaces to one person at a time.

In addition to department/institute-level plans, the College of Medicine as a unit will:

• Reevaluate its vendor/contractor policy and restrict access by external visitors to those deemed necessary for progress of critical research.
• Limit any on-site common areas that may have been opened as research was ramped up.
• Re-evaluate COM screening procedures for entry into the building.
• Restrict or suspend high school and/or undergraduate college students from participating in in-person lab-based research internships, unless exceptions are granted by the Associate Dean of Graduate Studies.
• Reiterate to all faculty, staff and students their responsibility to adhere to daily self-symptom monitoring, report symptoms to either Student Health or Employee Health, and not come to work when feeling ill.
• Assure all research activities will be consistent with University guidelines and made in partnership with OPP and EHS at the University, and coordinated with Biosafety and EHS at the COM.
• Render the decision to move through a ramp-down stage in consultation with EHS, Comparative Medicine, IRB, and appropriate administrative leadership.
• Encourage laboratory researchers to consult COVID-19 and Research website.
• Ensure all decisions will be first approved by the VDRGS and Dean of the College of Medicine, and then the decision reported to the OSVPR.

To achieve the required physical distancing and time averaged lab capacity requirements for this rapid ramp-down, PIs may consider the following criteria in considering how research activities will be prioritized:

• Activity deemed critical by the U.S. government
• Activities specifically requested by a U.S. government sponsor to be continued
• Graduate students and postdoctoral fellows nearing the end of their financial support and completion of research
• Experiments required for manuscript revision or grant submission
• Ongoing long-term studies that need to be completed
• Maintenance of unique resources (animals, cell lines)

If circumstances dictate, the College of Medicine also has a plan for rapid reduction of research to achieve an approximately 75% reduction in research capacity of that approved on the date the ramp-down is announced. If the SVPR or COM Dean directs research be rapidly or more severely curtailed the following plan will be enacted. Triggers for this rapid ramp down will be those outlined by the COCC and correspond to Off-Ramp 4. In such cases it will be necessary to more severely limit access to on-campus research facilities so only critical and time-sensitive research-related activities will be continued under stringent social distancing guidelines.

Triggers for ramping down to this research phase will include, but are not limited to:

• Increase in COVID-19 hospitalizations at Hershey Medical Center (HMC) for four consecutive weeks, when compared to a running average of the previous four weeks
• Limited availability of ICU beds within PSH system (i.e., “red” on the HMC COVID-19 Patient Placement and Surge Plan (available in the policy portal; Penn State Health ePass login required)
• COVID-19 testing at 90% of hospital capacity
• Increase in the average turnaround time to obtain test results, compared to the average of the previous two consecutive weeks
• Quarantine rooms at local hotels more than 90% of capacity
• Limited confidence infection can be contained in the College of Medicine
• All classes have been entirely moved to remote learning modalities
• PPE inventory of less than two weeks
• Gradual increase in number of persons under investigation (PUIs) and/or COVID-19 positive individuals within the College of Medicine over six consecutive weeks, compared to a running average of the three previous weeks
• Stay-at-home orders issued by state and federal agencies

In addition to all of the measures outlined in Section III above, the following additional steps will be implemented:

• An increase in physical distancing in the research environment from 300 to 600 sq feet per person.
• A decrease in the time-averaged laboratory and department/institute research capacity of 75% of that approved on the date the ramp-down is announced.
• A strategy to further reduce personnel time in lab to the new lower level. A flexed work schedule to accommodate both research activity; however, all non-research office staff will work remotely.
• The criteria used to prioritize research within departments/institutes and the COM will be the same as outlined in Section III developed so on-site research can be safely reduced to 25% (e.g., 75% reduction).
• A listing of pre-approved personnel that will be permitted on-site during this specific phase. Compliance of individual laboratories in submitting and adhering to their weekly research personnel and activity schedule will be done at the level of department chair or institute director. Labs will identify operations they deem critical to maintain and those than can be curtailed. Weekly work schedules will, as is currently done, be posted on lab doors and confirmed by DSO/LSOs. As has been done since March, all staffing rosters will be submitted by the department chair/institute director or their designee to Box.
• Implementation of additional measures for risk mitigation, as necessary, over those used in the previous phase.
• A moratorium on all large group in-person meetings that have been restarted during the ramp-up phase.

To achieve the required physical distancing and time-averaged lab capacity requirements for this rapid ramp-down, PIs may consider the following criteria in considering how research activities will be prioritized:

• Activity that if discontinued would generate significant data and sample loss
• Activity that if discontinued would pose a safety hazard
• Activity that maintains critical equipment in facilities and laboratories
• Activity that maintains critical samples, reagents, tissue cultures and materials
• Activity that maintains animal populations and allows completion of ongoing long-term studies
• COVID-19 related activity that has a timeline for deployment that could address the crisis
• Activity in support of essential human subjects research
• Clinical trial activity that if discontinued would negatively impact the patient’s care
• Activities specifically requested by a U.S. government sponsor to be continued

During this period of rapid lab shutdown:

• Each department will determine which research activities are deemed critical
• Only approved personnel performing critical or time-sensitive research activities will be permitted on site
• Human subjects research must be conducted remotely; no physical, face-to-face human subjects research unless there is a direct drug or device therapeutic benefit
• Non-critical research-related activities will be ramped down at the earliest possible time
• Graduate students will be required to have approval from their graduate program head to conduct on-campus research
• No high school or undergraduate college students will be permitted on-site, and external visitors and contractors will need to be preapproved by Biosafety
• Departments and institutes will present a plan for approval to the VDRGS by the announced date
• Investigators will adhere to all other guidelines described above in Section III of this document, including those related to COVID-19 safety protocols, occupancy plans and calendaring for personnel

All laboratory shutdown activities will be conducted under the direction of the PI and completed by a lab safety officer who will be familiar with safe lab practices.

For all research:

• Labs will begin by conducting a risk assessment to identify samples that will be destroyed, saved, or processed
  • Living cultures will be assessed for destruction or passage/freeze-down
  • Ongoing experiments will be evaluated to determine whether stopping the procedure immediately is appropriate or whether an approved worker will be assigned to finish the work on a temporary basis
• Labs will evaluate current inventory of supplies that may be needed in the event of a closure to keep safety systems functional, such as:
  • Liquid Syphon CO2 tanks for -80 ULT freezer backup systems
  • Gas-Delivery CO2 tanks for incubators that will remain online
  • Spill and cleanup supplies as described in the labs approved/posted SOPs
  • Correctness of contact info on door placards, freezer plans, and any wireless/BOC freezer monitoring
• Labs will put in place a written plan that describes what lab personnel would be required to respond to a lab emergency if all members are working remotely. The plan will:
  • Review each lab’s safety information including:
    • Sample handling and disposal SOPs
    • Emergency response plans and contact information
    • -80 freezer emergency plans and contact information
  • Ensure lab is supplied with PPE and disinfectant materials for future use
    • 70% ethanol and fresh 10% bleach, or SOP-approved disinfectant material
    • Gloves, eye protection, masks, face shields, lab coats, bleach, ethanol
  • Ensure the safe containment of lab/samples if employees take extended leave
    • Identify who will check freezers, incubators, animals. Provide a specific schedule and dedicate individuals to check all equipment that may house research product.
    • Ensure that lab locks are functional and items secured
    • Post list of approved personnel on lab schedules posted on door
    • Unplug all non-essential electrical equipment

Lab activity will be scaled back in the case of a potentially sick worker and/or COVID-19 exposure; the lab will be fully closed and a surface decontamination following CDC and EPA guidelines will be performed before the lab can be fully closed.

The College of Medicine operates centralized core facilities supporting researchers. The following guidelines will be instituted to maintain core operations.

• Increase in physical distancing (from 150 to 300 to 600 square feet per individual) will be implemented in conjunction with a reduction in the total capacity of the core lab facilities (to 50% to 25%), as circumstances dictate.
• As a result of the reduction in staffing and available open hours, such facilities will develop priority systems for projects originating from approved researchers performing critical experiments.
• Non-critical samples will be inventoried and prioritized for subsequent analysis.

The Animal Resource Program (ARP) will continue to provide full animal husbandry during all phases of the ramp down. ARP will follow the same process as outlined in March during the original ramp-down. The animal care staff are categorized as essential workers and expected to continue working during a ramp down or shut down. The ARP has also an approved contingency plan that can be enacted if personnel fall below a 50% staffing level. In addition, the ARP will platoon the clinical veterinarians and veterinary residents. Other staff will continue a hybrid of remote and on-site work.

Animal ordering will be prioritized to time-sensitive critical work and it will be requested that researchers scale back breeding to only that necessary to maintain lines. Animals may be ordered and animal research continued in accordance with the updated guidance for animal research found on the COVID-19 and Research website.

Conditions permitting, active studies may continue to their conclusion.

More severe restrictions will be instituted in the case of a significant reduction in the number of staff available to care for research animals. Decisions regarding termination of animal studies and reduction of animal populations will be made in consultation with the Dr. Ronald Wilson, Director, ARP (rwilson2@pennstatehealth.psu.edu).

The OSVPR continues to update the Revised Standards for Human Subjects Research. The Revised Standards indicate what human subjects research may be conducted in-person, describes the associated review and approval process, and applies to human subjects research, regardless of location. Human subjects research should continue to adhere to the Revised Standards for Human Subjects Research and related FAQs.

This guidance applies to human subjects research that is conducted both on-campus and off-campus, and in-person and remote. The Revised Standards will change if a gradual or rapid ramp down of research is warranted. All human subjects research that can be conducted remotely will be conducted remotely. Depending on the severity of the ramp-down, observational human-subjects research may take place with participants who are already coming to campus for a clinical care appointment. Researchers and the Associate Dean for Clinical Research and the VDRGS will consult with the Institutional Review Board (IRB) before making changes that affect human subjects.

For example, the following guidelines have been developed for human studies using the CRC:

• Visitation policy in the CRC will permit a single caregiver of a subject or an adult with a minor.
• All study teams will follow the guidelines for the appropriate COM research phase.
• The CRC will run at the capacity designated for other research laboratories and a scheduling application will be used to notify investigators of potential conflicts with availability.
• Investigators will use the Clinical and Translational Science Institute/College of Medicine phone script that includes a pre-screening phone call, as well as meeting and escorting participants from the hospital entrance to the CRC and out of the building.
• Investigators will disinfect rooms and surfaces used by their team and/or the participant once the visit is completed (purple-top wipes are provided).
• Investigators will provide PPE to staff which is to be worn at all times in the CRC.
• The CRC will follow the COM use of shared spaces policy; therefore, face shields will be worn by all staff coming within six feet of a subject. Masks, frequent handwashing and physical distancing will be followed at all times while in the CRC.
• The CRC will be badge access only. Investigators will notify the CRC of team members that require badge access; this number will be kept to a minimum.

Until more information becomes available, precautions will be taken in collecting and handling specimens that may contain SARS-CoV-2 (the virus that causes COVID-19). Timely and clear communication will be emphasized between clinical and research laboratory staff to minimize the risk incurred in handling specimens from patients with possible COVID-19 infection.

Laboratories that have the potential to handle specimens with COVID-19 will follow CDC-issued guidance.

This guidance underscores the importance of understanding Biosafety Level 2 precautions, PPE, and decontamination SOP. Labs engaged in such research will ensure PI and all lab staff review the proper use of a Biosafety cabinet, the sample-specific prep/handling/disposal methods, and emergency response SOP.

The Interim Dean and Vice Dean for Research and Graduate Studies will be responsible for ensuring their faculty, staff, and students comply with the plan put forth by the College of Medicine. If an individual is aware of any non-compliance, they should report it to the appropriate their departmental safety officer and/or the Pandemic Safety Officer. Alternatively, offences should be referred to the appropriate department chair, institute director, or Associate Dean for Graduate Studies. Persistent non-compliance, when confirmed by the appropriate Dean or Vice Dean, may result in removal of the individual’s approval for conducting research on campus. 

As the COVID situation is constantly evolving which requires a flexible approach from the University and College of Medicine, the most up-to-date information will be found on various institutional websites, which should be checked often.

Faculty, staff and trainees are directed the following for information specific to Penn State and the College of Medicine:

• General information: research.psu.edu/covid
• Biosafety: research.med.psu.edu/biosafety
• IRB and HSPO: research.psu.edu/covid_irb
• Penn State College of Medicine: med.psu.edu/coronavirus