ARCHIVE: COVID-19 Research Operations Under the Resilience Framework

EFFECTIVE ONLY AUGUST 31, 2020 - AUGUST 5, 2021

The information below was effective August 31, 2020 to August 5, 2021, while the Resilience Framework was in use. 

Implications for Research Activities in Move to Guarded Operational Posture

On Thursday, May 20, 2021, the University of Pittsburgh campuses moved from the Elevated to the Guarded Risk Posture. Details on Standards and Guidelines that vary operational guidance with changes to risk posture, and responses to frequently asked questions related to travel, quarantine and Tier 3 research protocols are below.

Four research-related standards & guidelines do not vary operational guidance between the Elevated and Guarded Operational Postures:

Similarly, EH&S’s PPE and Face Coverings Guidance for Special Use Cases does not vary recommended PPE use with changes in operational postures. Use cases of special concern include studies taking place off-campus, and those involving aerosol-generating research participants.

The following four research-related standards & guidelines do vary operational guidance between the Elevated and Guarded Operational Postures as excerpted below. If applicable to your work, please review the full standards & guideline document for a complete statement of the guidance.

       Policy 

          Elevated

          Guarded

COVID-19 Standards and Guidelines: Safe Mobility    

 

  • University-related travel restricted to that necessary to fulfill a core job function.

  • University-related travel must be approved by SLT member or their designated direct report.

 

  • All University-related travel is permitted.

  • University-related travel must be approved using the process set forth by the member’s unit.

 

 

COVID-19 Standards and Guidelines: Shared Spaces   

  • Indoor limit: 25
  • Outdoor limit: 50
  • Limited in-person office work permitted
 
 
 
 
 
  • Maximum number determined by physical distancing requirements and local, state and federal gathering guidelines.

  • In-person office work permitted. Refer to your unit’s Activity Area Plan.

COVID-19 Standards and Guidelines: Human and Animal Research Subjects

 

  • In-person activities involving research participants may continue for Tier 1 studies with IRB approval.

  • Tier 2 and 3 studies requiring in-person activities need to complete an IRB survey.

  • All in-person research involving research participants may continue provided EH&S recommended COVID mitigation is followed.

 

 

COVID-19 Standards and Guidelines: Meetings, Conferences, Events and Guests

 

 

 

  • Guests are restricted to only those that must be on campus in order to perform an identifiable function that cannot be achieved remotely.

  • Guests must be approved by the member of the SLT or a direct report of that member who has been delegated that authority.

 

  • Guests may be permitted on campus, subject to the approval process set forth by the department, school, or unit that wishes to host guests.

 

 

 

 

Frequently Asked Questions

Q: Do I need to quarantine after returning from University-related or personal travel?

A: University Members who travel outside of the local region and adjacent counties should self-quarantine for a full seven days after return from travel, and get tested between days 3 and 5 of that self-quarantine. If you receive a positive test result, isolate yourself to protect others from becoming infected. If you choose not to get tested after return from travel, it is recommended to self-quarantine for a full ten days after return from travel. Avoid being around people who are at increased risk of severe illness for 14 days after you return from travel, regardless of testing.

Q: Do I need additional IRB approvals to continue work on my IRB-approved protocol?

A: IRB-approved protocols involving in-person interactions with research participants on the University or UPMC campuses may continue or, if suspended, resume without further request to, and approval from, the IRB. Investigators must have an approved Conduct of Research Plan through their school, if not already obtained.

Q: Does the COVID-19 vaccination status of the researcher or the research participant change how my research protocol operates?

A: No. Our understanding of how long vaccine protection lasts and how much vaccines protect against emerging SARS-CoV-2 variants is still evolving. For now, fully vaccinated people in public spaces, including the workplace and in the classroom, should continue to follow guidance to protect themselves and others, including wearing a well-fitted mask, physical distancing (at least six feet), avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, and washing hands often.

Q: Can protocols involving close contact with aerosolizing research participants continue, and if so, what PPE is required?

A: Yes. Consult page 2 of EH&S’s PPE and Face Coverings Guidance for Special Use Cases for detailed guidance on aerosol generating research procedures.

Q: Can studies in community sites and nursing homes restart?

A: Tier 3 protocols conducted in community settings may resume.  will continue to monitor the number of COVID cases and positivity rates in the community to ensure those studies can be carried out safely.

Nursing home visitation is regulated by the Pennsylvania Department of Health. Pitt researchers will comply with that guidance: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Guidance/SNF-Guidance-FAQ.aspx (updated 2/11/21) and https://www.cms.gov/files/document/qso-20-39-nh.pdf (9/17/20)

If you have additional questions:

Contact Environmental Health and Safety at safety@ehs.pitt.edu for questions about COVID-19 resources, PPE and space concerns. Contact HRPO at askirb@pitt.edu for IRB related questions.

 

FAQs

The below details new resources and answers some of the most frequently asked questions we’ve been hearing:

Q: My research doesn’t involve a lab, and I don’t have a research group. Do I need a Conduct of Research plan?

A: Yes, if you are conducting research on campus, in the field or in the community, your dean, institute director or regional campus president needs to be assured you are conducting your research at an appropriate level of safety.

Q: I have an approved plan; do I need to revise it if the operational posture changes?

A: No, unless the circumstances or work processes of your research have changed or you’ve discovered in the execution that you need to revise and resubmit it for approval. Otherwise, your approved restart plan remains in effect for the duration of the COVID-19 pandemic.

Q: With a move from Guarded to Elevated on the Pittsburgh campus, what’s changed related to research?

A: You should review the University’s COVID-19 standards and guidelines (S&Gs).

 

Research Standards and Guidelines

Operational guidance for research is now available to offer Pitt researchers a proactive, flexible and resilient framework to enable research work as we all accommodate the circumstances of the pandemic.

Four Research Standards and Guidelines apply to each of the University's COVID-19 Operational Postures (High Risk, Elevated Risk, and Guarded Risk) to help researchers mitigate impacts throughout the duration of the pandemic. They, along with additional Standards and Guidelines covering health; academics; student life; employees; facilities; and meetings, events & travel, are found on the COVID-19 Standards and Guidelines page.

The Research Standards and Guidelines offer guidance on:

  • Research Operations and Governance: These guidelines define Conduct of Research templates for use at the school level and Conduct of Research plans for individual principal investigators. The guidelines establish the requirement that every investigator’s Conduct of Research plan explains how their research activities will be conducted safely under all three of the University’s COVID-19 operational postures and how transitions between postures will be managed.
  • Research Operations Prioritization: These guidelines establish the principle that operational activities will vary by broad categories of research. For example, during the pandemic, clinical research will have different needs than will libraries or studio spaces. The guidelines define priority research and research support activities that will be allowed to continue under all three of the University’s COVID-19 operational postures.
  • Fieldwork and Research Travel: These guidelines establish the principle that local conditions will govern the Conduct of Research plans for investigators engaged in fieldwork and that the health and safety guidelines implemented in the field must meet or exceed those of the University of Pittsburgh. These guidelines further define some of the responsibilities of investigators in the field with respect to the health and safety of their research team.
  • Human and Animal Research Subjects: The guidelines codify the Institutional Review Board’s tiers for protocols based on direct benefit to research participants. They further identify situations when new petition or survey submission to the Board are required. Links are given to the DLAR documents governing operations of their animal facilities during the high-risk posture as well as the elevated and guarded risk postures.

These documents codify the work of the Research Restart Taskforce and its seven working groups, which involved more than one hundred faculty and staff. The final Research Standards and Guidelines can be found on the Office of Policy Development and Management’s COVID-19 Standards and Guidelines page, along with relevant health, employee, facility, meetings, events and travel standards and guidelines.

Research Operations and Governance Standards and Guidelines

These guidelines define Conduct of Research templates for use at the school level and Conduct of Research plans for individual principal investigators. The guidelines establish the requirement that every investigator’s Conduct of Research plan explains how their research activities will be conducted safely under all three of the University’s COVID-19 operational postures and how transitions between postures will be managed.

School and Unit Conduct of Research Templates

Deans, Institute Directors, and Regional Campus Presidents are responsible for developing and obtaining approval of conduct of research template(s) for their unit(s). Contact your Dean or Associate Dean for Research, Institute Directors, and/or Regional Campus Presidents for approval of your individual Conduct of Research Plan.

PI Checklist

Complete the information requested in the appropriate Conduct of Research Plan selected by your Dean, Institute Director, Regional Campus President. They will be informing you of the local review process in your school, institute or campus.

If your school, institute or regional campus plan does not have its own checklist, you may use the Conduct of Research Plan Review Checklist

Research Operations Prioritization Standards and Guidelines

These guidelines establish the principle that operational activities will vary by broad categories of research. For example, during the pandemic, clinical research will have different needs than will libraries or studio spaces. The guidelines define priority research and research support activities that will be allowed to continue under all three of the University’s COVID-19 operational postures.

Human and Animal Research Subjects Standards and Guidelines

These guidelines codify the Institutional Review Board’s tiers for protocols based on direct benefit to research participants and DLAR documents governing operations of their animal facilities.

For researchers working with research participants, the Standards and Guidelines identify situations when new petition or survey submission to the Board are required. To determine if your human research studies can restart, consult this guide. For questions related to the survey or the conduct of human subject research, contact askirb@pitt.edu.

For researchers working with animal subjects, the Standards and Guidelines provide links to the DLAR documents governing operations of their animal facilities during the high-risk posture as well as the elevated and guarded risk postures. For questions related to the conduct of animal subjects research, contact the DLAR Director, Dr. Frank Jenkins.

Fieldwork and Research Travel Standards and Guidelines

University-related travel is governed by the Safe Mobility Standards and Guidelines.

The Fieldwork and Research Travel guidelines establish the principle that local conditions will govern the Conduct of Research plans for investigators engaged in fieldwork and that the health and safety guidelines implemented in the field must meet or exceed those of the University of Pittsburgh. These guidelines further define some of the responsibilities of investigators in the field with respect to the health and safety of their research team. 

Human Resources Information

Standards and Guidelines addressing Accommodations for Employees Returning to Campus, COVID-19 Training, Health Attestation and Contact Tracing for Employee, and On-Campus and Remote Work are available. Additional information is available on the Human Resources COVID-19 page

Supervisor and employee training is required.  Supervisors contact OHR to initiate their training. Once that training is completed, supervisors are then able to send training links to employees, who then complete their training. Further details can be found on the Power of Pitt website.

Guidelines for Research Trainees During COVID-19 Operations

The Provost’s Office has developed Guidelines for Research Trainees during COVID-19 Operations that define the requirements that must be contained in investigator’s Conduct of Research Plans for graduate student and postdoctoral trainees to be approved to be on campus. Post-doctoral and pre-doctoral trainees can be physically present on campus in any of the University’s operational postures to assist with research operations. The guidelines also apply to undergraduates who may be employed in a PI-led research lab as student hourly workers (paid off grants or other sponsored research funds) or who may have a fixed fellowship stipend rather than an hourly wage.

Environmental Health and Safety Information

EH&S has assembled online educational resources for COVID-19 general information as well as specific guidance for putting on, wearing, and taking off face coverings (what is COVID-19, why do I need a face covering, and how can I protect myself and others?).

Please review all health and safety related information for research restart such as cleaning information, non-laboratory workplaces, laboratory information, and mitigation templates.

PPE Guidance

The University of Pittsburgh COVID-19 Standards and Guidelines: Face Coverings, Personal Protective Equipment, and Personal Hygiene has been updated. 

Pitt Environmental Health and Safety (EH&S) has issued additional task-specific Guidance and Use Case Scenarios for Face Coverings and PPE that arise in the research environment.

Information about orders for PPE, COVID-mitigation supplies, and cleaning supplies to be distributed from the centralized inventory by the Dietrich School Stockroom, is available on the Purchase, Pay & Travel website.

For instructions on how to obtain PPE and COVID-mitigation supplies for your research program, please contact your Departmental Administrator.

Several suggested online resources describing appropriate use of face coverings and gloves as well as demonstrations for properly putting on and taking off these items have been reviewed by Pitt EH&S, and links are also available on the Pitt EH&S website.

Visitors and Vendors

The Meetings, Conferences, Events and Guests Standards & Guidelines state that since all University buildings are generally closed to the public, regardless of the University’s Operational Posture, only those who have been explicitly invited to campus are allowed and the University should limit the number of Guests on campus to the maximum extent possible for the duration of the COVID-19 pandemic. Alternatives, such as videoconferencing should be used to the maximum extent possible.

Academic Visitors are governed by the standard processes usually in place for these individuals, rather than the protocols relating to campus guests. Information about Academic Visitors and requirements related to their time on campus is available on the Academic Visitors websiteWhile the University is in the Guarded Risk Operational Posture, Category 1 visitors may be admitted to campus under the protocols for campus guests. Please see the University’s COVID-19 Standards and Guidelines: Meetings, Conferences, Events, and Guests for more information.

You may need to bring a service technician or field engineer to repair equipment in your lab. Vendors are required to complete a Provider Covenant to comply with COVID-19 policies and procedures. If you have questions related to vendors on campus, contact Purchase, Pay & Travel Customer Service.

Signage Templates

Facilities Management is responsible for installing signage in common areas (hallways, elevators, lobbies, etc.). Individual labs will need to post additional signage in their research spaces. Templates for locally printable campus signage are available for download. 

August, 2020 Survey Results: Restart Progress 

Research-Related Staff and Postdocs Comfortable with Restart Efforts and Communications

To monitor progress on Pitt’s research restart initiative from the perspective of research-related staff and postdocs, three senior leaders at Pitt asked them to weigh in on how policy and practice changed since they were last surveyed in May.

Senior Vice Chancellor for Research Rob Rutenbar, Acting Senior Vice Chancellor for Business and Operations and Vice Chancellor of Human Resources David N. DeJong, and Vice Provost for Graduate Studies Amanda Godley sent the survey on August 11 to 1,500 staff and postdocs involved in research-related work. About 25% responded.

Two-thirds of the respondents said that the restart had gone at least as well as they expected, or better. Half of the respondents expressed concern about their general safety, including wearing a mask properly, social distancing, using public transportation, and the lack of an enforcement mechanism to keep people accountable.

In more detail, research-related staff and postdocs offered the following (click on the graphic below to open a full-size PDF):

COVID-10 Staff and Postdocs Survey Results: •	They are the most satisfied or unconcerned with:  •	the condition of essential research resources (89%) •	the ability to safely access laboratory spaces (87%) •	access to proper guidance on new safety protocols (85%) •	They are most concerned with:  •	the ability to safely commute to and from work, including using public transportation and associated risks, the expense of parking, and lack of a system to express concerns (36%) •	the ability to maintain proper social distancing in other locations at work (30%) •	the ability to manage personal / family obligations (28%) •	77% know where to obtain information and updates on COVID-19 and the University’s research restart status; with the same percentage saying they receive timely updates from their supervisors or the principal investigators of their labs.

 
 

The three top sources of information on the University’s COVID-19 updates have been the COVID website, Pitt’s general website, and researchers’ department deans or chairs.

The survey results validate that employees are using Pitt’s communications channels, and that efforts should continue to improve how information is made available to the University community. Pitt’s main coronavirus webpage connects members of the University community to guidance on a broad range of topics, including specifics about returning to campus and tips on traveling modes and their risks.

Since the survey was introduced, the University has addressed many of the safety, childcare and transportation concerns expressed with the following initiatives or programs:

Implications for Research Activities in Move to Elevated Operational Posture

The University of Pittsburgh announced that on Wednesday, March 31, the Pittsburgh campus moved from the Guarded to the Elevated Risk Posture. Here are details on Standards and Guidelines that vary operational guidance with changes to risk posture, and responses to frequently asked questions related to travel, quarantine and Tier 3 research protocols below.

The University of Pittsburgh announced that on Wednesday, March 31, the Pittsburgh campus moved from the Guarded to the Elevated Risk Posture. Here are details on Standards and Guidelines that vary operational guidance with changes to risk posture, and responses to frequently asked questions related to travel, quarantine and Tier 3 research protocols below.

Four research-related standards & guidelines do not vary operational guidance between the Guarded and Elevated Operational Postures:

Similarly, EH&S’s PPE and Face Coverings Guidance for Special Use Cases does not vary recommended PPE use with changes in operational postures. Use cases of special concern include studies taking place off-campus, and those involving aerosol-generating research participants.

The following four research-related standards & guidelines do vary operational guidance between the Guarded and Elevated Operational Postures as excerpted below. If applicable to your work, please review the full standards & guideline document for a complete statement of the guidance.

       Policy 

          Guarded

          Elevated

COVID-19 Standards and Guidelines: Safe Mobility    

 

  • All University-related travel is permitted.
  • University-related travel must be approved using the process set forth by the member’s unit.

 

 

  • University-related travel restricted to that necessary to fulfill a core job function.
  • University-related travel must be approved by SLT member or their designated direct report.

 

COVID-19 Standards and Guidelines: Shared Spaces   

  • Maximum number determined by physical distancing requirements and local, state and federal gathering guidelines.
  • In-person office work permitted. Refer to your unit’s Activity Area Plan.

 

  • Maximum number determined by physical distancing requirements and local, state and federal gathering guidelines.
  • Limited in-person office work permitted.

 

COVID-19 Standards and Guidelines: Human and Animal Research Subjects

 

  • All in-person research involving research participants may continue provided EH&S recommended COVID mitigation is followed.

 

 

  • In-person activities involving research participants may continue for Tier 1 studies with IRB approval.
  • Tier 2 and 3 studies requiring in-person activities need to complete an IRB survey.

 

COVID-19 Standards and Guidelines: Meetings, Conferences, Events and Guests

 

 

 

  • Guests may be permitted on campus, subject to the approval process set forth by the department, school, or unit that wishes to host guests.

 

 

 

  • Guests are restricted to only those that must be on campus in order to perform an identifiable function that cannot be achieved remotely.
  • Guests must be approved by the member of the SLT or a direct report of that member who has been delegated that authority.

 

Frequently Asked Questions

Q: Do I need to quarantine after returning from University-related or personal travel?

A: University Members who travel outside of the local region and adjacent counties to fulfil a core job function should self-quarantine for a full seven days after return from travel and get tested between days 3 and 5 of that self-quarantine. If you receive a positive test result, isolate yourself to protect others from becoming infected. If you choose not to get tested after return from travel, the CDC and Pitt recommend you self-quarantine for a full ten days after return from travel. Avoid being around people who are at increased risk of severe illness for 14 days after you return from travel, regardless of testing.

Q: Do I need additional IRB approvals to continue work on my IRB-approved protocol?

A: IRB-approved protocols involving in-person interactions with research participants on the University or UPMC campuses may continue or, if suspended, resume without further request to, and approval from, the IRB. Investigators must have an approved Conduct of Research Plan through their school, if not already obtained.

Q: Does the COVID-19 vaccination status of the researcher or the research participant change how my research protocol operates?

A: No. Our understanding of how long vaccine protection lasts and how much vaccines protect against emerging SARS-CoV-2 variants is still evolving. For now, fully vaccinated people in public spaces, including the workplace and in the classroom, should continue to follow guidance to protect themselves and others, including wearing a well-fitted mask, physical distancing (at least six feet), avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, and washing hands often.

Q: Can protocols involving close contact with aerosolizing research participants continue, and if so, what PPE is required?

A: Yes. Consult page 2 of EH&S’s PPE and Face Coverings Guidance for Special Use Cases for detailed guidance on aerosol generating research procedures.

Q: Can studies in community sites and nursing homes continue?

A: As noted in the University of Pittsburgh’s COVID-19 Standards and Guidelines for Human and Animal Research, now that the University is in Elevated Risk posture, all in-person research involving human research participants may continue, including Tier 3 studies that take place in community settings like homes, churches, community centers, libraries, museums, and nursing homes.

All enhanced precautions mandated as of 14 December 2020 for such studies should continue to be incorporated into research practices and communicated to all research staff, trainees, and faculty. The PI should also have provided an attestation to this effect as an electronic signed letter to the Responsibility Center head.

Community COVID-19 incidence rates will continue to be evaluated, and the Pitt research community will be apprised if a change in Tier 3 research operations is warranted due to the community situation. However, for now, all Tier 3 studies may continue provided EH&S recommended COVID mitigation is followed.

Please remember that nursing home visitation is regulated by the Pennsylvania Department of Health. Pitt researchers will comply with that guidance: https://www.health.pa.gov/topics/disease/coronavirus/Pages/Guidance/SNF-Guidance.aspx (updated 3/29/21) and https://www.cms.gov/files/document/qso-20-39-nh-revised.pdf (3/10/21).

If you have additional questions:

Contact Environmental Health and Safety at safety@ehs.pitt.edu for questions about COVID-19 resources, PPE and space concerns. Contact HRPO at askirb@pitt.edu for IRB related questions.

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