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The UAB Office of Research is committed to the health and safety of faculty, staff, students, patients, and research participants, while ensuring our research community is informed of critical changes to operations as a result of the COVID-19 pandemic. UAB’s Coronavirus (COVID-19) Update webpage remains the definitive source of information about the University’s guidance and should be visited regularly. The UAB Office of Research’s COVID-19 Guidance webpage is updated regularly to provide the UAB research community additional information.

Faculty leading research groups and facilities are responsible for managing smooth and safe operations in a disrupted environment. As of now, there are no plans to close research laboratories, but faculty and Departments/Schools should limit in-person scholarship to essential research.

In addition to adhering to this guidance, researchers must follow any additional School/College-specific directives. In general, access to on campus laboratories should be ramped down and minimal, other than as noted below:

Essential, Permitted Research Activities (On-Campus, In-Person)

• In-person, COVID-19 research that has the potential to mitigate the pandemic.
• In-person, human subjects research that MUST be conducted for the participants’ health and well-being (determined by the Principal Investigator, participant, study sponsor and participants’ healthcare providers).
  • This includes prohibition of in-person study visits that are not mandatory for the participants’ health and well-being even when the participant is present for essential medical care.
  • All monitoring and site initiation visits for all clinical studies need to continue to be conducted remotely.
  • Any in-person study visits will need to follow appropriate screening guidelines, which were outlines in “COVID-19 UAB Guidance for Clinical Research: Participant and Sponsor Interactions” issued on March 18, 2020. It is important to follow all guidance of the CDC when in public, including the newer recommendation of the use of cloth face coverings (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html)
• On campus, laboratory procedures requiring timely and regular attention to maintain critical laboratory infrastructure and experimental conditions. For example, these may include:
  • Essential care for animals, plants and unique or expensive cell cultures or biological specimens that would otherwise be lost,
  • Preservation of unique reagents and other unique or expensive research materials,
  • Maintaining instruments and equipment (e.g., liquid nitrogen and liquid helium systems, and shared computational clusters) that cannot be maintained remotely or shut down without significant cost or consequences to the research effort, and
  • Studies in progress that must be completed in order to avoid catastrophic data loss;
• On-campus, laboratory studies that do not require interventions or interactions with human subjects and are needed for a thesis or dissertation defense during the 2020 Spring or Summer terms or the completion of studies for postdoctoral fellows who are within 3 months of an end of an appointment or fellowship funding that do not require interventions or interactions with human subjects. See the approval process for continuation of graduate student or postdoctoral fellows below.
• Exceptions may be granted on an extremely limited basis by submitting a written request for sequential approval to the Chair, Dean, and Vice President for Research. The request should include a description of the essential nature of the research and a detailed plan for promoting the safety of all personnel, including social distancing, laboratory layout, shift work possibilities, etc.

Other Permitted/Encouraged Research Activities

• Any research activities that can be conducted remotely or virtually, including the initiation of new projects, are encouraged and can proceed with required local scientific and institutional regulatory/sponsored award approvals, when applicable. Examples include the following:
  • Data processing/analysis
  • Survey research conducted via the web or telephone
  • Proposal writing
  • Publication and abstract composition and review
  • Patent applications
  • Grant and proposal reviews
  • Virtual focus groups
  • Research/laboratory administrative meetings
• New non-essential studies can be submitted for scientific, sponsored award, regulatory and/or budgetary review.
• Some research projects may involve sensitive and protected data that have security controls mandated by the sponsor, policy, or federal law (examples: HIPAA, FERPA, Export-controlled, etc.). If your project is subject to a data security plan that precludes remote access, contact your Department, School/College, or UAB IT security administrator.

Personnel

When individuals need to be present in the laboratory, best practices for social distancing must be used, including staggering work times, working six feet (two meters) apart, and limiting interactions. However, no one should work alone. If that is unavoidable, work when there is someone in an office on the same hall. If someone is not in the lab with you under these extenuating circumstances, you should always keep your mobile phone on your person, let someone know where you are, how long you will be there, and when to expect your return (a virtual buddy system). Rave Guardian (https://www.uab.edu/emergency/rave-guardian) provides a possible solution.

Trainees (undergraduate and graduate students and postdoctoral)

• No trainee should be compelled to come to campus for any purpose, and faculty and Departments/Schools must be flexible to support remote work arrangements.
• Undergraduate Students:
  • On-campus research by undergraduates is suspended, unless it can be conducted remotely or virtually. Exceptions for on-campus research may be granted if the student has a skillset not replicated by another lab member necessary for essential research (see guidelines for essential research above), or where the student is needed for the continuity of data collection. All exception requests must be submitted by the PI to Dr. Kent Keyser at ktkeyser@uab.edu.
• Graduate Students and Postdoctoral Fellows:
  • Graduate students and post-docs may be permitted in laboratories for completion of studies needed for a thesis or dissertation defense during the 2020 Spring or Summer terms or the completion of studies for postdoctoral fellows who are within 3 months of an end of an appointment or fellowship funding when those activities do not require interventions or interactions with human subjects and can meet the social distancing requirements.
  • Faculty advisors and mentors should work with their graduate students and postdocs to develop or update individualized plans (IDPs) to continue their research remotely.
  • In the event that a laboratory requires a trainee to maintain a physical presence in the lab for the completion of their specific studies or to maintain other essential research, a written exception request including at least the name of the trainee, the physical space they would occupy, and justification that the research is essential is required from the PI. The request must be approved by the following in sequential order as listed below:
    • Program Director for Graduate Studies Program (for the graduate student)
    • Department Chair (of the PI/advisor)
    • School/College Dean’s Office (of the PI/advisor)
    • Dean of the Graduate School (for graduate students) OR Senior Associate Dean of the Office of Postdoctoral Education (for postdoctoral fellows)
• The resulting decision will be reported to the trainee, PI, the Graduate Studies/Program Director, and the PI’s Department Chair and School/College Dean’s Office.

• While mandatory COVID-19 screenings conducted as part of the institution’s routine infection control measures do not require prior IRB approval, a change to the protocol (by either the sponsor or investigator) to incorporate the data collected as part of the research objective(s) of the study does require prior review and approval by the IRB.
• It is critical that participants are kept informed of changes that could impact them.
• Participants who screen positive for COVID-19 and have a cough, fever, or flu-like symptoms must be symptom free for at least 8 days and have a negative COVID-19 test result prior to returning to participation.
• These guidelines apply to research conducted both domestically and internationally.
• Bullet points relative to information in the 3/18/20 FDA guidance that is not covered in other UAB IRB FAQs.

UAB OFFICE OF RESEARCH GUIDANCE UPDATE (04/06/2020)

The UAB Office of Research is committed to the health and safety of faculty, staff, students, patients, and research participants, while ensuring our research community is informed of critical changes to operations as a result of the COVID-19 pandemic. UAB’s Coronavirus (COVID-19) Update webpage remains the definitive source of information about the University’s guidance and should be visited regularly. The UAB Office of Research’s COVID-19 Guidance webpage is updated regularly to provide the UAB research community additional information.

Faculty leading research groups and facilities are responsible for managing smooth and safe operations in a disrupted environment. As of now, there are no plans to close research laboratories, but faculty and Departments/Schools should limit in-person scholarship to essential research.

In addition to adhering to this guidance, researchers must follow any additional School/College-specific directives. In general, access to on campus laboratories should be ramped down and minimal, other than as noted below:

Essential, Permitted Research Activities (On-Campus, In-Person)

• In-person, COVID-19 research that has the potential to mitigate the pandemic.
• In-person, human subjects research that MUST be conducted for the participants’ health and well-being (determined by the Principal Investigator, participant, study sponsor and participants’ healthcare providers).
  • This includes prohibition of in-person study visits that are not mandatory for the participants’ health and well-being even when the participant is present for essential medical care.
  • All monitoring and site initiation visits for all clinical studies need to continue to be conducted remotely.
  • Any in-person study visits will need to follow appropriate screening guidelines, which were outlines in “COVID-19 UAB Guidance for Clinical Research: Participant and Sponsor Interactions” issued on March 18, 2020. It is important to follow all guidance of the CDC when in public, including the newer recommendation of the use of cloth face coverings (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/diy-cloth-face-coverings.html)
• On campus, laboratory procedures requiring timely and regular attention to maintain critical laboratory infrastructure and experimental conditions. For example, these may include:
• Essential care for animals, plants and unique or expensive cell cultures or biological specimens that would otherwise be lost,
• Preservation of unique reagents and other unique or expensive research materials,
• Maintaining instruments and equipment (e.g., liquid nitrogen and liquid helium systems, and shared computational clusters) that cannot be maintained remotely or shut down without significant cost or consequences to the research effort, and
• Studies in progress that must be completed in order to avoid catastrophic data loss;
• On-campus, laboratory studies that do not require interventions or interactions with human subjects and are needed for a thesis or dissertation defense during the 2020 Spring or Summer terms or the completion of studies for postdoctoral fellows who are within 3 months of an end of an appointment or fellowship funding that do not require interventions or interactions with human subjects. See the approval process for continuation of graduate student or postdoctoral fellows below.
• Exceptions may be granted on an extremely limited basis by submitting a written request for sequential approval to the Chair, Dean, and Vice President for Research. The request should include a description of the essential nature of the research and a detailed plan for promoting the safety of all personnel, including social distancing, laboratory layout, shift work possibilities, etc.

Other Permitted/Encouraged Research Activities

• Any research activities that can be conducted remotely or virtually, including the initiation of new projects, are encouraged and can proceed with required local scientific and institutional regulatory/sponsored award approvals, when applicable. Examples include the following:
  • Data processing/analysis
  • Survey research conducted via the web or telephone
  • Proposal writing
  • Publication and abstract composition and review
  • Patent applications
  • Grant and proposal reviews
  • Virtual focus groups
  • Research/laboratory administrative meetings
• New non-essential studies can be submitted for scientific, sponsored award, regulatory and/or budgetary review.

• Some research projects may involve sensitive and protected data that have security controls mandated by the sponsor, policy, or federal law (examples: HIPAA, FERPA, Export-controlled, etc.). If your project is subject to a data security plan that precludes remote access, contact your Department, School/College, or UAB IT security administrator.

Personnel

When individuals need to be present in the laboratory, best practices for social distancing must be used, including staggering work times, working six feet (two meters) apart, and limiting interactions. However, no one should work alone. If that is unavoidable, work when there is someone in an office on the same hall. If someone is not in the lab with you under these extenuating circumstances, you should always keep your mobile phone on your person, let someone know where you are, how long you will be there, and when to expect your return (a virtual buddy system). Rave Guardian (https://www.uab.edu/emergency/rave-guardian) provides a possible solution.

Trainees (undergraduate and graduate students and postdoctoral)

• No trainee should be compelled to come to campus for any purpose, and faculty and Departments/Schools must be flexible to support remote work arrangements.
• Undergraduate Students:
  • On-campus research by undergraduates is suspended, unless it can be conducted remotely or virtually. Exceptions for on-campus research may be granted if the student has a skillset not replicated by another lab member necessary for essential research (see guidelines for essential research above), or where the student is needed for the continuity of data collection. All exception requests must be submitted by the PI to Dr. Kent Keyser at ktkeyser@uab.edu.
• Graduate Students and Postdoctoral Fellows:
  • Graduate students and post-docs may be permitted in laboratories for completion of studies needed for a thesis or dissertation defense during the 2020 Spring or Summer terms or the completion of studies for postdoctoral fellows who are within 3 months of an end of an appointment or fellowship funding when those activities do not require interventions or interactions with human subjects and can meet the social distancing requirements.
  • Faculty advisors and mentors should work with their graduate students and postdocs to develop or update individualized plans (IDPs) to continue their research remotely.
  • In the event that a laboratory requires a trainee to maintain a physical presence in the lab for the completion of their specific studies or to maintain other essential research, a written exception request including at least the name of the trainee, the physical space they would occupy, and justification that the research is essential is required from the PI. The request must be approved by the following in sequential order as listed below:
    • Program Director for Graduate Studies Program (for the graduate student)
    • Department Chair (of the PI/advisor)
    • School/College Dean’s Office (of the PI/advisor)
    • Dean of the Graduate School (for graduate students) OR Senior Associate Dean of the Office of Postdoctoral Education (for postdoctoral fellows)
  • The resulting decision will be reported to the trainee, PI, the Graduate Studies/Program Director, and the PI’s Department Chair and School/College Dean’s Office.

Additional Resources

Office of Research Guidance For Researchers During COVID-19 Crisis

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

CDC Coronavirus Disease 2019 (COVID-19) Prevention Guidance

Use of Cloth Face Coverings to Help Slow the Spread of COVID-19