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Guidance For Researchers During the COVID-19 Pandemic

 

    • Guide to Re-entry Monday, May 18, 2020 at 4:37 PM
      Guide to Re-entry (05/18/2020)

      UAB faculty and staff,

      On Tuesday, May 26, UAB will transition from the university’s Limited Business Model into Modified Business Operations. During Modified Business Operations, UAB will begin a gradual, phased approach with some groups/functions returning to campus before others.

      It is important to gradually bring individuals back on campus to promote social distancing. This phased approach will also allow us to evaluate strategies for effectiveness and minimize risk. Read more…

    • Resumption of Research Update Sunday, May 10, 2020 at 4:19 PM
      Resumption of Research Update (05/10/2020)

      Dear Colleagues:

      We are eight weeks into the COVID saga. Since March 16, UAB has been in a limited business operations mode and our research community has shown resourcefulness and resilience during this time. UAB is up 12% (over $37M) in new awards through the month of April over the same period last year. Proposal submissions have increased as well, with a jump of 7% over last year. The work we do makes a real difference as evidenced by UAB’s tremendous effort to the state’s response in logistical preparation, caring for patients, testing therapies, supporting testing and tracking, innovative research, and working towards re-opening the state.

      We all want to get back to some semblance of normal. The Office of Research, along with colleagues from across the university and the UA system, are working diligently to develop a safe resumption of research operations on campus to enable our faculty, staff, and students to return to campus and carry out our important work. While we want this to happen as quickly as possible, it is important that we coordinate with other critical components of university operations, including facilities, human resources, procurement, health & safety, and others in order to avoid a return followed by a second shutdown.

      I appreciate your understanding and patience as we navigate this together. I ask that you continue to employ the methods we have to slow and stop the virus – masks, hygiene, and social distancing. Meanwhile, know that we are diligently working toward a plan to resume normal research operations, and will be in communication along those lines as soon as possible.

      We will get through this together.

      Best,

      Christopher S. Brown, PHD
      Vice President for Research
      University of Alabama at Birmingham

    • Updated – Office of Research Guidance (Revised April 06, 2020 at 4:42 PM, Supersedes April 2, 2020 Guidance)

      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 This email address is being protected from spambots. You need JavaScript enabled to view it..
      • 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

    • Updated – Essential Research Guidance (Revised April 06, 2020 at 4:42 PM, Supersedes April 2, 2020 Guidance)
      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.

    • Updated – Mentored Research Guidance (Revised April 06, 2020 at 4:42 PM, Supersedes April 2, 2020 Guidance)

      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 This email address is being protected from spambots. You need JavaScript enabled to view it..
      • 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.
    • Guidance for Mentored Research under Limited Business Operations Monday, March 16 at 7:15 PM

      Guidance for Mentored Research under Limited Business Operations

      Dear Research Colleagues:

      Many of you have contacted School/College Deans’ Offices, the Graduate School and the Office of Postdoctoral Education with questions regarding the efforts of graduate students and postdoctoral fellows engaged in mentored research while under the Limited Business Operations plan.

      Similarly, numerous graduate students and postdoctoral fellows have contacted us in the past several days with concerns related to their dissertation defenses already scheduled, delays in their research productivity and interruptions in ongoing studies, and laboratory resources, including research animals. They have also shared concerns that mentors’ expectations may be outside of the guidelines put forth. Students and postdocs are experiencing significant stress, and some have personal health and family concerns that are magnified at this time.

      As noted in the guidance for mentored research sent out on Friday, March 13th, 2020 from the Office of the Vice President for Research, it is expected that research mentors articulate a plan for their trainees and allow flexibility due to illness or other personal concerns. As of now, there is no plan to close research laboratories. Absolutely NO CHILDREN should be in laboratories at any time.

      Mentor Guidelines:

      • Clearly communicate which studies are absolutely critical and which lab members should do these experiments. Crucial experiments include those in progress that must be completed within a specific timeframe to avoid major data loss, those needed for an upcoming dissertation defense, and/or maintenance of research animals, cell cultures, liquid nitrogen, CO2 tanks, etc. over the coming weeks.
      • Do not start any new studies.
      • Curtail all studies that are not immediately necessary and can be postponed for the next few weeks.
      • All trainees and laboratory personnel who are not involved in the most crucial studies should be instructed to read, analyze data, and write manuscripts, grants, thesis, and dissertation proposals at home.
      • All trainees and laboratory personnel must keep their cell phone on them at all times.
      • Trainees and laboratory personnel should let faculty mentors know when they are in lab and when they leave.
      • When several trainees and laboratory personnel need to be present in the laboratory, best practices for social distancing must be used, including staggering work times, working 6’ 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 no one in your lab is able to be on site, there may other lab personnel who would be willing to check on your lab. If you are in your lab and see that a package has been delivered outside an empty lab, please secure it somewhere safe (especially if needing to be put in fridge/freezer), and contact someone in that lab. Further, if you are on the floor and hear a beeping alarm (freezer, incubator, etc.), please notify someone if no one is present. Collaboration will be key at this time, so be sure everyone’s contact information in your lab and on your floor is readily accessible.

      Research Supplies:

      • Purchase Orders (POs) for urgent research supplies will be approved at the level of the School/College Dean’s Office, except for the SOM, which will be approved at the department level due to the size of the School.
      • Shipping and Receiving will be fully staffed unless research supply orders dictate otherwise. Those with questions regarding the delivery of their shipment will need to contact Shipping and Receiving at This email address is being protected from spambots. You need JavaScript enabled to view it.

      We are aware that these measures may slow the pace of significant research, but we greatly appreciate your efforts to work together during this challenging time. By enacting these measures, we can play a small role to “flatten the curve” in terms of spreading the virus and consequently be able to get back to our research as soon as possible. This is a quickly evolving situation, so please watch for updates regarding our policies and guidelines.

      Also, please be mindful of the additional stress being experienced by you and your lab members. They need strong support, patience, and guidance during these unprecedented times.

      We appreciate your thoughtfulness and leadership. Please reach out if additional information or assistance is needed.

      Best,
      Lori McMahon, PhD., Dean, Graduate School
      Lisa Schwiebert, PhD., Senior Associate Dean, Graduate School/Office of Postdoc Education
      David Schneider, PhD., Associate Dean, Graduate School
      Tika Benveniste, Ph.D., Senior Vice Dean for Basic Sciences, School of Medicine (SOM)

    • Additional Guidance for Mentored Research Friday, March 13 at 4:32 PM
      Additional Guidance for Mentored Research

      In light of the COVID-19 pandemic, research involving undergraduates conducted on our campus will be suspended immediately. In the case of extenuating circumstances, such as instances where an undergraduate researcher has a skillset not replicated by another laboratory member, or when the student is needed to ensure the continuity of data collection, special permission may be granted by submitting a written request for review to Dr. Kent Keyser This email address is being protected from spambots. You need JavaScript enabled to view it.

      Research conducted by graduate students and postdoctoral fellows will continue, although it is expected that research mentors articulate a plan for these trainees and allow flexibility due to illness or other personal concerns.

      Please be aware that these guidelines will be updated as conditions change. We appreciate your patience during this time.

    • Update to Clinical Research Guidance and IRB FAQs Thursday, March 19, 2020 at 5:33 PM
      Update to Clinical Research Guidance and IRB FAQs

      The UAB IRB FAQs and the Clinical Research Guidance related to the COVID-19 response have been updated, including the incorporation of the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (issued 3/18/20). These revisions include the following information:

      • 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.
      Thank you for your continued commitment to the conduct of research and the protection of human subjects during this unprecedented time. Please stay tuned for additional updates.
    • Research Regulatory Oversight COVID-19 FAQs Wednesday, March 18 at 12:08 PM
      Research Regulatory Oversight COVID-19 FAQs

      The Offices of the CIRB, IACUC, and Research Safety Committees have provided answers to frequently asked questions related to the response to COVID-19 and business continuity. These FAQs can be found at the links provided below.

      Conflict of Interest Review Board (CIRB) – FAQs

      Institutional Animal Care and Use Committee (IACUC) – FAQs

      Research Safety Committees (Institutional Biosafety Committee (IBC), Chemical Safety and Environmental Management Committee (CSEMC) and Radioisotope and Radiation Safety Committee (RRSC)) - FAQs

      The IRB previously shared FAQs which can be accessed at IRB COVID-19 FAQs. Please check back frequently as these FAQs will be continuously reviewed and updated as needed.
    • IRB Business Continuity FAQ’s Tuesday, March 17 at 9:51 AM
      IRB Business Continuity FAQ’s

      The UAB Office of the Institutional Review Board is committed to facilitating the safe and ethical conduct of human subjects research throughout the current challenge of the COVID-19 outbreak. This commitment includes the timely review of research related to the COVID-19 outbreak and minimizing risk of exposure to participants, as well as UAB faculty, staff, and students.

      Recognizing that the current uncertainty raises a host of questions about both new research and ongoing projects, we have developed a set of FAQs that can be accessed at https://www.uab.edu/research/home/business-continuity-plan/irb-faqs.

      Please check back frequently as these FAQs will be continuously monitored and updated. If you have additional questions or concerns, you may contact Adam McClintock at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it.

    • UAB COVID-19 Containment Guidance for Researchers, March 31, 2020 at 3:45 PM
      The UAB Department of Environmental Health and Safety has issued UAB COVID-19 Containment Guidance for Researchers. Biosafety Level 2+ (BSL2+) is not a containment level officially recognized by the NIH or CDC, but the term is often used to describe BSL-2 laboratory facilities that operate using BSL-3 practices and procedures. This enhanced containment level is used for biological agents that pose a higher risk than standard agents found in BSL2 laboratories, but the greater associated risks can be adequately addressed through more stringent practices and procedures.

      At this time, the CDC and the NIH guidelines clearly define research with the actual virus as BSL3, which means all research isolating and propagating the virus will have to be performed in the UAB SEBLAB. This includes any culture involving cells isolated from, or exposed, to COVID-19+ patient tissues that may be permissive to virus replication. This manual is provided to assist Principal Investigators (PIs) in the development of a laboratory-specific biosafety manual with instructions to safely handle and manipulate COVID-19+ patient samples under BSL2+ laboratory conditions.

      For additional information concerning this guidance, please contact a biosafety representative at 934-7488, or This email address is being protected from spambots. You need JavaScript enabled to view it.

    • Update to Clinical Research Guidance and IRB FAQs Thursday, March 19, 2020 at 5:33 PM
      Update to Clinical Research Guidance and IRB FAQs

      The UAB IRB FAQs and the Clinical Research Guidance related to the COVID-19 response have been updated, including the incorporation of the “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” (issued 3/18/20). These revisions include the following information:

      • 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.
      Thank you for your continued commitment to the conduct of research and the protection of human subjects during this unprecedented time. Please stay tuned for additional updates.
    • Revised COVID-19 UAB Guidance for Clinical Research: Participant and Sponsor Interactions Thursday, March 19 at 3:49 PM

      COVID-19 UAB Guidance for Clinical Research: Participant and Sponsor Interactions

      Origination (V1): March 13, 2020

      Update (V2): March 17, 2020

      Update (V3): March 18, 2020 (new information found in RED)

      Background

      The University of Alabama at Birmingham (UAB) aims to assure the safety of all persons both within the University as well as that of its patients, vendors, visitors, etc. during the COVID-19 outbreak and is taking steps to mitigate the risk of the virus’ spread throughout our area. The COVID-19 pandemic affects clinical research and this document provides guidance on measures to mitigate the impact on participants and to research studies. Additional information regarding Human Subjects Protections and contact with sponsors can be found here

      NEW INFORMATION: Participant Study Visits and Study Team Preparedness Non-Essential Research Visits- Research visits that cannot be performed remotely and are not essential to the participants’ health and/or well-being should be postponed until further notice. Currently, the determination of whether or not a research visit is "essential to the health and/or well-being" of a participant should be evaluated by the principal investigator of the research study, the participant, the sponsor, and if relevant, the participant's care provider. PIs are strongly encouraged to consider the safety of the research personnel and subjects in making their decisions, keeping in mind that the risks posed by COVID-19 to participants may greatly outweigh in many cases the benefits of a particular study.

      Essential Research Visits-Research visits that cannot be performed remotely and are essential to a participant's health and/or well-being may be performed in person, with the following additional guidance:

      • Research participants should be contacted and screened for fever, cough and flu-like symptoms by research staff prior to the research visit. Screening should be an ongoing process with each subsequent encounter, and should include consideration of travel to a COVID-19 hot-spot, known or potential contact with infected individuals, and/or a positive COVID-19 test result. Those participants who screen positive but are asymptomatic must quarantine for at least 14 days following the positive screen before being seen. Those screen positive participants who 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. The UAB OIRB does not need to approve the incorporation of mandatory screenings, unless you or the sponsor wishes to incorporate the data collected as part of a new research objective of the clinical study. If so, the protocol will need to be amended and approved by the IRB.
      • Enrollment of new patients on a clinical study might be allowed only if: 1) participation in the trial is essential to a participant's health and/or well-being, as noted as above; or 2) the enrollment and longitudinal participant management can be conducted remotely for the duration of the COVID-19 outbreak.
        • As knowledge about COVID-19 pandemic continues to develop, investigators and study teams should prepare contingency plans for active clinical research projects. Issues for consideration include:
      • Temporary holds on enrollment or other study activities for non-essential studies
      • Necessary modifications to the approved research protocol and adverse event reporting
      • Distribution of investigational products
      • Ongoing review of research data, such as lab results or other testing
      • Coordinating with collaborators and/or collaborating institutions
      • Ongoing oversight on research activities

      Changes to IRB-approved protocols

      Except as noted above relative to COVID-19 screening procedures, changes to human subjects protocols must be approved in advance by the IRB except when necessary to eliminate apparent immediate hazards to the subject. If you have a COVID-19 related protocol change or an initial submission that is related to COVID-19 that should be prioritized for review by the IRB, please contact Adam McClintock, Director of the Office of the IRB This email address is being protected from spambots. You need JavaScript enabled to view it. and copy This email address is being protected from spambots. You need JavaScript enabled to view it.

      Study Sponsor Visits to the University (e.g., monitoring visits, site initiation visits, supplier, etc.)
      • UAB is deferring all in-person monitoring visits and site initiation visits (SIVs) with Sponsors as a precautionary measure. If there is an urgent need to maintain an in-person monitoring visit, please contact Mark Marchant, Director of the UAB Clinical Trials Administrative Office (205-934-2098; This email address is being protected from spambots. You need JavaScript enabled to view it. for such requests. The COVID-19 screening algorithm (no hot-spot travel, no personal contact with infected individuals, lack of fever, negative test results within the previous 24 hours) noted above would be applicable to this consideration.
      • Remote monitoring and communications are required. This should be coordinated through the study’s point of contact (Principal Investigator/Coordinator) at the University.
        • Additional Resources: https://www.fda.gov/media/136238/download

    • Updated – Office of Research Guidance (Revised April 06, 2020 at 4:42 PM, Supersedes April 2, 2020 Guidance)

      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 This email address is being protected from spambots. You need JavaScript enabled to view it..
      • 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

    • NIH Support for Extramural Research Friday, March 20, 2020 at 3:30 PM
      NIH Support for Extramural Research

      We are writing to share that although the National Institutes of Health announced that only mission critical laboratory operations at its Bethesda campus will be supported, the NIH will continue to support its extramural recipients and application processes.

      The Institute is deeply concerned for the health and safety of all people involved in NIH research and on the effect that the COVID-19 pandemic may have on the research enterprise. They have provided assurances that they will do their part to help us continue to do our research and submit applications.

      We know you may have questions. The NIH has posted a set of FAQs for researchers that cover general questions, plus topics such as
      • Application submission
      • Delays in research progress
      • Financial and performance reporting
      • Costs, and
      • Animal Welfare
      These are extraordinary times, and the work you do is critical to the success of the institution and greatly appreciated.

      Chris Brown
      Selwyn Vickers
    • COVID-19 Planning for Research Continuity Friday, March 13 at 11:00 AM
      COVID-19 Planning for Research Continuity

      UAB is committed to ensuring our research community is prepared with a response plan relating to research continuity. As you can imagine, safety measures that are put in place by the University, the city, and the state could ultimately result in staffing and supply disruptions as local schools close and available staff is reduced. UAB’s Coronavirus (COVID-19) Update is the definitive source of information about the University’s operating status. All announcements regarding changes to the University’s operating schedule will be posted to this site as soon as decisions are made.

      Expectations for Externally Sponsored Research Faculty/Staff/Students The Office of Research has created a webpage to provide the UAB research community with business continuity information related to the coronavirus outbreak. For now, research activities should continue—however, Principal Investigators (PIs) and labs should plan now for reduced workforce due to illness or local school closures, therefore we are asking all PIs and directors of laboratory facilities to develop contingency plans for their own labs. Labs should also anticipate a shortage of lab supplies, including personal protective equipment (PPE), and should limit the number of personnel entering lab areas requiring PPE (masks, gowns, face shields, etc.) to those necessary for tending to critical lab functions. Anyone with specific questions about their lab roles should reach out to their PI; if PIs have questions, they should consult with their department chair or dean, and then the Office of Research (This email address is being protected from spambots. You need JavaScript enabled to view it.).

      In light of the COVID-19 virus, the Office of Management and Budget has given federal agencies authority to offer certain “administrative relief” to some awardees and applicants, including automatic no-cost extensions and approval of pre-award costs, OMB announced in a March 9 memorandum. All approval requests should be submitted to OSP at This email address is being protected from spambots. You need JavaScript enabled to view it..

      If you are the Principal Investigator of a grant and you anticipate that your grant deliverables will be delayed by offsite work, please email your Program Officer immediately to let them know of your work plan adjustments and copy Melinda Cotten, Associate Vice President for Research Business Operations This email address is being protected from spambots. You need JavaScript enabled to view it. on the communication. Melinda will ensure that the appropriate OSP staff are aware. Additionally, please be prepared to briefly explain if your next progress report is going to be delayed or impacted. The explanation should outline the alternative work completed and your plan for accomplishing the original aims/deliverables.

      In the event of a UAB shutdown and you are planning to submit a grant, OSP will continue to submit proposals while working remotely. All new grant applications should go through the usual submission and review process. Federal agencies are aware of the current challenges and we will share additional guidance as it becomes available.

      Functions of Research Regulatory Oversight Units
      If necessary, the Offices of the CIRB, IACUC, IRB, and Research Safety Committees have the capability to operate remotely and conduct virtual meetings of oversight boards and committees to minimize disruptions in project reviews and approvals.

      The IRB is compiling a list of frequently asked questions related to the impact COVID-19 may have on research participants, including protocol deviations and violations. Changes to human subjects protocols must be approved in advance by the IRB except when necessary to eliminate apparent immediate hazards to the subject. If you have a COVID-19 related protocol change or an initial submission that is related to COVID-19 that should be prioritized for review by the IRB, please contact Adam McClintock, Director of the Office of the IRB (This email address is being protected from spambots. You need JavaScript enabled to view it.) and copy Jonathan Miller, Assistant Vice President for Research Regulatory Oversight This email address is being protected from spambots. You need JavaScript enabled to view it.

      The following is an adaptation that closely mirrors a Princeton University communication.

      Roles and Responsibilities In the event of staff shortages, shut-downs of specific buildings, or closing of campus, UAB will make every effort to maintain essential services, such as power, HVAC, and information technology to research buildings. In addition, the Animal Resource Program and Environmental Health and Safety will maintain critical functions. People responsible for these essential operations may be stretched further than usual and will thus have essentially no ability to help support research within individual labs. In addition, general support services such as maintenance may be delayed.

      Faculty who lead research groups and facilities are responsible, and best-positioned, for planning how to operate smoothly in a disrupted environment or how to safely curtail research. In particular, we urge you to think through how you would cope with a lack of people who can physically be in your lab and disruptions in supplies of materials you need to run your labs. Part of good planning will be to establish clear communications and roles within your group for addressing these questions.

      Planning Scenarios
      While it's impossible to predict exactly what to plan for, it could be useful to consider disruptions that last two weeks or more across a few general scenarios:
      • What can you do to implement social distancing in your research? What would it take to stagger work times in the lab, increase distances between people to six feet or more for extended work times, or find alternatives to write-up spaces in close quarters?
      • What would you do if just your group or building were quarantined or unable to come to work?
      • What would you do if the entire campus were closed (except for maintenance of essential services as listed above)?
      • What supplies are critical to your operations and how can you best protect against disruptions in the availability of those materials?
      • What changes would be required in your operations if core facilities and other fee-for-service resources, such as clean rooms or machine shops, were not available?
      In thinking through these questions, you might further consider:
      • How would you organize a system where you were allowed to send an individual person, one at a time, into the lab to perform essential functions? Such functions might include research animal monitoring and care, cell culture maintenance, or equipment maintenance. (For example, using a Google calendar to organize and communicate visits)
      • How would you assign such roles?
      • How would you communicate needs within the group (slack channels, email, etc.)?
      • Are there areas of cross-training that could be organized in your lab, making your operations more robust?
      • Are there people in other lab groups, separated enough that they might not be affected by a quarantine in just your group or building, who could help maintain critical operations in your lab?
      • Are there cell lines or tissues that could be preserved by freezing? If so, how long would it take to do so?
      • How long would it take to shut down equipment and experiments? Have you documented the safest and most expeditious procedures for doing so?
      • Are there remote control monitoring devices or back-up power supplies that would help maintain critical equipment?
      • Even with essentially normal services of electricity and other utilities, brief outages could occur. What special contingencies might arise if such a disruption occurred when your lab was unoccupied?
      • Have you reviewed contingency planning and emergency procedures with all researchers and staff in your group?
      In all cases, we urge you to keep the safety of yourselves, your lab group members, and the broader community foremost in your mind. For information on basic safety practices and planning, please see updates and FAQs on the University’s page: https://www.uab.edu/news/coronavirus

      Thank you for your care and thoughtful attention to developing contingency plans.
    • Office of Research Original Announcement Friday, March 05 at 5:15 PM
      Office of Research Original Announcement

      Over the past several days, the UAB community has received several communications concerning the potential impacts of the novel coronavirus (COVID-19), and its effect on UAB’s operations. The Office of Research has been monitoring this issue very closely and working diligently to ensure business operations within the research administration units have up-to-date continuity of business plans in place. Know that research support and administrative processes with the Office of Research will be provided, and our capacity to support UAB research will be impacted to the minimal extent possible.

      In particular, the Animal Resource Program, Research Business Operations, and Research Regulatory Oversight units all have reviewed their business continuity plans and addressed important contingency issues such as animal care, remote system access for staff, transitioning from in-person to virtual board and committee meetings, adequate resource procurement, and supply-chain management. As additional information becomes available, we will continue to provide appropriate updates. If you have questions or specific concerns, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it..

    • Research Business Operations COVID-19 FAQs Thursday, March 19 at 12:31 PM
      Research Business Operations COVID-19 FAQs

      Research Business Operations, which includes the Office of Sponsored Programs, Research Technology and Communications, and the Material Transfer Office, continues to closely follow the COVID-19 outbreak. We are committed to serving the UAB research community and reassuring everyone that our staff is working hard to maintain “business as usual” while working remotely.

      Recognizing that the current uncertainty may raise some questions about both new research submissions and ongoing projects, we have developed FAQs about our COVID-19 limited business model, funding opportunities, processes, and who to contact if you need help. We will update the webpage frequently as new information is received. If you have additional questions or concerns, you may contact Melinda Cotten at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it..

    • UAB COVID-19 Containment Guidance for Researchers, March 31, 2020 at 3:45 PM
      The UAB Department of Environmental Health and Safety has issued UAB COVID-19 Containment Guidance for Researchers. Biosafety Level 2+ (BSL2+) is not a containment level officially recognized by the NIH or CDC, but the term is often used to describe BSL-2 laboratory facilities that operate using BSL-3 practices and procedures. This enhanced containment level is used for biological agents that pose a higher risk than standard agents found in BSL2 laboratories, but the greater associated risks can be adequately addressed through more stringent practices and procedures.

      At this time, the CDC and the NIH guidelines clearly define research with the actual virus as BSL3, which means all research isolating and propagating the virus will have to be performed in the UAB SEBLAB. This includes any culture involving cells isolated from, or exposed, to COVID-19+ patient tissues that may be permissive to virus replication. This manual is provided to assist Principal Investigators (PIs) in the development of a laboratory-specific biosafety manual with instructions to safely handle and manipulate COVID-19+ patient samples under BSL2+ laboratory conditions.

      For additional information concerning this guidance, please contact a biosafety representative at 934-7488, or This email address is being protected from spambots. You need JavaScript enabled to view it.

    • Research Regulatory Oversight COVID-19 FAQs Wednesday, March 18 at 12:08 PM
      Research Regulatory Oversight COVID-19 FAQs

      The Offices of the CIRB, IACUC, and Research Safety Committees have provided answers to frequently asked questions related to the response to COVID-19 and business continuity. These FAQs can be found at the links provided below.

      Conflict of Interest Review Board (CIRB) – FAQs

      Institutional Animal Care and Use Committee (IACUC) – FAQs

      Research Safety Committees (Institutional Biosafety Committee (IBC), Chemical Safety and Environmental Management Committee (CSEMC) and Radioisotope and Radiation Safety Committee (RRSC)) - FAQs

      The IRB previously shared FAQs which can be accessed at IRB COVID-19 FAQs. Please check back frequently as these FAQs will be continuously reviewed and updated as needed.

    • Research Regulatory Oversight COVID-19 FAQs Wednesday, March 18 at 12:08 PM
      Research Regulatory Oversight COVID-19 FAQs

      The Offices of the CIRB, IACUC, and Research Safety Committees have provided answers to frequently asked questions related to the response to COVID-19 and business continuity. These FAQs can be found at the links provided below.

      Conflict of Interest Review Board (CIRB) – FAQs

      Institutional Animal Care and Use Committee (IACUC) – FAQs

      Research Safety Committees (Institutional Biosafety Committee (IBC), Chemical Safety and Environmental Management Committee (CSEMC) and Radioisotope and Radiation Safety Committee (RRSC)) - FAQs

      The IRB previously shared FAQs which can be accessed at IRB COVID-19 FAQs. Please check back frequently as these FAQs will be continuously reviewed and updated as needed.

    • Research Business Operations COVID-19 FAQs Thursday, March 19 at 12:31 PM
      Research Business Operations COVID-19 FAQs

      Research Business Operations, which includes the Office of Sponsored Programs, Research Technology and Communications, and the Material Transfer Office, continues to closely follow the COVID-19 outbreak. We are committed to serving the UAB research community and reassuring everyone that our staff is working hard to maintain “business as usual” while working remotely.

      Recognizing that the current uncertainty may raise some questions about both new research submissions and ongoing projects, we have developed FAQs about our COVID-19 limited business model, funding opportunities, processes, and who to contact if you need help. We will update the webpage frequently as new information is received. If you have additional questions or concerns, you may contact Melinda Cotten at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it..