COVID-19 Research Update

March 23, 2020: To the extent possible, Baylor researchers are encouraged to engage in activities that can be performed remotely (e.g., writing, data analysis, etc.). Essential laboratory operations are permissible, provided they can be performed while meeting the “6-feet” requirement for social distancing. The local COVID-19 scenario is fluid and University officials will continue to monitor the situation and provide guidance as things progress. Here, we provide answers to a series of frequently asked questions (FAQs) that have arisen over the last few days. Our intent in this communication is to provide guidance on how faculty, staff, and students can best manage research activities in this time of uncertainty. These resources are also intended to prompt proactive planning in the event we find ourselves in a situation where research activities need to be ramped down or suspended for some time period.

Principle investigators (PIs) that wish to temporarily “close” their labs should use this checklist to ramp down laboratory operations. Send completed checklist to Craig Moehnke and copy your chair and dean.

Additionally, if you're lab remains open, each laboratory should be using this sign-in/sign-out sheet. This information will be extremely valuable if someone in the lab contracts the virus. Use of Microsoft Teams will allow you to conduct virtual research group meetings, if that is desirable.

General Research FAQs

What should research labs be evaluating in terms of their laboratory research continuity?

  1. Update your Facility, Department and Laboratory member contact list and distribute electronically and in paper from.
  2. Organize your research group to ensure normal operations occur while also minimizing contact. Consider staggering work hours/days to lower density and interactions, while also avoiding working in isolation(alone). Consider doing work remotely that can occur outside the lab, e.g. data analysis, grant and journal article preparation.
  3. Ensure appropriate cross training for critical functions are done, e.g. cell culture maintenance, instrument maintenance, animal studies, waste handling, etc.
  4. Identify key personnel that could continue organizing operations and communications in the event of lab personnel becoming ill.
  5. Identify any non-critical research experiments that can be ramped down or delayed.
  6. Coordinate with colleagues who have similar research to develop redundancies to ensure coverage of critical activities
  7. Evaluate and plan to maintain enough inventory of critical supplies that would be impacted by domestic and international shipping delays.
  8. Utilize provided sign-in, sign-out sheet on the door. Everyone entering or leaving must put a legible name, contact phone number, and a time and date of entry and exit onto this sheet. The sign-in sheet will be critical in the event of the need for contact tracing if a member of the lab tests positive for COVID-19. The sheets must therefore be archived for at least 4 weeks.

What should I take into consideration if I decide to ramp down research? If possible, shut down and secure equipment consistent with equipment requirements.

  1. Secure, label, and properly store chemical, biological, and radioactive materials.
  2. Ensure all water sources are turned off (e.g. circulating water baths, aspirators, etc.).
  3. Ensure regulated wastes are full, properly packaged, and follow your usual procedure for pick-up and removal.
  4. Secure compressed gas cylinders. Shut down, remove, and place caps on cylinders if possible.
  5. Turn off and unplug non-essential electrical devices, particularly heat-generating equipment such as hot plates, stir plates, and ovens.
  6. Ensure that all refrigerator, freezer, and incubator doors are tightly closed.
  7. Remove chemicals and close sashes on chemical fume hoods.
  8. Remove biological material and turn off biological safety cabinets and UV lights.
  9. Contact Environmental Health and Safety (EHS) with any safety related concerns or questions pertaining to hazardous materials, x-ray, or laser equipment. Email should be used as the primary means of contact.

Is the IBC and IACUC operating normally?

  1. The IACUC and IBC are operating normally. Research Compliance has processes in place to remotely conduct meetings and other official business, including but not limited to: meeting regularly to review the animal welfare program; conducting IACUC/IBC review and approval; accepting reports of and investigating animal welfare concerns; reporting to federal agencies; and completing grant congruency reviews. However, the availability of committee members to perform reviews may be affected, and reviews may take longer than normal.
  2. Compliance staff are able to work remotely and will be able answer questions. Email should be used as the primary means of communication rather than phone. Contact the IBC at IBC@baylor.edu and the IACUC at IACUC@baylor.edu

Do I have to stop or put a hold on my animal research?

  1. You may continue animal research so long as you adhere to all university guidance and any stricter guidance from your college, your chair, animal facility staff, or Research Compliance.
  2. The BSB Vivarium will continue to operate as normal to ensure an appropriate level of animal care is maintained. If we experience a reduction in staffing, arrangements will be made as necessary to continue providing husbandry services.
  3. For fish facilities, principal investigators are responsible for continued care. If investigators and other personnel are unable to care for their fish, you must contact the BSB Vivarium and the Research Compliance Office.
  4. Surgical procedures in all animals should be planned to be postponed, unless there is prior approval by the Attending Veterinarian. There is no guarantee post-operative care can be provided should there be staff shortages due to sickness. For this reason, adherence to the IACUC protocol is mandatory and should not be compromised.

What can we do to ensure animal research can continue?

  1. Identify essential staff to perform animal work to keep facility traffic to a minimum. This will ensure we have a proper supply of PPE and maintain social distancing. All training of students should cease, and only essential tasks should be performed.
  2. Rodent colony maintenance should be performed regularly to avoid extra or unneeded rodents and reduce colony size.
  3. Where possible breeding animals should be separated to cease production of new offspring.
  4. All animal orders or transfers to/from other institutions should be put on hold. Researchers with standing orders should consult with the Attending Veterinarian if there is a need for these to proceed.

How will my grants and sponsored programs be impacted?

  1. Generally, grant funding will be available during remote work periods. If your work is grant-funded, your grant funds may still be expended even though personnel are remote. If there are future interruptions to administrative processes that impact grant expenditures, additional communication will follow.
  2. Salary payments that are grant-funded, including those for students, will continue to be made against grant accounts, in accordance with Baylor employment policies.
  3. Graduate tuition remission for the current semester will not be impacted.
  4. Sponsors of certain non-federal student programs may not continue payment if services are suspended. An OVPR representative will contact each Principal Investigator of these projects to make plans for the specific students involved.

Will OVPR continue to intake and submit proposals during any possible remote work period?

Yes. Principal Investigators will have access to uninterrupted proposal submission and sponsored programs services though OVPR. Contact your URA with any questions. Standard lead times will apply.

What assumptions should I plan for if there is a widespread COVID-19 outbreak?

  1. All critical research infrastructure and communication will be maintained.
  2. Some or most of your laboratory work force will be out sick or quarantined.
  3. Orders for supplies may be significantly delayed.
  4. Core facilities and other common resources may have limited support or no access.
  5. Repairs and renovations performed by Facilities or outside contractors will be delayed.
  6. Decontamination of your space may be necessary in the event of illness
  7. The University will communicate any disruption to laboratory access.

Human Subject Research FAQs

Are Research Compliance and the Baylor IRB operating as usual?

Research Compliance and the IRB are fully functional and operating at our standard capacity. We expect this to continue even if Baylor suspends operations for contagion control purposes. All IRB staff are able to work from home and IRB meetings can be held remotely, should it become necessary. All email addresses will continue to be monitored with the same or greater frequency as typically provided. We encourage email over phone calls and for researchers to email IRB@baylor.edu which is a mailbox shared with all IRB staff.

Can I still interact with my research participants?

  • General Policy The IRB does not have a blanket recommendation or requirement about postponing or cancelling study visits, but you should minimize in-person interactions following the recommendations of the CDC, Texas Department of Health & Human Services, the McLennan County Health District, and Baylor University.
  • Participant Screening In addition, the IRB is asking study teams to conduct a short phone or email screening for exposure to COVID-19 or symptoms of illness before any study-related visits and in-person interactions. Research participants with possible exposure or symptoms of illness should not participate in in-person interactions until after the time recommended by current public health recommendations. This screening procedure does not require IRB approval.
Appropriate screening questions might include the following, which could be modified to fit your participant population and the location of in-person interactions. Any YES answer should be considered sufficient reason to postpone in-person visits. Decisions about in-person visits should be especially conservative for people at higher risk per public health recommendations:
  • Over 60 years of age
  • Underlying health conditions including heart disease, lung disease, or diabetes
  • Weakened immune systems
  • Pregnant
  1. Have you had any of the following symptoms in the past two weeks, even if they were mild?
    • Fever
    • Cough
    • Shortness of breath
  2. Have you had close contact* with a person who is under investigation for possible COVID-19?
  3. In the past three weeks, have you visited a country with sustained (ongoing) occurrence of COVID-19, such as:
    • China
    • Iran
    • Japan
    • South Korea
    • Any country in Continental Europe (Italy, Spain, France, Germany, etc.)
In addition, researchers should:
  • Follow the recommendations from public health authorities.
  • Follow any guidelines or instructions from the specific facility where participant interaction would occur.
  • Consider the participant population (e.g., are they considered “high risk” for COVID-19?) and the setting in which the interaction would occur.
  • Develop possible alternatives to in-person study visits that are important for subject safety and monitoring.
  • Ensure that hand sanitizer, hand washing facilities and/or cleaning wipes are readily available for screened participants, when in-person interactions will occur.
*Close contact is defined by the CDC as (a) being within approx. 6 feet (2 meters) of a COVID-19 case for a prolonged period of time. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case OR (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).

I want to modify my study procedures to occur remotely. How do I do that?

Studies may modify their procedures to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening, and consenting. Remember that these changes must be approved in advance by the IRB as a Change to the study, unless they are necessary to eliminate immediate apparent hazards to participants. The submission requirement for a change only applies to expedited and full board studies, not to exempt research. If you have any questions about whether a remote option is possible or approvable (especially for consent), contact research compliance staff at IRB@baylor.edu. Staff and the IRB are prioritizing these change requests.

Is study visit cancellation recommended?

The IRB does not have specific recommendations or requirements about postponing or cancelling study visits, but we believe it would be prudent for investigators to follow recommendations of public health authorities to minimize risks to participants.
  • You may choose to hold study visits remotely if feasible for the study and in person visits are not required. You may also consider changing the schedule of study visits or postponing your research.
  • You will need to change your protocol before implementing any changes (unless they are necessary to eliminate apparent hazards to the participant and there is not time to obtain IRB approval) if the study is not exempt and the protocol specifies in-person visits.
  • You do not need to change your protocol in order to hold visits remotely or change the schedule if the study is exempt or if the protocol does not describe whether the visit would be in person or remote or give specifics about visit schedule.
  • You might also consider whether you will need other flexibility in order to continue conducting the research. For example, many low risk procedures qualify for a waiver of written documentation (signed) consent. If the protocol describes written consent, you may wish to change and request a waiver to remove that requirement to allow for easier remote implementation.

If I continue in-person visits, do I need to update my consent form with COVID-19 risks?

You do not need to modify the risks section of consent materials. Potential exposure to COVID-19 should not be considered a risk of study procedures.

I want to place a temporary halt on study enrollment. What do I do?

Researchers may voluntarily halt or delay participant enrollment because of COVID-related public health recommendations, facility requirements, study team availability, and/or participants considered to be at high risk for susceptibility to COVID-19. This does not need to be reported to the IRB unless the study hold is initiated at the request of an external funding agency.

Are there any changes to handling human specimens?

No. Researchers are reminded to follow proper safety procedures for handling human specimens that may contain COVID-19. Human specimens are handled at Biosafety Level 2 (BSL-2). Researchers are reminded that appropriate PPE (lab coats, gloves, eye protection, and face shields) should be worn in BSL-2 laboratories and procedures should be performed within a biological safety cabinet if there is a risk of infection. The CDC offers additional guidance: https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html.

Do I need to register modifications with ClinicalTrials.gov?

If your study is registered at ClinicalTrials.gov and you are modifying research procedures to include assessment of COVID-19 symptoms, you will need to update the ClinicalTrials.gov information for the study to include this new procedure, if the assessment is being done for research purposes. If it is being added as screening to help determine if an in-person visit should occur, the registration information does not need to be modified. The federal requirement about modifications is that any research-related changes that are communicated to the participants (past, ongoing, future) must be added to the study's ClinicalTrials.gov registration within 30 days after IRB approval of the modification.

If a student or researcher needs to access and/or analyze a data set from home in order to keep working on a project, how do we address privacy requirements, if the data set contains sensitive or private information?

As Baylor prepares to support remote operations, we anticipate that research teams may need to rethink how they access and analyze research data sets. Successful remote research operations require maintaining compliance with required controls. If your research data use is covered by a data use agreement (DUA) or other contractual obligations or if it involves identifiable private sensitive information, please submit a protocol change through IRBNet.org if your storage and use location will no longer match your protocol due to remote operations. Ensure the change is approved before moving data sets to a new technology platform. Visit ITS's website for Resources for Working Remotely. We encourage the use of BOX and Microsoft Office 365 through your Baylor accounts. Our staff will expedite change reviews to the extent possible to support continuity. This change requirement only applies to expedited and full board studies, not to exempt research.

Questions?

If you have any questions please contact us at research@baylor.edu