Home / DOR / COVID-19 FAQs Relating to Research

Update: Re-engaging in Research

Updated: July 6, 2020 - 6:00 p.m.

The Division of Research developed the FAU Research Re-engagement Plan as a supplement to the university’s Reopening Plan COVID-19. The research plan addresses situations specific to a variety of research scenarios.

Daniel C. Flynn, vice president for research, discussed the plan during a recent videoconference. He and his executive staff members answered many questions, which are posted below. In addition, they are available to answer any additional questions at fau.research@fau.edu.

See Flynn’s presentation.

The division is here to support university faculty in their pursuit to answer novel research questions, creative endeavors and scholarly work during these unprecedented times. This page will be updated regularly. Please check back and don’t hesitate to contact us.

FAU Research Re-engagement Plan

Zoom in on Research Questions & Answers


Frequently Asked Questions


Answers to Submitted Questions

Q: Are undergraduates allowed to work in labs?

A. We are following the rules that differentiate employees from students. If an undergraduate student is paid to work in the lab, then they may come to work. But, the PI should use discretion following rules of social distancing, decreasing the density of workers in a lab by at least one-half, perhaps staggering the times workers come into the lab. Of course, Undergraduates require oversight (most times) and we should be cognizant of having someone there to provide oversight when they are working.

If a student is working for college credit, they do not have to come. rather, it might make more sense to provide them with a reading assignment of review articles or manuscripts relevant to their research project and determine if there is a way to develop a grade around that activity.

Q: Are there any regulations in place to limit environmental research in the field?

A. Yes, there are limits. Consistent with other Florida System Universities, FAU is stopping all scientific diving activity for the time. I think the rationale is related to the close interactions we have with people as we prepare to dive as well as not overwhelming the medical response teams should something happen.

We were allowing small boats to go out consistent with social distancing, but many launch ramps in Miami Dade and Palm Beach County have been taken off line. Therefore, scientific boating from these ramps are not allowed until further notice.

Field work that requires hiking is still allowed as long as social distancing is practiced.

As always, things could change. We will provide UPDATES, as they come in.


FAU Research Guidance

COVID-19 (SARS COV-2) FAU Research Biosafety FAQ

Q: Are there any federal guidelines for COVID-19 research?

A. Currently, biomedical research laboratory work into COVID-19 is governed by recently adopted Centers for Disease Control and Prevention guidelines: https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html.

Q: Can research with isolated SARS-COV-2 virus be done at FAU?

A. Research involving isolation, amplification or propagation of virus will NOT be allowed. The guidelines require biosafety Level (BSL)-3 facilities for such work. FAU does not currently have the capability to facilitate such work.

Q: What COVID-19 research can be done at FAU?

A. Research involving molecular or other types of analyses of human samples (blood, nasopharyngeal swab samples, etc.) will be permitted at a minimum of BSL-2 conditions. However, the Institutional Biosafety Committee (IBC) may impose additional requirements (personal protection equipment, work practice controls, etc.) for this type of work.

Q: Does COVID-19 research require approval by the university?

A. At a minimum, all research work with COVID-19-based samples will be required to undergo review by the FAU IBC as well as the Institutional Review Board (IRB), depending on the source of the specimens.

Q: What other responsibilities should researchers be aware of?

A. The virus responsible for the COVID-19 pandemic, SARS-CoV-2, will likely be designated a Select Agent in the near future. Therefore, any samples associated with this virus/disease will need extensive cataloging and researchers should consider secure storage of these samples at this time. If SARS-COV-2 is designated a Select Agent, samples may need to be destroyed — this would require verification by the biosafety officer.

Q: Who should I contact if I have questions related to research involving SARS-COV-2 and biological safety?

A. Contact Frank Novembre, Ph.D. RBP, FAU's biosafety officer, at fnovembre@fau.edu or call 561-213-0488.

COVID-19 (SARS COV-2) FAU Research Human Subject FAQ

Q: Can FAU help me with developing projects for COVID-19 research?

A. Researchers planning to work with human bio-specimens are strongly urged to contact the IRB office personnel at the time of project design to obtain advice on procedures. Many considerations need to be assessed including information related to administrative procedures and compliance regulations. Protection of study team members is a priority and involves coordination with Environmental Health and Safety (EH&S) and Biosafety.

Q: What documentation is needed from outside institutions?

A. At a minimum, a letter/e-mail of cooperation from the institution providing access to patients/samples should be included in the initial communication with the IRB office.

Q: What formal agreements are needed between FAU and outside institutions prior to receipt of data or materials?

A. Projects involving data or specimens require either a Data Use Agreement (DUA) or Material Transfer Agreement (MTA). These agreements require institutional legal review as well as a signature from an authorized institutional official. Please contact the Office of Sponsored Programs or Research Integrity for additional information and guidance. DUA and MTA review can occur in parallel to IRB and IBC review, but IRB and IBC review and approval is needed prior to final approval of an agreement.

Q: Can researchers interact directly with participants who may have been exposed to or have the coronavirus?

A. FAU researchers must not interact directly with participants. Should researchers wish to interact indirectly to collect data they are encouraged to seek advice from both the IRB and IBC prior to initiation of the research project.

Q: Who should I contact if I have questions?

A. Contact Ximena Levy, MD, MPH, at xlevy@health.fau.edu.


Office of Research Development

Q: Will FAU deadlines for limited submissions remain the same?

A. Yes, all limited submissions internal deadlines will remain the same. However, if agency deadlines change, then limited submissions deadlines within FAU may also be adjusted. Stay tuned to current deadlines on the Office of Research Development limited submissions website: http://www.fau.edu/research/research-development/limited-submissions.php.

Q: Will I still be able to obtain editing assistance from Research Development during the Covid-19 quarantine period?

A. Yes, ORD staff will be working remotely and be able to assist you via email, Skype, telephone, and/or Microsoft Teams.

Q: What is the status of existing ORD workshops scheduled for the Spring 2020 semester?

A. We will offer WebEx training for the March 18th (Strengthening Your Study Design) and April 8th (NSF CAREER) workshops. This will allow faculty to participate remotely from their home or office computer. The Early Career Academy capstone celebration will be postponed until early Fall.


Office of Sponsored Programs

Q: Will proposals continue to be submitted?

A. Yes. We will continue to submit proposals. OSP will continue to monitor the sponsors and should anything change we will let everyone know.

Q: Are sponsors providing any guidance related to COVID-19?

A. Both NIH and NSF have issued FAQs related to COVID-19. As information is made available from other sponsors, we will update. https://www.cogr.edu/institutional-and-agency-responses-covid-19-and-additional-resources .

Q: If my PCA is out sick, who will take care of my submission?

A. OSP staff are cross-trained and each are assigned as a back-up to other OSP staff to ensure continuity of services.

Q: If employees are quarantined, how will this affect OSP services?

A. Services will continue as normal. OSP staff have been granted VPN access, which allows OSP staff to access FAU servers while working at remote locations.


Research Integrity and Compliance

Q. Who do I contact about my IRB, IACUC, IBC or other approval while normal operations are interrupted?

A. Please contact any team member of Research Integrity. RI personnel is working remotely and available via email or telephone. http://www.fau.edu/research-admin/research-integrity/#staff-directory


IRB / Human Subject Research

Q. Should I pause the research studies involving human subjects?

A. For those studies which have little to no prospect of direct benefit to participants, study procedures involving in-person contact with participants must be paused, effective immediately until further notice from the Research Integrity Office.

In-person research conducted by FAU faculty, staff or student investigators utilizing subject pools in which students receive course credit (e.g., Psychology, Education) should be modified into an online format or postponed until normal classes resume. Procedures that involve telephone contact, monitoring or remote data collection may continue uninterrupted.

Studies which have direct benefit to participants may continue. You should have a compelling reason why in-person interactions need to occur or continue and contact the IRB to justify the direct benefit for the participant. If there is a compelling reason to continue the in-person activities, you should:

  • Screen all participants for possible exposure to COVID -19 or symptoms of exposure to respiratory illnesses before scheduling (and immediately before the occurrence of) any 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.
  • Ensure that hand sanitizer, hand washing facilities and/or cleaning wipes are readily available for participants and study personnel, when in-person interactions will occur.
  • Abide by all recommendations and actions of the appropriate public health authorities and FAU recommendations.
  • Ensure every day that study personnel who will interact with participants are symptom-free and have not had possible exposure to COVID-19.

Q: Do I need to amend study procedures to include remote procedures?

A. Yes, many studies are modifying their procedures to replace in-person study visits with “remote” options for questionnaires, surveys, check-ins, screening, and consenting. These changes must be approved in advance by the IRB as an amendment to the study.

If you have any questions about whether a remote option is possible or approvable (especially for consent), contact the HRPP / RI team. We are working to prioritize such amendments.

Q: What if I or one of my study team must have an in-person interaction with study participants? What should we do?

A. FAU recommends asking research participants to complete a short screening for exposure to COVID-19 or symptoms of illness before they are scheduled for any study-related visits and in-person interactions. This specific screening procedure does not require IRB approval.

*In addition, FAU researchers should:

  • 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.

Q: Do we need approval from the IRB for communications to study subjects explaining the pause in activities?

A. No. It is not necessary to submit a modification.

Q: Will the IRB provide blanket language?

A. The wording and language may need to be specific to each study. The guidance is as follows:

Due to the potential or perceived risks of COVID-19, FAU has paused human subjects research studies involving direct subject contact that provide little or no potential benefit to subjects. These studies will be able to maintain telephone contact and remote data collection activities during this pause and may resume when the risk of COVID-19 has passed.

Q: What do I, as the responsible faculty PI, do to eliminate immediate hazards to research assistants?

A. Follow CDC and other expert guidance to reduce potential exposure to COVID-19.

  • Cancel non-essential study visits
  • Conduct phone visits in lieu of in-person visits
  • Conduct safety screening (initiated by the Principal Investigator) prior to in-person justified (and IRB approved) visits occurring
  • Other changes as deemed appropriate to eliminate immediate hazards to subjects because of the risk of exposure to this highly communicable disease.
  • In some cases, changes may include temporarily stopping subject recruitment or placing a temporary hold on all study procedures. * such holds should be communicated to the funding agency or sponsor (if any) as needed.

Q: What kind of protocol changes will likely need prior IRB approval?

A. The following changes would not eliminate an immediate hazard, but may still be desired, so consider doing a proactive amendment for the following circumstances:

  • Changing reimbursement for travel expenses, if travel requirements or compensation to the participant changes
  • Using digital technology to conduct remote visits/ interviews. Consider what types of technology you may wish to use.

Q: For any clinical research studies, what do I do if virus screening becomes mandatory for research participants?

A. If COVID-19 screening becomes mandatory in your clinical area, then that screening would not be considered part of the research procedures, therefore it does not constitute a change in the IRB-approved protocol. If you wish to incorporate the screening data into your research, however, then you would need to submit a protocol amendment.

Q: What should I do to change an ongoing study?

A. As is always the case, changes in IRB-approved research must be submitted to the IRB for review and approval prior to implementing the change.

  • An exception is when changes are necessary to eliminate apparent immediate hazards to the subject (permitted in both OHRP and FDA regulations) Should this happen the changes must be reported to the IRB as a protocol deviation within 5 days. If the changes need to be sustained for multiple visits, then an amendment to the protocol should be submitted to the IRB for review and approval.

Q: What about studies reviewed by a non-FAU IRB?

A. You do not need to submit anything to FAU – IRB unless you are changing the PI, changing the IRB, closing the study or the non-FAU IRB has requested that you contact Research Integrity for guidance.

Each non-FAU IRB may have different policies for what to report about suspending enrollment, activities, etc. However, in most cases if you are changing study procedures or moving from paper-based consent to e-consent, you will need to modify the study.

For multi-site studies, you may need to work with the primary center, lead study team, as part of implementing changes.

Q: Will new protocols continue to be reviewed by FAU’s IRB?

A. Yes, the FAU IRB will continue to review new protocol submissions per normal review procedures.

Q: What will happen if FAU closes?

A. The FAU RI / IRB personnel are all capable of working remotely. We are also experienced with holding Committee meetings via teleconference. University closure should not significantly impact our ability to review research, including high-priority studies and amendments.

Q: What should I do if I have additional questions?

A. If you have additional questions, please contact us at: www.fau.edu/research-admin/research-integrity/


IACUC / Animal Subjects Research

Q: Will FAU’s IACUC office and the IACUC continue to conduct official business if the university shuts down?

A. Yes. The IACUC office and the committee will continue to conduct official business, including but not limited to: continuing scheduled monthly meetings, conducting protocol review and approval, accepting reports of and investigating animal welfare concerns, reporting to federal agencies and AAALACi and completing grant congruency reviews.

Q: Will semi-annual inspections happen in April as originally planned?

A. Yes. The plan is still to conduct semi-annual inspections as planned but they may need to be conducted with smaller inspection groups or they may need to be delayed. RI / IACUC office is monitoring the guidance from the Office of Lab Animal Welfare regarding maintaining institutional guidance related to semi-annual inspections.

Q: I was scheduled to have in-person training and that has been postponed. What do I do?

A. All trainings have been postponed until further notice. Questions regarding future trainings should be directed to the appropriate personnel within Research Integrity at http://www.fau.edu/research-admin/research-integrity/

Q: How can I get assistance with my IACUC protocol, questions about my research program or complete the required ethics training?

A. IACUC personnel are available to answer questions, assist in protocol preparation and provide training and consultation as needed. http://www.fau.edu/research-admin/research-integrity/

Q: How will the IACUC conduct their monthly meetings?

A. If campus operations are interrupted, the IACUC and IACUC staff will arrange for alternatives to face-to-face meetings such as teleconference or video conferencing.


DBB/Diving and Boating Research Activities

Q. Should I suspend scientific diving activities?

A. Yes. The SARS-CoV-2 virus and the associated COVID-19 disease has spread through populations and overwhelmed hospitals in other countries, our primary priority is to not exacerbate the problem. Should the EMS and healthcare resources in our surrounding areas become strained, emergency services will become scarce. The suspension of scientific diving operations was made with the approval of the President’s Executive Leadership Team.

Q. Are scientific boating activities continuing?

A. Effective March 22, 2020 Palm Beach County and Miami-Dade County have closed all county marinas and boat ramps to all but law enforcement and commercial fishing vessels and will not grant a scientific boating exemption. Therefore, FAU is suspending all scientific boating in waterways solely served by these county ramps. If there are other ramps (such as municipal or private) that can be used to access these areas, research is still permitted.

The current status of municipal marinas and boat ramps may differ. Please contact FAU’s DBSO if you hope to use a municipal boat ramp and she will work with you to determine if it is still accessible.

This suspension will be in place until further notice. We will continue to be in contact as things continue to change.

For scientific boating activities that are continuing where boat ramps allow please follow all appropriate guidelines including washing hands, wearing PPE as necessary and remaining 6 feet away from others. Additional considerations include:

  • Incident response mechanisms that may be part of lab response plans might not be functioning or have limited capacity.
  • Many public lands are restricting both public and research related access (e.g., at least one of the National Wildlife Refuges one of our labs works in has suspended all activities not directly related to site management). Please contact them if planning field work.
  • If you are not comfortable participating in field research, due to preexisting medical conditions or to being immunocompromised for any reason, you should not feel pressured to do so. You are not required to disclose personal medical detail, but please tell your PI if you have to restrict yourself and are unavailable per the President’s guidance.

Q. Who should I contact if I have questions:

A. EH&S and Research Administration personnel are working remotely for all tasks that do not require onsite assistance. Should you have an extenuating circumstance requiring immediate approval to conduct scientific diving activities please contact Lizzie McNamee who will coordinate communication and necessary approval. http://www.fau.edu/research-admin/research-integrity/diving-and-boating-board/

Q. What is the status of scientific boating activities?

A. The tri-county area (Miami-Dade, Broward, and Palm-Beach) have worked together to open some of their parks and boat ramps. The following announcement and official order links for each county have the most up to date information.

Some waterways that have been inaccessible due to boat ramp closures in these counties may now be open. Check ahead to see if the ramp you wish to use is open.

The Division of Research and Environmental Health and Safety remind researchers to keep the number of persons involved to a minimum and continue to follow all CDC recommendations and county regulations regarding continued closures, social distancing, face covers and expediting time spent at the dock.

West Palm
http://discover.pbcgov.org/Lists/Newsroom/NewsDispForm.aspx?ID=2808
http://discover.pbcgov.org/PDF/COVID19/Emergency-Order-Number-5.pdf

Broward
https://www.broward.org/Parks/Pages/COVID19PARKUPDATES.aspx
https://www.broward.org/CoronaVirus/Documents/EmergencyOrder20-08.pdf

Miami-Dade
https://www.miamidade.gov/global/initiatives/coronavirus/openings-boating-waterways.page
https://www.miamidade.gov/information/library/04.27.20-emergency-order-21-20.pdf

City of Port St. Lucie
https://www.cityofpsl.com/government/departments/emergency-management/covid-19-coronavirus-information

FWC Boat Ramp Status
https://atoll.floridamarine.org/dle_gis/javascript/boat_ramp_status/

Q. Are scientific diving activities still suspended?

A. Yes, until further notice.

Comparative Medicine

Q: What general rules should I follow in the vivarium?

A. Please abide to the recommended rules of social distancing and proper PPE (see below). Sanitize your hands at the entrance. Don gloves in the procedure/housing room. Reserve the room in advance including housing rooms when working in there for longer than 5 min. Ideally, only one person should work in a room. If more people have to be in the same room comply with social distancing norms. Sanitize the cage changing station/biosafety cabinet before and after use including the work surface and the functional buttons (e.g. light/blower). Wash your hands before you leave the vivarium and of course while working in the vivarium as well if applicable.

Q: What kind of PPE do I need to wear when entering the vivarium?

A. Enter the vivarium without PPE. Sanitize your hands at the entrance where you will find hand sanitizer. Don lab coat and surgical mask at the PPE station. Don gloves only in the room where you will work and discard the gloves before you leave the room. Our staff is sanitizing all door handles as well as faucet handles regularly but at least twice a day depending on the frequency of use. If you like take a disinfectant wipe to sanitize the door handles you will use on your way out.

Q: Can I take the PPE to my lab?

A. NO. Please do not remove any PPE from the vivarium either worn or clean one. We also are having trouble to find enough of the PPE items needed. If you have a specific request please talk to Carrie List and we will try our best to support you.

Q: Should I cryopreserve my valuable mouse strain(s)?

A. In general, the answer is YES. It is always advisable to cryopreserve strains that are not easily available through a commercial vendor, to avoid losing them to any unforeseeable events such as a disease outbreak or any emergency situation. We still continue to, and will in the future, care for all your animals, but we cannot foresee any unusual events either. Therefore, if you want to cryopreserve a strain as a backup plan please contact Helen at 561-843-0572 or email her. She will help arrange with the vendor.

Q: Could I get help with my genotyping since my lab is closed and students/staff not available?

A. Yes, this is possible. Please communicate with Carrie List or Sylvia Gografe that we can discuss what CM staff should do to help. Samples can be sent to Transnetyx for genotyping after collection by CM staff. Transnetyx has offered assistance to all our PIs who would need to use their services for genotyping and discounts for first time users. Read the email here.

Q: Will Comparative Medicine be able to care for our research subjects?

A. Yes, CM is well prepared having enough food, water, bedding, environmental enrichment devices for our animals available. We have plenty of chemicals on hand for sanitizing caging, disinfecting during cage changing, cleaning/disinfecting work surfaces and high traffic items such as door handles, faucet handles, elevator buttons etc.

Q: Do CM has enough staff even if some would become sick?

A. Yes, all our personnel including student workers are designated Essential Personnel. We have identified additional help for the vivarium operations if our lab animal techs should become sick:

  • CM management personnel
  • Colleagues from other DoR units who have worked with animals before
  • Faculty and staff members from research laboratories working with animal models.

Q: Will we have access to our research subjects?

A. Yes, currently access is not restricted. Should the university go to a remote work only model, it will be important that you have Essential Personnel status to be allowed to come on campus.

Q: Will our studies in the CM- or satellite facilities be restricted?

A. At this time, we have the capacity to support our researchers and no studies or breeding are being restricted.  However, as this unprecedented public health concern continues, there may be additional restrictions that need to be put into place. Therefore, we recommend that you start thinking about prioritizing studies and have a backup plan in place. Make sure to attach VIP stickers on cages that house the most important animals.

Q: Do I need Essential Personnel status and how do I get it?

A. It is certainly advisable to get your Essential Personnel status established now. Work with you HR partner who can request this through WD. Once done make sure to have your Essential Personnel Designation letter with you all the time (e.g. in your car or purse).

Q. Are vendors such as Charles River, Jax labs, Taconic, Envigo etc. still delivering?

A. Yes, animal deliveries are still happening as usual. All the vendors have CM staff contact information that we don’t have to rely on building or college receiving departments or personnel.

Q. What should I do if I need supplies? Do we have enough available?

A. Please follow process as usual and request drugs and supplies through VSATS. We have stocked up on all important drugs and supplies.

Q. What happens if I have questions re the health of my subjects?

A. Both veterinarians, Drs. Salleng and Gografe are available. Please make sure that we have your contact information on file that we will be able to call/email you to discuss any such cases with you in a timely fashion.

Q. What happens if I as a researcher become sick?

A. Please stay home and communicate with your lab colleagues. If they cannot attend to your animals please call Sylvia Gografe (561-400-3770), Carrie List (561-558-4217), Dr. Ken Salleng (615-715-5805), or Helen Munchow (561-843-0572). We have highly trained personnel who can perform certain experimental procedures for you or manage your breeding colony. We can discuss and arrange help.

Q. What happens if I as a researcher was exposed to a person having coronavirus?

A. If you got exposed to a person confirmed for COVID-19 you definitely should not come to work but self-quarantine at home. Refer to the official FAU emergency website in this regard. If you need help with your animal subjects please contact Sylvia Gografe (561-400-3770), Carrie List (561-558-4217), Dr. Ken Salleng (615-715-5805), or Helen Munchow (561-843-0572). We have highly trained personnel who can perform certain experimental procedures for you or manage your breeding colony. We can discuss and arrange help.




 Last Modified 7/6/20