As we continue to navigate our way through the coronavirus pandemic, I want to thank you for your patience and thank all of our staff for their understanding and support. Each day brings new information and guidance, and I wanted to take a moment to share some of the latest issues related to research with you.
In a call with the Florida State University System vice presidents for research, we learned the following:
When a health care agency calls a university and asks if they have medical-related supplies that they can donate, we are allowed to do that — but only under certain circumstances.
If a federal grant paid for the supplies and it has expired, then the materials are considered excess and can be donated. However, if an active grant paid for them, then they have to be kept in-house for research purposes. I assume that this applies to state grants as well. With corporate grants, it may be negotiable.
We have been getting calls from health care providers regarding access to 3D printers to make medical devices, such as N95 masks. As a university community, we have been very responsive to this. One of our engineers noted that 3D printers cannot make one-size fits all masks. He suggested that a better approach may be printing a mask that can have a filter inserted.
Note: If you are 3D-printing a device to be donated for use on patients, this activity should not proceed until FAU gets further guidance from legal counsel.
At the moment, access to research labs is still allowed and we appreciate your discretion in employing social distancing and staggered work schedules. Federal guidance for paying employees from grants who cannot take their work home are posted on the Division of Research web page under FAQs.
Faculty are allowed to pay technicians and temporary employees (OPS) who cannot come into work and cannot take their work home, but ONLY if that is consistent with university policy. All SUS institutions are working on a policy that will incorporate some form of emergency vacation pay, some use of saved time off or some other form of coverage. It’s evolving and I will keep you up to date.
As always, DOR is here to help. Please reach out to any of us with concerns or questions.
Daniel C. Flynn
Vice President for Research
View the archive for recent updates from the VPR's office.
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.
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.
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.
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.
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.
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.
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.
A. Contact Frank Novembre, Ph.D. RBP, FAU's biosafety officer, at email@example.com or call 561-213-0488.
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.
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.
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.
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.
A. Contact Ximena Levy, MD, MPH, at firstname.lastname@example.org.
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.
A. Yes, ORD staff will be working remotely and be able to assist you via email, Skype, telephone, and/or Microsoft Teams.
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.
A. Yes. We will continue to submit proposals. OSP will continue to monitor the sponsors and should anything change we will let everyone know.
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 .
A. OSP staff are cross-trained and each are assigned as a back-up to other OSP staff to ensure continuity of 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.
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
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:
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.
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:
A. No. It is not necessary to submit a modification.
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.
A. Follow CDC and other expert guidance to reduce potential exposure to COVID-19.
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:
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.
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.
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.
A. Yes, the FAU IRB will continue to review new protocol submissions per normal review procedures.
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.
A. If you have additional questions, please contact us at: www.fau.edu/research-admin/research-integrity/
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.
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.
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/
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/
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.
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.
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:
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/
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.
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.
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.
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:
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.
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.
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).
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.
A. Please follow process as usual and request drugs and supplies through VSATS. We have stocked up on all important drugs and supplies.
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.
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.
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.
Please follow the links below for guidance related to Coronavirus impacts on research from federal funding agencies:
As researchers, we know many of you are looking to do your part in the fight against COVID-19. Here’s a look at some relative funding opportunities: