CORONAVIRUS (COVID-19) RESEARCH GUIDANCE
Information for FAU Researchers regarding research involving COVID-19 (SARS COV-2)
Currently, biomedical research laboratory work into COVID-19 is governed by recently adopted CDC Guidelines.
Researchers are advised of the following:
- All research work with COVID-19-based samples will be required to undergo review by the FAU Institutional Biosafety Committee as well as the Institutional Review Board, depending on the source of the specimens.
- Research involving isolation, amplification or propagation of virus will NOT be allowed. The guidelines require BSL-3 facilities for such work. FAU does not currently have the capability to facilitate such work. .
- 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 IBC may impose additional requirements (PPE, work practice controls, etc.) for this type of work.
- Please be aware that 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.
Please contact FAU’s Biosafety Officer for any questions:
Frank Novembre, PhD RBP
Institutional Review Board (IRB)
Guidelines for research projects utilizing human specimens and related to COVID-19:
- 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 or study team members is a priority and involved coordination with Environmental Health and Safety (EH&S) and Biosafety.
- 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.
- 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 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.
- Under NO circumstances are researchers, research assistants or students volunteering to collect samples to be exposed to persons with symptoms of coronavirus infection or patients who have tested positive.
- Under NO circumstances are FAU researchers to conduct testing on potential COVID-19 individuals (i.e.: symptomatic or previously exposed) without approval/clearance from the IRB and IBC.
Please contact Dr. Ximena Levy for any questions. E-mail: firstname.lastname@example.org.