View this in your browser, here.
Catch the latest news, tips and advice that supports you and
 Florida Atlantic University in building a culture of research compliance.

August 2020
Welcome Back Owls!

Here’s what’s been happening this summer:

Research Integrity Institutional Review Board (IRB) personnel update:

Effective Aug. 1, 2020, Ximena Levy, left, MD, MPH, director of the FAU Clinical Research Unit (CRU), will transition full time to this position. She was promoted this position in January, but continued to serve both as director of the CRU and as associate director of the Human Research Protection Program (HRPP) in Research Integrity.
The Division of Research – especially the Research Integrity unit – thank her for her assistance and support of the IRB/HRPP team during what was supposed to be a transition period of a couple of months, but ended up being an extended period of time.
Elisa Gaucher, assistant vice president for Research Integrity will assume the role on an interim basis relying on the current IRB/HRPP team, Donna Simonovitch, manager HRPP and Judith Martinez, manager of training and unit operations.
Connect with any of them if you need assistance with human subjects research.
Human Subjects Research During the Pandemic

Research is still happening at FAU with limitations on research that involves in-person procedures. The following research may be allowed to continue:
  • Research that is in a remote format may continue. Research that can be modified to an online or remote format may begin or continue with the appropriate submission to IRBNet of amendment and related documents.
  • In-person research which is COVID-related
  • In-person research that is part of a longitudinal study (with documented justification as to necessity)
  • In-person research that provides direct benefit to participants that is also documented
Assistance Converting to Virtual Platform

Contact the Research Integrity office to confirm continuation or to submit modifications as needed. Researchers are strongly encouraged to communicate directly with their College IT teams and Central OIT for assistance on virtual options available.

  • Research Integrity can assist you with modifying your research to a virtual format and advise what documents you will need to submit an amendment to address these changes.
  • Human subjects research frequently asked questions are online along with other COVID-19 updates and related guidelines.
Research and Anti-Racism

The mission and purpose of Research Integrity’s Human Research Protection Program is to ensure the equal and ethical treatment and considerations of all human subjects in research without limitations or exclusions. Our office believe in equal justice across all of our areas and interactions with FAU and the global community.
Public Responsibility in Medicine and Research (PRIM&R) articulates our values in the statement: “The research enterprise has a distinct obligation to grapple with systemic racism, given its historical abuse of Black communities. The ethics framework governing research with human subjects was created in direct response to the exploitation of Black men in the U.S. Public Health Service Syphilis Study at Tuskegee.”

See additional education and guidance in research from PRIM&R.
AAALAC Re-accreditation and Timeline

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) re-accreditation process is underway. Accredited animal care and use programs are reviewed at three-year intervals by AAALAC in order to maintain accreditation. FAU's animal care and use program received AAALAC accreditation in June of 2018 and our program is due for re-accreditation in 2021.

FAU’s program description is due to AAALAC April 1, 2021 and an AAALAC site visit will occur during the summer of 2021. Bi-weekly meetings are underway with AAALAC task force representatives from FAU’s Institutional Animal Care and Use Committee (IACUC), Animal Research Protections Program (ARPP) office, Comparative Medicine and Environment, Health and Safety (EH&S) to discuss preparations for re-accreditation, including updating the AAALAC program description. More information will be forthcoming during the fall semester.
Diving and Boating Board (DBB) Leadership and Administration

The Vice President for Research Daniel C. Flynn, Ph.D., recently sent an announcement to the Diving and Boating Board paraphrased here:

Congratulations to Brian Benscoter, Ph.D., who began his one-year appointment as an intergovernmental personnel act program manager at the U.S. Department of Energy effective June 15, 2020. We appreciate and would like to express our gratitude to him for his exceptional service as chair of the DBB and wish him the best on his new position where we know he will be a great asset. The vice president for Research and Division of Research have worked diligently with EH&S since his departure and we are very pleased to announce that John Baldwin, Ph.D., professor in biological sciences is our new chair of the DBB.
Through additional discussions between Administrative Affairs, the Division of Research, EH&S and Research Integrity, it has been decided that administration of the DBB will return to EH&S. With FAU’s Diving and Boating safety officer and director, EH&S managing the Diving and Boating Safety Program at FAU, this will create a comprehensive, effective and seamless synergy of components. The Division of Research will continue to be integrally involved as the assistant vice president for Research Integrity serves in an ex-officio capacity on the DBB. 
We sincerely appreciate the efforts of all those involved over the past several years as we have worked together to revamp the Diving and Boating Safety Program at FAU and we will continue that effort with the team now in place.  
IRBNet Signature Verification

IRBNet, the portal for submitting projects to the IRB, now has a signature certification. This new feature will provide researchers the opportunity to confirm all required signatures have been received prior to submitting to the IRB.
The IRB cannot review projects that have not received all the necessary signatures and submissions without all required signatures create undue delays which this new feature aims to solve.
Other Updates:

  • Team Research Integrity is still here for you. Research submissions are still being reviewed by the respective compliance committees. Monthly committees continue to meet as needed, and both IRB/IACUC trainings are offered twice a month all virtually.

  • Check on either the virtual IACUC Ethics training and virtual IRB 101 workshops to register for any of our training sessions which are offered twice a month. These interactive workshops invite researchers to ask questions and participate in the conversation on the ethics of animal research and the human subject research process respectively.

  • Responsible Conduct of Research (RCR) is not required for the IRB, check with your college/department who may require this training. RCR is required for students or post-doc researchers receiving federal funding. RCR certificates submitted to IRBNet will be rejected in the system.

  • Novelution, the new proposal submission system replacing grantsERA has officially launched. Training videos are available here.

  • There are new Institutional Biosafety Committee (IBC) policies which outline the role of the IBC and the basic procedure for submitting and reviewing applications and can be found on our IBC website. New policies are currently under review and will be posted in the coming weeks. The EH&S office is currently developing a biosafety manual which will provide standard procedures for common processes that are potentially biohazardous.

  • Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB is recommended for researchers collaborating with other universities on a project. Following principal investigator eligibility policies, anyone can submit through SMART IRB for reliance on the collaborating institution’s IRB to encourage single IRB review. National Institutes for Health multi-site studies require single IRB.
Check Out the Beacon Online
The archived editions of The Beacon can be found online here. 
Please share with colleagues or use as references to our tips and hints!
If you have any questions, please contact us at or Elisa Gaucher.