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SPRING 2021
Catch the latest news, tips and advice that supports you and
 Florida Atlantic University in building a culture of research compliance.
Research Re-Engagement

As in-person activities resume at FAU campuses, Research Integrity will ensure research activities continue safely. Until further notice, re-engagement of in-person studies will continue to be limited to those studies with 1) direct benefit to the participant and/or 2) studies which are time sensitive such as COVID-19 research or 3) existing/longitudinal studies. Researchers are encouraged to submit the three Research Re-Engagement Resource documents listed below which are on the IRBNet library to request to resume in-person research studies meeting the criteria described.

Research Re-Engagement Resource 1
– Request for In-Person Research to resume/start during COVID-19

Research Re-Engagement Resource 2
– COVID-19 Screening Tool

Research Re-Engagement Resource 3
– Consent Form Addendum COVID-19 Safety

*Note that the return to campus and in-person activity guidelines are frequently changing. Research Integrity will continue to inform researchers as guidelines and requirements evolve.
FAU Clinical Research Unit (CRU)

FAU’s Clinical Research Unit’s (CRU) mission is to provide researchers at FAU with the facilities, tools, training, services and guidance to conduct high-quality clinical research. The CRU offers services such as study design and feasibility, assistance with completing Institutional Review Board (IRB) submissions, and is playing a critical part with in-person research re-engagement projects. The CRU is providing the facility, medical services and personnel therein as well as having safety measures already in place to carry out in-person research using the CRU space.

Visit the CRU page for contacts and more information.
IRB Updates

Data Security
When preparing your IRB project, contact the college Informational Technology (IT) representative to discuss your research and plans to ensure your research data is collected, stored and transferred in a secure manner as appropriate. Share your IRBNet project submission with your IT rep for their e-signature to confirm the data security plans you describe in your protocol and consent forms are up to the appropriate safety standards for the level of risk involved. Additionally, researchers must upload a Data Safety or Data Monitoring plan when your IT representative has deemed it appropriate or as required by the college. Visit our Research Data Security website for guidance on additional considerations as you prepare your research project.

When and which consent to use for remote research methods
An e-Consent Guidance is now available on IRBNet for researchers looking to conduct research online which includes advice on which consent methods can be used as well as the options available.

Updates to IRB Forms
Several of our forms have been updated on the IRBNet library including the Application Form, Consent Form Templates and Supplemental Personnel Appendix. Be sure to download and use the latest forms from the IRBNet forms and templates library.
 
Scientific Merit Review of IRB Submissions
New project submissions require signature from the college department head and, in some cases, may require additional signatures from college representatives. This review and sign-off ensures the college is aware of the research and has checked the research design for scientific merit. Discuss who should review and sign the IRBNet submissions with the department head or college’s research office and review the last pages of the IRB application form for a general overview of signature requirements.
IACUC Updates
 
Changes in Medical Monitoring Enrollment
Environment, Health and Safety (EH&S) has changed the process for enrollment in the medical monitoring program for animal research. Enrollment in the program is now through BioRaft. For more information on how to enroll, click here. 
AAALAC Re-accreditation
The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) re-accreditation process is underway. FAU’s program description was submitted to AAALAC on April 1. AAALAC has confirmed that site visitors will be at FAU June 15 to 18. More information regarding the site visit will be forthcoming.
IBC Updates

BioRAFT Submission Platform
Institutional Biosafety Committee (IBC) compliance is in the process of moving to BioRAFT. This platform is already in use by EH&S and will integrate and streamline registration for both areas, and should be up and running soon.
 
IBC Requirements
  • All projects involving the use of human cell lines or transgenic animals should be registered with the IBC.
  • IBC registration is required regardless of the project funding source.
  • IBC approval is required prior to IRB/IACUC and Office of Sponsored Programs approvals.
  • For an overview of requirements and procedures for IBC registration, see the Biosafety Review Process (10.12.03) and Training (10.12.04). Some projects (including those involving recombinant or synthetic DNA) will require more training and a more in-depth review process.

IBC Website
Visit the new IBC webpage for information on training requirements, downloading the most current forms, reviewing policy, identifying contact persons and so forth. To access the webpage, click here. 
Training Calendar & Office Hours

Monthly training is available for researchers working with human or animal subjects. Check out the training calendars to register now. Set a virtual appointment for IRB or IACUC related questions – even before submitting a protocol – by contacting researchintegrity@fau.edu.
IRB Virtual
Training Workshop & Education

It’s recommended human subject researchers attend the IRB 101 workshop to gain familiarity with the IRBNet submission portal as well as the steps and documents needed to complete a submission. Register by clicking the IRB training calendar icon.
 
IRB Education Course on Canvas is a learning community which serves as a virtual assistance and training platform, allowing you to get answers you need any time, from any device, and to connect with Human Research Protections Program staff or other researchers.
IACUC Virtual
Training Workshop

The required Ethical Use of Animals, IACUC function and the 3R's workshop is available in virtual format. Click the IACUC training calendar icon to register for an upcoming training date.
 
Contact Dana Mulvaney for ethics training workshops cancellations.
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 researchintegrity@fau.edu or Elisa Gaucher.