Starting Oct. 1, 2024, minimal risk study changes in non-key study personnel do not need to be submitted via amendment. Instead, use Form 116, “Non-Key Study Personnel” to track changes and submit the form at the next study amendment. If there is a change in PI, Co-Investigator, external collaborator, or other key personnel, these must undergo an amendment review and approval prior to initiating the change. A sample process is illustrated below.

This new process will expedite changes to study team members who are not key personnel. As a reminder, PIs are responsible for ensuring all study team members complete and maintain proper training prior to joining any study requiring IRB review.

Research Match

FAU is a partner of ResearchMatch, which is a nonprofit program funded by the National Institutes of Health (NIH). It helps to connect people interested in research studies with researchers from top medical centers across the U.S. This national volunteer research registry brings together researchers and willing volunteers who want to get involved in research studies. It provides a secure, web-based approach to address a key barrier to advancing research: finding research participants. There is no cost to use ResearchMatch. You do, however, need materials approved by the IRB. Visit the ToolKit for Researchers webpage for more information about how to use ResearchMatch in your research recruitment.

All of Us Research Program

The National Institutes of Health’s (NIH) All of Us Research Program provides health data from diverse U.S. research participants. FAU researchers can now access the National Institutes of Health’s (NIH) All of Us Research Program datasets that include genomic data, called “Controlled Tier.” For a description of the tiers, or to access the data, register with the All of Us Researcher Workbench with a Florida Atlantic email address, by visiting the All of Us website.

Semi-Annual Scheduling:

Fall semester brings semi-annual inspections of facilities in October. Researchers will receive notifications regarding time and details of the inspection schedule.

Summer Re-Cap:

FAU’s animal care and use program was reviewed onsite by AAALAC for triennial reaccreditation July 15 – 18. Thank you to all who participated in the triennial reaccreditation visit! The site visit resulted in the recommendation for full continued accreditation with minor suggestions for improvement that will be addressed in the coming year.

On July 30, FAU’s animal care and use program was notified of a site visit by the members from the Office of Lab Animal Welfare (OLAW) on Aug. 13 – 14. The site visit went very well and OLAW was very complementary of FAU’s animal care and use program. OLAW’s site visit also resulted in minor recommendations which will be addressed in the coming months.

USDA performed their annual unannounced site inspection on Aug. 14. The inspection resulted in no noncompliant items identified during the inspection. Kudos to the research team involved in the USDA inspection process!

IACUC Protocol Tip: 

When preparing your IACUC protocol, for USDA category D and E protocols, in section B.2, Literature Search for Alternatives to Painful Procedures, if alternatives to potentially painful procedures are identified, but cannot be used, please mark “Yes, but they are not suitable for the following reasons”. Checking that box “yes” will open a text box for you to include the references identified during your literature search as well as reasons why those potential alternatives are not appropriate for the current study. This information is a critical part of the IACUC review to address the 3 R’s – Reduction, Replacement, Refinement!

Animal Care Program changes:

FAU’s animal care and use program has undergone some recent personnel changes. We appreciate your patience and support as administrative units work through this transition time. Please continue to review and adhere your approved IACUC protocol procedures.

IBC registration is required for the use of recombinant or synthetic DNA (including transgenic animals), human or primate biological materials (including blood, saliva, nasal swabs, or cell lines), biological toxins or venoms, microorganisms, viral vectors, and anything classified as Dual Use Research of Concern. Registration is required regardless of funding status. All IBC registrations should now be in SciShield (formerly known as BioRaft). No new registrations or amendments will be reviewed using the old paper form

Please update your Significant Financial Interest Disclosure annually, or when outside interests change. All of the questions in the Project Specific Disclosure should be answered in adequate detail, even when indication of an outside interest has no direct relationship with a sponsored research project and (in your opinion) does not have a financial conflict. The answers should contain enough information so that a reviewer can independently confirm that there is no overlap between the goals of the project and the goals of the outside interest without consulting any other document or asking the PI follow up questions. Include enough detail to make this possible and to avoid delaying the review of a disclosure.

Research Roundtables



The Research Roundtables are back for the Fall 2024 semester! We are looking forward to upcoming sessions in October and November. To register for upcoming sessions visit the IRB Training calendar page.

Join us for these timely topics and learn from experts in the field as well from your research colleagues.

Visit the Research Roundtable page for more information and to view slides from previous sessions.

The Fall RCR sessions are currently underway with the remaining sessions taking place on the Jupiter Campus at Max Planck Florida Institute for Neuroscience (MPFI). This four-part series is offered in the fall and spring semesters with workshops offered at FAU Boca and at MPFI on the Jupiter campus. All researchers interested in topics such as authorship, mentorship, conflict of interest, protection of human subjects, animal welfare and more are welcome to attend. Note that certain NIH training grants require this in person training in addition to the CITI RCR. Visit the RCR training page for more information or click to view the RCR flyer for more information and to register for sessions in October.

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 that human subject researchers attend the IRB 101 workshop to gain familiarity with the IRB Novelution submission portal as well as the steps and documents needed to complete a submission. Register by clicking the IRB training calendar icon.

IACUC Virtual Training Workshop

The required Ethical Use of Animals, IACUC function and the 3R's workshop is a required training that is available in virtual format. Click the IACUC training calendar icon to register for an upcoming training date.

Contact Daniela Esquenazi for ethics training workshops cancellations.

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