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WINTER 2021
We hope everyone had a great semester. As we look ahead to the Spring 2022 semester, the Research Integrity (RI) office is gearing up to update policy documents and streamline research processes for efficiency and clarity using new submission systems such as BioRaft, and Novelution for FCOI. Keep reading to learn more about what’s happening in the various compliance areas in Research Integrity.
Research Data Security

Data security continues to be an ever-growing area that researchers must pay close attention to. Human subject research includes direct interaction with the human subject, as well as the person’s data or biological samples.

The role of the Institutional Review Board (IRB) is to protect human subjects in research. This means maintaining the privacy of their medical information, as well as their personal opinions. Researchers should work with their information technology (IT) departments prior to submission to the IRB to discuss the level of data security that must be established for the type of research collected and the population involved in this research. For more information, visit Research Data Security.
Updates have been made to a few of our policies including:
 
10.4.2 Exempt Animal Studies
The Institutional Animal Care and Use Committee (IACUC) exempt animal studies policy has been revised to reflect a change in the mandatory IACUC training. For activities qualifying as exempt, researchers are no longer required to enroll in FAU’s Medical Monitoring program. However, researchers must still attend the didactic training on the Ethical Use of Animals, IACUC Function and the 3R’s. To access the revised policy, click here.

The application for exempt status form has been updated. To access the revised form, please click here.

10.4.19 Expired and Suspended Protocols
As a reminder, IACUC policy 10.4.19 Expired and Suspended Protocols, details actions taken when IACUC protocols expire and/or are suspended. IACUC protocols are active for a period of three years from the approval date. If a previously IACUC-approved animal activity, as described in an Animal Care and Use protocol, is allowed to expire or is suspended, regardless of the circumstances, all experimental animal activity conducted under that expired protocol must cease. Continuation of experimental animal activities in the absence of a valid approved protocol is a violation of Public Health Service (PHS) Policy, terms and conditions of PHS-funded grants, FAU Policy and becomes an issue of noncompliance. For more information, refer to IACUC policy 10.4.19.

Deadlines for revised IACUC Protocol and Amendment Applications
When submitting protocols and amendment applications for review, be aware of the deadline for submitting revised application versions. A revised protocol or amendment application must be submitted within 90 days from any of the requested reviews; pre-review, designated member review or full committee review. An email reminder will be sent to the principal investigator within eight weeks. Failure to submit the revised application within 90 days of notification from the IACUC/RI office request will result in withdrawal of the protocol or amendment application. For more information, refer to IACUC policy 10.4.1c.
 
Submitting IACUC Personnel Amendments
When submitting amendment applications to add personnel to approved IACUC protocols, please remember to submit a copy of each individual’s section G form. Additionally, the role of new personnel in the study should be described and whether the person will perform survival surgical procedures should be indicated. The information can be included under the Description of Change section within the amendment form.  

All Hands Meeting
RI will host an all hands meeting in the new year for FAU researchers using animal models in research, teaching or testing activities. The meeting will include updates from the IACUC Chair, IACUC Office, Comparative Medicine and Environmental Health and Safety (EH&S) representatives. More information will be forthcoming.
Institutional Biosafety Committee (IBC) registration has been moved to BioRAFT and all new registrations and renewals should be submitted in BioRAFT.

Principal investigators (PI) gave good feedback and have moved their registrations into the system and it should be easier to register with BioRAFT than through the previous process using the old forms. The majority of existing registrations should be moved into BioRAFT next year. The system has added some new features:
  • A new BioRAFT lab was created to accommodate FAU High biology projects.
  • BioRAFT has added a new delegation system where a PI can delegate the responsibility to a knowledgeable member of the lab.
Novelution is currently underway for submissions to the Financial Conflict of Interest.

For questions about using the system or to set up a one-on-one training session, contact Judith Martinez at researchintegrity@fau.edu.  
Update for in-person research projects:
The COVID Resource documents have been shortened once again to include only the COVID-19 Information Sheet.

Forms have been combined into one document:
  • The Research Re-Engagement
  • Resource COVID-19 Screening Tool form and Research Re-Engagement Resource
  • Consent Form Addendum - COVID-19 Safety form

Notable changes include an information sheet that must be provided to participants for in-person research. It does not require a participant’s signature.

As of Dec. 6, 2021, all IRBNet reviews from the FAU IRB must be addressed within 10 business days of the date of the message, unless otherwise noted. Not addressing the items in the reviews within the designated time frame will result in the package being withdrawn. Withdrawn packages due to missed deadlines will require new package project submission.
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 tips and hints!
If you have any questions, please contact us at researchintegrity@fau.edu or Elisa Gaucher.