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FALL 2022

Throughout the last fiscal year, Research Integrity has experienced continuous growth in research-related activities as summarized here: 


325 Institutional Animal Care and Use Committee (IACUC) protocol related actions

105 Institutional Biosafety (IBC) registration related actions

376 Financial Conflict of Interest (FCOI) disclosure related actions

494 Institutional Review Board (IRB) protocol related actions across the two IRB’s


While these metrics reflect actions, they do not incorporate other programmatic responsibilities of the unit, such as standard operating procedures, policies, guidance, inspections, annual reporting, non-compliance management and reporting, trainings, forms and more. 


The unit wants to thank researchers, but more importantly, those who serve as committee members for their dedication and support in managing these institutional research compliance programs.


Check Research Integrity websites for updated compliance policies:


The HRPP/IRB Policies & Procedures page

The ARPP/IACUC Policies & Procedures Page

HRPP/IRB Conference Takeaways


Donna Simonovitch, manager of Florida Atlantic University's Human Research Protection Program (HRPP) and IRB, attended the Association for the Accreditation of Human Research Protection Programs (AAHRPP) conference in Denver, Colorado in May. The focus was on the three pillars of the AAHRPP accreditation process: 1) education, 2) voluntary accreditation and 3) peer review. 


The accreditation process is about evaluating an institution's human research protection program including education efforts, and ensuring that institutions are in compliance with laws, regulations, codes and guidance. 

 

Tips for institutions to achieve accreditation include identifying a core accreditation team; developing key stakeholders to engage in the process, such as ancillary offices, safety committees, legal and researchers; developing an accreditation plan and timeline, setting measurable goals and deadlines, engaging an organization’s leadership throughout the process, and building educational moments. Education of all parties involved in the accreditation process is critical to success.

New IRB Application and Consents 

 

Recently, the Institutional Review Board (IRB) team revised consent templates and the IRB application to ensure IRB reviewers have the necessary information to make an informed decision about the risks and benefits of research conducted at FAU. The new application format incorporates a protocol look and feel, and eliminates the need for a separate document for minimal risk projects. Merging these documents will save the researcher and reviewer time by addressing the required regulatory components for approving a research project. Researchers are prompted to complete the document by asking who, what, when, where and how for each of the eight elements of criteria for approval.


To ease the transition for researchers, the IRB team has been hosting weekly training sessions outlining the changes to the document, where to find it, and how to complete it. In addition, RI is approaching this with a collaborative lens by asking researchers to provide real-time feedback to improve the usability of the document. This new approach has received overwhelming positive feedback since beginning the trainings in early July. Attendees have included department chairs, faculty, graduate students and research staff, with all sessions well attended and having lively discussion. Attendees have commented on the more streamlined approach to obtaining information on research submissions and removing the guesswork of what an IRB needs to know.


The new application will be required as of Oct. 1, after which, previous versions of applications and protocols will no longer be accepted.


For more information or questions about this process, contact the Office of Research Integrity.

Updated FAU-wide COI-Outside Activity Policy 

The Office of Compliance and Ethics recently announced that FAU has updated its Conflicts of Interest, Conflicts of Commitment, and Outside Activity Policy:

https://www.fau.edu/compliance/conflict-of-interest/announcements/index.php.


The updated policy may be found on the University’s Policies Website and at this direct link:

Policy 8.3 Conflicts of Interest, Conflicts of Commitment and Outside Activity. Please visit the FAQ page for additional information on the updated requirements and process. Outside activity reports under the updated policy are due for each fiscal year on or before September 30.

 

The outside activity disclosure process, criteria and office are different and independent from the Office of Research Integrity’s Financial Conflict of Interest in research, which oversees potential financial conflicts of interest as they may effect the design, conduct or reporting of research.

CITI Affiliation 

When registering a new Collaborative Institutional Training Initiative (CITI) account, it is critical to select Florida Atlantic University. FAU’s Office of Research Integrity holds a membership with CITI for all FAU researchers and those collaborating with FAU researchers or otherwise working on FAU research. Registering as an Independent Learner will result in a $300 personal charge as it will not recognize that you are working under the auspices of FAU. 

Who We Are and What We Do 

Research Integrity facilitates several boards and committees, which are composed of university faculty representing FAU’s colleges, staff representing the FAU community, and non-affiliated members of the community to represent the community at large to review the research submitted at FAU. These boards and committees are as follow: 

Institutional Review Boards (IRBs) – oversee use of human subjects in research. FAU has two IRBs: the Social, Behavioral and Educational Research (SBER) IRB and the Health Sciences (HS) IRB. For questions regarding IRB submissions contact Cortni Romaine at cromaine@fau.edu, Donna Simonovitch at dsimonovitch@fau.edu, or Judith Martinez at martinezj2012@fau.edu


Institutional Biosafety Committee (IBC) – oversees use of Biological Materials in Research. All projects involving recombinant DNA, microorganisms, biological toxins or venoms, human or animal biological materials, or contact with wild animals must be registered with and approved by the IBC, and all personnel involved in these projects must complete appropriate training. For questions regarding using biological materials in research, contact Kristen Ware at kcware@fau.edu or Andrew Donovan at adonovan@fau.edu.

Institutional Animal Care and Use Committee (IACUC) – oversees use of Animals in Research and Teaching. For questions regarding use of animals in research and teaching, contact Kristen Ware at kcware@fau.edu or Dana Mulvaney at dmulvane@fau.edu.


Financial Conflict of Interest Committee (FCOIC) – oversees management of financial conflicts of interest in research. The FCOI committee is charged with ensuring that a significant financial interest does not compromise the integrity of research activity, including its reporting, protection of the welfare of research participants or the development of intellectual property. For questions regarding potential conflicts of interest in research or disclosures contact Elisa Gaucher at egaucher@fau.edu, Kristen Ware at kcware@fau.edu or Andrew Donovan at adonovan@fau.edu. 

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.
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