Catch the latest news, tips and advice that supports you and Florida Atlantic University in building a culture of research compliance.
New Year Brings Big Changes
The new year brings big changes to National Institutes of Health policies on human subjects research, including s
ingle IRB policy requirements, clinical trial being newly defined, and certificates of confidentiality. Click here for an overview video.
The National Institutes of Health (NIH) has issued a policy on the use of a single Institutional Review Board (IRB) for multi-site research with the expectation that a single IRB (sIRB) of record will be used for the ethical review of NIH funded, multi-site, non-exempt human subjects research protocols. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible.
What this means:
In the NIH application/proposal for research funding, the applicant (PI) is expected to submit a plan describing the use of a single IRB to serve as IRB of record for all study sites
The PI will need to select the sIRB. This can be pre-determined by the study sponsor or grant, established by prior arrangement (e.g. network central IRB) by the IRB from the lead PI's institution, or selected based on expertise in the study area (e.g. type of procedures to be performed or subject population). It is important that the PI discuss this with Sponsored Programs and Research Integrity at the proposal development stage of the proposal application.
The PI needs to budget the costs associated with the sIRB as applicable.
For more information on applying the sIRB policy to your next NIH proposal, click here.
FAU Joins SMART IRB Platform
SMART IRB is a Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform designed to harmonize and streamline the IRB review process for multisite studies, while also ensuring a high level of protection for research participants. SMART IRB is funded by the National Center for Advancing Translational Sciences and is intended to serve as a roadmap for institutions to implement the National Institutes of Health requirement for sIRB policy compliance.
To learn more, click here.
Does Your Human Subjects Study Meet the
New NIH Definition of a Clinical Trial?
In an effort for the NIH to improve clinical trial data collection and establish a process for using this data effectively, clinical trial policy changes have been implemented to ensure rigor, transparency and effectiveness of the US federally-funded clinical trial enterprise. To learn more, click here.
Grant to Compliance Congruency Process
The Division of Research has formalized the process regarding Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) congruency and a 1:1 ratio of grant proposal to approved protocol application on federally funded projects. Please refer
here for more information.
HRPP Staff attended PRIM&R Conference
L to R: Elisa Gaucher, assistant vice president for research; Donna Simonovitch, IRB coordinator;
Kathryn Keller, professor in the College of Nursing; Ximena Levy, assistant director of Research Integrity
FAU was represented at the National Advancing Ethical Research Public Responsibility in Medicine and Research (PRIM&R) Conference in San Antonio, TX this past November. Attendees learned about changes in federal regulations governing human subjects research as well as best practices to help strengthen the human research protections program at FAU.
L to R: Elisa Gaucher; Elisa Hurley, executive director of PRIM&R; Ximena Levy
Path to AAALAC Accreditation of Animal Research Protections Program
The long awaited program description for the Animal Research Protections Program was submitted to the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) by the Dec. 1 deadline. The next step toward accreditation will be a site visit by AAALAC Council Members in February. Stay tuned for updates.
Compliance Training Opportunities
Research Integrity will continue to offer many training opportunities throughout the spring semester for:
Please refer to the training calendars available on our
website to sign up for these valuable workshops.
"The Lab" Avoiding Research Misconduct
To view the latest interactive training video released from the federal Office of Research Integrity on how to avoid research misconduct, click
Research Compliance Member Appreciation Reception
Recognizing the outstanding commitment of our committee members, Vice President for Research Dr. Daniel Flynn hosted a reception to recognize all the faculty, staff and community members who participate in the research compliance committees and training programs facilitated by the Division of Research. Research Integrity extends a special thank you to our 54 faculty, staff and community members who volunteer across five compliance committees and four-part instructional training program:
Social Behavioral & Educational IRB
Financial Conflict of Interest
Health Sciences IRB
Diving Boating & Safety
Institutional Animal Care and Use Committee
Responsible Conduct of Research
Thank you to those who were able to attend the reception.
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!