compass pointing to compliance

Human Subjects (IRB)

The Institutional Review Board (IRB)

The IRB is a committee charged with carrying out the important task of reviewing minimal risk to high risk research protocols submitted by our investigators. The IRB reviews research protocols to determine and certify that the protocols conform to the regulations and policies set forth by the federal agencies – including the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) – regarding the health, welfare, safety, rights and privileges of human subjects. Research Integrity assists the IRB and our researchers by providing day-to-day administrative management of approximately 400 new and continuing IRB protocols.
Novelution logo

The new submission platform for IRB projects is
launching on
August 28, 2023


Last day to submit via IRBNet: August 18th
Transition Week: August 21-25th

researchintegrity@fau.edu

The highly anticipated day is almost here! We are pleased to announce the new IRB Novelution Submission system will go live on August 28, 2023. See below for important dates leading up to the launch.

August 14, 2023 New IRB Novelution Training Page goes live
August 15, 2023 Training Workshops begin & training videos and resources go live on our website
August 18, 2023 IRBNet Closes
August 21-25 Transition Week
August 28, 2023 IRB Novelution Launch

Training materials including video tutorials and how-to-guides will become available on Monday, August 14th for researchers to become familiar with the submission platform.

Virtual training workshops will begin on Tuesday, August 15th at 10am via Zoom. At these workshops the HRPP team will provide an overview of the Novelution system including how to navigate the system, where to find templates and forms, how to submit, and answer any questions researchers have.

The last day to submit via IRBNet will be on Friday, August 18th . Any new projects or amendments must be submitted through IRBNet by this date before the transition period into Novelution begins. Note if the project is greater than minimal risk, a multi-year study, or you anticipate needing to submit amendments with updates soon after review, it is strongly recommended you wait to submit via Novelution for a seamless lifecycle of your project.

During the transition week the HRPP office and IRB will be working diligently to process all submissions that are pending in IRBNet as we transition into Novelution.

On August 28th all IRB projects must be submitted using the Novelution platform! More information will be provided in separate communications to those who have existing approved studies in IRBNet and how we will facilitate moving those projects over into Novelution.

IRB is:

  • Providing pre-submission consultation to faculty and students for IRB proposals.
  • Assisting with research protocol and informed consent preparation.
  • Providing assistance in navigating IRBNet, our electronic protocol submission system.
  • Coordinating monthly committee meetings and daily expedited reviews of IRB proposals.
  • Developing policies, procedures, and guidance documents.
  • Communicating with IRB members, FAU faculty and students, to resolve IRB review concerns.
  • Issuing IRB approvals for new and continuing studies as well as amendments and related other actions.
  • Providing training on protection of human research subjects in research.
  • Maintaining the university s federal assurances and providing regular updates/reports.
  • Serving as liaison between external IRBs and the Division of Research.
  • Interfacing with Division of Research offices to ensure coordination, consistency & compliance at all levels.
  • Resolving non-compliance issues related to the protection of human subjects.

In addition to managing the IRB and IACUC functions, Research Integrity provides input and coordination on related issues involving Conflict of Interest, Good Clinical Practices, and clinical research monitoring.

Please direct questions and comments to researchintegrity@fau.edu