Guidance on Submissions to External Institutional Review Board
FAU's Division of Research uses the services of external IRBs as an additional resource for overseeing specific types of human subjects' research.
FAU faculty, staff or students can conduct clinical trials including:
- Industry-sponsored clinical trials involving drugs, biologics, devices (FDA-regulated)
- Investigator-initiated clinical trials involving drugs, biologics, devices (FDA-regulated)
- Certain multi-site studies.
FAU currently has agreements with Western IRB (WIRB) and Advarra.
How does the process work?
The Division of Research recognizes that the process of starting a clinical research study has many components that often need to occur simultaneously. To ensure the process runs efficiently, please follow the steps below as closely as possible:
- Log in IRBNet at www.irbnet.org or register in "New User Registration".
- Download Central IRB submission checklist here and the Scientific Review Form from the IRBNet library.
- Use the industry sponsored consent form developed for multi-site studies when preparing your consent document. Alternatively use the FAU Clinical Trials Consent form template from IRBNet library if a consent form was not provided.
- Download the WIRB or Advarra initial review submission forms
- Refer to relevant FAU policies forstudies involving children, cognitive impaired participants, international research, devices, etc.
- Compile the Florida Atlantic University required items indicated on the checklist, located in the IRBNet library.
- Upload to IRBNet the submission materials, along with the submission checklist. For this step follow the instructions on How to submit to IRB located here.
- Obtain a signed copy of the submission checklist from Research Integrity. The signed form will be uploaded in IRBNet. Research Integrity will review the submission package for completeness & adherence to administrative requirements.
- Access the signed checklist. You will receive an e-mail from the IRBNet system to access the protocol and retrieve the signed checklist.
- Submit the materials to:
Notify your Proposal and Contract Administrator in Sponsored Programs once you receive a WIRB or Advarra approval letter; your FAU Sponsored Programs account cannot be set up without this approval letter.
How much money should be budgeted for external IRBs reviews?
Please note that central IRBs are fee-based and submissions must be approved by the Division of Research first. Some federal granting agencies do not allow grantees to bill for IRB fees. These studies may not be eligible for submission or you may need to identify an administrative source of funding for IRB fees. When planning your budget, make sure you include IRB fees as direct charges in your budget, and plan enough funds to cover amendments, continuing reviews, and other actions during the life of the study. Please contact Sponsored Programs for additional assistance regarding budgeting for IRB fees.