Submissions to Western Institutional Review Board
As of September 1, 2009, FAU investigators conducting industry-sponsored and investigator initiated clinical research protocols will undergo IRB review by Western IRB (WIRB ). FAU has an agreement with WIRB to help relieve some of the workload of the FAU IRB related to clinical trials. WIRB is an independent central IRB located in Olympia, Washington. FAU has implemented a process to manage submissions to WIRB . The following questions and answers are provided to assist investigators with these submissions:
What FAU studies are eligible for WIRB submission?
A study may be submitted to WIRB if it meets the following criteria:
Please note that this applies only to those studies where the sponsor provides funding for IRB fees and/or outside IRB review. Some federal granting agencies do not allow grantees to bill for IRB fees; therefore these studies may not be eligible for submission to WIRB . If you are uncertain about whether your study should go to WIRB , please contact Research Integrity, located within the Division of Research, at 561.297.0777.
- It is a multi-centered, industry-sponsored and FDA regulated drug or device clinical trial/study. This applies whether the study receives an FDA exemption or not.
If WIRB will be the IRB for my study, why must I go through
WIRB provides ethical review, which is only one part of clinical trial oversight. Certain regulatory responsibilities still remain the responsibility of FAU. These responsibilities include:
- Centralized coordination of clinical studies/trials.
- Ensuring adequate personnel training in Protection of Human Subjects and Good Clinical Practice.
- Maintaining a compliance oversight role locally.
- Ensuring that site specific requirements are in place.
How much money should be budgeted for WIRB studies?
Make sure you include WIRB s 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 see WIRB Fee Schedule Contact Sponsored Programs for additional assistance regarding budgeting fees.
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. However, to ensure the process runs efficiently, please follow the steps below as closely as possible:
Download WIRB Submission Checklist
Scientific Review Form. If you have previously submitted a study to WIRB , and certain items are already on file, note ON FILE on the checklist.
Submit the Florida Atlantic University required items indicated on the checklist.
Download the WIRB initial review submission form (Click here to get WIRB forms) and prepare the WIRB submission materials indicated on the checklist.
Use WIRB - FAU Clinical Trials Consent form template when preparing your consent document unless the industry sponsor already has one developed for multi-site studies. Follow the template provided, tailoring the procedures and language to that of your study. Remember, keep the language simple. Please note: the Compensation for Injury language cannot be altered without prior approval from Research Integrity.
E-mail or mail one copy of the WIRB submission materials along with the WIRB submission checklist to Research Integrity (if using e-mail, send to: firstname.lastname@example.org or email@example.com)
Obtain a signed copy of the WIRB submission checklist from Research Integrity. Research Integrity will review the WIRB submission checklist for completeness, sign it, place a copy in your sponsored programs file, and send you back a signed copy.
Submit the WIRB submission materials and signed WIRB submission checklist to WIRB via your mechanism of choice (mail, email, or online submission) Note: WIRB will
review your submission without the WIRB submission checklist signed by an authorized signatory from Research Integrity.
Notify your Proposal and Contract Administrator in Sponsored Programs once you receive a WIRB approval letter; your account cannot be set up without this approval letter.
How can I obtain assistance with the WIRB submission?
You can visit the WIRB web site at www.wirb.com in order to learn more about WIRB and download their submission forms. You may also contact WIRB at: 800.562.4789 or via e-mail at firstname.lastname@example.org. If you have any questions, please contact the Research Integrity staff.