Western IRB (WIRB) Application Submission Steps
The Western Institutional Review Board (WIRB) is the oldest and most experienced independent IRB in America. The Board has provided review services for the research of more than 10,000 investigators in over 30 countries, and in all 50 United States. WIRB has reviewed the research of independent investigators since 1968, and has provided institutional and international services since 1986.
FIU relies upon the WIRB approval process for all clinical trials that are conducted by FIU faculty, which meet one of more of the following conditions:
- Studies involving Drugs, Biologics, (FDA-regulated), single-site and multi-site clinical trials
- Studies involving Devices (FDA-regulated), single-site and multi-site clinical trials
- Other Industry-Initiated Research Protocols, single-site and multi-site clinical trials
All studies that do not meet the above criteria will normally be reviewed by the FIU IRB unless determined otherwise by the FIU Office of Research Integrity. Separate instructions for submitting a protocol through the FIU IRB are available on the Obtaining FIU IRB Approval web page.
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Step 1: Determine your Eligibility for WIRB ReviewInvestigators are required to obtain clearance through the FIU Office of Research prior to submitting a project to WIRB for review.
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Step 2: Complete the CITI Online IRB Training CourseAll research personnel that will be engaged in conducting research with human subjects (including analysis of data) are required to complete the CITI Online IRB Training Course (“Biomedical Human Research Investigators Course” or the “Social & Behavioral Human Research Investigators Course”). Note: Additional CITI training courses are required for studies that involve certain types of activities. Research personnel that will be working with Protected Health Information (PHI) are also required to complete the CITI “Health Information Privacy and Security (HIPS) Course”. Research personnel that will be working with FDA regulated Drugs, Devices, or Biologics are also required to complete the CITI “Good Clinical Practice (GCP) Course”. |
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Step 3: Review the WIRB Billing ProceduresWIRB fees can be directly billed by most sponsors. The Office of Research and Economic Development will pay the WIRB fees if the project is federally funded. Otherwise, the WIRB fees will be charged to grant if the project is non-federally funded. If there is no external funding, then your department will be required to pay for it. Any questions regarding payments should be directed to Mirtha Alberto, Director of Budget (305) 348-0166. |
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Step 4: Prepare the WIRB Informed Consent DocumentAll protocols being submitted to WIRB are required to use a special WIRB Informed Consent Template, which contains FIU’s and WIRB’s required language. Information on Obtaining Informed Consent |
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Step 5: Review the FDA IDE and IND RequirementsFIU Requirements: Investigators are required to first discuss their proposed FDA-related plans with the Office of Research and Economic Development prior to communicating directly with the FDA. In addition, all IDE and IND submissions must first be sent to the Office of Research and Economic Development for a pre-review prior to formally submitting the application packet(s) to the FDA. Investigators are required to send the IDE/IND documentation in an email to the following three recipients:
FIU Permission: You should expect to receive a reply to your email within approximately 5 business days. That email response will let you know if you are permitted to proceed with sending the IDE/IND submission to the FDA. WIRB Requirements: Investigators should plan to obtain their IDE/IND approval letter(s) from the FDA prior to submitting their projects to WIRB for review. WIRB is unable to assign a study to the Full Board for review until they are in receipt of the appropriate FDA approval letter(s). FDA Instructions: The instructions on the IDE submission process can be accessed at the IDE Approval Process and IDE Application web pages. The instructions on the IND submission process can be accessed at the IND Forms and Instructions web page. |
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Step 6: Review the WIRB Submission InstructionsWIRB allows investigators to submit their application packets via standard forms or via “smart forms”. If using the smart form, there is a question on page 1 that asks if the research will be conducted through an organization which has a contract to use WIRB for IRB services. You will need to enter Florida International University (WIRB institution #69515). Further instructions on submitting your packet are available from the WIRB website and in the WIRB Investigator Handbook. Access the WIRB Submission Forms |
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Step 7: Submit your Application to WIRB
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Step 8: WIRB Application Review Process
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Step 9: Responsibilities After obtaining WIRB ApprovalConsent Documents: For WIRB approved projects, you must use the WIRB-stamped Consent Document for enrolling subjects. You will not receive a Consent Form with an FIU IRB stamp on it because the FIU IRB is not the IRB of record for the protocol. Post-approval submissions to WIRB: The following items will need to be submitted directly to WIRB with copies also being sent to the FIU Office of Research Integrity (FIU WIRB Liaison):
Making changes in project personnel: Whenever you add a research team member, FIU requires that the added team member have training in human subject protections. Research team members include the principal investigator and all other individuals (faculty, staff, or student) who have contact or interactions with research subjects or with their private, identifiable information must be certified. Investigators are required to notify the FIU WIRB Liaison of changes in the research team. Monitoring of WIRB approved protocols: WIRB will arrange for monitoring ongoing research, as its policies and procedures require. However, the FIU ORI staff may monitor any WIRB approved protocol as part of its quality assurance program. Record-keeping: You should establish record-keeping procedures for your files, and store WIRB documents, e-mails, notifications, and other correspondence just as you would for a normal FIU IRB approval. |
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Step 10: WIRB Listing of ContactsIf you still have questions about the WIRB review process, feel free to utilize one of the resources provided below. Contact WIRB at: Contact a WIRB Representative at: Contact FIU’s WIRB Liaison at: |