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:

  1. Studies involving Drugs, Biologics, (FDA-regulated), single-site and multi-site clinical trials
  2. Studies involving Devices (FDA-regulated), single-site and multi-site clinical trials
  3. 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.

Step 1: Determine your Eligibility for WIRB Review

Investigators are required to obtain clearance through the FIU Office of Research prior to submitting a project to WIRB for review.

  1. Download and prepare the WIRB Pre-Submission Eligibility Form.
  2. Submit an electronic copy of the completed WIRB Pre-Submission Eligibility Form to the FIU WIRB Liason along with the required attachments (as noted in the form).
  3. The Office of Research Integrity (ORI) will then review the submission to determine if it is eligible for submission to WIRB.
  4. You will receive an email notice from the ORI regarding the outcome of the review. Please do not submit your protocol to WIRB until you have received the clearance notice from the ORI.
  5. Once you have received clearance from ORI, you will be able to proceed with submitting your project to WIRB. You will need to follow all of WIRB’s guidelines and instructions as noted on the WIRB website.

Step 2: Complete the CITI Online IRB Training Course

All 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”.

Instructions to Sign Up for CITI Online IRB Training

Step 3: Review the WIRB Billing Procedures

WIRB 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.

Current WIRB IRB Fee Schedule

Step 4: Prepare the WIRB Informed Consent Document

All 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
Access the WIRB Informed Consent Form Template
Access the WIRB HIPAA Authorization Form Template

Step 5: Review the FDA IDE and IND Requirements

FIU 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:

  1. Chris Grayson, Director of Research Integrity
  2. Robert Gutierrez, Assistant Vice President for Research and Pre-Award

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.

Step 6: Review the WIRB Submission Instructions

WIRB 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
Access the WIRB Investigator Handbook

Step 7: Submit your Application to WIRB

  1. Submit the application packet to WIRB according to the instruction outlined on the WIRB website.
  2. Send an email to the FIU WIRB Liaison as soon as this project has been submitted to WIRB. The email will need to include the following items:
    1. A copy of the WIRB Initial Review Submission Form that was completed and sent to WIRB. Note: If you elected to use the WIRBNet Web Portal (in lieu of the PDF/Word version of their Initial Review Submission Form), you will still have the ability to generate a PDF version of your submission form through your web portal after it has been submitted to WIRB.
    2. Any additional attachments (or altered attachments) that you provided to WIRB as part of your submission (if they differ from what you provided to FIU as part of your FIU WIRB Pre-Submission Eligibility Form submission)

Step 8: WIRB Application Review Process

  • Upon receipt of the submission, WIRB will issue a tracking number via email directly to the investigator by which the investigator can track the application.
  • WIRB will contact the investigator directly about any issues that may arise during the review process.
  • WIRB will notify the PI of its approval decision and will provide the PI with copies of all regulatory documents and approved consent forms.
  • Any questions that the PI may have regarding the WIRB review process should be directed to WIRB.

Step 9: Responsibilities After obtaining WIRB Approval

Consent 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):

  • “Promptly Reportable Information” Form (submit within 5 days)
    • New or increased risk to subjects
    • Protocol deviation that harmed a subject or placed subject at risk of harm
    • Protocol deviation made without prior IRB approval to eliminate an immediate hazard to a subject
    • Audit, inspection, or inquiry by a federal agency
    • Written reports of federal agencies (e.g., FDA Form 483)
    • Allegation of Noncompliance or Finding of Noncompliance
    • Breach of confidentiality
    • Unresolved subject complaint
    • Suspension or premature termination by the sponsor, investigator, or institution
    • Incarceration of a subject in a research study not approved to involve prisoners
    • Adverse events or IND safety reports that require a change to the protocol or consent
    • State medical board actions
    • Unanticipated adverse device effect
    • Information where the sponsor requires prompt reporting to the IRB
  • Amendments to the approved protocol
  • Continuing review of the approved protocol
  • Project closure of the approved protocol

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.

Step 10: WIRB Listing of Contacts

If you still have questions about the WIRB review process, feel free to utilize one of the resources provided below.

Contact WIRB at:
Telephone: 800-562-4789
Fax: 360-252-2498
E-mail: clientservices@wirb.com
Web: www.wirb.com
Mail: P.O. Box 12029, Olympia, Washington, USA 98508-2029

Contact a WIRB Representative at:
Elaine Azarenko
Associate Director, Institutions
E-mail: eazarenko@wirb.com
Telephone: 360-252-2446

Contact FIU’s WIRB Liaison at:
Christopher Grayson
Director, Research Integrity
Telephone: 305-348-8379
E-mail: graysonc@fiu.edu