Step 1: Determine your Eligibility for WCG IRB Review

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

1. Download and prepare the WCG IRB Pre-Submission Eligibility Form.
2. Submit an electronic copy of the completed WCG IRB Pre-Submission Eligibility Form to the FIU WCG IRB Liaison 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 WCG IRB.
4. You will receive an email notice from the ORI regarding the outcome of the review. Please do not submit your protocol to WCG IRB 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 WCG IRB. You will need to follow all of WCG IRB’s guidelines and instructions as noted on the WCG IRB 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 WCG IRB Billing Procedures

WCG IRB fees can be directly billed by most sponsors. The Office of Research and Economic Development will pay the WCG IRB fees if the project is federally funded. Otherwise, the WCG IRB 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 WCG IRB IRB Fee Schedule

Step 4: Prepare the WCG IRB Informed Consent Document

All protocols being submitted to WCG IRB are required to use a special WCG IRB Informed Consent Template, which contains FIU’s and WCG IRB’s required language.

Information on Obtaining Informed Consent
Access the WCG IRB Informed Consent Form Template
Access the WCG IRB HIPAA Authorization Form Template
Access the WCG IRB Informed Consent and HIPAA Authorization Form (Combined)

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 two recipients:

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

FIU Permission: You will need to wait until you have received an email response stating that you are permitted to proceed with sending the IDE/IND submission to the FDA.

WCG IRB Requirements: Investigators should plan to obtain their IDE/IND approval letter(s) from the FDA prior to submitting their projects to WCG IRB for review. WCG IRB 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 and IND Application Procedures web page.

Step 6: Review the WCG IRB Submission Instructions

WCG IRB uses an online submission portal called WCG IRB Connexus.

When filling out the online submission, you will be prompted to provide to provide billing information. Please provide the following information:

• Select “Email” as the method for sending invoices to the billing contact.
• List Mirtha Alberto as the billing contact person (Phone: 305-348-0166; Fax: 305-348-4117; Address: 11200 SW 8th Street, MARC 430, Miami, FL 33199)

Access the WCG IRB Connexus Submission Instructions
Access the WCG IRB Guide for Researchers
Access the WCG IRB Frequently Asked Questions

Step 7: Submit your Application to WCG IRB

1. Submit the application to WCG IRB according to the instruction outlined on the WCG IRB website.
2. Send an email to the FIU WCG IRB Liaison as soon as this project has been submitted to WCG IRB. The email will need to include the following items:
   1. A copy of the WCG IRB Initial Review Submission Form that was completed and sent to WCG IRB (a PDF version of the submission can be generated in the WCG IRB Connexus system after it has been submitted).
   2. Any additional attachments (or altered attachments) that you provided to WCG IRB as part of your submission (if they differ from what you provided to FIU as part of your FIU WCG IRB Pre-Submission Eligibility Form submission)

Step 8: WCG IRB Application Review Process

• Upon receipt of the submission, WCG IRB will issue a tracking number via email directly to the investigator by which the investigator can track the application.
• WCG IRB will contact the investigator directly about any issues that may arise during the review process.
• WCG IRB 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 WCG IRB review process should be directed to WCG IRB.

Step 9: Responsibilities After obtaining WCG IRB Approval

Consent Documents: For WCG IRB approved projects, you must use the WCG IRB-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 WCG IRB: The following items will need to be submitted directly to WCG IRB with copies also being sent to the FIU Office of Research Integrity (FIU WCG IRB 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 WCG IRB Liaison of changes in the research team.

Monitoring of WCG IRB approved protocols: WCG IRB will arrange for monitoring ongoing research, as its policies and procedures require. However, the FIU ORI staff may monitor any WCG IRB approved protocol as part of its quality assurance program.

Record-keeping: You should establish record-keeping procedures for your files, and store WCG IRB documents, e-mails, notifications, and other correspondence just as you would for a normal FIU IRB approval.

Step 10: WCG IRB Listing of Contacts

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

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

Contact a WCG IRB Representative at:
Jacob Johnson
WCG Institutions Partnership Manager
E-mail: jhjohnson@wcgclinical.com 
Telephone: 360-570-1310

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