Instructions for WIRB Submission

USA Logo

UNIVERSITY OF SOUTH ALABAMA PROCEDURES FOR WORKING WITH WIRB

July 2017

WIRB Copernicus Group
WIRB Logo The University of South Alabama has an agreement authorizing Western Institutional Review Board (WIRB), an independent commercial IRB, to review and approve selective industry sponsored multi-center clinical trials.
WIRB Contacts

For General Questions:  Client Services
Telephone: 1-800-562-4789
Email: clientservices@wirb.com
Web: www.wirb.com

Institutional Issues: Elaine J. Azarenko
Telephone: 1-360-252-2446
Email:  eazarenko@wirb.com
Web: www.wirb.com

Eligibility Criteria:

WIRB Submission

Studies NOT eligible for WIRB submission:

  1. Phase I clinical trials
  2. Planned emergency research
  3. Single patient emergency use or compassionate use situations
  4. Embryonic stem cell or gene therapy research
  5. Protocols funded by a Cooperative Oncology Group and federally funded protocols
  6. Investigator initiated research
  7. Protocols where the Principal Investigator holds the IND/IDE
  8. Research involving prisoners

Studies Eligible for WIRB Submission:

  1. The trial is a phase II, III or IV, multi-centered, industry-sponsored and for a FDA regulated drug or device study.
  2. The protocol must be written and designed by the sponsor
  3. The study must meet the National Institutes (NIH) definition of a clinical trial (A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions [drugs, treatments, devices, or new ways of using known drugs, treatments, or devices]).
  4. The sponsor of the research must be a for-profit entity/company.

The principal investigator must meet USA requirements to serve as PI on a research study.

Instructions for Submission to WIRB

Investigator begins LOCAL processes for submission to USA IRB

WIRB Copernicus has partnered with IRBNet and the online submission portal will remain unchanged.

NOTE:   WIRB should be selected from the drop down menu and the WIRB link to the forms menu should be accessed for the appropriate submission forms. 

Create a New Project in IRBNet

 Package 1:

  • USA IRB Part A Application
  • WIRB Pre-Submission and Authorization Form 
  • PI must electronically sign package 1 for USA IRB local review
  • All key personnel listed on Part A IRB application must have completed the required applicable human subjects training, ACRP (as applicable), and HIPPA for Research.
  • Submit Package 1 preliminary documents for USA IRB pre-preview and acknowledgment
  • Acknowledgment will be published in Package 1

 NOTE:  Fees: 

  • IRB fees should be included in the study budget.  There is a one-time USA administrative review fee of $2000 for initial submissions. The contract agreement will include this fee to be paid to USA by the sponsor.
  • The WIRB IRB fee schedule is available in the IRBNet Library

WIRB will bill the sponsor directly, if allowed.  Include this information on the WIRB Billing Section of the Initial Review Form.

Submission to WIRB

Create New Package in IRBNet

Package 2: 

Standard Submission Requirements Include:

  • Current WIRB initial review submission form (Note:  WIRB Institution #87329)
  • consent form
  • PI’s current professional license (unless already on file)
  • PI’s CV (unless already on file)
  • site specific documents such as subject material and advertisements
  • Attach acknowledgment from package 1 into package 2 - WIRB will NOT initiate protocol review until receipt of USA’s IRB acknowledgment. This acknowledgment will be published as a board document upon completion of USA IRB pre-review.
  • Submit to WIRB

 Instructions on submitting your project are available from the WIRB website. (Access the WIRB Submission Forms)

WIRB Review

Submit to WIRB: 

  • Package 2 will update from “work in progress” to “pending review”
  • WIRB will issue a tracking number via email upon receipt of submission
  • WIRB will contact the investigator/contact person directly with questions about the submission, and with determination of approval, modifications, or disapproval
  • Once approved, all approval documents will be uploaded as published board documents in IRBNet. 
  • Any questions that the PI/contact person may have regarding the WIRB review process should be directed to WIRB

Consent Documents: For WIRB approved projects, the WIRB stamped consent document for enrolling subjects must be utilized.  The USA IRB is not the IRB of record for the protocol, and will not be USA stamped.

NOTE:  Commencement of project should not begin until all approvals and the clinical trial agreement are in place

Submission to WIRB After Initial Approval

What documents should be submitted to WIRB after initial approval?

Continuing Review, Amendments, Adverse Events, Protocol Deviations, Closure Notifications, and any other submissions required by WIRB’s reporting requirements.

NOTE: Some sponsors will submit materials on behalf of the USA site (i.e. amendments); otherwise the USA research team is responsible.  USA IRB will be notified by WIRB about USA investigator’s submission activity, thus there is no requirement to provide copies of these submissions to USA IRB.  Approval for these items will be returned through IRBNet.

Submission/Notification to USA IRB After WIRB Initial Approval

To ensure adequate institutional oversight of research activities, investigators should directly notify the USA IRB of event on WIRB protocol’s

After WIRB Initial Approval, notify USA IRB for:

  • Subject complaints
  • Change in PI/key personnel
  • Conflict of Interest updates
  • Breaches of confidentiality
  • HIPAA Privacy and/or Security violations
  • Study suspensions/terminations from WIRB or Sponsor

Project Personnel Updates:   USA IRB application Part A should be updated, as needed, (i.e., study personnel, PI change and submitted to USA IRB)

Monitoring of WIRB approval protocols: WIRB will arrange for monitoring ongoing research, as its policies and procedures require.  The USA IRB/ Office of Research Compliance and Assurance may monitor any WIRB approved protocol as part of its quality assurance program.

Record keeping: Record keeping procedures for all files must be established, and WIRB documents, e-mail notifications, and other correspondence must be stored / filed as previously maintained through normal USA IRB approval.