As of July 12, 2017 the University of South Alabama (USA) has entered into an agreement with the WIRB Copernicus Group (WCG) to become the IRB of record for eligible studies. WIRB is AAHRPP accredited and used by many institutions across the country. WIRB conducts rigorous reviews of the materials provided to them and ensures that the informed consent and HIPAA Authorization documents meet the stipulations set forth in the agreement. The conditions and procedures concerning the IRB review are contained in a memorandum of understanding between USA and WIRB. Materials submitted for WIRB review will be pre-screened by the IRB staff to ensure USA IRB requirements are fulfilled.
Be sure to review the complete USA policy and procedure for the use of the WIRB.
The criteria for studies to be eligible for review by the WIRB include:
- Research meets the 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)”.
- Research is a Phase II/III/IV clinical trial.
- Protocol must be written and designed by sponsor.
- The sponsor is a for-profit entity or company.
- The sponsor holds all INDs/IDEs.
- The research has not previously been submitted to the USA IRB for review.
Studies which involve any of the following are not eligible for submission to WIRB:
- Phase I Studies (including I/II, studies)
- Planned emergency research
- Single patient emergency use or compassionate use situations
- Embryonic stem cell or gene therapy research
- Federally funded protocols
- Protocols funded by a Cooperative Oncology Group/NCI sponsored trials
- Investigator-initiated research
- Industry sponsor that refuses to pay WIRB fees and/or the USA IRB fees
- Research involving prisoners
USA may also require dual review by the USA IRB when the institution deems that the rights and welfare of subjects would be better served by local review.
How to Submit WIRB
|Step 1: Investigator begins LOCAL processes for submission to USA IRB||
WIRB Copernicus has partnered with IRBNet and the online submission portal will remain unchanged.
Create a New Project in IRBNet
WIRB will bill the sponsor directly, if allowed. Include this information on the WIRB Billing Section of the Initial Review Form.
|Step 2: Submission to WIRB||
Create a New Package in IRBNet under the same project
Standard Submission Requirements Include:
Instructions on submitting your project are available from the WIRB website. (Access the WIRB Submission Forms)
|Step 3: Review by WIRB||What happens after you submit Package 2 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
The WIRB is now the IRB of records for your study. You should refer to WIRB’s policy and procedures for their reporting requirements of continuing review, amendments, adverse events, protocol deviations, closure notifications, and any other submissions.
However, the USA IRB must still ensure adequate institutional oversight of research activities. Therefore, in addition to notifying WIRB, investigators should notify the USA IRB of any of the following events:
- Protocol deviations that may represent a systematic problem requiring local evaluation by USA IRB to determine that sufficient local resources are available for safe conduct of the study
- Study holds or suspensions that are not built into the study design from CIRB or Sponsor (eg: interim analysis or enrollment complete need not be reported)
- Study Closure
- Study Terminations from CIRB or sponsor
- Subject complaints
- Amendment to change PI or key personnel (NOTE: IRB Application Part A must be updated to reflect personnel changes)
- Conflict of Interest updates
- Breaches of confidentiality/HIPAA Privacy and/or Security violations
- Completion of annual check-in form (more information below)
Annual Check-In: This is not the same as a continuing review. Therefore, it may occur at a different time than the continuing review required by WIRB.
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.
The USA IRB local context consent language for WIRB provides an outline of sections which may need to be included in your consent form. All sections may not be applicable, rather they are dependent on the study to be conducted.
Review the USA IRB Local Context Language for WIRB to determine what specific USA language is required to be in the consent form. Generally, the HIPAA, Research Related Injury, Bill of Rights, ClinicalTrials.gov reporting, Reportable Income, and Source of Funding is required for the majority of studies.
Questions during Step 1 of submitting a new study- Submission to USA IRB for Pre-Review and for any USA IRB related issues:
USA IRB Compliance Specialist
Office of Research Compliance and Assurance Email: firstname.lastname@example.org
Telephone: (251) 460-6308
Questions during Step 2 of submitting a new study- Submission to WIRB and for general questions while the study is open with WIRB:
Questions or concerns that WIRB Client Services cannot address: