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. WCG is AAHRPP accredited and used by many institutions across the country. WCG 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 WCG. Materials submitted for WCG 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 WCG.
The criteria for studies to be eligible for review by the WCG 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 WCG:
- 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 WCG fees and/or the USA IRB fees
- Research involving prisoners
- Other studies to be determined by the local IRB, such as COVID-19 trials
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 do I Submit to WCG?
|Step 1: Investigator begins LOCAL processes for submission to USA IRB||
WCG Copernicus has partnered with IRBNet and the online submission portal will remain unchanged.
Create a New Project in IRBNet
WCG will bill the sponsor directly, if allowed. Include this information on the WCG Billing Section of the Initial Review Form.
|Step 2: Submission to WCG||
Create a New Package in IRBNet under the same project
Standard Submission Requirements Include:
Instructions on submitting your project are available from the WCG website. (Access the WCG Submission Forms)
|Step 3: Review by WCG||What happens after you submit Package 2 to WCG?
Consent Documents: For WCG approved projects, the WCG 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 WCG is now the IRB of records for your study. You should refer to WCG’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 WCG, 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 WCG or Sponsor (e.g.: interim analysis or enrollment complete need not be reported)
- Study Closure to both WCG and USA IRB
- Study Terminations from WCG 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 WCG.
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 WCG approval protocols: WCG will arrange for monitoring ongoing research, as its policies and procedures require. The USA IRB/ Office of Research Compliance and Assurance may monitor any WCG approved protocol as part of its quality assurance program.
Record keeping: Record keeping procedures for all files must be established, and WCG 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 WCG 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.
The site is required to communicate with the sponsor to determine the applicable language and to seek sponsor approval. Sponsor approval for consent language should be received before submitting to the USA IRB for preliminary review.
The site should ensure that the current consent template is used to insert the Local Context Language. The USA IRB’s account manager at WCG should be contacted to obtain the current WCG approved consent template. If WCG does not have an approved consent, then the site should obtain the consent template from the sponsor.
IMPORTANT: No deletions or modifications can be made to the USA IRB Local Context Language. The sponsor can request additional language. However, the addition cannot duplicate local language. Furthermore, additions can only be inserted before or after local language. Additions cannot be inserted in between local language paragraphs, sentences, etc.
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
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: