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The criteria for studies to be eligible for review by the WCG include:

1. Research meets the NIH definition of a clinical trial.  鈥淎 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)鈥�. 
2. Research is a Phase II/III/IV clinical trial.
3. Research meets the criteria for Full Board review.
4. Protocol must be written and designed by sponsor.
5. The sponsor is a for-profit entity or company.
6. The sponsor holds all INDs/IDEs.
7. The research has not previously been submitted to the USA IRB for review.
8. The PI meets USA requirements to serve as the PI on a research study.

Studies which involve any of the following are not eligible for submission to WCG:

1. Phase I Studies (including I/II studies)
2. Research meets the criteria for Expedited review
3. Planned emergency research
4. Single patient emergency use or compassionate use situations
5. Embryonic stem cell or gene therapy research
6. Federally funded protocols
7. Protocols funded by a Cooperative Oncology Group/NCI sponsored trials
8. Investigator-initiated research
9. Protocols where the Principal Investigator holds the IND/IDE
10. Industry sponsor that refuses to pay WCG fees and/or the USA IRB fees
11. Research involving prisoners
12. Research requires a HIPAA Waiver of Authorization from the USA IRB
13. 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	Action
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 Package 1: Upload the following items: USA IRB Part A Application IRB External Review Request Form (located in IRBNet) WCG Boilerplate Consent checklist (ensure the sponsor specific additions to the USA IRB Consent language is noted) Consent form with track changes is only needed if the consent template has NEVER been reviewed by WCG Documentation of consent language approval, generally an email, from the sponsor Sponsor Protocol   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 and HIPAA for Research. Submit Package 1 for USA IRB pre-preview and acknowledgment. NOTE:   WCG should be selected from the drop down menu and the WCG link to the forms menu should be accessed for the appropriate submission forms.  Acknowledgment will be published in Package 1  Signed WCG boilerplate checklist will be published 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 WCG IRB fee schedule is available in the IRBNet Library 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 Package 2:  Standard Submission Requirements Include: Current WCG initial review submission form (Note:  WCG Institution #87329) PI鈥檚 current professional license (unless already on file) PI鈥檚 CV (unless already on file) The USA IRB Acknowledgment Letter (from package 1 in IRBNet) Signed WCG Boilerplate Checklist (from package 1 in IRBNet) Correspondence, such as an email, that the sponsor approves the consent language If the study has never been reviewed by WCG then include: Consent form with track changes Protocol Investigator's Brochure (if applicable) site specific documents such as subject material and advertisements Instructions on submitting your project are available from the WCG website. ()
Step 3: Review by WCG	What happens after you submit Package 2 to WCG? An IRBNet submission notification is generated and located in IRBNet Messages and Alerts WCG will unlock package 2 if there are questions about the submission.  Attach / drag updated documents into package 2 and select mark revisions complete.  This will notify WCG that the requested revisions are ready for additional review. Once the submission has been reviewed, WCG will issue an IRBNet email notification of Board Action / Multiple Board Documents Published when the review has been completed.  All approval documents will be published in IRBNet, and located under Reviews when the title of the project has been selected.  Any questions that the PI/contact person may have regarding the WCG review process should be directed 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 record for your study. You should refer to WCG鈥檚 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:

• Change in PI or key personnel (NOTE: IRB Application Part A must be updated to reflect personnel changes)
• Change in funding
• Change of study title
• Updated local recruitment/advertising materials
• Participant complaints
• Conflict of Interest (COI) updates
• Breaches of confidentiality/HIPAA privacy or security violations
• 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
• Serious or continuing non-compliance that involves the USA research site
• Study holds or suspensions from WCG or Sponsor that are not built into the study design (e.g.: interim analysis or enrollment complete need not be reported)
• Study Terminations from WCG or sponsor
• Any death of a participant outside of death as a result of study disease progression
• Study Closure

Annual Check-In: This is not the same as a continuing review and may occur at a different time than the continuing review required by WCG. Annual check-in with USA IRB is required to report on the status of the project and remind the study team of their local responsibilities. 

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 informed consent boilerplate language 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鈥檚 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.

USA Informed Consent Boilerplate Language

Questions during Step 1 of submitting a new study- Submission to USA IRB for Pre-Review and for any USA IRB related issues:

IRB Administrator
Office of Research Compliance and Assurance                                                             
Email: irb@southalabama.edu
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:

WCG Client Services
Telephone: (800) 562-4789
Email: clientservices@wcgirb.com
Web:  

Questions or concerns that WIRB Client Services cannot address:

Glori Schmeckpeper
Telephone: (360) 252-2429
Email: gschmeckpeper@wcgclinical.com 
Web:  

USA Informed Consent Boilerplate Language

IRB SOP 1101: WCG IRB