WCG IRB (WIRB, WCG, CGIRB, etc.)

In 2020, after integrating WIRB with four leading independent IRBs (Copernicus Group IRB, New England IRB, Aspire IRB, and Midlands IRB), WIRB became known as WCG IRB.  

Emory has designated WCG IRB as its IRB for

  • Industry-funded, designed, and sponsored clinical trials (Phases I to IV).  
  • Multi-site collaborative research that requires Single IRB review per NIH policy.

For WCG studies, the Emory study team completes the submission to WCG IRB through the Connexus online system and WCG IRB conducts the ethical review on behalf of Emory.

Study teams must also submit an external IRB submission to the Emory IRB so that Emory can track the research conducted at Emory and ensure all local requirements are met. 

REMEMBER: Emory Decatur cannot serve as a study site until permission is obtained from Emory leadership.

Click here for a chart detailing all the steps in this process.

 

General Information

WCG IRB (Formerly WIRB)

WCG IRB is a commercial IRB that is not affiliated with Emory University.  

Emory IRB's role in WCG IRB-reviewed studies

As with other external IRB studies, the Emory IRB analyst assistant assigned to the study will verify that all local institutional requirements are met via a local eIRB submission, including

  • study team training requirements
  • ancillary committee reviews

Studies that may be reviewed by WCG IRB:

  • All NEW Phase I-through-IV drug or analogous device studies that are industry-designed, initiated, and sponsored will be sent to WCG IRB for review (with a few exceptions listed below). Note, the Emory IRB reserves the right to withhold any new research study from being sent to WCG IRB. 
  • Federally funded studies where use of a single IRB is required and the funding agency or lead study team has chosen WCG IRB to serve in that role. 

Studies that cannot be sent to WCG IRB (unless used to comply with NIH's sIRB mandate):

  • Investigator-initiated
  • Cooperative Group-led/coordinated
  • Industry-funded studies for which an Emory PI holds the IND/IDE
  • Industry-funded studies in which any member of the Emory research team has a Conflict of Interest in the project.
  • Those with the Atlanta VAMC or CHOA as a study site

Fees associated with WCG IRB review

Please contact wirb-l@listserv.cc.emory.edu or clientservices@wirb.com for current WCG IRB fees. (Please note: Emory charges an administrative fee of $550, plus 30% indirect cost, for all WCG IRB initial review submissions.)

For grant-funded multi-site studies that will be sent to WCG IRB, it is very important to calculate the cost of single IRB review into the budget that is submitted with the grant application. Follow the instructions at the top of this Single IRB Quote Request Form to obtain a quote.

WCG IRB Submission Process

Click here for a chart detailing all the steps in this process.

WCG IRB Submission Process:

STEP 1) Determine eligibility for submission to WCG IRB

  • Fill out Form A (now electronic form) and save a copy of the submitted form.  If the Form says that the study is not eligible for WCG IRB review, submit to the Emory IRB as usual.  If the form agrees that you can use WCG IRB, you will create an "external IRB" submission in eIRB. See instructions in Step 2D.

STEP 2) STEPS 2A, B, C, and D can be done in parallel...

A- Obtain WCG IRB Connexus account on the WCG IRB Submission page

  • Required for those needing to submit to WIRB or receive notifications
  • Everyone on your study team can have Connexus accounts. 

B - Develop your site-specific informed consent forms (See separate section below on consent forms)

C - Submit study to WCG IRB via the Connexus system

  • Study team will submit the study directly to WCG IRB using WCG IRB Connexus 

D– Submit external IRB submission to Emory in eIRB and obtain Institutional Sign-Off

  • Concurrently with Step 2C, submit an external IRB submission to Emory IRB using this guidance.
  • Be sure to include the following documents:
    • WCG IRB-approved protocol
    • WCG IRB-approved master consent form(s)
    • WCG IRB study-wide approval letter
    • completed XIRB consent checklist
    • completed Form A
  • Once Emory IRB has determined that all local institutional requirements have been met, the analyst assistant will provide Institutional Sign-Off via email to the WCG IRB and will copy the Emory PI and study coordinator.  
Local requirements include but are not limited to the following
  • departmental review
  • confirmation of "Costs" and "In Case of Injury" consent language options
  • ancillary approvals such as radiation safety, biosafety, etc.
  • confirmation of current human subjects/GCP training for all study team members

STEP 3- WCG IRB Review

  • Once WCG IRB confirms the submission in Connexus is complete and the Emory IRB has provided Institutional Sign-Off, WCG will begin reviewing the submission. 
    • If the Sponsor has made any changes to Emory's institutional consent language, WCG IRB will confirm the changes are acceptable to the Emory IRB, copying the study team.
  • Once pre-review is complete, WCG IRB estimates 2 business days for review of expedited studies and 3-7 business days for full board studies.
  • Once the study is approved by the WCG IRB, an institutional hold is placed on the study to allow the Emory IRB (and Sponsor, if they request) a last brief review. 

STEP 4- Emory post-review and release of approval documents (usually within 2 to 5 business days of approval)

  • WCG IRB sends notification of approval via email stating the study has been approved and Emory has to do release the institutional hold for the study to move forward.
  • The Emory analyst assistant reviews final consent language for local requirements and ensures all ancillary approvals are in place and releases the hold.
  • Once Emory IRB releases the institutional hold for an approved study, the approved study documents are available via Connexus.  

AFTER APPROVAL...

  • Log a comment in the Emory study with the approval documents. Be sure to select the IRB Coordinator as a recipient of the comment.
  • The Emory analyst assistant will update the status of the study to Active.
  • Forms for completing submissions to WCG IRB can be found here
  • Guidance as to what needs to be reported to the Emory IRB can be found in the tabs below. 

 

Forms Required for Submission

Forms for WCG IRB Review

  • Electronic Form A submission record. Save a copy of the form response to attach to your eIRB submission.  To prevent time loss, please ensure that the form is directing you to submit to WCG IRB before submitting to connexus. 
  • External IRB Consent Checklist 
    • This checklist is required for every study you submit to WCG IRB, whether you choose to utilize WCG IRB's consent-merging process or merge the Emory language into the master template yourself.
    • Note on "Costs" language: if you choose to submit your study before the Emory IRB has verified the correct "Costs" language, please use Option#2 which is the most commonly selected (unless you have other reason to know the likely Option choice, e.g. very similar prior study with same Sponsor). For "Injury" language: you can ask the Sponsor what they believe the most likely Option will be or base your guess on past experience.
  • WCG IRB Forms can be found here

WCG IRB Connexus Guidance

  • Who should we list as “contacts” on the initial submission form?
    • You should add the Principal Investigator and one other contact, usually the Study Coordinator, as contact people in the initial form. You may ask Client Services if you want to add more staff members to the list, but no more than 15 people
  • What if I forgot a document in my initial submission?
    • If you submitted your study documents and later realized you forgot an important document, email Chris Gennai (information below) and he will add the information to their internal documents.
  • How do I fill out the “billing” section of my application?
    • You are required to complete the billing section of the application. At this time, ALL studies should state that WCG IRB should bill Emory.
  • How can I tell if my submission is completed correctly?
    • At the very end of the initial review form there is a button to validate the document and it will highlight the missing items.
  • How do I identify Emory as the local institution when submitting a study via Connexus?
    • When submitting through Connexus, the study team can ensure that WCG IRB links the study to Emory's research program by naming "Emory University" as the institution which has a contract to use WCG IRB for IRB services.  The Emory IRB institution number is 62571. 
  • How can I check the status of my submission once the study has been submitted to WCG IRB, including when the study seems to be delayed?
    • WCG IRB timeline for the review of a study starts with the assignment of the study to a WCG IRB staff member within the first 24 hours. Within 48 hours, the WCG IRB analyst will send the study staff a list of issues that need to be reconciled, including the institutional sign-off required by Emory. Once all the issues have been reconciled, the study is sent to review.  Contact Chris Gennai (cgennai@wirb.com) for a breakdown on the timeline of your specific study. For all inquiries, please contact our WCG IRB contact Christopher Gennai (information below) or email clientservices@wirb.com.

Consent and HIPAA authorization Documents

How do I create the consent/HIPAA form for our study?

  • First, if not already known, contact clientservices@wirb.com to see if WCG IRB already has an approved master consent template for the study (Sponsor may also have told you this). If not, request the approved master consent template from the Sponsor.
  • Insert Emory's boilerplate provisions via the tracked changes feature using the External IRB Consent Checklist.
  • The checklist is required for every study whether you choose to use WCG IRB's consent preparation process or merge the Emory language into the master template yourself.
  • WCG IRB can assist you with consent form preparation if there is not enough manpower within your team and if the sponsor is already using WCG IRB for the review of the study. If you'd like to use this service, please indicate this under the "Consent Form Processing" question of the Checklist.  If the sponsor requires its review of the Emory-ized consent before WCG IRB can send the study to the board for IRB review, please indicate this under the "Consent Form Pre-Review" question of the Checklist.
  • If there are any site-specific parts of the master template which are not covered by the checklist, WCG IRB will reach out to you to determine what Emory-specific information to insert into those parts of the template.

What if the sponsor wants me to create the Emory consent form before our team has submitted to WIRB?

Notify the Sponsor that Emory has an established workflow with the WCG IRB through which the Emory team uses a checklist to indicate the Emory language that must be embedded into the master consent. WCG IRB uses that information to create the Emory site-specific consent form. The WCG IRB can send the Emory site-specific consent form for Sponsor pre-review before sending to the board for IRB approval.

How do I know which version of the ICF/HIPAA form is the currently approved version for our site, in Connexus?

WCG IRB recommends using the form with the most recent review date. It will be entitled “rendition” (ignore the versions entitled “IN1”, “IN2”, etc). 

What consent form(s) should I provide to OCR for PRA analysis?

OCR will accept sponsor master consent templates with your submissions to them.

Add a comment at the end of their submission form noting that the Emory site-specific consent form is not available because the study is being reviewed by WCG IRB. 

They may also request to see the External IRB Consent Checklist completed for your study.

Modifications (Changes to ongoing research), Continuing Review, Close Out

Modifications:

Submit study modifications to WCG IRB via Connexus. You can view instructions and download forms from their website.  

You must promptly inform the Emory IRB of the following changes to research:

  • changes to drugs or devices used in the study
  • change to Emory PI and study personnel who need immediate access to eIRB
  • changes to Emory-affiliated study sites
  • changes in financial interests on the part of Emory investigators
  • new funding mechanisms
  • changes to the Clinical Research Key Points (CRKP) Summary

No other changes need to be submitted locally to us at this time (subject to change).

Ancillary Review Changes: It is the responsibility of the Emory Principal Investigator to notify ancillary review committees if changes are made to approved research that may impact the reviews of these committees. Examples include, but are not limited to, changes relevant to radiation, conflict of interest, and biosafety review. 

How to Submit Modifications to Emory IRB in eIRB

Depending on the state of your approved study, do the following:

Close-Outs

  • You will submit the closeout to WCG IRB via Connexus.  WCG IRB will let us know when the closeout has been granted.  Submit a closeout in eIRB by submitting a CR submission and checking the first four options under study milestones.

Continuing Review (WCG IRB “Progress Report”)

First, submit to WCG IRB. Upon receipt of the Continuing Review approval, update the Emory IRB. 

Submitting to WCG IRB:

  • WCG IRB sends reminders only to the primary contact(s) at first. To make changes to the study staff receiving regulatory documents or study team primary contacts, download and complete the “contact information update form.” Go to the WCG webpage, click Download IRB Forms and search by the name of the form. This process can be completed at any time, not only during the continuing review. To update support staff, please wait for continuing review.
  • The Progress Report (Continuing Review) is due about 60 days prior to the expiration date. WCG IRB sends out the form request to the primary contact person (77 days before expiration, with a reminder if it is not received shortly thereafter. About ten days after the due date, WCG IRB will send a notice to all contacts listed to receive approval documents for our site (i.e. Emory IRB staff and listed support staff)
    • 30 days prior: WCG IRB needs to send to board for scheduling, with or without the progress report
    • The WCG IRB may decide to suspend the study if no Progress Report is received.
  • If you know the study will close out prior to the expiration date, complete the closure form for a future date to avoid renewal.
  • WCG IRB tries to use the “30-day rule” to preserve the same expiration date each year. WCG IRB doesn’t review until that period starts. It helps them to use the same expiration dates for all sites in a study.
  • Connexus does not show the status and review schedule for continuing reviews.  Call client services from 8 am to 8 pm for a status check.
  • Call Client Services to see who your Continuing Review contact person is on your staff, if not sure.

Submitting to Emory IRB: 

Once your site has received continuing review approval from the WCG IRB, the next steps depend on whether you are the PI or a Co-I/Coordinator...

If you are the PI, select "Report Continuing Review Data" on the left menu in the study workspace in eIRB to update the Emory IRB, and submit the documents listed below.

If you are not the PI, submit the below items via "Log Comment" and select that you want to notify the IRB Coordinator. The coordinator will process the continuing review on your behalf.

Please submit the following to the Emory IRB:

  • The renewal approval letter from WCG IRB.
  • Updates to local study team members (that have not already been reported)
    • This must be done via a simultaneous study update (see Modifications section above)
  • A summary of all internal Reportable New Information (RNIs) submitted to WCG IRB since the last review, if any (and if not already reported promptly).
    • RNIs include but are not limited to unanticipated problems that increase risk of harm to others, noncompliance, breaches of confidentiality, wrong site surgeries, wrong drug administered, wrong patient, fabrication of data and falsification of data. 
    • In the summary, provide the outcome of the reviewing IRB's review (e.g. "Noncompliance," "Serious noncompliance," "Unanticipated Problem"...) 
    • Note: The reviewing IRB may call these submissions something different, e.g. "Reportable Events" 
    • Upload a copy of the report(s) submitted to the WCG IRB. 
    • attach the completed CR workbook.

Reportable New Information

Report events/information to WCG IRB according to WCG IRB's policies and process.

Most reports should be made to WCG IRB only. However, some reports must also be submitted to the Emory IRB.  If in doubt: report anything that Emory IRB would require to be reported, and if WCG IRB’s rules go beyond our requirements, you must follow their policies.

Emory IRB:

Report egregious reportable events promptly to Emory office of Compliance, Risk
Management Office, and Emory IRB IN ADDITION to WCG IRB.

Examples of egregious reportable events:

  • the wrong side surgery
  • the wrong drug, wrong patient
  • fabrication or falsification of data
  • HIPAA privacy matter (report any inadvertent data disclosure and we will help determine further actions)

How to report to Emory IRB: Click on "Report New Information" on the left menu of the study workspace in eIRB

  • Egregious events (reported promptly): Upload a copy of the report(s) made to the reviewing IRB, and any correspondence from the reviewing IRB (but do not delay to wait for their determination).
  • Events reported to the External IRB in the past approval period: See instructions for Continuing Review above. 

1.PNG

See our submissions guidance table here.

My CRO is asking me for a current list of study staff as approved with WIRB. How can I obtain that list?

WCG IRB has advised emailing a list of current staff members to client services or Christopher Gennai directly (see information below), asking them to confirm its accuracy.  WCG IRB will email you back confirming the personnel listed in your list.

WCG IRB Contacts

Emory WCG IRB Contacts

  • WCG IRB Listserv
  • One of the Analyst Assistants listed on the IRB Staff webpage
  • Julie Martin (Team Lead) at julie.t.martin@emory.edu 

WIRB Contact

Christopher Gennai, CIP (Senior Account Manager, Institutions) 

Deena Horowitz (Account Manager, Institutions)