Western IRB (WIRB, WCG, CGIRB...)
News Update: As of October 2020, Western IRB (WIRB) rebranded as "WCG IRB" to reflect that it is a family of IRB's that have joined wtih WIRB's parent company over time. Gradually we will revise our documents and tools to reflect this.
Emory has designated Western IRB (WIRB and its family of IRB's) 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 all WIRB studies, the Emory study team makes their IRB submission to WIRB through their online system and WIRB conducts the ethical review on behalf of Emory.
An abbreviated Emory IRB submission is also needed so that Emory can track the studies we do and so that we can ensure certain 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.
Western IRB (WIRB)
WIRB is a commercial IRB that is not affiliated with Emory University. See http://www.irb.emory.edu/forms/external-irbs/WIRB.html and Umbrella Agreements and MOUs on the Collaborative Research and External IRBs page.
Emory IRB's role in WIRB-reviewed studies
As in 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 reviewed by WIRB
All NEW Phase I-through-IV drug or analogous device studies that are industry-designed, initiated, and sponsored will be sent to WIRB 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 WIRB.
WIRB will also be Emory's IRB of record for NIH-funded multi-site studies that are subject to the NIH Single IRB Mandate, with very limited exceptions. See NIH Single IRB Policy: What if I'm applying for NIH funding? at the Collaborative Research and External IRBs page.
Note: WIRB costs need to be included in the study budget. See the main Collaborative Research page, under "NIH and Federal Single IRB Requirements."
WIRB (or one of its subsidiary IRB's) may have already done the protocol-level review for the Sponsor. In this case Emory, is simply added as an additional study site via an amendment. If the Sponsor does not use WIRB, WIRB does a full initial review of the study for us. Learn more at www.wirb.com.
Studies that cannot be sent to WIRB (unless used to comply with NIH's sIRB mandate):
- 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
- Other types of federally-funded studies besides NIH-funded multi-site studies
Fees associated with WIRB review
Please contact firstname.lastname@example.org or email@example.com for current WIRB fees. (Please note: Emory charges an administrative fee of $550, plus 30% indirect cost, for all WIRB initial review submissions.)
For grant-funded multi-site studies that will be sent to WIRB, it is very important to calculate the cost of single IRB review into the budget as part of the grant application process. Follow the instructions at the top of this Single IRB Quote Request Form to get a quote.
WIRB Submission Process:
STEP 1) Determine eligibility for submission to WIRB
- 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 WIRB reivew, submit to the Emory IRB as usual. If the form agrees that you can use WIRB, 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...
NOTE: WIRB is moving to a new Connexus system around October 15. Instructions will be updated at that time. Existing studies will be migrated and both systems will remain online and synced for a transition period.
A- Obtain WIRB Connexus accounts for study team
- Required for those needing to submit to WIRB or receive notifications
- Everyone on your study team can have Connexus accounts.
B - Go through Process for Developing Consent Documents
- See separate section below on consent documents
C - Submit study to WIRB via WIRB’s Connexus system
- Study team will submit the study directly to WIRB using WIRB Connexus (see tips directly below).
- If the Sponsor is already using WIRB for protocol review, then you will be submitting an amendment; contact firstname.lastname@example.org to be given access to the study in order to submit the amendment (if the Sponsor has not already provided you access to the study). Otherwise, you will submit the study materials as a new study to WIRB.
- If the Emory IRB has already emailed our "institutional sign off" (from Step 2D below) to WIRB and your study team, please include a copy of that email along with your WIRB submission.
- WIRB analysts will not sent your study for review until they receive Emory IRB sign-off (see Step 2D below).
D– Emory Local Submission and Sign-Off
- Concurrently with Step 2C, your study team complete a eIRB submission using this guidance.
- Once Emory IRB has determined that all local institutional requirements have been met it will email WIRB and you with our sign-off.
STEP 3- WIRB Review
- Once WIRB has received a completed WIRB application and the Emory IRB sign-off, it will pre-review the study.
- if the Sponsor has made any changes to our institutional consent language, WIRB will contact the Emory IRB for our okay, copying the study team.
- Once pre-review is complete, WIRB targets 2 days for expedited studies and 3-7 business days for Full Board studies.
- After the WIRB Board reviews, the study enters the “finalization” phase. In this phase, the WIRB staff created a clean consent, issue approvals, and obtain final sponsor and Emory final review.
- Once the study is approved, WIRB will place an institutional hold on the study, for Emory IRB (and Sponsor, if they request) to to have a last brief review.
STEP 4- Emory post-review and release of approval documents (usually within 2 to 5 business days of approval)
- Once the study is approved, WIRB sends you a notification via email letting you know that your study has been approved but that Emory has to do a post-review and release the institutional hold for the study to move forward.
- Your Emory analyst reviews final consent language for local requirements and ensures all ancillary approvals are in place (mainly Office of Quality).
- Your Emory analyst reaches out to you within 2-5 business days of the WIRB email notification to release the institutional hold.
- Once Emory IRB releases the institutional hold for an approved study, the approved study documents are available via WIRB Connexus.
After your study is approved, WIRB will be the IRB of record for the life of the study. All communication regarding the study will be between the Investigator and WIRB.
Documents for submitting amendments, continuing reviews, and reportable events are available at www.wirb.com.
See the Modifications tab below for more informaiton regarding requirements to update the Emory IRB.
- 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 WIRB before submitting to connexus.
- WIRB Emory Consent Checklist
- This checklist will be required for every study you submit to WIRB, whether you choose to utilize WIRB'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.
- WIRB Smartform Guidance (ver. 1/31/2020). This shows what parts of the Emory eIRB smartform must be completed to allow Emory IRB to provide our administrative sign-off to WIRB.
- WIRB Investigator Handbook Guide for researchers (version 4.30, released on 8/17/2017)
- WIRB Promptly Reportable Information form (version 2.0.0, released on 8/19/2016)
- 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 WIRB 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 WIRB links the study to Emory's research program by naming "Emory University" as the institution which has a contract to use WIRB 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 WIRB, including when the study seems to be delayed?
- WIRB timeline for the review of a study starts with the assignment of the study to a WIRB staff member within the first 24 hours. Within 48 hours, the WIRB 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 (email@example.com) for a breakdown on the timeline of your specific study. For all inquiries, please contact our WIRB contact Christopher Gennai (information below) or email firstname.lastname@example.org.
UPDATE: Emory and WIRB are no longer using the Emory/WIRB consent template we previously posted here. For efficiency and to reduce errors, WIRB now requires Emory's language to be inserted into the Sponsor's master template.
How do I create the consent/HIPAA form for our study?
- First, if not already known, contact email@example.com to see if WIRB already has an approved master consent template for the study (Sponsor may also have told you this). If not, get the master consent template from the Sponsor.
- Plug in Emory's boilerplate provisions via the tracked changes feature using the WIRB Emory Consent Checklist.
- The checklist is required for every study whether you choose to use WIRB's consent preparation process or merge the Emory language into the master template yourself.
- WIRB can assist you with consent form preparation if there is not enough manpower within your team and if the sponsor is already using WIRB 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 WIRB 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, WIRB will reach out to you to determine what Emory-specific information to plug 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?
You may let the Sponsor know that Emory has a workflow process with WIRB through which the Emory team uses a checklist to indicate which Emory language needs to be embedded into the sponsor template and WIRB is able to merge that language with the sponsor template to create the Emory consent form. Once merged, WIRB can send the consent form for a pre-review to the Sponsor before the consent form goes to the board for IRB review.
How do I know which version of the ICF/HIPAA form is the currently approved version for our site, in Connexus?
WIRB recommends using the form with the most recent review date. It will be entitled “rendition” (ignore the versions entitled “IN1”, “IN2”, etc). WIRB is working on a better way to identify active consent forms.
What consent form(s) should I provide to OCR for PRA analysis?
OCR will accept sponsor master consent templates with your submissions to them.
Please just add a comment at the end of their submission form noting that an Emory-specific consent form is not available because the study is being reviewed by WIRB (or whichever external IRB is reviewing your study in lieu of Emory).
They may also request to see the WIRB Emory Consent Checklist as completed for your study.
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
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:
- "Active" status- submit via 'Create Site Modification" (for Emory-specific information changes) or "Update Study Details" (for study-wide changes). You can find more information here.
- "External IRB" status- you need to submit an "Update" to the submission. You can find more information about this process here.
- You will submit the closeout to WIRB via Connexus. WIRB 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 (WIRB “Progress Report”)
First, submit to WIRB. Upon receipt of the Continuing Review approval, update the Emory IRB.
Submitting to WIRB:
- WIRB 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, use the “contact information update form” located at http://www.wirb.com/Pages/DownloadForms.aspx. 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 (aka Continuing Review) is due about 60 days prior to the expiration date. WIRB 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, WIRB 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: WIRB needs to send to board for scheduling, with or without the progress report
- The WIRB Board 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.
- WIRB tries to use the “30-day rule” to preserve the same expiration date each year. WIRB 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:
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 WIRB.
- 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 WIRB 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 WIRB.
- attach the completed CR workbook.
Report events/information to WIRB according to WIRB's policies and process.
Most reports should be made to WIRB 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 WIRB’s rules go beyond our requirements, you must follow their policies.
Report egregious reportable events promptly to Emory office of Compliance, Risk
Management Office, and Emory IRB IN ADDITION to WIRB.
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.
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?
WIRB 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. WIRB will email you back confirming the personnel listed in your list.
Emory WIRB Contacts
- WIRB Listserv
- One of the Analyst Assistants listed on the IRB Staff webpage
- Maria Davila (Team Lead) at firstname.lastname@example.org
Christopher Gennai, CIP (Senior Account Manager, Institutions)
- Office: (800) 562-4789
- Fax: (360) 252-2498
- Email: email@example.com
Deena Horowitz (Account Manager, Institutions)
- Office: (360) 252-2442
- Email: firstname.lastname@example.org