Western IRB (WIRB)

Emory has designated Western IRB (WIRB) as its IRB for most industry-funded, -designed, and -sponsored clinical trials.

Emory also designates WIRB as its IRB for 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 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. 

Please click on the frequently-asked questions below for information about WIRB.

UPDATE! WIRB has revised its submission form to comply with the New Common Rule!  See our NEW SECTION below for more information.


 

What is Western IRB (WIRB)?

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

All new drug or analogous device studies that are industry-designed, initiated, and sponsored will be sent to WIRB for review (with select exceptions). See http://www.irb.emory.edu/forms/external-irbs/WIRB.html.  Please also see What umbrella agreements and MOUs are in place? on the Collaborative Research and External IRBs page.

We will also use WIRB for multisite studies required to use a single IRB per the NIH mandate for which Emory is selected as the site to provide IRB review.  We also recommend WIRB when all sites are not willing to rely on the same institutional IRB as the single IRB. Note that WIRB costs need to be included in the study budget. See the main Collaborative Research page, under "NIH Single IRB Policy."

WIRB may have already done the protocol-level review for the Sponsor, in which case Emory is simply added as an additional study site via an amendment. Otherwise, WIRB does a full initial review of the study for us. Learn more at www.wirb.com.

 

What is Emory IRB's role in WIRB-reviewed studies?

As in other external IRB (XIRB) 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
  • Office of Quality, etc

Emory IRB provides a template smartform embedded with guidance about which questions must be  completed and which may be ignored.

Please see this flowchart to better understand Emory's process for WIRB studies.

What types of studies are sent to 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.

Studies that cannot be sent to WIRB (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 as a study site
  • Other types of federally-funded studies besides NIH-funded multi-site studies

What if I submitted a study to Emory IRB, instead of WIRB, by accident?

Emory IRB will likely catch when a newly submitted study should have gone to WIRB instead and ask you via email why it did not (e.g., was there investigator conflict of interest?). If there was no reason, we'll ask that you start your WIRB submission (see steps below). 

Do not worry! Your eIRB efforts will not be wasted! We can just rename your Emory eIRB submission (preface the title with "WIRB") and do our local administrative review (see next FAQ below). 

What are the fees associated with WIRB review?

Please contact wirb-l@listserv.cc.emory.edu or clientservices@wirb.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 graht-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.

 

What is the WIRB submission process like?

WIRB Submission Process:

STEP 1) Determine eligibility for submission to WIRB

  • Send the Form A (WIRB Eligibility Checklist) to the Emory IRB via the WIRB listserv. Save a copy of the form in your desktop before completing.
  • The Emory IRB will send an e-mail within 2 business days notifying you of eligibility, and if eligible, providing access to an abbreviated eIRB smartform for the study team to complete. See next steps below.

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

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 FAQ 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 clientservices@wirb.com  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 completes an abbreviated eIRB submission for the study, which we provided you in Step 1 above.
    • See "WIRB Forms" section at bottom, for the WIRB smartform guidance.
  • Once Emory IRB has determined that all local institutional requirements have been met it will email WIRB and you with our sign-off. 
Local requirements examples: departmental review, Cost and In Case of Injury consent language options, ancillary approvals such as radiation safety, and human subjects/GCP training for all investigators
Note: To speed things up, study team can request that Emory send our sign-off prior to confirming Cost and/or In Case of Injury options - just supply us with your best guesses. An amendment (paid by Sponsor) will be needed later if the guesses were incorrect.

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 (Note: If your study has not been approved by Office of Quality, the institutional hold will not be released until that approval is secured).
  • Once Emory IRB releases the institutional hold for an approved study, the approved study documents are available via WIRB Connexus.  

AFTER APPROVAL...

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.  

No further updates will need to be done via eIRB.

The study team can download documents for amendments, continuing reviews, and reportable events at www.wirb.com.

 

NEW SECTION! Frequently Asked Questions about the Initial Submission

  • 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.  If needed, ask the sponsor how to respond.  The sponsor is usually billed directly.
  • 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. Please see our online tool for submitting to WIRB's system properly.
  • 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 (cgennai@wirb.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 clientservices@wirb.com.

What forms do I need for a WIRB submission?

WIRB Forms

  • Form A (WIRB Eligibility Checklist) (ver. 11-20-2018). No study may be submitted to WIRB until Emory IRB has verified WIRB-eligibility via this checklist. Save a copy in your desktop before completing. 
  • 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. 9-27-16). 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)

NEW SECTION: WIRB has revised its submission form to comply with the New Common Rule.

WIRB has a new Initial Review Submission Form as of January 2019.  This form replaces any previous forms.  The changes to the form include new common rule requirements, ascetics, and Board ease on reviewing the information.

The list of major changes are as follows (changes most likely to affect Emory researchers in bold):

  • Clinical use of a HUD broken out in to a separate submission form
  • Single patient expanded access branch removed – see new standalone forms now on the WIRB website expanded access page
  • New question about exempt research (current exemption form will be retired)
  • New questions regarding investigator brochures for IND research and product labeling for investigational devices on an IDE
  • New questions - “Does the investigator hold the IND?” and “Does the investigator hold the IDE?”
  • New question “Have you submitted this device to FDA for an SR/NSR determination?”
  • New section “The following questions apply to all research locations” collects information about the site formerly collected in various other sections
  • Canadian sites now required to submit stand-alone Canadian supplemental form
  • Recruitment Bonus section minimized – submitters directed to submit standalone form
  • Removed check boxes for "Send bills for review to this contact" and "This person will receive and complete continuing review forms" on all contacts
  • Changed formatting of warnings for additional submission materials
  • All contacts related to the research are now collected in one section of the form
  • Minor revisions to the section on Federal Funding (formerly “Federal Oversight”)
  • Revised question about minimal risk
  • Minor revisions to format and content of the Vulnerable Populations section
  • Expanded consent waiver section
  • HIPAA waiver initial options broken out into four categories rather than three
  • Affirmations previously in the Consent Documentation section moved into the Consent Process section
  • Minor change to the way number of sites are collected in the Countries Where the IRB Will Have Oversight section
  • Added “CRO” as an option for “Who will submit IND safety reports to the IRB?”
  • Changed from “Will data be submitted to or held for inspection by the US Food and Drug Administration (FDA)?” to “Will you or others submit data from this research to the US Food and Drug Administration (FDA) or hold data from this research for inspection by the FDA?”
  • Updated Gene Transfer section
  • Updated Subject Payment section
  • Consent Customization section replaced with new Consent Form Processing section
  • “Research Personnel” section renamed “Research Team Information”
  • “Training” section renamed “Research Team Training” section and revised.
  • “Principal Investigator (PI) Licensure” section updated
  • “Principal Investigator (PI) Experience” section updated
  • “Investigator and Research Personnel History” renamed “Administrative Actions” and content updated
  • Emergency Procedures section replaced with this statement in the Acknowledgement section “Sites will have the emergency equipment required by the protocol”
  • “Privacy” section replaced with revised “Subject Privacy” section
  • Moved administrative sections to the beginning
  • Grouped sections needed by IRB members

What do I need to know about consent and HIPAA authorization documents?

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 clientservices@wirb.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.

Where should I submit amendments (including PI changes), renewals, and close-out requests?

Please submit all of the above to WIRB via Connexus. You can view instructions and download forms from their website at http://www.wirb.com/Pages/DownloadForms.aspx.  The Emory IRB does not need to review amendments or continuing reviews. 

PI changes

  • If your study has a PI change, forward the WIRB approval letter of the PI change to the WIRB listserv.  Make sure that the CITI certification is up to date.  The IRB staff will update our eIRB shell

Close-Outs

  • You will submit the close out to WIRB via Connexus.  WIRB will let us know when the close out has been granted.

Important information for Continuing Review (WIRB “Progress Report”)

  • Reminders will only be sent 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 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 the study team knows the study will close out prior to expiration date, you can 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, so they don’t review until that period starts-it helps them to sync expiration dates across all sites.
  • Connexus does not show status and review schedule for continuing reviews.  Call client services from 8am to 8pm for status check.
  • Call Client Services to see who your Continuing Review contact person is on your staff, if not sure.

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.

Who are my WIRB contacts?

 

Emory WIRB Contacts

WIRB Contact

Christopher Gennai, CIP (Senior Account Manager, Institutions) 

Deena Horowitz (Account Manager, Institutions)