Western IRB (WIRB)
What is the Western IRB?
WIRB is a commercial IRB that is not affiliated with Emory University. Learn more at www.wirb.com
What is the Emory IRB's role in WIRB-reviewed studies?
The Emory IRB will verify that all local institutional requirements are met, including study team training requirements, ancillary committee reviews, Office of Quality, etc.
What can be 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). Emory will not be the IRB of record for these studies. Note, the Emory IRB reserves the right to withhold any new research study from being sent to WIRB.
Studies that cannot be sent to WIRB:
- Cooperative Group
- Federally Funded
- PI holds the IND/IDE
- Those of which any member of the research team has a Conflict of Interest in the project.
- Those with the Atlanta VAMC or Children's Healthcare of Atlanta (CHOA) as a study site.
Please see here: WIRB Fees (Please note: Emory charges an administrative fee of $550, plus 30% indirect cost, for all WIRB initial review submissions.)
WIRB Submission Process:
STEP 1- To 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 the study team of eligibility, and if eligible, providing access to a specialized eIRB smartform for the study team to complete. See next steps below.
STEPS 2A/B/C, and Step 2D can be done in parallel:
Obtain WIRB Connexus accounts for those needing to submit to WIRB or receive notifications
- Everyone on your study team can have Connexus accounts.
Draft consent form using the WIRB consent form template.
- 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 are using this service, state as special instructions, “merge our consents then give to me to pass to the sponsor.” The sponsor still needs to review the Emory-ized consent before WIRB can send the study for review. It’s best if the Emory team corresponds with the sponsor.
Submit study to WIRB via WIRB’s Connexus system. See instructions further below.
Study team will submit the study directly to WIRB using WIRB Connexus. 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 to WIRB and your study team, please include a copy of that email along with your WIRB submission.
The WIRB study analyst will review the study within 48 hours of receipt, and will ask you about any issues to resolve. The WIRB analys will not sent your study for review until they receive Emory IRB sign-off (confirming the completion of local requirements such as study team training). Here are some other important points about the initial submission in Connexus:
- 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.
STEP 2D– Concurrently with Step 2C, the study team will complete a specialized eIRB submission for the study (see "WIRB Forms" section at bottom, for the WIRB smartform guidance). Once Emory IRB has determined that all local institutional requirements have been met (e.g. departmental review, ancillary approvals such as radiation safety, and human subjects training for all investigators), it will email WIRB to let them know they can proceed with their review.
- After study receives Emory sign-off and any other requested changes are made, the study is reviewed by WIRB in about 2 days for expedited studies and a minimum of 3-4 business days to a maximum of 6-7 business days for Full Board studies.
STEP 3- Once WIRB has received a completed WIRB application and the Emory IRB sign-off, it will review the study. Once the study is approved, WIRB will place an institutional hold on the study, until Emory IRB can verify that the Office of Quality Checklist has been completed (or is not applicable to this study).
- 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. The finalization can take a few days or couple of weeks, depending on whether there are any issues with consent form language.
STEP 4- Once Emory IRB has released 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. 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.
More Frequently Asked Questions
What consent and HIPAA authorization templates should I use for my WIRB study?
Emory and WIRB have agreed on a combined consent/HIPAA template, which can be found on the Emory IRB website, on the WIRB Forms section of this page. Please note that any deviations from the template language will need to be reviewed and approved by the Emory IRB.
How do I know which version of the ICF/HIPAA form is the currently approved version 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.
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.
Once my study is enrolling, to whom do I report unanticipated problems involving risk to participants or others, serious adverse events, and/or noncompliance? Are there any fees associated with these reports?
Please report all of the above to WIRB. You can find the requirements under the WIRB’s “Guide for researchers” (under “WIRB Reporting Requirements”). We recommend following the Emory IRB reporting guidelines if unsure, which are at least as strict and offer more detail. You should report an event using WIRB’s “Promptly Reportable Information form” under WIRB’s “Download Forms” page. In case you want to report an event but you do not find it listed as a requirement in this form, you may report it as “Other information the sponsor/CRO/other has directed.…”
There are no fees associated with the report of these issues.
Where should I submit amendment, renewal, and close-out requests?
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.
Emory WIRB Contacts
- WIRB Listserv
- Ashton Hughes at email@example.com
- Ameenah Lashley at firstname.lastname@example.org
- Anna Lum at email@example.com
- 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
- Form A- WIRB Eligibility Checklist (ver. 10-13-2017). 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.
- Emory-WIRB Consent/HIPAA Template (ver. 11-6-2017). 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)