Advarra IRB

Emory is willing to rely on Advarra for studies where single IRB review is required by the NIH or other federal sponsor and the non-Emory lead site has chosen Advarra as the single IRB during the grant proposal stage.

For all Advarra studies, the Emory study team makes their IRB submission to Advarra through their online CIRBI system and Advarra 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 Advarra.


 

What is Advarra IRB?

 

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

Emory is willing to rely on Advarra for studies where single IRB review is required by the NIH or other federal sponsor and the non-Emory lead site has chosen Advarra as the single IRB during the grant proposal stage.

For these studies, Advarra should have already done the protocol-level review for the lead site/sponsor, in which case Emory is simply added as an additional study site via amendment. Learn more at www.advarra.com.

 

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

As in other external IRB (XIRB) studies, Emory IRB 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.

What is the Advarra submission process like?

Step 1 – Determine Emory IRB’s willingness to rely on Advarra

  • Send Reliance Request Form to the Emory IRB Reliance Listserv
  • Emory IRB will send an email within 2 business days notifying you of eligibility, and if eligible, providing access to an abbreviated eIRB smartform for the study team to complete.

Step 2 – Obtain Advarra CIRBI accounts for study team

  • Required for those needing to submit to Advarra or receive notifications
  • Advarra recommends scheduling a CIRBI demo so that they can walk you through the use of the CIRBI platform.

Step 3a – Submit study to Advarra via Advarra’s CIRBI system

  • Since the sponsor/lead site will have already used Advarra for protocol review, you will be submitting an amendment.  Contact Bette Bayne or Betsy Casillo to be given access to the study in order to submit the amendment (if the sponsor/lead site has not already provided you access to the study).
  • Make sure you list "Emory" as the site where the research is taking place on the site/investigator application.
  • Please use our guidance form to complete the Site and Local Context information section.
  • Advarra only requires that you list the site PI as a contact on the site/investigator application, but you can add whomever you wish as long as the individual has a CIRBI account.
  • If Emory IRB has already provided you “institutional signoff” via a logged comment in your local eIRB submission, you will screenshot that and include a copy with the Advarra submission (Note: Advarra coordinator will not send your study for review until they receive that Emory IRB signoff).
  • Once you submit, you will be assigned an Advarra coordinator.  The Advarra coordinator will check that your submission was done correctly.  If you've forgotten a document in your submission, your coordinator will reach back out and ask for clarification.

Step 3b – Emory Local Submission and Signoff

  • Concurrently with Step 3a, your study team should complete the abbreviated eIRB submission for the study, which the Emory IRB personnel will provide you.
  • Make sure you upload the Advarra-approved master consent templates and your Advarra Emory Consent Checklist so that Advarra can merge Emory's site-specific language into the Advarra consent templates to create Emory's site-specific consent documents. Make sure that you follow the instructions to create your HIPAA authorization language closely.
  • Once Emory IRB has determined that all local institutional requirements have been met, a comment will be logged giving you “institutional signoff.”  Screenshot this comment and include it in your submission to Advarra.
  • Examples of local requirements: departmental reviews, Cost and In Case of Injury language options from OCR and OSP, ancillary reviews (such as radiation safety, biosafety, or LITS), investigator training.

Step 4 – Advarra Review

  • Once Advarra has received a completed Advarra application and the Emory IRB signoff, it will pre-review the study.
  • if the Sponsor/lead site has made any changes to our institutional consent language, Advarra will contact the Emory IRB for our okay, copying the study team.
  • Once pre-review is complete, Advarra will send your amendment for review.
  • After the Board reviews, the study enters the final phase.  In this phase, the Advarra staff created a clean consent, issue approvals, and obtain final sponsor and Emory final review. 

*You may log into CIRBI at any point to check the status of your submission via the "status bar."

What if CHOA is involved?

If an Emory PI is conducting research either 1) at a CHOA site and an Emory site or 2) at a CHOA site only, only ONE application to Advarra is needed.  You may list both CHOA and Emory as "research locations" under the one submission.

If there will be two PIs for a study, one for a CHOA/child site and one for an Emory/adult site, you should do two separate submissions for the two different PIs.  You should still list Emory as a "research location" on the CHOA/child site if the CHOA/child site's PI is an Emory faculty member.

What happens post-approval?

After your study is approved, Advarra will be the IRB of record for the life of the study.  All communication regarding the study will be between the investigator and Advarra.  The only updates you need to make to your eIRB submission will be to upload any new approval letters or approved consent documents into the logged comments section.

You can download documents for amendments and continuing reviews at CIRBI via the study's hyperlink.

How do I handle reportable events?

Emory researchers must report to Advarra any reportable event which Advarra requires according to Advarra's policies and process.  Since Advarra is your IRB of record and reviews reportable events, your report should be made to Advarra, not through Emory's eIRB system.

Emory researchers must report every event that you would have been required to report to Emory had we been the Reviewing IRB.

Egregious reportable events have to be reported to Emory offices (Office of Compliance, Risk Management Office, Emory IRB) IN ADDITION to Advarra as soon as possible.  The following are examples of egregious reportable events: wrong side surgery, wrong drug, wrong patient, fabrication or falsification of data, HIPAA privacy concern matter, etc.

Where an egregious reportable event occurs, you must report the event using Advarra's process and also screenshot or save a copy of the report and email to the IRB Reliance Listserv and the QA Team Lead, Maria Davila.

What forms do I need for my submission?

Reliance Request Form – No study may be submitted to Advarra/CIRBI until Emory IRB has verified that we are willing to rely on Advarra for the study.

Advarra Emory Consent Checklist

XIRB Smartform Guidance Document

IRB Handbook (Reference Materials section of the Advarra CIRBI Platform)

Advarra promptly reportable information form (Reference Materials Section of the Advarra CIRBI Platform)

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

  • Get the already-approved master consent template for the study.  Advarra’s CIRBI platform provides a downloadable PDF version of the study’s ICR, and Advarra will also send you a Microsoft Word document version of the ICF upon request.
  • Plug in Emory’s boilerplate provisions via the tracked changes feature using the Advarra Emory Consent Checklist .  Make sure you create the HIPAA authorization language for your study so that Advarra can copy and paste it into your site-specific consent form (last page of checklist).
  • Make sure to upload the Advarra master template and Advarra Emory checklist to your local Emory submission.
  • Advarra can merge the Emory-specific language you've indicated on the checklist into the Advarra master template for you to create the Emory consent form.
  • If there are any site-specific parts of the master template which are not covered by the checklist, Advarra will reach out to you to determine what Emory-specific language to plug into those parts of the template.

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 Advarra (or whichever external IRB is reviewing your study in lieu of Emory).

They may also request to see the Advarra Emory Consent Checklist as completed for your study.

Emory and Advarra Contacts

Emory Contacts

Advarra Contacts