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.


 

General Information

Advarra IRB

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

Emory is willing to rely on Advarra for studies where a 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

 

Submission Process

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

  • Send Reliance Request Form to the Emory IRB at irb.reliance@emory.edu
  • Emory IRB will review your request and let you know if the study is eligible to be reviewed by Advarra.

Step 2 – Obtain Advarra CIRBI accounts for the 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 the 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. 

Documents for submitting amendments and continuing reviews to Advarra can be located on CIRBI via the study's hyperlink.

See the Modifications tab below for more informaiton regarding requirements to update the Emory IRB.

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)

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.
  • Plugin 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 the 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.

Modifications (Changes to ongoing research)

All modifications need to be submitted to the Advarra IRB. However, note that most reviewing IRBs do not review local study team changes.

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 to Emory IRB in eIRB

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

Continuing Reviews

The Advarra IRB is responsible for conducting the continuing review. When prompted by Adviarra or the lead study team, submit your renewal documents to Advarra.

Once your site has received continuing review approval from the Advarra IRB, 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 IRB Coordinator will then process the continuing review on your behalf. 

Please submit the following to the Emory IRB:

  • The renewal approval letter from the Advarra 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 the reviewing 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 reviewing IRB. 
    • attach the completed CR workbook.

Reportable Events

You must report reportable events/new information to the Advarra IRB according to the Advarra IRB's policies and procedures.

Most reports should be made to the Advarra  IRB only. However, some reports must also be submitted to the Emory IRB (see below).  If in doubt, report to Emory anything that Emory IRB would require to be reported, and if the Advarra's IRB’s rules go beyond our requirements, you must follow their policies as well. 

Emory IRB:

Report egregious reportable events promptly to Emory office of Compliance, Risk Management Office, and Emory IRB IN ADDITION to the Advarra 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: Submit to the Emory IRB at the time of continuing review.  Click Report Continuing Review Data on the left menu.  Under question 4, attach the filled CR workbook.

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See our submissions guidance table here.

Contacts

Emory Contacts

Advarra Contacts