Collaborative Research and External IRBs

Collaborative/multi-site research is research conducted in cooperation with an institution or facility that is not affiliated with Emory.  

  • Collaborative research - when non-Emory investigators are coming to Emory's site to aid the Emory study team with some aspect of the research (help with consenting Emory subjects, access to Emory subjects' identifiable information, assisting with administering study interventions at Emory); could also be when some part of the protocol is taking place at another institution (e.g. other institution doing data analysis only).
  • Multi-site research - when Emory is serving as one of many participating sites running a full protocol (each institution enrolling its own subjects and carrying out the protocol at its own site).

Use this Engagement Determination Checklist to determine if a site is engaged.

See the left-hand menu to tabs for information specific to WIRB, CIRB and Advarra.


 

The Reliance Process

  1. Submit a reliance request form by completing this form. Note: At this time, the Emory IRB is not resourced to serve as the reviewing IRB for multi-site studies but is evaluating the resources to serve in this capacity in the future.
  2. Email us the form at irb.reliance@emory.edu. The reliance team will review the form and let you know whether Emory agrees to the request.
  3. If Emory agrees to rely on an external IRB, submit a XIRB study in eIRB once the study is approved by the reviewing IRB. Use this guidance document to complete the smart form
    1. Upload any reliance documents or forms provided by the reviewing IRB.
    2. Upload the study-wide approval letter from the reviewing IRB.
    3. Upload the protocol and model consent form(s) approved by the reviewing IRB.
    4. Upload the Emory-specific consent form(s) with Emory language inserted using TRACKED CHANGES.
  4. Emory will conduct local context review (including all ancillary reviews) and will execute the reliance agreement.
Emory IRB will issue institutional signoff once local context review is complete and a reliance agreement is in place. Important Note: You cannot submit your site to the reviewing IRB for approval until you receive institutional signoff from Emory, even if Emory has already signed the reliance agreement.

Frequently Asked Questions

How do I add Emory study staff to my XIRB study, or modify the submission?

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

How do I add an external site or non-Emory study team member to a study approved by the Emory IRB?

  • Confirm the other institution/organization's IRB or leadership considers the employee/agent's activities to "engage" them in the project and they consider them an agent of their institution
  • Contact your study's Emory IRB analyst to discuss the next steps.

What Single IRB Plan should I use if I'm applying for federal funding?

Most multisite federally funded studies now require the use of a single IRB.

There are several options for the single IRB of record (Reviewing IRB).

  • Commercial IRB such as WIRB
  • Emory IRB
  • Another Academic IRB

Follow this process:

  1. Submit the Single IRB Intake Form via email to the IRB Reliance Listserv (irb.reliance@emory.edu) as early in the grant application process as possible so that Emory IRB can advise you on how to draft your Single IRB Plan.
  2. You may need to prepare a Single IRB Plan and Communication Plan to submit with your grant application. NOTE: the plan can say that you have not yet identified the specific IRB of record.
    1. Single IRB Plan instructions/guidance
    2. Single IRB Plan template
    3. Communication Plan template
    4. Sample of Completed Communication Plan
  3. Many academic IRBs now charge for serving as the reviewing IRB for multi-site studies. Be sure to include the cost of the review in your budget.  If WIRB will be the single IRB, follow the instructions at the top of this Single IRB Quote Request Form to get a quote from WIRB.

NOTE: Please remember that this quote is based on the assumptions provided, and Emory will only be billed for the services that are rendered.  Also, keep in mind that if translations are needed, that is an extra charge.

CHOA Involvement: How do I know whether I should submit a reliance request to Emory IRB, CHOA IRB, or both?

 

NOTE: A NEW AGREEMENT WITH CHOA REGARDING RESEARCH OVERSIGHT AND ADMINISTRATION EFFECTIVE 09/01/2018 DUE TO THE FORMATION OF THE EMORY + CHILDREN'S PEDIATRIC INSTITUTE.

The Pediatric Institute is not a physical building.  Rather, it's an entity created which employs physicians and clinicians from Emory and CHOA itself rather than those physicians and clinicians (PhDs/PsyDs) being directly employed by Emory or CHOA (whereas, coordinators and lab staff are still employed directly by Emory and CHOA).  For more information about the Pediatric Institute, watch our webinar.

The new agreement covers human subjects research in which both Emory and CHOA provide some or all of the following: funding, personnel, site access, patient access, medical records access, research records access, or other material support.  This agreement does NOT cover research for which either Emory or CHOA provides support to the other via a Fee for Service Agreement.

The location of your study's IRB review and research administration (CHOA or Emory) depends on the type of research.  This flowchart dictates where you will undergo IRB review.

For studies that are combination adult and pediatric trials, Emory and CHOA are currently working on a streamlined process.  Reach out to the CHOA and Emory IRB directors via email for assistance.

For the most part, the grant will route through the institution that is responsible for IRB review (as set forth in the flowchart above).  However, there are some exceptions:

  • Industry-sponsored chart reviews- CHOA IRB but contract routes through Emory. 
  • Federally-funded studies that only include surveys- CHOA IRB but contract routes through Emory.
  • Non-profit (non-COG) funded data registries- CHOA IRB but contract routes through Emory.

The ancillary review will take place where the performance site is.

FOR STUDIES WHERE YOU'RE BEING ASKED TO RELY ON AN EXTERNAL OR SINGLE IRB: You should send a reliance request to Emory, and Emory will give you further instruction.

If my study is reviewed by CHOA IRB, do I need a XIRB local context submission in Emory's eIRB?

  • Studies that are being reviewed by CHOA automatically under the Pediatric Institute agreement described above DO NOT require an Emory local submission.  This includes studies where CHOA would automatically review the study but an Emory-employed coordinator is working on the study (subcontract or no subcontract).
  • Any study that is not addressed under the Pediatric Institute agreement but which ultimately is reviewed by CHOA DOES require an Emory local submission.
  • Any study for which Emory and CHOA decide to deviate from the Pediatric Institute agreement and have CHOA review DOES require an Emory local submission.
  • Any study which involves some steps of the protocol occurring at Emory labs or involves clinical interventions taking place at Emory Healthcare sites DOES require an Emory local submission.

Reportable Events

Emory researchers are responsible for following the reviewing IRB’s policies for reporting events that occur at the Emory site(s). 

Once the event has been reported to the reviewing IRB, the Emory study team is responsible for following Emory’s policies for reporting the event to the Emory IRB.

To report egregious reportable events such as wrong-side surgery, wrong drug, wrong patient, fabrication or falsification of data, and HIPAA privacy matters:

  1. CC irb.reliance@emory.edu and the QA Team Lead (Maria Davila) on your email reporting the event to the external IRB; or
  2. If reporting via the other IRB's online platform, screenshot or save a copy of the online report and email to the IRB Reliance Listserv and the QA Team Lead (Maria Davila).

See our submissions guidance table here.

Contact Us

Send general questions to irb.reliance@emory.edu.  

If you have questions about a specific study at Emory that is ongoing, please contact your assigned IRB analyst.

If you have questions about WIRB or NCI CIRB specifically, please email the WIRB Listserv (wirb-l@listserv.cc.emory.edu) and one of the Emory IRB analyst assistants will do their best to address your issue