Collaborative Research/Single IRBs/Reliance Agreements

Collaborative Research 

Collaborative research is 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); or, when some part of an Emory protocol is taking place at another institution (e.g. other institution is doing data analysis only). While there are multiple institutions involved, they are not all conducting the full protocol.

Multi-site Research 

Multi-site research is when Emory is one of many participating sites conducting a full protocol (each institution is enrolling subjects and carrying out the protocol at their site).

In Collaborative/Multi-site research, each institution's IRB can review independently or one IRB can rely on another. 

Reliance Agreements

Reliance agreements, also known as IRB Authorization Agreements (IAAs), are needed to document one institution's reliance on another institution's IRB or a commercial IRB.  The reliance agreement or IAA documents respective authorities, roles, responsibil­ities, and communication between an organization providing the ethical review and a participating organization relying on a reviewing IRB.  

Single IRBs

A single IRB is one IRB that provides ethical oversight to multiple sites conducting the same protocol involving human research participants.  The goal of Single IRB Review is to streamline the IRB review process for domestic sites conducting the same research protocol without compromising ethical principles or the protection of human research participants.

While it is beneficial to use Single IRB Review for some studies, it does not mean that relying institutions no longer complete any reviews of the research when relying on a single IRB. It simply means the relying institution’s IRB is not providing approval of the research. The work that would normally take place at the Emory IRB when reviewing and approving research for Emory study teams is simply replaced with other work by the Emory IRB to ensure all local requirements are met and execute reliance agreements.

For important guidance about the reliance process, click on the tabs below.

NOTE: For multisite, industry-sponsored trials, Emory uses commercial IRBs for review. See the left menu for submission guidance to Western IRB (WIRB) or Advarra IRB. 


 

The Reliance Process

To avoid delays in processing your submission, read the following information carefully. 

  • At this time the Emory IRB is not resourced to serve as the single IRB for multisite research studies, but we hope to be in the future.
  • We will agree to rely on AAHRPP accredited IRBs for non-exempt research when the use of a single IRB is required by the Revised Common Rule or the NIH Single IRB Mandate.
  • If you are planning to conduct research as a participating site in a multi-site federally funded study that has chosen to use a single IRB other than Emory, WIRB, Advarra or the NCI CIRB, complete this document and upload it in an XIRB submission. 
  1. Submit an 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 master consent form(s) approved by the reviewing IRB.
    4. Use this checklist to determine the Emory language to be inserted into the master consent form.
    5. Upload the Emory-specific consent form(s) with Emory language inserted using TRACKED CHANGES.
  2. Emory will conduct local context review (including all ancillary reviews) and will execute the reliance agreement.
  3. Emory IRB will issue institutional signoff once local context review is complete and a reliance agreement is in place.

Important: Do not 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.

Modifications (Changes to ongoing research)

All modifications need to be submitted to the Reviewing IRB. However, 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

When Emory relies on another IRB (Reviewing IRB), the Reviewing IRB is responsible for conducting the continuing review. Once your site has received continuing review approval from the Reviewing IRBthe 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 coordinator will process the continuing review on your behalf.

1.PNG

Please submit the following to the Emory IRB:

  • The renewal approval letter from the reviewing IRB.
  • Changes to local study team members (that have not already been reported).
  • 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"...) 
    • 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 filled CR workbook.

Reportable Events

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

Most reports should be made to the Reviewing 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 Reviewing 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 Reviewing IRB.

Examples of egregious reportable events:

  • Surgery on the wrong side
  • Drug provided to the wrong patient or a patient received the wrong drug
  • Fabrication, plagiarism, 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 a CR update clicking on   under the study history.  Under question 4, attach the filled CR workbook.

1.PNG

See our submissions guidance table here.

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. 

Always submit this form to the Children's IRB even when Emory is the IRB of record: CHOA IAA Acknowledgement Form 

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.

What is SMART IRB?

SMART IRB is the term for the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform. It is a master reliance agreement that uses a harmonized set of standard operating procedures.  Institutions no longer need to use institution-specific reliance agreements that require review by legal departments on a study by study basis.  

How does it work?

As part of SMART IRB, institutions may choose to rely on another IRB to review, approve, and oversee a research study.  

The Reviewing IRB (often referrred to as the single IRB sIRB) provides ethical review of the research for the life of the study. Relying Institutions provide local context information about state law, study team member training and qualifications, any applicable conflict of interests and any applicable ancillary reviews.

Investigators and institutions retain their respective responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms of the institution's FWA.

For more information, go to the SMART IRB website

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 an email to the Emory IRB reliance team at (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.

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