Collaborative Research and External IRBs
Collaborative and multi-site research is research conducted in cooperation with an institution or facility that is not affiliated with Emory. Here is how we use these terms:
- 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); or, when some part of an Emory protocol is taking place at another institution (e.g. other institution doing data analysis only). While there are multiple institutions involved, they are not all conducting the full protocol
- 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).
in Collaborative/Multi-site research, either each institution's IRB can review independently, or there can be "Reliance Agreements" (also known as IRB Authorization Agreements or IAA's), to let one IRB serve as the "IRB of record" for all institutions. This may be one of the collaborating institution's IRB's, or an independent IRB (like WIRB, NCI CIRB, or Advarra).
Note: Not all institutions may need IRB review. Use this Engagement Determination Checklist to determine if a non-Emory site is "engaged" in human subjects research; if not, then the study may be reviewed instead as a single-site study, even if the study is conducted in a non-Emory location. (E.g., another site is just providing space for the research, or informing people about the study. See the Engagement checklist for more examples.)
See the left-hand menu to tabs for information specific to WIRB, CIRB and Advarra.
- 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.
- Email us the form at email@example.com. The reliance team will review the form and let you know whether Emory agrees to the request.
- 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
- Upload any reliance documents or forms provided by the reviewing IRB.
- Upload the study-wide approval letter from the reviewing IRB.
- Upload the protocol and model consent form(s) approved by the reviewing IRB.
- Upload the Emory-specific consent form(s) with Emory language inserted using TRACKED CHANGES.
- Emory will conduct local context review (including all ancillary reviews) and will execute the reliance agreement.
Reviewing IRB: All modifications need to go through the reviewing IRB, except that most reviewing IRB's do not review local study team changes.
Emory IRB: You must promptly inform the Emory IRB informed of certain changes to research. Specifically:
- changes to drugs or devices used in the study
- changes to local study personnel
- 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:
- "Active" status- submit via 'Create Site Modification" (for Emory-specific information changes) or "Update Study Details" (for study-wide changes). You can find more information here.
- "External IRB" status- you need to submit an "Update" to the submission. You can find more information about this process here.
Reviewing IRB: Continuing review is done via the Reviewing IRB.
Emory IRB: Use "Report Continuing Review Data" on the left menu in the study workspace in eIRB. Please see the below items that are required for our review.
When? In advance of the study expiration date but after the central IRB has reapproved.
- Upload the renewal approval letter from the reviewing IRB.
- Review the main study and verify that all updates have been made per the guidelines in "Modifications" above. If not: submit the changes to Emory IRB at this time, along with an RNI for the late submission.
- Upload a summary of all internal Reportable New Information submissions reviewed by the central IRB since the last review, if any (and if not already reported promptly per the guidelines further below)
- In the summary, state the outcome of the central IRB's review (e.g. "Noncompliance," "Serious noncompliance," "Unanticipated Problem"...)
- The reviewing IRB may call these submissions something different, e.g. "Reportable Events"
- Also upload a copy of the report(s) submitted to the reviewing IRB
- RNIs include, but are not limited to: unanticipated problems that increase risk of harm to others, noncompliance, protocol deviations, breaches of confidentiality, wrong site surgeries, wrong drug administered, wrong patient, fabrication of data and falsification of data.
Report events/information to the REVIEWING IRB according to the Reviewing IRB's policies and process.
Most reports should be made to the REVIEWING IRB only.
Some reports must also be submitted through Emory's eIRB system (see below).
If in doubt: report 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.
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:
- 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 a CR update clicking on under the study history. Under question 4, attach the filled CR workbook.
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.
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:
- "Active" status- you need to submit a modification or an update to the submission. You can find more information here.
- "External IRB" status- you need to submit an update to the submission. You can find more information about this process here.
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:
- Submit an email to the Emory IRB reliance team at (firstname.lastname@example.org) as early in the grant application process as possible so that Emory IRB can advise you on how to draft your Single IRB Plan.
- 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.
- 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.
Send general questions to email@example.com.
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 (firstname.lastname@example.org) and one of the Emory IRB analyst assistants will do their best to address your issue