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  submission guidance to WCG IRB (WIRB) or Advarra IRB for more information.  For multi-site studies, please use the same IRB that the sponsor is using for other sites. 

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

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

Emory 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.

Submit an XIRB study in eIRB once the study is approved by the reviewing IRB and the following information is available (as applicable):

  1. EPEX number 
  2. Confirmation of the cost option from OCR or Peds RAS (Only if Options #1 and #3 apply)
  3. Confirmation of the in case of injury option from RAS/OSP (listed in eCTS
  4. Approvals from ancillary review committees
  5. Required CITI training for all study team members (click "View CITI Training" on left menu)

Note: While you can create a study in eIRB in advance to get a Study ID number for routing and work on the smartform, all of the above must be in place before the PI clicks "Submit."  

Submission Instructions:

  1. Use this guidance document (PDF) to complete the smart form.
  2. Upload the study-wide approval letter from the reviewing IRB in the Study-Related Documents section.
  3. In the protocol section, upload the most recent protocol approved by the reviewing IRB and this completed document (DOCX).
  4. In the Study-Related Documents section, upload the master consent form(s) approved by the reviewing IRB.
  5. Use this checklist (DOCX) to determine the Emory language to be inserted into the master consent form and upload the completed checklist in the Local Documents section of the smartform.
  6. Using the completed checklist, insert Emory's required language into the approved master consent form(s) using TRACKED CHANGES and upload in the Local Documents section of the smart form. 
  7. Upload any reliance documents provided by the reviewing IRB in the local documents section. 

Once the submission is complete, the Emory IRB will conduct a local context review and execute the reliance agreement.  Once the local context review is complete, the Emory IRB will issue institutional signoff. 

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.

Once your site has received approval from the reviewing IRB, log a comment in the study with the approval letter and stamped consent forms. Please let your analyst know when you have done this so we may update the status of the study.

Submit modifications to the Reviewing IRB per their policies and procedures. (Note: most reviewing IRBs do not review local study team changes, other than PI.)

You must also promptly inform the Emory IRB of the following changes:

  • changes to drugs or devices used in the study
  • change of Emory PI, and addition of 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
  • changes to the Clinical Research Key Points (CRKP) Summary

No other changes need to be submitted promptly to us at this time (subject to change).

Study team updates must be submitted to Emory IRB at the time of annual review.

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 Updates to Emory IRB

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

  • "Active" state
    • Use "Create Site Modification" for Emory-specific information changes, including study team changes
    • Use "Update Study Details" for study-wide changes or change in Emory PI
Updating a study with "active" status (PDF)

When Emory relies on another IRB (Reviewing IRB), the Reviewing IRB is responsible for conducting continuing reviews and study closeouts. Once your site has received continuing review approval from or the study has been closed by the Reviewing IRB, submit the IRB letter to the Emory IRB following the steps below. The steps you will follow 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.

Please submit the following to the Emory IRB:

  • The renewal approval or study closeout 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"
    • Attach a copy of the report(s) submitted to the reviewing IRB.
    • attach the filled CR workbook (Excel file).

You must submit Reportable New Information (RNIs) to the Reviewing IRB according to the Reviewing IRB's policies and procedures.

Most RNIs should be submitted to the Reviewing IRBonly.

However, some RNIs 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.

Notify the following of egregious RNIs promptly:

  • Emory Office of Compliance
  • Emory Risk Management Office
  • Emory IRB 
  • Reviewing IRB

Examples of egregious RNIs:

  • Internal (at this site) death related or possibly related to the research
  • 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 submit RNI: 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 (Excel file).

See our submissions guidance table (PDF).

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 (PDF) 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 (DOCX)

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.

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 referred 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.

The Emory IRB is not currently resourced to serve as the reviewing IRB for multiple enrolling sites, although we hope to be in the future. 

If you are planning to submit a grant for a multi-site research study that requires the use of a single IRB, please contact the Reliance Team early in the process to discuss options for the single IRB.  You can contact the reliance team at irb.reliance@emory.edu

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

  • Commercial IRB such as WCG IRB or Advarra
  • Emory IRB
  • Another Academic IRB

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.

Some academic IRBs now charge for serving as the reviewing IRB for multi-site studies. Be sure to inquire about review fees and include the cost of the review in your budget.  If WCG IRB will be the single IRB, follow the instructions at the top of this Single IRB Quote Request Form to get a quote from WCG IRB.

NOTE: Please remember that the WCG 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.

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 IRBs such as WCG IRB and Advarra IRB
  • 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 (PDF)
    2. Single IRB Plan template (PDF)
    3. Communication Plan template (PDF)
    4. Sample of Completed Communication Plan (PDF)
  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 WCG IRB will be the single IRB, follow the instructions at the top of this Single IRB Quote Request Form (PDF) to get a quote from WCG IRB. To obtain a quote from Advarra IRB, email the Advarra contact listed on our Advarra page. 

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 WCG IRB 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 question.

WCG IRB (WIRB, WCG, CGIRB, etc.)

In 2020, after integrating WIRB with four leading independent IRBs (Copernicus Group IRB, New England IRB, Aspire IRB, and Midlands IRB), WIRB became known as WCG IRB.

Emory has designated WCG IRB as its IRB for

  • Industry-funded, designed, and sponsored clinical trials (Phases I to IV).
  • Multi-site collaborative research that requires Single IRB review per NIH policy.

For WCG studies, the Emory study team completes the submission to WCG IRB through the Connexus online system and WCG IRB conducts the ethical review on behalf of Emory.

Study teams must also submit an external IRB submission to the Emory IRB so that Emory can track the research conducted at Emory and ensure all local requirements are met.

REMEMBER: Emory Decatur cannot serve as a study site until permission is obtained from Emory leadership.

WCG IRB (Formerly WIRB)

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

Emory IRB's role in WCG IRB-reviewed studies

As with other external IRB studies, the Emory IRB analyst assistant assigned to the study will verify that all local institutional requirements are met via a local eIRB submission, including

  • study team training requirements
  • ancillary committee reviews

Studies that may be reviewed by WCG IRB:

  • All NEW Phase I-through-IV drug or analogous device studies that are industry-designed, initiated, and sponsored will be sent to WCG IRB for review (with a few exceptions listed below). Note, the Emory IRB reserves the right to withhold any new research study from being sent to WCG IRB.
  • Federally funded studies where use of a single IRB is required and the funding agency or lead study team has chosen WCG IRB to serve in that role.

Studies that cannot be sent to WCG IRB (unless used to comply with NIH's sIRB mandate):

  • Investigator-initiated
  • Cooperative Group-led/coordinated
  • Industry-funded studies for which an Emory PI holds the IND/IDE
  • Industry-funded studies in which any member of the Emory research team has a Conflict of Interest in the project.
  • Those with the Atlanta VAMC or CHOA as a study site

Note: If an industry sponsor is using an IRB other than WCG IRB, you will need to use the IRB chosen by the sponsor.

Fees associated with WCG IRB review

Please contact wirb-l@listserv.cc.emory.edu or clientservices@wirb.com for current WCG IRB fees. (Please note: Emory charges an administrative fee of $550, plus 30% indirect cost, for all WCG IRB initial review submissions.)

For grant-funded multi-site studies that will be sent to WCG IRB, it is very important to calculate the cost of single IRB review into the budget that is submitted with the grant application. Follow the instructions at the top of this Single IRB Quote Request Form (PDF) to obtain a quote.

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

Before creating a submission, first determine if the study is eligible for review by WCG IRB.

  1. Fill out Form A (electronic form) to determine if the study is eligible for review by WCG IRB. Save a copy of the submitted form.
  2. If Form A indicates the study is not eligible for review by WCG IRB, submit to the Emory IRB as usual.
  3. If Form A indicates the study is eligible for review by WCG IRB, follow the submission steps below.

Submit in eIRB once the study is approved by the WCG IRB and the following information is available (as applicable):

  1. EPEX number
  2. Confirmation of the cost option from OCR or Peds RAS (Only if Options #1 and #3 apply)
  3. Confirmation of the in case of injury option from RAS/OSP (listed in eCTS)
  4. Approvals from ancillary review committees
  5. Required CITI training for all study team members (click "View CITI Training" on left menu)

Note: While you can create a study in  eIRB  in advance to get a Study ID number for routing and work on the  smartform, all of  the above must be in place before the PI clicks "Submit."

Submission Instructions:

  1. Upload the study-wide approval letter from the reviewing IRB in the Study-Related Documents section.
  2. In the protocol section, upload the most recent protocol approved by the reviewing IRB.
  3. In the Study-Related Documents section, upload the master consent form(s) approved by the reviewing IRB.
  4. Complete the External Consent Checklist (DOCX) to determine the Emory language to be inserted into the master consent form and upload the checklist in Local Documents section.
  5. Using the completed checklist, insert Emory's required language into the approved master consent form(s) using TRACKED CHANGES and upload in the Local Documents section.
  6. Upload the completed Form A in the Local Documents section.

Once the submission is complete, the Emory IRB will conduct a local context review and issue institutional signoff.

Important: Do not submit your site to the WCG IRB for approval until you receive institutional signoff from Emory.

Once your site has received approval from the WCG IRB, log a comment in the study with the approval letter and stamped consent forms. Please let your analyst know when you have done this so we may update the status of the study.

Guidance as to what needs to be reported to the Emory IRB can be found in the tabs below.

  • Who should we list as "contacts" on the initial submission form?
    • You should add the Principal Investigator and one other contact, usually the Study Coordinator, as contact people in the initial form. You may ask Client Services if you want to add more staff members to the list, but no more than 15 people.

  • What if I forgot a document in my initial submission?
    • If you submitted your study documents and later realized you forgot an important document, email Chris Gennai (information below) and he will add the information to their internal documents.

  • How do I fill out the "billing" section of my application?
    • You are required to complete the billing section of the application. At this time, ALL studies should state that WCG IRB should bill Emory.

  • How can I tell if my submission is completed correctly?
    • At the very end of the initial review form there is a button to validate the document and it will highlight the missing items.

  • How do I identify Emory as the local institution when submitting a study via Connexus?
    • When submitting through Connexus, the study team can ensure that WCG IRB links the study to Emory's research program by naming "Emory University" as the institution which has a contract to use WCG IRB for IRB services. The Emory IRB institution number is 62571.

  • How can I check the status of my submission once the study has been submitted to WCG IRB, including when the study seems to be delayed?
    • WCG IRB timeline for the review of a study starts with the assignment of the study to a WCG IRB staff member within the first 24 hours. Within 48 hours, the WCG IRB analyst will send the study staff a list of issues that need to be reconciled, including the institutional sign-off required by Emory. Once all the issues have been reconciled, the study is sent to review. Contact Chris Gennai (cgennai@wirb.com) for a breakdown on the timeline of your specific study. For all inquiries, please contact our WCG IRB contact Christopher Gennai (information below) or email clientservices@wirb.com.

Modifications:

Submit modifications to WCG IRB per their policies and procedures via Connexus. You can view instructions and download forms from the WCG IRB website. (Note: most reviewing IRBs do not review local study team changes other than PI.)

You must also promptly inform the Emory IRB of the following changes:

  • 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
  • changes to the Clinical Research Key Point (CRKP) summary form

No other changes need to be submitted promptly to us at this time (subject to change).

Study team changes other than PI change and addition of study staff who need immediate access to eIRB are to be submitted at the time of continuing review. 

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:

  •  

The WCG IRB is responsible for conducting continuing reviews and study closeouts. Once your site has received the continuing review approval or study closeout letter from WCG IRB, submit the IRB letter to the Emory IRB following the steps below. The steps you will follow 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 or closeout on your behalf.

Please submit the following to the Emory IRB:

  • The renewal approval or study closeout letter from the reviewing IRB.
  • Changes to local study team members that have not already been reported (if applicable).
  • 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, death of a participant, 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.

You must submit Reportable New Information (RNIs) to the WCG IRB according to their policies and procedures.

Most RNIs should be submitted to the Reviewing IRB only.

However, some RNIs 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.

Notify the following of egregious RNIs promptly:

  • Emory Office of Compliance
  • Emory Risk Management Office
  • Emory IRB
  • Reviewing IRB

Examples of egregious RNIs:

  • Internal (at this site) death related or possibly related to the research
  • 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 submit RNI: 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 completed CR workbook (Excel file)

WCG IRB has advised emailing a list of current staff members to client services or Christopher Gennai directly (see information below), asking them to confirm its accuracy. WCG IRB will email you back confirming the personnel listed in your list.

Emory WCG IRB Contacts

WIRB Contact

Christopher Gennai, CIP (Senior Account Manager, Institutions)

Andy Parkhurst (Institutions Partnership Manager)

National Cancer Institute Central Institutional Review Board (NCI CIRB)

National Cancer Institute eligible studies are sent to the NCI CIRB for IRB review.

NCI CIRB is the central institutional review board for the National Cancer Institute. For more information, visit:

National Cancer Institute - Central IRB Website

NCI CIRB is the IRB of record for many NCI-funded cooperative group studies. The NCI CIRB may review the following type of studies; please see the NCI CIRB Participant's Area for more detailed information on eligible studies.

  • Adult CIRB - Late Phase Emphasis - reviews NCI-sponsored adult phase 3 and large phase 2 studies
  • Adult CIRB - Early Phase Emphasis - reviews NCI-sponsored adult phase 0, 1, and 2 studies
  • Pediatric CIRB - reviews NCI-sponsored pediatric studies of all phases

The Emory IRB, as with other external (XIRB) studies, verifies that local Emory study requirements are met, such as the below. We also still serve as the Privacy Board, thus grant partial HIPAA waivers.

  • Clinical Trial Readiness Checklist sign-off
  • Clinical Research Key Points Summary
  • Emory- or Georgia-specific consent language (e.g., costs to participants, injury coverage...)
  • HIPAA waivers and review of HIPAA authorization language
  • Education and Certification of investigators
  • Any other local requirements

If you have never used NCI CIRB before, you need access to their "Participant's Area."

Steps to Register with NCI CIRB

  1. Step 1: Obtain access to NCI CIRB Participants Area

    • Complete the webform below to obtain an account to NCI CIRB's IRBManager.
    • This information will be submitted to NCI CIRB by the Emory IRB.
    • Once NCI CIRB processes the request, a separate email with login information will be sent to the new personnel's email address.
  2. Step 2: Registering a PI for access to NCI CIRB studies

    • Complete the "Annual Principal Investigator Worksheet About Local Context" form via IRBManager.
    • While the form can be filled out by coordinators, the PI will need to submit the final form.
    • Once the CIRB has accepted the PI's worksheet, contact the Emory IRB at wirb-l@listserv.cc.emory.edu to request that the PI role be given to the investigator in the CIRB database.

Submitting the form below will contact one of the Analyst Assistants on the IRB staff webpage who then requests your access to the NCI CIRB Participant's Area. The NCI requires the following information to gain access:

Personnel Name:*
Personnel Degree:*
Personnel Email:*
CTEP Person ID:*
Personnel Telephone*
Role* PIResearch Staff
Requester email:*

Note: This information will be submitted to NCI CIRB by the Emory IRB. Once NCI CIRB processes the request, a separate email with login information will be sent to the new personnel's email address.

Upon submission you will see a confirmation page,
if not, the IRB did not receive the request.

NCI will inform you whether CIRB will be the IRB of record for a given study. Studies and related materials approved by NCI CIRB are made available to participants on the NCI CIRB website.

To get started with the Emory IRB portion:

Beginning the NCI CIRB approval process:

  • Studies are opened by a "Signatory Institution Principal Investigator" by submitting the Study-Specific Worksheet to the CIRB for review via IRBManager.
  • Note: The "Study-Specific Worksheet" must include any deviations from Emory/NCI CIRB's Boilerplate Language (i.e. "in case of injury" language, COI language... See our consent FAQ below).
  • CIRB may email you to ask at which Emory/affiliated sites the study will open. The Study team shall reply to CIRB with the correct site codes.

Processing the NCI CIRB approval

  • NCI CIRB emails PI/study team contact an approval letter, which includes additional instructions
  • The study team merges the CIRB-approved model consent with any applicable Emory boilerplate language (very limited; most Emory language will be in the site-specific addendum).
  • Study team should add the following to the study submission:
    • NCI IRB approved consent
    • Site-Specific Consent-HIPAA Addendum (completed)
    • NCI CIRB approval letter for Emory site
    • NCI CIRB expiration date (via overall study approval letter)
  • Study team uploads the merged consent form, and the NCI CIRB approval letter for their eIRB submission, and the overall study approval letter (to show the CIRB expiration date) .

Processing Emory's local acknowledgment

Emory IRB will verify:

  • all study personnel have the required training (CITI, GCP, Key Concepts/Intro to Clinical Research)
  • all ancillary reviews have been completed (CTRC, Radiation Safety, COI, REMS review, etc.,)
  • the language in the consents is accurate (costs, injury coverage, etc.)
  • the study meets the criteria for a partial HIPAA waiver, if needed

Once the requirements have been verified, Emory will issue an acknowledgment letter and change the Status of the study to "Active" in eIRB.

NCI CIRB limits changes to consent forms. Please review the NCI CIRB's Guidelines for Permitted Boilerplate Language Additions and Boilerplate language Q & A for more information.

Please note:

  • CIRB requires a stand-alone HIPAA authorization document separate from the consent form.
  • CIRB does not allow changes in the main consent form, other than injury coverage language.
  • You must therefore use Emory's Site-Specific Consent-HIPAA Addendum.
  • You may also use our Withdrawal-Revocation Letter Template (DOCX), at any time. It does not require IRB review or stamping.
  • CIRB does not review Assent forms. Use our usual Assent template for your CIRB studies, and submit with the above (see Consent Toolkit section of our website).
  • Do not submit these additional Emory-specific forms to NCI CIRB. Just upload them in your local eIRB submission.
  • Emory IRB will stamp the additional Emory-specific documents at initial review, but not re-stamp unless they change (e.g. due to change in PI).

After NCI CIRB Approval: upload the NCI-CIRB-approved consent form to your submission and other Emory offices (such as OCR) ALONG WITH the NCI CIRB approval letter with the consent form's version date, so that Emory offices can cross-check the two.

The Emory IRB will NOT stamp your NCI-CIRB-approved consent forms, but will stamp the Site Information and HIPAA Authorization form described further below. We will also restamp older combination forms at amendment and renewal.

*For VA studies, the consent forms will continue to be stamped with Emory's date of acknowledgement. For VA studies only, you should continue to put the main NCI CIRB consent forms on the document stamping template.

  • The "3_5 - Change of PI Worksheet," allows the PI to be changed for multiple studies with a single submission. 
  • Submit a separate revised Annual Principal Investigator Worksheet or revised Study-Specific worksheet for any affected study that has a change in the local context considerations.
  • Refer to the Changing the PI on a Study Quickguide posted to the NCI CIRB website for assistance in completing the new Change of PI worksheet.
  • Contact the CIRB Helpdesk at 1-888-657-3711I if you have any questions regarding the use of a new Change of PI worksheet, please. contact the CIRB Helpdesk or 1-888-657-3711.
  • Submit a modification in Emory's eIRB system to update the PI.

NCI CIRB will notify the study team of any modifications to the overall study.

Modifications that require submission to NCI CIRB and Emory IRB

  • Changes to PI
  • Changes to Emory consent form language in the main consent form (not just in the Emory addendum)
  • Updates to drugs or devices used

Modifications that require review by Emory IRB only:

  • Changes to study staff that require immediate access to eIRB (other staff changes are reported at CR)
  • Changes to research sites
  • Changes in financial interests on the part of any study team members (if determined to be a COI, an update to the main consent form will need to be submitted to NCI CIRB)
  • Changes to Emory consent form language in the main consent form (not just in the Emory addendum)
  • Changes to our local consent/addendum

Modifications that do not require any notice to Emory IRB:

  • All other modifications

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:

  1. Step 1: Submit renewal documents to the appropriate cooperative group when requested
  2. Step 2: Once your site has received the continuing review approval or study closeout letter from the NCI CIRB, 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.

Please submit the following to the Emory IRB:

  • The renewal approval or study closeout letter from the reviewing 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 (Excel file).

NOTE: The Emory IRB will not restamp any consent documents except older consent-HIPAA combination forms.

You must submit Reportable New Information (RNIs) to the NCI CIRB according to the NCI CIRB's policies and procedures. You can find the requirements under the CIRB's "CIRB Standard Operating Procedures" (under CIRB STANDARD OPERATING PROCEDURES entitled UNANTICIPATED PROBLEMS AND SERIOUS OR CONTINUING NONCOMPLIANCE).

Check with your CIRB contact or email the CIRB helpdesk for more information about reporting mechanisms.

Most RNIs should be submitted to the Reviewing IRB only.

However, some RNIs 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.

Notify the following of egregious RNIs promptly

  • Emory Office of Compliance
  • Emory Risk Management Office
  • Emory IRB
  • Reviewing IRB

Examples of egregious RNIs:

  • Internal (at this site) death related or possibly related to the research
  • 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 submit RNI: 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 (Excel File).

Advarra IRB

Advarra is a commercial IRB and is not affiliated with Emory University. Emory has agreed to rely on the Advarra IRB for some multi-site industry sponsored clinical trials and for federally funded research when use of a single IRB is required and Advarra has been chosen as the single IRB.

When using Advarra as the single IRB, the Emory study team must first submit an external IRB (XIRB) submission to the Emory IRB to ensure local requirements are met and will then submit to Advarra through the online CIRBI system.

Even though the Advarra IRB is considered the single IRB of record for the study, Emory study teams are responsible for reporting certain information to the Emory IRB for the life of the study. Click on the tabs below to learn more about these reporting requirements.

Advarra IRB

For studies reviewed by Advarra, the protocol-level review for the lead site/sponsor should already be completed, and Emory is simply added as an additional study site via amendment. Learn more from Advarra's website.

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

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

Before creating a submission, first determine if the study is eligible for review by the Advarra IRB.

  1. Fill out Form A (electronic form) to determine if the study is eligible for review by the Advarra IRB. Save a copy of the submitted form.
  2. If Form A indicates the study is not eligible for review by the Advarra IRB, submit to the Emory IRB as usual.
  3. If Form A indicates the study is eligible for review by the Advarra IRB, follow the submission steps below.

Submit in eIRB once the study is approved by the Advarra IRB and the following information is available (as applicable):

  1. EPEX number
  2. Confirmation of the cost option from OCR or Peds RAS (Only if Options #1 and #3 apply)
  3. Confirmation of the in case of injury option from RAS/OSP (listed in eCTS)
  4. Approvals from ancillary review committees
  5. Required CITI training for all study team members (click "View CITI Training" on left menu)

Note: While you can create a study in eIRB in advance to get a Study ID number for routing and work on the smartform, all of the above must be in place before the PI clicks "Submit."

Submission Instructions:

  1. Upload the study-wide approval letter from the reviewing IRB in the Study-Related Documents section.
  2. In the protocol section, upload the most recent protocol approved by the reviewing IRB.
  3. In the Study-Related Documents section, upload the master consent form(s) approved by the reviewing IRB.
  4. Complete this External Consent Checklist (DOCX) to determine the Emory language to be inserted into the master consent form and upload the checklist in Local Documents section.
  5. Using the completed checklist, insert Emory's required language into the approved master consent form(s) using TRACKED CHANGES and upload in the Local Documents section.
  6. Upload the completed Form A in the Local Documents section.

Once the submission is complete, the Emory IRB will conduct a local context review and issue institutional signoff.

Important: Do not submit your site to the Advarra IRB for approval until you receive institutional signoff from Emory.

Once your site has received approval from the Advarra IRB, log a comment in the study with the approval letter and stamped consent forms. Please let your analyst know when you have done this so we may update the status of the study.

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 information regarding requirements to update the Emory IRB.

Submit modifications to the Advarra IRB per their policies and procedures. (Note: most reviewing IRBs do not review local study team changes other than PI 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
  • changes to the Clinical Research Key Points (CRKP) summary

No other changes need to be submitted promptly 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:

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

Once your site has received the continuing review approval or study closeout letter from the Advarra IRB, provide it to the Emory 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 or study closeout letter from the Advarra IRB.
  • Changes 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 (Excel file).

You must submit Reportable New Information (RNIs) to the Reviewing IRB according to the Reviewing IRB's policies and procedures.

Most RNIs should be submitted to the Reviewing IRB only.

However, some RNIs 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.

Notify the following of egregious RNIs promptly :

  • Emory Office of Compliance
  • Emory Risk Management Office
  • Emory IRB
  • Reviewing IRB

Examples of egregious RNIs:

  • Internal (at this site) death related or possibly related to the research
  • 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 submit RNI: 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.

See our submissions guidance table (PDF).

Emory Contacts

Advarra Contacts

  • For very general questions, view the General Contacts page.
  • For questions about how to submit in CIRBI, contact Caitlin Ziemak at caitlin.ziemak@advarra.com
  • For other questions about Advarra-reviewed studies, contact Michieva Flores at michieva.flores@advarra.com.
  • For questions regarding a specific Advarra submission, contact the Your Advarra analyst assigned to your study.