Collaborative Research/Single IRBs/Reliance Agreements

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 to work on the smartform, all of the above must be in place before the PI clicks "Submit."  

Link to Video with submission instructions

Submission Instructions:

1. In the protocol section, upload the most recent protocol approved by the reviewing IRB and this completed document (DOCX). NOTE: This document is not needed for studies reviewed by WCG IRB, Advarra IRB or the NCI CIRB. 
2. In the Study-Related Documents section, upload the master consent form(s) approved by the reviewing IRB and the initial study-wide approval letter from when the protocol was first approved.
3. 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.
4. Note: The Emory IRB does not allow edits to our institutional language unless OSP confirms the injury language CONFLICTS with the executed CTA. If the sponsor believes the injury language conflicts with the CTA, confirmation is needed from OSP. 
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 of the smart form. 
6. 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.

For all External IRB studies, follow the guidance below for Modifications, Continuing Reviews and RNIs.

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:

• adding or removing 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

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 Emory PI and other study team changes
  • Use "Update Study Details" for study-wide changes or change in Lead PI

• "External IRB" state (rare)- you need to submit an "Update" to the submission. Updating a study with "external IRB" 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. 

Continuing Reviews

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 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).

Study Closeouts

Once you receive the study closeout letter from the reviewing IRB, log a comment in the history tab of the study stating that the study has been closed by the reviewing IRB, attach the letter and mark the comment to go to the IRB coordinator. The Emory IRB analyst will then close the study in eIRB. 

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 IRB 
• Reviewing IRB

Note: Some events will also require reporting to the Emory Office of Research Integrity and Compliance and the Emory Risk Management offices (Emory Healthcare).

The IRB can assist in determining what types of reports are required, so please reach out immediately in the above scenarios.

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)
• Study Suspension (related to compliance concerns)

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).

 THE EMORY and CHILDREN'S PEDIATRIC INSTITUTE AGREEMENT

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 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 (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.

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 now serving as the single IRB for multi-site federally funded research when Emory is the prime awardee of the grant for studies including no more than five sites.   

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.  The Emory IRB has a choice about whether to serve as the single IRB for a multi-site study, and there are important factors for investigators to consider when choosing the single IRB for their projects.  You will need to schedule time to meet with the reliance team to discuss the research activities that will be conducted, the sites you plan to include and the impacts on your study team.  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

Below are documents you may need to complete and include with your grant application. 

• Single IRB Plan instructions/guidance
• Single IRB Plan template
• Communication Plan template
• Sample of Completed Communication Plan

Single IRB Fees

Some academic IRBs, including the Emory IRB, charge fees for serving as the reviewing IRB for multi-site studies. Be sure to inquire about review fees and include the cost of the reviews 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.

Quotes for single IRB fees are based on the assumptions provided, and the study will only be billed for the services that are rendered.  Also, keep in mind that if translations are needed, the cost of translation is an extra charge that you will want to include in your budget.

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- submit via 'Create Site Modification" (for Emory-specific information changes) or "Update Study Details" (for study-wide changes). Updating a study with "active" status (PDF)
• "External IRB" status- you need to submit an "Update" to the submission. Updating a study with "external IRB" status (PDF)

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

• Send an email to IRB.reliance@emory.edu with the following information:
  • name of the the external study team member(s) you wish to add to your submission.  
  • name of the external study team member's home institution
  • description of the specific research activities the external study team member will perform
  • time period the external team member is expected to conduct research activities
  • a link to the study in eIRB
  • the completed External Study Team Member List template (use only one list per study and include all external study team members.)
• We will review the information and determine if we need to contact the external study team member's home IRB for additional information. If the external study team member does not have a home IRB, we will execute an agreement with the individual rather than an institution. 
• We will respond to your email with any questions and/or the completed documents that will need to be included in the modification to add the external study team member. Note that the protocol may need to be updated to reflect the involvement of the external study team member. This modification would need to be for "other parts of the study."

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

Please review the information in the accordian titled "Emory as the Single IRB of Record."  Reach out to the reliance team at irb.reliance@emory.edu if you have any questions.

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.

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.

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
• Those with the Atlanta VAMC 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.

Follow the submission guidance under the "Emory Relying on External IRBs" tab. 

Fees associated with WCG IRB review

Please contact 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.

• 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.

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

• WCG IRB Listserv
• One of the Analyst Assistants listed on the IRB Staff webpage
• Julie Martin (Team Lead) at julie.t.martin@emory.edu

WIRB Contact

Christopher Gennai, CIP (Senior Account Manager, Institutions)

• Office: (800) 562-4789
• Fax: (360) 252-2498
• Email: cgennai@wirb.com

Jonathan Gellert (Institutions Partnership Manager)

• Email: jgellert@wirb.com
• Phone: 1-855-818-2289

The NCI CIRB is the IRB of record for many NCI-funded cooperative group studies. The NCI CIRB may review the following type of 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

Please review the NCI CIRB's guidance for new users as well as guidance on when to use the NCI CIRB, IRB Manager and CTSU websites.

You can find an overview of the NCI CIRB's study review process here. 

After reviewing this information, send an email to irb.reliance@emory.edu if you need to be added to the NCI CIRB roster. 

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:

• The NCI CIRB requires a stand-alone HIPAA authorization document separate from the consent form.
• The NCI CIRB does not allow changes in the main consent form, other than injury coverage language.
• Study teams must use Emory's Site-Specific Consent-HIPAA Addendum.
  • Use Emory's latest consent section table (DOCX) when modifying the main consent, and creating the Emory addendum.
• Study teams may also use our Withdrawal-Revocation Letter Template (DOCX), at any time. It does not require IRB review or stamping.
• The NCI 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 Emory external IRB submission.
• The Emory IRB will stamp the additional Emory-specific documents with the NCI CIRB approval date at initial review, but will 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 provide them to 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.

• Contact the CIRB Helpdesk at 1-888-657-3711I if you have any questions regarding the use of a new Change of PI worksheet.
• Don't forget to 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:

• "Active" state
  • Use "Create Site Modification" for Emory-specific information changes
  • Use "Update Study Details" for study-wide changes 
  • How to update a study with an "active" status (PDF) 
• "External IRB" state (rare) - you need to submit an "Update" to the submission. 
  • How to update a study with an “external IRB” status (PDF)

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)
• Study Suspension (related to compliance concerns)

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).

• External IRB Consent Checklist (DOCX)
• XIRB Smartform Guidance Document (PDF)
• IRB Handbook (Reference Materials section of the Advarra CIRBI Platform)
• Advarra promptly reportable information form (Reference Materials Section of the Advarra CIRBI Platform)

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.