Collaborative Research and Central IRBs (including WIRB)



***ABOUT THE COMING NIH SINGLE-IRB REVIEW POLICY...***

In January, most new NIH grant proposals for multisite research will need to use a single IRB of record. Per the NIH: "This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.  It does not apply to career development, research training or fellowship awards."

See policy here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html and an FAQ here.

After lengthy internal discussion and analysis of resources, Emory IRB has determined that we can not serve as the reviewing IRB for multisite clinical research studies. (We may be able to serve as the single IRB of record for multisite minimal risk studies.)

If Emory is the lead site on an NIH grant, and is asked to take on the IRB responsibility, then the Emory IRB will work with you to obtain a quote from an independent IRB to serve as the single IRB of record. We have consulted with the NIH, who have confirmed that this option as acceptable, and we have also heard from various peer institutions that they will be taking the same path.

What this means for you: Early in the proposal stage for multisite studies, where Emory is asked to take on IRB responsibility, you must work with OSP and the Emory IRB to identify the IRB solution, and to ensure that it is worked into the proposed budget. Consult with our IRB as early as possible, to avoid complications. And thank you!

What constitutes collaborative research?

Collaborative research is defined as research conducted in cooperation with an institution or facility that is not affiliated with Emory.  When two or more institutions are engaged in research, multiple IRBs are responsible for providing oversight.  As such, separate applications may be necessary; however, to avoid duplicate review an IRB  Reliance Agreement may be arranged to establish one IRB as the designated IRB of Record.

What is an IRB Reliance Agreement?

It is a formal, written agreement that provides a mechanism by which one institution or individual engaged in research delegate IRB oversight to an independent IRB, or an IRB of another institution. Institutions may use different terms for this kind of agreement, e.g. reliance agreement, IRB authorization agreement (IAA), individual investigator agreement (IIA), or memorandum of understanding (MOU).

A reliance agreement is NOT required unless both institutions are "engaged" in human subjects research. For example, if one site is only analyzing coded, deidentified data, and no one at that site can ever access the key linking codes to identifiers, then that site may not be "engaged" in human subjects research. There would be no need for an IRB reliance agreement in that case. For more information about engagement, please see the OHRP Guidance on Engagement of Institutions in Human Subject Research, and discuss with an IRB analyst.

IRB Authorization Agreement (IAA) - This allows an institution to extend its IRB oversight to cover another institution. In practice, this means one institution's IRB will be the IRB of record which reviews the study or group of studies. The reviewing IRB will likely need some input from the relying institution about their local context. 

Individual Investigator Agreement (IIA) - This allows an institution to extend its oversight to cover collaborating independent investigators (e.g. self-employed consultants), or investigators that are employed by institutions which do not typically conduct human subjects research (e.g. some nonprofit organizations). These are very simple agreements. 

Memorandum of Understanding (MOU) - generally are used to designate an IRB of record for a two ore more closely aligned institutions. Emory's current MOUs are listed below with additional details for each institution.

How do I request an IAA or IIA?

First, please work with your study analyst, or another representative from the IRB, to determine if a reliance agreement may be appropriate. The IRB Reliance Agreement Worksheet is a helpful tool to use, but it should be in the context of a discussion with an IRB representative. We prefer to work right from the start with the Emory study team, instead of getting requests from the other institution's IRB or PI. In this way, we are sure that the Emory study team agrees with the request. 

When a funder or cooperative group requests that Emory rely on a single IRB for a study or group of studies, the Emory IRB staff will work with you to gather information needed to determine if we can do so, via the Central IRB Reliance Decision Checklist.

What happens after I submit the IRB Reliance Agreement Worksheet? 

Once the Worksheet is submitted, the IRB staff will ask for clarification if needed and will determine if reliance is appropriate. If so, the Emory IRB staff will need to know with whom to communicate at the other site, or we can work through the Emory study team if preferred.

One of the two sites will draft the reliance agreement - usually the site agreeing to provide the IRB review - and both institutions will sign (or the independent investigator, if applicable). Once the agreement is finalized, some follow-up may be needed.

If Emory is the reviewing IRB, the following might be necessary:

  • Updating the consent form (to include the relying institution's right to look at study records),
  • Updating the eIRB smartform (to include the relying site and their personnel)
  • Ensuring sign-off from the relying institution re: their local requirements (ancillary approvals, investigator training and financial disclosures, appropriateness of the protocol for their site...)

If Emory will be relying on another IRB:

  • The Emory PI will likely need to submit an abbreviated application in eIRB so that the Emory IRB office can track the research for the institution, and do administrative review of Emory-specific requirements.
  • If this is needed, we will provide you with a special pre-filled smartform to use that guides you through what items you can skip.

You may observe that IRB reliance agreements do not eliminate work for any of the sites; but they do avoid the need to submit ongoing amendments and continuing reviews to the relying sites' IRBs.

How long does it take to get an IRB Authorization Agreement in place?

First, Emory IRB must determine if the agreement is appropriate to start with. Once that is confirmed, the form must be reviewed for legal purposes (if Emory's template is not used), and then signed by institutional officials from both institutions (Emory’s institutional official is the Vice-President for Research Administration for federally-funded studies; or the IRB Director for other funding sources). Different institutions may wish to use simpler or more complex agreements. It may take several weeks to evaluate the agreement and obtain the necessary signatures from both parties. 

Are there collaborations for which IRB Authorization Agreements are not appropriate?

Yes, if local review by each site's IRB is the best way to ensure that the rights and welfare of research subjects are protected. In particular, Emory rarely enters into reliance agremeents for the review of clinical studies, unless (a) one of the parties is only doing a minimal-risk component of the study (e.g. data analysis), or (b) reliance is required in order to participate in the multisite study. Also, Emory generally does not rely formally on the review of international IRB's/Ethics Committees, and we try to limit our reliance on non-AAHRPP-accredited IRB's.

Who decides if IRB Authorization Agreements are appropriate?

Emory's institutional official makes the determination whether an IRB authorization agreement is appropriate.  Emory IRB staff can make a preliminary assessment, however.

What if my research qualifies for exempt review?

Per Emory's P&P's, an IRB Authorization Agreement, or other form of reliance agreement, will not automatically be required if the research is deemed exempt by any institutions considered engaged in the collaborative research.

In cases where Emory has determined collaborative research to not be Exempt, instead requiring Expedited or Full Board review, but other engaged institutions have determined the research to be Exempt, Emory shall proceed with its own review. Emory shall evaluate the exempt determinations of the other engaged institutions. A reliance agreement may not be required.

What if I need to transfer data to or from Emory?

You may need to contact either the Office of Technology Transfer or Office of Sponsored Programs to establish a data transfer agreement; please see "Data Transfer Agreements" under the Frequently Asked Questions section.

How to identify Emory as the local institution when submitting a study via Connexus?

When submitting through Connexus, the study team can ensure that WIRB links the study to Emory's research program by naming "Emory University" as the institution which has a contract to use WIRB for IRB services.  The Emory IRB institution number is 62571.

Who do I contact if I have more questions?

Contact Maria Davila at maria.davila@emory.edu or at (404)712-0724.


Current MOUs:

Atlanta VA Medical Center

AVAMC - Emory IRB will serve as the IRB of record except when relying on NCI's CIRB (see below).

Children's Healthcare of Atlanta

The CHOA-Emory agreement defines “collaborative research” as human subjects research for which both Emory and CHOA have provided some or all of the following: funding, personnel, site access, patient access, records access, or other material support. 

CHOA IRB will review collaborative research in which (i) the Human Subjects Research is limited to medical records reviews of CHOA patients; or (ii) the Human Subjects Research is conducted under the supervision of a principal investigator or investigator who is solely employed by CHOA, but which involves the participation of other Emory-employed study personnel, such as sub investigators.

Emory IRB will review all other collaborative research.  Note: a form must be submitted to the CHOA IRB when a collaborative research study is reviewed by the Emory IRB. See the CHOA IAA Acknowledgment Form.

Fred Hutchinson Cancer Research Center

Fred Hutchinson - serves as IRB of record for all collaborative research programs administered through the HIV Vaccine Trails Network (HVTN) Coordinating Center and the Cancer Immunotherapy Trials Network (CITN).

Georgia Tech

GA Tech

(a) Student Research:

i. If a Protocol is initiated by an Emory student who is working on the Protocol with a PI whose Home Institution is Georgia Tech or an Emory student wishes to join the research team on a protocol initiated by a PI whose Home Institution is Georgia Tech, and the majority of the Protocol activities (excluding data analysis) are to be completed at a Georgia Tech site, then the Emory IRB shall rely upon the Georgia Tech IRB for review/oversight of the Protocol.

ii. If a Protocol is initiated by a Georgia Tech student who is working on the Protocol with a PI whose Home Institution is Emory or a Georgia Tech student wishes to join the research team on a protocol initiated by a PI whose Home Institution is Emory, and the majority of the Protocol Activities (excluding data analysis) are to be completed at an Emory site, then the Georgia Tech IRB shall rely upon the Emory IRB for review/oversight of the Protocol.

iii. If a Protocol is initiated by either a Georgia Tech or Emory student and the Protocol Activities (excluding data analysis) take place both at Emory and Georgia Tech sites, then both the Emory and the Georgia Tech IRBs shall be responsible for review/oversight of the Protocol.

iv. Notwithstanding anything to the contrary above, if the Protocol activities (including data analysis) involve the use and/or disclosure of Protected Health Information from Emory University's Covered Entity, then the Emory IRB, acting as privacy board, shall review the Protocol solely for HIPAA Privacy Rule purposes.

(b) Faculty/Staff Research:

i. If a PI or co-investigator on a Protocol has Georgia Tech as a Home Institution, but the majority of the Protocol activities (excluding data analysis) take place at an Emory site, then the Georgia Tech IRB shall rely upon the Emory IRB for review/oversight of the Protocol.

ii. If a PI or co-investigator on a Protocol has Emory as a Home Institution, but the Protocol activities (excluding data analysis) take place entirely at a Georgia Tech site, then the Emory IRB shall rely upon the Georgia Tech IRB for review/oversight of the Protocol.

iii. If the PI on a Protocol has either Emory or Georgia Tech as a Home Institution, and the Protocol activities (excluding data analysis) take place at both Emory and Georgia Tech Sites, then both the Emory IRB and the Georgia Tech IRB shall be responsible for review/oversight of the Protocol.

iv. Notwithstanding anything to the contrary above, if the Protocol activities (including data analysis) involve the use and/or disclosure of Protected Health Information from Emory University's Covered Entity, then the Emory IRB, acting as privacy board, shall review the Protocol solely for HIPAA Privacy Rule purposes.

Morehouse School of Medicine

Morehouse School of Medicine

(a) Faculty/Staff Research:

i. If a PI or Co-Investigator on a protocol has Morehouse as a Home Institution, but the majority of the Protocol activities (excluding data analysis) take place at an Emory site, then Morehouse shall rely upon the Emory IRB for review/oversight of the Protocol.

ii. If the PI or Co-Investigator on the Protocol has Emory as a Home Institution, but the Protocol Activities (excluding data analysis) take place entirely at a Morehouse site, then the Emory IRB will rely upon the Morehouse IRB for review/oversight of the Protocol.

(b)Grady Memorial Hospital, Hughes-Spalding Hospital:

i. The IRB of the PI's home institution will provide review/oversight for both institutions.

National Cancer Institute

NCI CIRB - NCI CIRB will be the IRB of record for all NCI CIRB eligible studies. See http://www.irb.emory.edu/forms/external-irbs/cirb.html.

NEALS

Emory may cede review to the NEALS CIRB.

NeuroNext

NeuroNext - Emory may cede review to the NeuroNext CIRB.

St. Joseph's Hospital of Atlanta

St. Joseph's -  If a PI has Emory as a Home Institution, then Emory will be the IRB of record.  

Guidance for study teams conducting clinical research and/or clinical trials at Emory St. Joseph's Hospital.

StrokeNet

StrokeNet - Emory may cede review to the StrokeNet CIRB.

University of Alabama - Birmingham

UAB CCIRB- Emory may cede review to the UAB CIRB for Collaborative Antiviral Study Group protocols coordinated by the UAB Central Unit.

Western IRB

WIRB - All new drug or analogous device studies that are industry-designed, initiated, and sponsored will be sent to WIRB for review (with select exceptions). See http://www.irb.emory.edu/forms/external-irbs/WIRB.html.