Collaborative Research and External IRBs
When Emory is involved in a collaborative or multi-site research study, there are a few options for IRB review: 1) each site's IRB can review the research for its site activities or 2) all participating sites can cede IRB review to one single IRB. For each site that cedes IRB review to a single IRB, a fully-executed reliance agreement must be in place with the single IRB.
Please click on the frequently-asked questions below for information about reliance agreements and the single IRB process.
Collaborative/multi-site research is research conducted in cooperation with an institution or facility that is not affiliated with Emory.
- Collaborative research - when non-Emory investigators are coming to Emory's site to aid the Emory study team with some aspect of the research (help with consenting Emory subjects, access to Emory subjects' identifiable information, assisting with administering study interventions at Emory); could also be when some part of the protocol is taking place at another institution (e.g. other institution doing data analysis only).
- Multi-site research - when Emory is serving as one of many participating sites running a full protocol (each institution enrolling its own subjects and carrying out the protocol at its own site).
When two or more institutions are engaged in collaborative or multi-site 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. Emory IRB has the discretion to decide whether to pursue a reliance agreement or not.
A reliance agreement is NOT necessary or appropriate 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 send any general questions to the IRB Reliance Listserv. You may also use our Engagement Determination Checklist to help you understand the concept of "engagement" better.
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).
- 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.
- Umbrella/Master Agreement - This covers multiple studies at once and can especially useful when Emory is participating in a group of studies or a network which requires the use of one single IRB. The agreement can specifically list each protocol which is covered or it can allow Emory IRB to cede review and oversight for every study within a certain network. Please see "What umbrella agreements and MOUs are in place?" for a list of our relationships with other institutions.
- Memorandum of Understanding (MOU) - This document is drafted between two institutions and defines the institutions’ relationship long-term. It’s generally more broad than an umbrella agreement and may list a number of different scenarios under which either institution’s IRB would review the research. Please see "What umbrella agreements and MOUs are in place?" for a list of our relationships with other institutions.
The reliance process comes with a lot of new or additional responsibilities for lead study teams and study teams at the relying institution. You may find that the reliance process requires more work and coordination during the initial stages. It's very important that you have the knowledge to handle the role and that you have the staff and resources in place to handle these responsibilities. If you are the Overall PI, you are the person ultimately responsible for the regulatory and institutional compliance of ALL study team members (at the lead site and relying sites). You must make a plan to ensure this compliance.
Please see our flowchart which visualizes what study teams are required to do during the process.
Please also see our list of Lead PI and Site PI duties during the reliance process.
See our guidance document for creating a plan to manage your duties as the lead site.
IF YOU NEED A RELIANCE AGREEMENT FOR A STUDY THAT HAS ALREADY BEEN APPROVED AS A SINGLE-SITE STUDY BY EMORY, STOP. PLEASE GO TO THE NEXT SECTION DOWN FOR INFORMATION ABOUT HOW TO ONBOARD NON-EMORY SITES/INVESTIGATORS TO AN ONGOING STUDY.
The first step to pursue a reliance agreement for a new multi-site/collaborative study requires you to download and fill out the IRB Reliance Request Form and send the completed form to our IRB Reliance Listserv (IRB-RELIANCE@LISTSERV.CC.EMORY.EDU).
Each question on the form MUST be filled out fully. There will be questions about the other institution you might not know offhand. You MUST reach out to your counterparts at the other institution to get that information.
If you submit a Request Form that is not completed in full, your Request will not be considered.
Once the Request Form is submitted, an IRB staff member will reach out and ask for clarification if needed and will determine if reliance is appropriate.
Please ensure that you do not communicate to the other institution that the Emory IRB is willing to enter into a reliance agreement prior to receiving confirmation of Emory’s willingness from Emory IRB.
We prefer to work right from the start with the Emory study team instead of receiving requests from the other institution's IRB or PI. In this way, we are sure that the Emory study team agrees with the request. The PI at the other institution will also need to use the other IRB's system for making a reliance request before Emory IRB can negotiate the reliance agreement with the other IRB.
If reliance is determined to be appropriate, the IRB staff member will reach out to the other institution's IRB to negotiate the agreement and have the agreement signed by the institutional officials for both institutions.
To pursue an IIA or an IAA for ongoing studies that were initially approved by Emory, please contact your analyst (found on eIRB).
You should contact your study's assigned Emory IRB analyst to handle this situation on an individualized basis. Our Reliance Request process, described in the section above, is tailored specifically to studies that are known to be multi-site or collaborative at the time of initial IRB review.
In this situation, your analyst will have you submit an Ongoing Study Reliance Request Form to them. Once it has been determined that reliance on Emory is appropriate for your study, your IRB analyst will make sure that the correct type of agreement (IIA or IAA) is executed with the other institution, entity, or individuals. At that time, you'll be responsible for adding the study site and/or all non-Emory study members via an amendment to the study as described in this guidance.
A reliance agreement may need to be established where Emory is being onboarded as a participating site in a consortium or network and the sponsor requires a single IRB.
The study team must fill out the Network/Consortium Request Form in lieu of a general Reliance Request Form when Emory is being asked to RELY on a single IRB (whether commercial IRB or another institutional
IRB) for a consortium or network of studies. Fill out the form fully and send via email to the IRB Reliance Listserv so that Emory can determine whether we are willing or able to cede IRB review to the designated single IRB. DO NOT EXPRESS to the lead site or the single IRB that Emory is willing to rely until you receive a determination to that effect from Emory IRB.
Where Emory is the LEAD SITE of a consortium or network, Emory IRB does not have the resources to serve as the Single IRB. Where the sponsor requires a single IRB, Western IRB (WIRB) will be our designated Single IRB. The request form should NOT be used for this situation. Instead, the study team should send an email regarding the consortium or network to the IRB Reliance Listserv.
NIH SINGLE-IRB POLICY
For most multisite NIH grant proposals due on or after January 25, 2018, NIH policy will require the use a single IRB of record. THIS POLICY APPLIES ONLY TO NIH-FUNDED RESEARCH. OTHER RESEARCH DOES NOT REQUIRE A SINGLE IRB UNLESS THE SPONSOR SPECIFICALLY STATES THAT DOES.
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..."
There are also some exceptions to the policy. The following awards are NOT required to use a single IRB: Career development (K), institutional training (T), or fellowship awards (F).
See policy here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html and an FAQ here.
See exceptions here: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-003.html.
Also see FAQ here on single IRB costs and budgeting for grant applications.
It is generally presumed that the lead site/prime awardee will either serve as the Reviewing IRB or designate an independent IRB as their IRB of record. Much like we do with our industry-funded studies, Emory has designated Western IRB (WIRB) as our IRB of record for multi-site NIH studies. This is a direct charge fee-for-service activity. There are some very limited circumstances when we might review the research in-house, but that is determined on a study-by-study basis by us (which we determine when we’re reviewing the Single IRB Intake Form). There might also be situations where another participating site’s IRB volunteers to be the single IRB, and we will also consider that on a study-by-study basis.
What this means for you:
- YOU MUST FIRST SPEAK WITH YOUR NIH PROGRAM OFFICER AND CONFIRM THAT YOUR RESEARCH FALLS UNDER THE MANDATE.
- If you are applying for one of the awards above that is an exception to the policy, DO NOT STATE THAT A SINGLE IRB WILL BE USED. Instead, you should NOT upload a single IRB plan and should instead choose "N/A" to Question 3.2 of the PHS Human Subjects and Clinical Trial Information form. See the Application Guide for more information.
- You must then submit the Single IRB Intake Form via email to the IRB Reliance Listserv as early in the grant application process as possible so that Emory IRB can advise you on how to draft your Single IRB Plan.
- You will need to prepare a Single IRB Plan to submit with your NIH grant application. NOTE: the plan can say that you have not yet identified the specific IRB of record. Also, the Plan is not part of what goes into your score.
- Part of the Single IRB Plan is a "Communication Plan" that shows the division of responsibilities between the lead and participating sites and the sIRB.
- We can help you get a quote/cost estimate for single IRB review to add to your budget. Follow the instructions at the top of this Single IRB Quote Request Form to get a quote. You should use this process for studies that will be reviewed by an independent IRB or external institutional IRB. Please remember that this quote is based on the assumptions provided, and Emory will only be billed for the services that are rendered. Also, keep in mind that if translations are needed, that is an extra charge. PLEASE FOLLOW UP WITH Western IRB (WIRB) to let them know whether your project has been funded or not.
If you will be a participating site's PI:
- In this case, you are not responsible for the grant submission or the Single IRB Plan. That is the job of the Lead Study Team. You may be asked by the Lead Study Team to provide a Letter of Support from Emory IRB.
- If a Letter of Support is required by the Lead Institution, you should send their letter template, a completed Single IRB Intake Form, and a copy of the drafted Single IRB Plan to the IRB Reliance Listserv.
- If the Lead Institution does not have a template for you to use, here is a template.
UPDATED! CHOA Involvement: How do I know whether I should submit a reliance request to Emory IRB, CHOA IRB, or both?
NOTE: A NEW AGREEMENT WITH CHOA REGARDING RESEARCH OVERSIGHT AND ADMINISTRATION EFFECTIVE 09/01/2018 DUE TO THE FORMATION OF THE EMORY + CHILDREN'S PEDIATRIC INSTITUTE.
The Pediatric Institute is not a physical building. Rather, it's an entity created which employs physicians and clinicians from Emory and CHOA itself rather than those physicians and clinicians (PhDs/PsyDs) being directly employed by Emory or CHOA (whereas, coordinators and lab staff are still employed directly by Emory and CHOA). For more information about the Pediatric Institute, watch our webinar.
The new agreement covers human subjects research in which both Emory and CHOA provide some or all of the following: funding, personnel, site access, patient access, medical records access, research records access, or other material support. This agreement does NOT cover research for which either Emory or CHOA provides support to the other via a Fee for Service Agreement.
The location of your study's IRB review and research administration (CHOA or Emory) depends on the type of research. Where your grant is "routed" according to this table is where you will undergo IRB review and conflict of interest review.
- For unfunded studies, contact the Department of Pediatric Administration.
- For studies funded by internal department funds, reach out to the CHOA and Emory IRB directors via email for assistance.
- For studies conducted at CHOA plus an outside affiliated facility (such as Hughes-Spaulding), submit to Emory.
- For chart review studies with CAP patients, submit to CHOA.
- 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.
ANCILLARY REVIEWS will take place where the PERFORMANCE SITE is.
FOR STUDIES WHERE YOU'RE BEING ASKED TO RELY ON AN EXTERNAL OR SINGLE IRB: You must undergo the respective reliance request process with both Emory and CHOA IRBs.
If my study is reviewed by CHOA IRB, do I need an 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 for 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.
First, Emory IRB must determine if the agreement is appropriate. Once that is confirmed, the proposed reliance agreement may have to be reviewed for legal purposes, and it is 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, and the negotiation process can be longer or shorter depending upon many different factors. It may take several weeks to evaluate the agreement and obtain the necessary signatures from both parties.
Emory IRB staff will make a preliminary assessment regarding whether a reliance agreement is appropriate. These factors are used by Emory to make a decision. Then, Emory's institutional official approves the final decision. Emory's Office of Research Administration has the discretion to decline any Reliance Request and to pursue an agreement. Study teams are NOT allowed to make the decision for themselves.
If local review by each site's IRB is the best way to ensure that the rights and welfare of research subjects are protected, Emory may choose to decline your reliance request. In particular, Emory rarely enters into reliance agreements 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 pursue reliance agreements with international IRBs/Ethics Committees and tries to limit reliance on non-AAHRPP-accredited IRBs
For international studies: The Emory IRB will generally not agree to rely on international IRBs/Ethics Committees, but we may enter into a reliance agreement with a domestic (i.e. US) site in a multisite study where there are also international sites. An international site may request to rely on Emory IRB review if they have no available alternative, but if that site does have an IRB or Ethical Committee available, their review is helpful to satisfy our need for local context input. The IRB Director should be consulted for such requests.Recruitment-only sites: If a site is simply allowing outside investigators to recruit subjects or conduct a study at their site, without collaborating as researchers on the study that would not make the site “engaged” in the research per OHRP guidance. An agreement will therefore not be needed. Some sites do not observe that guidance, however, and require IRB oversight of their involvement; if such sites request to rely on Emory IRB, consultation with the IRB Director is required.
Student Research: What if an Emory student needs to work on a study at another institution or a student from another institution needs to work on an Emory study?
Emory Students at Other Institutions
Emory IRB Review is required when an Emory student 1) will be working as a study team member on a protocol at another institution as an agent of Emory, and 2) the student's participation in the research activities constitute "engagement" in the research.
Emory considers a student to be an agent of Emory on a protocol when the student is working on the protocol for 1) academic credit at Emory, 2) practicum or capstone credit at Emory, 3) as some other requirement of their Emory degree, or 4) payment on Emory payroll. The researcher would not be considered an agent of Emory on a protocol when the student is working on the protocol as part of a formal internship with the other institution (or another organization) or is being paid by the other institution (or another organization). The researcher's status as an Emory student would be incidental to their involvement in the research under these circumstances.
Where Emory IRB Review is required for a student's involvement in an external institution's research as described above, it may be possible for Emory to cede IRB review to the other institution's IRB rather than make a submission to Emory. Please submit a reliance request form to pursue this avenue.
Other Institutions' Students at Emory
Where a student comes to Emory to work on a protocol, the student's participation in the research must undergo IRB review when the student's activities constitute "engagement" in the research.
If the student's institution considers the student to be an "agent" of the institution through his/her participation in the research, the institution may choose to conduct its own IRB review for the student or may choose to cede review to Emory via a reliance agreement. You, the student, or the student's faculty advisor will need to get in touch with the institution's IRB to ask if the institution considers the student to be "engaged" in the research and an "agent" of the institution. If yes, and if the institution is willing to cede review to Emory, please submit a reliance request form.
If the institution does not consider the student to be an "agent" of the institution through his/her participation in the research, Emory IRB may want to pursue an individual investigator agreement with the student. This will require the student to undergo CITI training at Emory and to disclose any conflicts of interest to Emory's COI office. Please submit a reliance request form to pursue this avenue.
If your study is using an external IRB, use the study staff change feature in eIRB as you normally would for an Emory-approved study. You should also report any study staff changes to the REVIEWING IRB using their process as they are your IRB of record.
You might think that an IIA is appropriate any time that only a few investigators from another institution are coming to Emory to participate in the protocol, but this is NOT the case.
An IIA is only appropriate when an investigator involved in Emory's research:
- Is NOT affiliated with an FWA-holding institution that regularly conducts research (not affiliated with an institution at all or affiliated with an institution that does not hold an FWA and does not conduct research); and
- Is NOT acting as an "agent" of Emory through his/her participation in the protocol (not on Emory payroll, not operating as an employee of Emory for this protocol specifically, not acting as a student of Emory receiving academic or practicum credit, not acting as an intern of Emory)
If the investigator does not meet both of the above qualifications, an IIA is not appropriate and another course of action would be needed. Please see our flowchart for a better understanding.
An Individual/Independent Investigator Agreement is not required for investigators WITHOUT an IRB of record who are working on exempt studies. They can be simply added to a new study submission after their training has been verified (amendment not required if adding them after initial approval).
Per Emory's P&Ps, in cases where Emory has previously reviewed and made an exempt determination for a study, any non-Emory study team members who come aboard must request an exempt determination at their own institution and follow the instructions of their institution and are not permitted to request a “reliance” or “acceptance” of the Emory exempt determination by their IRB. If the non-Emory study team member is not affiliated with an FWA-holding institution and would be determined by Emory IRB for an expedited or full board review-level study to need an IIA, no IIA or new Emory exempt determination is needed. The Emory study team should consult the Emory IRB Reliance Specialist for guidance.
In cases where another engaged institution has already reviewed and determined the collaborative research to be exempt, Emory IRB will not “rely on” or accept the exempt determination of the other institution. The Emory study team must request an Emory exempt determination through the normal process.
If Emory is the reviewing IRB (and use the Checklist to follow your progress):
- Submit the main study for the Emory study team only and pass approval documents along to relying sites
- Await the full-execution of the reliance agreements (set up separately with each relying site)
- Receive all necessary documents from the relying site (Local Context Worksheet, Institution Information Sheet, site-specific consent forms and HIPAA authorization forms)
- Onboard the relying sites to the study via amendment in eIRB (see Guidance on this)
- Send any site-specific approval letters and documents to the relying sites
- Throughout the study, complete any site-specific or protocol-wide amendments on behalf of Emory and all of the relying sites and provide amendment approval letters and new approved documents to the relying sites
- Upon renewal, complete the multi-site continuing review process using this guidance document (providing the Relying Site with the CR Site-Specific Update Form)
- Upon closeout, complete the close-out process for the study and send the close-out letter to the relying sites
- The IRB will create an eIRB XIRB shell for the Emory study team. The Emory PI will need to submit the local XIRB submission using the shell so that the Emory IRB office can track the research for the institution and do administrative review of Emory-specific requirements (see Guidance on this). Use the XIRB Smartform Guidance document.
- The Emory PI will have to upload the approved protocol, the model consent/HIPAA documents, and site-specific versions of the consent/HIPAA documents to the submission. Please see the guidance above.
- The Emory PI will have to fill out the Reviewing IRB's local context worksheet(s), as well as any other required forms, to the best of his/her ability and email to the Emory IRB for review and signature. For help with what to include in the local context worksheet, see our copy and paste language here.
- The Emory PI will have to complete all other Emory requirements (departmental review, biosafety review, radiation safety review, Office of Quality, contract negotiation, OCR/OSP routing, conflict of interest review, CITI training, etc.)
- The Emory PI will have to await institutional signoff from Emory IRB before being onboarded as a participating site with the Reviewing IRB
- Once approved as a site, the Emory PI must upload any approval letters and approved documents into a logged comment in eIRB.
- The Emory PI must give the Reviewing IRB's site approval letter for Emory and a fully-executed copy of the reliance agreement (logged into an eIRB comment upon execution) to other Emory offices that need proof of the reliance relationship in order to process the research.
- The Emory PI must continue to provide the Emory IRB and other Emory offices with new approval letters and newly approved documents throughout the course of the research.
- Upon closeout, the Emory PI must provide the Emory IRB and other Emory offices with the closeout letter from the Reviewing IRB.
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.
NEW SECTION! What if I'm a non-Emory researcher who wants access to Emory medical records for my study?
If you are a researcher not affiliated with Emory who would like to use Emory's medical records for your research, and....
- there will be Emory-affiliated researchers 1) enrolling/consenting, 2) doing data analysis with identifiable information, or 3) administering interventions/handling study interactions, you'll need to get IRB review at your institution and Emory, or alternatively, request a reliance agreement.
- there will NOT be Emory-affiliated researchers engaged in the above-listed activities, the IRB is not the correct department to go through to gain access to those records. You should request "site permission" to access the records by contacting the Emory department that has the records. Do not submit a reliance request.
Emory researchers must report to the REVIEWING IRB any adverse event which the Reviewing IRB requires according to the Reviewing IRB's policies and process. The Reviewing IRB is your IRB of record and reviews reportable events. Therefore, your report should be made to the REVIEWING IRB, not through Emory's eIRB system.
Emory researchers must report every event that you would have been required to report to Emory had we been the Reviewing IRB, and if the Reviewing IRB’s rules go beyond our requirements, you must report any event that they require according to their policies as well.
Egregious adverse events have to be reported to Emory offices (Office of Compliance, Risk Management Office, Emory IRB) IN ADDITION to the Reviewing IRB. The following are examples of egregious adverse events: wrong side surgery, wrong drug, wrong patient, fabrication or falsification of data, etc.
Where an egregious adverse event occurs, you must report the event using the Reviewing IRB's process and also:
Where do I submit an amendment if the study details change when an external IRB is reviewing the study?
Please follow our guidance on this.
SMART IRB MASTER AGREEMENT
SMART IRB is NOT an IRB nor other type of HRPP. SMART IRB is the name of a model reliance agreement which is designed to streamline the reliance process. It has all of the provisions which would normally be negotiated into a reliance agreement. Institutions which have signed up as "Participating Institutions" with SMART IRB may use the model agreement for any given study instead of drafting a brand new agreement.
Emory is currently a "Participating Institution" with SMART IRB.
When Emory has been asked to serve as the IRB of Record for another institution, Emory IRB prefers to use the SMART IRB Agreement when the relying site is a "Participating Institution" with SMART IRB. If the relying site agrees to use SMART IRB with Emory, the institutional officials for both institutions must sign the SMART IRB Agreement Letter of Acknowledgment and Implementation Checklist. All other parts of the process when Emory is serving as the Reviewing IRB will be the same as described in the main section.
Some SMART IRB Participating Institutions use online platforms for their SMART IRB reliance processes when serving as Reviewing IRB. Emory IRB staff will help you navigate those on a study-by-study basis when Emory is asked to be relying site.
If you have questions about a specific study at Emory that is ongoing, please contact your assigned IRB analyst.
The IRB now has Reliance Office Hours on Tuesdays 9:00 am – 12:00 pm. If you would like to set up a meeting to speak about reliance face-to-face, please submit your availability (your availability must be during Reliance Office Hours) by leaving a voicemail at 404-727-8485, and you will receive a calendar invite for the meeting. If you do not want to meet face-to-face, you can call that number at any time during Office Hours to ask your question.
If you have questions about WIRB or NCI CIRB specifically, please email the WIRB Listserv (email@example.com) and one of the Emory IRB analyst assistants will do their best to address your issue.