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 has the discretion to accept your reliance request or not.
Use this Engagement Determination Checklist to determine if a site is engaged.
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.
- 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 the tab entitled "Umbrella Agreements/MOUs" 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.
NOTE: 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 or investigators to an ongoing study. If you need a reliance agreement for a brand new study, please continue on...
In order to request a reliance agreement for a brand new multi-site study, first download and fill out the New Study 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 in order to be considered. There will be questions about the other institution you might not know offhand, so you should reach out to your counterparts at the other institution to get that information. 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:
- You should first check with the other institution/organization's IRB or leadership to make sure their employee/agent's activities on the project "engage" them in the project and to make sure they are willing to rely on Emory IRB.
- Once you've done that, 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 and is required to rely on a single IRB for all studies in a network or consortium.
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 unless another participating site is willing to serve as the 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.
Most multisite federal and NIH grant proposals will now require the use a single IRB.
The new Common Rule dictates that any multi-site federally-funded studies which transition to the new Common rule or which receive IRB approval after January 19, 2019, will be required to use a single IRB by January 2020. More guidance from OHRP about this requirement is forthcoming...
For NIH proposals specifically, the NIH Single IRB Policy applies to "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 this policy. The following awards are NOT required to use a single IRB: Career development (K), institutional training (T), or fellowship awards (F).
Where Emory is the lead site on a grant proposal:
Emory IRB has designated Western IRB (WIRB) as our IRB of record for multi-site federal or NIH studies via a direct charge fee-for-service activity. In some limited circumstances, Emory IRB may decide to keep IRB review for a given proposal in-house as determined on a study-by-study basis. Follow the steps below:
- Speak with your Federal Sponsor Representative or NIH program officer and confirm that your proposal falls under the requirement.
- NOTE: If your proposal falls under an NIH exception, stop here. 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 NIH 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 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.
- If WIRB will be the single IRB, you need to add single IRB costs to your budget. Follow the instructions at the top of this Single IRB Quote Request Form to get a quote from WIRB.
- NOTE: Please remember that this quote is based on the assumptions provided, and Emory will only be billed for the services that are rendered. Also, keep in mind that if translations are needed, that is an extra charge.
- Once you've secured funding:
- If Emory has agreed to serve as single IRB, you'll submit to eIRB following the process under the "What Happens After My Reliance Request is Approved?" tab.
- If another institution is going to be the single IRB, you'll email the IRB Reliance Listserv to notify us so that we can provide you with an XIRB shell and then you'll follow the rest of the process under the "What Happens After My Reliance Request is Approved?" tab.
- If WIRB is serving as single IRB, there's no need to fill out a Form A. Email the IRB Reliance Listserv to notify us, and we'll forward your request for a WIRB shell to the appropriate Emory IRB staff. You'll then follow the rest of the process on the Western IRB (WIRB) page of this website.
If you will be a participating site's PI:
You are not responsible for the grant proposal or Single IRB Plan, but you MUST still send a Single IRB Intake Form to the IRB Reliance Listserv so that we can determine whether we are willing to rely on the chosen single IRB. If you do not send the form, we cannot guarantee that we will be willing to rely on the chosen single IRB once the grant is funded, which may prevent Emory from being a participating site.
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 along with your completed Single IRB Intake Form to the IRB Reliance Listserv. If the Lead Institution does not have a template for you to use, here is a template.
CHOA Involvement: How do I know whether I should submit a reliance request to Emory IRB, CHOA IRB, or both?
NOTE: A NEW AGREEMENT WITH CHOA REGARDING RESEARCH OVERSIGHT AND ADMINISTRATION EFFECTIVE 09/01/2018 DUE TO THE FORMATION OF THE EMORY + CHILDREN'S PEDIATRIC INSTITUTE.
The Pediatric Institute is not a physical building. Rather, it's an entity created which employs physicians and clinicians from Emory and CHOA itself rather than those physicians and clinicians (PhDs/PsyDs) being directly employed by Emory or CHOA (whereas, coordinators and lab staff are still employed directly by Emory and CHOA). For more information about the Pediatric Institute, watch our webinar.
The new agreement covers human subjects research in which both Emory and CHOA provide some or all of the following: funding, personnel, site access, patient access, medical records access, research records access, or other material support. This agreement does NOT cover research for which either Emory or CHOA provides support to the other via a Fee for Service Agreement.
The location of your study's IRB review and research administration (CHOA or Emory) depends on the type of research. This flowchart dictates where you will undergo IRB review.
For studies that are combination adult and pediatric trials, Emory and CHOA are currently working on a streamlined process. Reach out to the CHOA and Emory IRB directors via email for assistance.
For the most part, the grant will route through the institution that is responsible for IRB review (as set forth in the flowchart above). However, there are some exceptions:
- Industry-sponsored chart reviews- CHOA IRB but contract routes through Emory.
- Federally-funded studies that only include surveys- CHOA IRB but contract routes through Emory.
- Non-profit (non-COG) funded data registries- CHOA IRB but contract routes through Emory.
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 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 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. 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. Emory has the discretion to decide whether to pursue a reliance agreement or not.
A number of determinations must first be made to determine whether Emory needs a reliance agreement or IRB review:
- Agency: Whether any researchers working on the study are "agents" of Emory. Every institution categorizes its "agents" differently, so you must work with Emory IRB to determine if you are considered an Emory agent.
- Engagement: Once we've determined whether we have agents working on the study, we have to determine if those agents are conducting activities which "engage" us 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.
Once Emory determines that we must either complete IRB review or enter into a reliance agreement, we must assess whether Emory can enter into a reliance agreement under its policies:
These factors are used by Emory decide whether we are able to enter into a reliance agreement. 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.
Transitioning Employment: How do I handle studies if I'm a new Emory employee or moving from Emory to a new institution?
You will need to email the IRB Reliance Listserv with information regarding your transition and provide the following:
- A list of studies for which you are currently PI and you are taking the award with you to your new institution, and no other work will happen at your old institution;
- A list of studies for which you are currently PI and you are taking the award with you to your new institution, but work will continue at your old institution in some capacity; and
- A list of studies at your old institution where you aren’t the PI, but are simply listed as a co-I, and you will continue to work on the studies even after your move to the new institution.
For List 1, you will go through the IRB approval process and award process at your new institution. Once your new institution has approved the study, you will close out the study at your old institution.
For List 2, you will complete the amendment/modification process at your old IRB and assign the study to a new institutional site PI. Your old IRB will have to decide whether they are willing to act as the Reviewing IRB for your new institution. If yes, you will go through the reliance process. If no, you will leave the submission open and approved at your old institution and submit a new IRB submission at your new institution to pursue concurrent IRB approval.
For List 3, you will complete the amendment/modification process at your old IRB to have yourself removed from the old institution's study staff listing. Your old IRB will have to decide whether they are willing to act as the Reviewing IRB for your new institution. If yes, you will go through the reliance process. If no, you will pursue your own IRB approval at your new institution for your limited involvement in the study.
If your study is using an external IRB, you should report ALL changes in Emory study team members to the Reviewing IRB via their method for doing so.
You must also notify Emory IRB of any changes in EMORY study team members so that we can check their qualifications and training. You do NOT need to notify us about non-Emory study team changes. For study staff, you'll use the study staff change feature in eIRB as you normally would for an Emory-approved study. For changes in Site PI or co-Is, you'll log a comment in the submission notifying Emory about the change, and Emory IRB will make the change administratively.
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 Reviewing Team 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, site-specific consent forms and HIPAA authorization forms)
- Onboard the relying sites to the study via amendment in eIRB (see Onboarding a Site Guidance ). Please note that each relying site has to create its own site-specific consent document(s) using the Emory-approved model consent document(s). Please provide this consent guidance to relying sites so they know which parts of the consent document(s) can be changed.
- Send any site-specific approval letters and documents to the relying sites
- Keep copies of all sites' approval letters, approved documents, and reliance agreements in study documentation.
- 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 CR 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. Use the XIRB Smartform Guidance document. (Why is this necessary? Because generally, institutions need to identify research that falls under our purview, even if an IRB outside of the institution oversees it and because there are other necessary processes like departmental review and ancillary reviews which a study must undergo before it can be approved by the external IRB).
- The Emory PI will have to upload the approved protocol, the grant/award document, and the model consent/HIPAA documents. If Emory is an enrolling site, also upload the site-specific versions of the consent/HIPAA documents and the completed XIRB Consent Guidance Checklist to the submission. Please see the guidance documents 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. (Why is this necessary? The external IRB needs information about our local culture, which can include informed consent language, training requirements, policies, or other cultural context).
- 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.
- The Emory PI will need to do what's necessary for Emory to be onboarded as a site with the external IRB (How do you find out what to do? Emory IRB can't help you with this. You must get in touch with your contact who is handling the reliance process, whether that is the lead study team, coordinating center, sponsor, or a direct employee of the external IRB or institution, and ask how to be onboarded).
- 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 keep copies of the approval letters, approved documents, and reliance agreement in his or her documentation.
- 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.
What if I'm a non-Emory researcher who wants access to Emory patients, departments, or records for my study?
If you are a researcher not affiliated with Emory who would like to use Emory's patients or records for your research or would like to conduct your research in a particular Emory department, 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 the department, patients, or records. You should request "site permission" to access the records/patients by contacting the Emory department that has the records/patients. Do not submit a reliance request.
Emory researchers must report to the REVIEWING IRB any reportable 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 reportable events have to be reported to Emory offices (Office of Compliance, Risk Management Office, Emory IRB) IN ADDITION to the Reviewing IRB using the method below. The following are examples of egregious reportable events: wrong side surgery, wrong drug, wrong patient, fabrication or falsification of data, HIPAA privacy concern matter, etc.
If the event is not an egregious reportable event but the Reviewing IRB ask you to report it to Emory as well as them, you can use the method below to notify us about the reportable event.
Where an egregious reportable event occurs, you must report the event using the Reviewing IRB's process and also:
- cc the IRB Reliance Listserv and the QA Team Lead (Maria Davila) on your email reporting the event to the external IRB; or
- if reporting via online platform, screenshot or save a copy of the online report and email to the IRB Reliance Listserv and the QA Team Lead.
See our submissions guidance table here.
Where do I submit an amendment if the study details change when an external IRB is reviewing the study?
The REVIEWING IRB is in charge of reviewing any amendment or modification to the study whether that amendment is a change to the overall study, a lead site change, or a change to just one relying site.
If Emory is the Reviewing IRB, the Emory Study Team must submit any changes (whether for a specific site or for the overall study) via our eIRB system. Amendments do not get submitted to the Relying IRBs. For changes that need to happen at a specific relying site, the relying site must report those to the Emory study team so that the Emory study team can do the amendment. When the amendment is approved, the Emory study team is responsible for dispersing the amendment approval letter to the relying sites that are affected by the amendment.
If Emory is relying, the Reviewing IRB’s study team is responsible for submitting any amendment through the Reviewing IRB’s system. It’s possible that if a new amendment requires a new Emory ancillary review (radiation safety, biosafety, or other), the Reviewing IRB will require you to contact us for a new institutional signoff before approving the amendment. You can do this by logging a comment in the local XIRB submission. Where Emory is relying, the Emory study team should upload any amendment approval letters or new approved documents from the Reviewing IRB into a logged comment in the local XIRB submission so that we can stay in the loop.
Where do I submit my continuing review if the study details change when an external IRB is reviewing the study?
Just like amendments, continuing review for all sites is the responsibility of the Reviewing IRB.
If Emory is serving as the Reviewing IRB, the Emory study team is responsible for providing information necessary for continuing review for Emory plus all of the relying sites in the CR submission. We have a form you will have each of the relying site study teams fill out and your analyst will provide you guidance on where to upload those forms in the CR submission. Once you get the continuing review approval letter, you will be responsible for dispersing the approval letter to all of the relying site study teams.
If Emory is relying, the Reviewing IRB’s study team is responsible for handling continuing review for the sites. You should track your local site information to provide to them when the time comes. Once you receive the continuing review approval letter, you should upload it into a logged comment in the local XIRB submission. As stated in the Amendment tab, if the continuing review triggers a new Emory ancillary review (radiation safety, biosafety, or other), the Reviewing IRB will likely require you to contact us for a new institutional signoff before issuing re-approval. You can do this by logging a comment in the local XIRB submission. Where Emory is relying, the Emory study team should upload any continuing review approval letters or new approved documents from the Reviewing IRB into a logged comment in the local XIRB submission so that we can stay in the loop.
See our submissions guidance table here.
What if Emory needs to acknowledge a recruitment material, brochure, or IB when an external IRB is reviewing the study?
AFTER the recruitment material or brochure has been approved by the Reviewing IRB, the study team should upload the material into a logged comment in the local XIRB submission so that Emory IRB can have a reviewer provide signoff.
For Investigational Brochures for FDA-regulated studies, the study team should upload the IBs as well as the approval letter from the Reviewing IRB and documentation of the conclusion/justification for the approval into a logged comment so that a reviewer can provide signoff.
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.
For information on what institutions/departments are covered by our IRB (including what research our partner institutions rely on us for), please see our guidance document.
Please see the table of our current umbrella agreements/MOUs. We are regularly pursuing new agreements and will be updating this table as new ones are finalized.
If you have questions about a specific study at Emory that is ongoing, please contact your assigned IRB analyst.
If you have questions about WIRB or NCI CIRB specifically, please email the WIRB Listserv (email@example.com) and one of the Emory IRB analyst assistants will do their best to address your issue.