Occasionally, protocols require investigators or other institutions to rely on one another to perform an IRB review. Please see this guidance if wanting more information about Individual Investigator Agreements (IIA) or IRB Authorization Agreements (IAA)
Full Description
Individual Investigator Agreements (IIA)
This agreement allows to investigators/individuals who are affiliated with an entity (i.e., external/outside organization, business, or agency) that does not have an IRB. This agreement allows the extension of William & Mary's Federalwide Assurance (FWA) to cover external independent investigators engaged in research who do not work at an FWA covered institution.
For additional information and to determine if this agreement is required for your research project, please review the OHRP guidance
Table is dropdown of information about how to submit an investigator agreement
The external collaborator completes CITI training or sends proof of equivalent ethics training
Complete the hyperlinked "W&M Individual Investigator Agreement" form below. You and your collaborator will need to the sign the agreement.
Once both parties have signed, submit the agreement with your SPARCS protocol.
The agreement will be routed to the W&M FWA Signatory Official (or their designee).
The agreement can be in process while the IRB reviews the protocol. The collaborating members cannot begin research until the IRB initial/modification submission has been approved.
The completed agreement will be shared with the PI (either via email or within the protocol)
The PI will update the protocol to attach the finalized agreement
Protocol can be approved once finalized agreement is attached and all other comments have been addressed.
IRB Authorization Agreement (IAA) is an agreement between two institutions/organizations that are engaged in human subjects research to establish the Single IRB (sIRB) reviewing, or IRB of record. In this agreement, there is a the reviewing institution(IRB of Record)that serves as the reviewing IRB, and a relying institution that is relying on the reviewing IRB.
The "other" institution(s) must be covered by an FWA.
Many institutions do not enter into reliance agreements for EXEMPT studies. However, W&M can accept exemption determinations from other institutions.
Email the Research Compliance to request assistance with this type of request.
IRB of Record/Reviewing Institution
Determining who is the IRB of record is dependent on where the majority of the research will be conducted, the main funding recipient, or the institutional affiliation of the lead principal investigator. Sometimes, it is best to choose an institution whose IRB has expertise reviewing the type of research that is proposed in the protocol. For example, W&M would likely not serve as the reviewing IRB on a clinical trial if the other institution is a research hospital that completes this type of research regularly.
If you are unsure of which IRB should act as the IRB of record, you should discuss this with your co-PIs, then reach out to the Research Compliance Office for further guidance.
Table shows instructions for IAAs
W&M is the Reviewing Institution/IRB of Record
When W&M is the reviewing institution, the process is as follows:
Confirm with the collaborating, external investigators that they are working under an institution that has an active FWA registration.
Ensure all W&M and external personnel are up-to-date on required researcher trainingsbefore the protocol is submitted. (See External Members guidance for additional details about training)
Create a draft protocol in SPARCS
Complete the hyperlinked "W&M IRB Authorization Agreement (IAA)" form below. You will need the following information to complete the document:
Site Principal Investigator (of relying institution)
Sponsoring Agency (if applicable)
Contact information of the FWA official from relying institution
Submit the agreement with your SPARCS protocol. The following information needs to be included in the protocol:
Make sure to list the PIs at the relying sites as Non-W&M Personnel. You should also complete the "external sites" question if the research and/or recruitment will not occur at W&M campuses.
W&M is acting as the Reviewing IRB
List of collaborating sites, each site’s investigator, and the specific research activities that will occur at each relying site.
A description of the oversight plan to describe how the W&M PI will oversee the research conducted at the relying institutions, considering communication, training, reporting, and both the site regulatory file and site study documentation
Attach the unsigned IAA document
The agreement will be routed to the collaborating institution's FWA listed on the SPARCS IRB protocol application.
The agreement can be in process while the IRB reviews the protocol. The collaborating members cannot begin research until the IRB initial/modification submission has been approved.
Once signature from relying institution received, the agreement will be routed to the W&M FWA Signatory Official (or their designee) by the W&M IRB analyst.
The completed agreement will be shared with the PI (either via email or within the protocol)
The PI will update the protocol to attach the finalized agreement
Protocol can be approved once finalized agreement is attached and all other comments have been addressed.
Name/Contact of Reviewing Institution's Principal Investigator
Sponsoring Agency (if applicable)
Contact information of the IRB Office/FWA official from Reviewing Institution
Full protocol from Reviewing IRB
Approval letter from Institution's IRB (if available at time of submission to W&M IRB)
Consents, surveys, etc.
IRB Authorization Agreement (IAA) from the Reviewing Institution
The W&M IRB office will review submission and attached documents (e.g. consents) to ensure they align with W&M policy and state laws.
The agreement will then be signed by the W&M FWA Official and sent to the reviewing institution for signature.
Once all parties have signed the IAA, the final version of the protocol should have:
The completed IAA
Approved protocol from reviewing IRB
Letter of Approval from the reviewing IRB
Final versions of any documents (e.g. consents, surveys, etc.)
If modifications are made to the study after initial approval, the protocol can be updated via a modification submission once the change has been approved by the reviewing IRB
The PI is responsible for keeping the IAA on file in case it is requested in the future.
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