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
To submit an agreement, please complete the hyperlinked "W&M Individual Investigator Agreement" form below. Then, fill out the "IIA Submission" so that your request can be processed.
Once the W&M FWA Signatory official has added their signature, the IIA should be attached to your protocol. This can be done during the "initial submission" process or as a "modification" after initial protocol approval. The collaborating members cannot begin research until the IRB initial/modification submission has been approved.
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" W&M institutions must be covered by an FWA.
Many institutions do not enter into reliance agreements for EXEMPT studies. Please work with your external collaborators to determine the best route.
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 institution that the main PI is affiliated with. Sometimes it is best to choose an institution whose IRB has expertise reviewing the type of research that is proposed in the protocol. If you are unsure of which IRB should act as the IRB of record, you should discuss this with your co-PIs.
Table shows instructions for IAAs
W&M is the Reviewing Institution
When W&M is the reviewing institution, the process is as follows:
Ensure all personnel are up-to-date on required CITI trainings BEFORE protocol is submitted.
Site Principal Investigators (of relying institution)
Sponsoring Agency (if applicable)
Contact information of the FWA official from relying institution
Submit protocol to the W&M IRB via SPARCS. The protocol should include:
That 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
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.
Attach the unsigned IAA document
Notify your collaborators of submission.
The other institution should be made aware that an IAA will be processed for a protocol.
Some institutions require additional documentation for IAAs so please make sure to notify the Research Compliance office so that those documents can be processed in a timely manner.
W&M will review the protocol and all attachments. Once IRB has reviewed the protocol, the IRB will request a "Local Context Questionnaire" (LCQ) and Consent template review by the relying sites to ensure that local regulations and policies are followed in the protocol/consent.
The Research Compliance Office will send the LCQ and Consent to the sites to complete/review. The IRB will use the information provided to ensure that the W&M approved protocol and documents are aligned.
The IAA will be signed by the relying institution for signature FIRST, then to the W&M FWA signatory official for signature.
Research cannot begin until your protocol has been approved.
The Reviewing IRB may require a local context form/questionnaire (LCF/Q), which will provide specifics about local policy and institution-specific requirements (HIPAA, compensation for injury, etc.). The W&M site PI should work with the Research Compliance Office and Reviewing IRB to complete this form and any other required documentation.
If W&M investigators will consent participants, the consent document(s) form must include the W&M Institutional Language. The W&M PI must submit the consent template to be used for review by the IRB before submission to the Reviewing IRB for review and approval.
The Research Compliance office will conduct a review of the protocol and any participant-facing 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 passed back 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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