Reliance agreements (also called IRB authorization agreements) are arrangements between two or more institutions that allow IRBs to cede review to one another.
When investigators are collaborating on research across multiple institutions that have IRBs, they may request that one IRB become the IRB of Record for some or all institutions engaged in research activities (see FAQ below for information about “engagement”). This is often referred to as ceding review, executing a reliance agreement, or deferring IRB oversight. The IRBs that agree to cede review for the research are called Relying IRBs.
While reliance agreements help investigators avoid duplicate IRB review, they do not lessen investigators’ responsibilities for oversight of the research at all institutions and sites. It is also important to note that institutions, not investigators, make the final determination about whether a reliance agreement can be executed, and which IRB will be the IRB of Record.
As of January 25, 2018, the National Institutes of Health (NIH) requires a single IRB of record (sIRB) for all NIH-funded research. As of January 2020, the same requirement will be extended to all non-exempt human subjects research, regardless of funding source.
An IAA is an agreement between Tufts University and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) receiving funds from HHS must have a FWA. This agreement type is used to establish the IRB of Record (whether that's Tufts or the other institution). The IAA is signed by the Institutional Officials or designee at each institution.
Master Reliance Agreement (MRAs)
Master Reliance Agreements are IAAs that may involve multiple projects and/or multiple FWA-holding institutions. MRAs can be utilized in a variety of different situations. For example, when two institutions are ceding review of multiple protocols to one another, when multiple institutions are ceding review of a single protocol to a specific IRB, or when multiple institutions enter into a general agreement to cede review of protocols when their investigators collaborate. Master Agreements may be reciprocal in that signatory institutions can act either as the IRB of Record or the Relying IRB. The Tufts SBER IRB is a member of SMART IRB, a master reliance agreement with over 400 participating institutions.
Individual Investigator Agreement (IIA)
An Individual Investigator Agreement (IIA) is an agreement between Tufts University and an individual collaborator who is not affiliated a FWA-holding institution. Examples of individual investigators include: community partners, former students working after graduation with their faculty mentor, professionals or experts who do not normally conduct research, and occasionally affiliated investigators whose home IRB has determined that their institution does not need to conduct a review.
The IIA form outlines the responsibilities of the individual investigator for the protection of human subjects. Individual investigators must sign a separate IIA for each study on which they are working. They must also complete Tufts’ human subjects protection training requirements.
Investigators must request reliance agreements prior to conducting human subjects research on new studies, and before adding new research team members or study sites to approved studies. Communication about reliance agreement requests should come from the Tufts research team, not collaborating non-Tufts investigators/teams.
The SMART IRB online reliance system will be used for IRB reliance agreements with any institutions that participate in SMART IRB. Please contact the SBER IRB office to notify us of any forthcoming requests. Click here for more information about SMART IRB, participating institutions, and the online reliance request process.
Upon receiving a new request to be the IRB of Record or to rely on another IRB for review, the main factors the Tufts SBER IRB considers are:
• Where the research activities are taking place • What research activities will be conducted by each institutions’ investigator(s) • The research methods and procedures • The study population • Any risks to participants • The qualifications and experience of the investigator(s) • The investigator’s record of conducting research overseen by Tufts SBER IRB • The external IRB, institution, or individual investigator • Funding (source and awardee institution)
This depends on the type of submission and the reliance agreement being requested, and whether Tufts SBER IRB will be the IRB of Record or the Relying IRB.
For requests that Tufts SBER IRB serve as the IRB of Record, we would need to ensure that the other site is engaged in human subjects research and that the protocol accurately reflects the role of each institution involved. The non-Tufts institution would also need to have a Federal Wide Assurance (FWA) in place prior to executing the agreement.
For all reliance agreements where Tufts SBER IRB will be the IRB of Records, and for IIAs, non-Tufts investigators must provide documentation that have completed required human subjects protection training requirements . Training must meet or be commensurate to the Tufts University training standards.
For requests that Tufts SBER IRB cede review to another IRB (Tufts IRB is the Relying IRB), we would need to review the protocol, consent template, and any other relevant study documentation being submitted to the IRB of Record. We would also need to receive documentation of approval from the IRB of Record when it becomes available.
Generally, an institution is engaged in the conduct of human research when investigators from that institution do any of the following:
• Help with the informed consent process • Interact or intervene with participants as part of the research. This may include helping with recruitment. • Obtain or analyze personally-identifiable data • Receive federal funding for human subjects research
Tufts SBER IRB does not enter into IRB Authorization Agreements or master reliance agreements with international sites. However, Tufts does accept IIAs from international researchers. For example, if you are hiring enumerators to conduct field research, each enumerator will have to sign an IIA.