Collaborative Research Agreements
When Brandeis University investigators collaborate with non-Brandeis US investigators, the Brandeis IRB will often enter into a reliance agreement with either the collaborating investigator’s institution, or with the outside collaborator themselves (depending on the collaborator’s institutional affiliation).
If the collaborator comes from an institution with a Federalwide Assurance (FWA – which generally means they have an IRB), Brandeis will often enter into an IRB Authorization Agreement (IAA) with the outside institution, which allows one institution with a FWA to rely on another institution's FWA. This means that one of the institutions' IRB will be the IRB of record, while the other institution cedes the IRB review to the first institution.
If the collaborator comes from an institution without an FWA (or is institutionless), Brandeis will enter into an Individual Investigator Agreement (IIA) with the individual, which allows the collaborator to conduct research under Brandeis’ FWA.
IRB Authorization Agreement (IAA) Form
Individual Investigator Agreement (IIA) Form
An IAA is an agreement between two institutional IRBs. An IIA is an agreement between one institutional IRB and an individual whose research is not overseen by another IRB.
Many institutions will not enter into an IAA for exempt research. If they will, Brandeis is happy to enter into one, as well. If they will not enter into an agreement, the Brandeis investigator will need to submit an IRB Initial Protocol – the Brandeis HRPP cannot simply accept another institution’s exempt determination.
Yes. When the collaborator signs the IIA, they are certifying that they are properly trained, and will abide by Brandeis’s policies and procedures, as well as the federal regulations.
The Brandeis HRPP and the HRPP/IRB administration at the collaborating institution, in conjunction with the principal investigators, will make this determination.
This determination is made after the review of a number of factors, such as:
- If funded, which institution is the prime recipient of the funding
- If funded, whether the funder specifies which IRB is to act as the IRB of record
- If a multi-site project, whether one institution is coordinating the research
- If the research is subject to the NIH Single (sIRB) policy for multi-site research (NOT-OD-16-094)
- The components of the research being conducted at each institution
- If the majority of contact with research subjects is at one institution
- If one institution’s IRB has more appropriate experience and expertise to review the research
- If one IRB does not feel it has sufficient understanding of the context in which the research is being conducted
Contact the Brandeis HRPP to discuss which institution’s IRB should be the IRB of record, or have the collaborating institution’s HRPP/IRB administration contact us.
- Complete and submit the IRB Initial Protocol with all relevant documents. List all collaborating investigators as personnel and note within the protocol which investigators will be conducting what research activities.
- Complete the IAA form and submit it to the HRPP. The HRPP will send the completed form to the ceding intuition for signature. Once they have signed the agreement, it will be signed by the Brandeis signatory official.
- Submit to the Brandeis HRPP the protocol that was submitted to the IRB of record, along with the approval letter. (Note, the Brandeis investigator is not required to submit an IRB Initial Protocol.)
- Have the collaborating PI give their HRPP/IRB administration our HRPP contact information.
- The IRB of record will send the Brandeis HRPP their agreement form. The Brandeis signatory official will sign their form and it will be returned to the IRB of record for their signature.
Have your collaborator complete the IIA form and submit it to the HRPP with your protocol.
In general, IAAs and IIAs do not expire but are good for the duration of the research. If the principal investigator(s) change, the agreement will need to be updated, however.
Collaborators coming from an institution with an FWA and training requirements of their own, should follow those requirements. If there are no training requirements associated with the collaborator's institution, or if the collaborator is an independent investigator, they will be required to follow Brandeis University's training requirements.
Effective January 25, 2018, NIH-funded non-exempt multi-site research, where each site will conduct the same human subjects protocol, may be subject to the NIH Single IRB (sIRB) policy. The goal of this policy is to streamline the IRB review process in the context of multi-site research by requiring the research to be reviewed at one site, by a single IRB of record. This policy applies to domestic sites only. For more information, please see the NIH policy notice.
Revised Common Rule
Effective January 20, 2020, the federal regulations governing human subjects research (45 CFR 46) will require that most US institutions engaged in non-exempt cooperative research conducted or supported by a federal department or agency rely upon a single IRB (sIRB) review. For more information, please see Initial Considerations for Single IRB Review: Points to Consider.