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IRB Authorization Agreements

An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution. In practice, this means an institution’s IRB will be the IRB of Record which reviews the study. These agreements help to minimize regulatory burden on the IRB review and approval process by limiting the IRB review to one institution. IAAs are sometimes referred to as IRB of Records. When signing the IAA, one institution is designated the lead IRB or IRB of Record.

IAAs can be requested by entering information within your Cayuse IRB submission.

How do I request an IAA at Montclair State?

  1. The PI or primary contact should contact the Montclair State University IRB for a preliminary conversation on using an IAA.
  2. Once both institutions verbally agree to enter into the agreement, complete the appropriate IAA information required for IAAs within your Cayuse submission.
    1. If Montclair State is to be the IRB of Record (lead IRB), a study protocol or pending submission (in Cayuse IRB) must be available. or
    2. If Montclair State is to rely on another institution’s IRB, please submit the other institution’s IRB approval, FWA #, and any other study-related documents, such as consents within Cayuse IRB submission.
  3. After signatures from both institutions have been obtained, the IRB Coordinator will provide you with a final signed copy of the agreement.

What is the timeframe for an IAA?

It varies by institution. IAAs generally take a couple of weeks for processing, but the timeframe is ultimately driven by the availability of the Institutional Officials who are responsible for signing these agreements.

I am collaborating with another institution, can I request an IAA?

If you are working with a collaborator who is engaged in human subjects research, they must have IRB review and approval*. This can be accomplished in one of two ways:

  • The research team submits to both institutions for IRB approval; OR
  • The research team requests an IRB Authorization Agreement (IAA).

*Note: Anyone covered by the IAA may not begin any work on the project until IRB approval has been granted AND the agreement has been signed by all parties.

Montclair State University should be the IRB of Record if a University investigator is the prime awardee of a grant or other funding, or if the majority of research activities will take place at Montclair State with other institutions collaborating. If you are requesting Montclair State University be the IRB of Record please provide the necessary information within the Cayuse IRB submission.

Another institution may be best served as IRB of Record if all research activities are taking place there, or if the Montclair State IRB does not have the relevant expertise to review a study (i.e. clinical trial at an external medical facility).

Who decides if an IRB Authorization Agreement is appropriate?

Usually, the IRB Coordinator, the IRB Chair and Staff in consultation with the researchers will decide if an IAA is appropriate. The funding source, potential risks of harm to research subjects and the research site where the risks are incurred are factors in making the decision. Students conducting their thesis or independent study at a collaborating site must still submit to the Montclair State University IRB for approval.

What if my role in a multi-institutional study is advisory only?

If you are not interacting with human subjects or collecting or analyzing identifiable information, your role on the project does not meet the definition of research with human subjects.  You do not need IRB approval.

How long do IAAs last?

IAAs last for the duration of the research study or for however long the collaborator remains engaged in human subjects research. They need not be updated unless an expiration date is provided or the Principal Investigator (PI) or study information changes.

Now that I have an IAA, what do I need to do?

After obtaining an IAA you will need to do the following:

  • If Montclair State University is the IRB of Record, you should continue to correspond with the University IRB as you would normally do, such as submitting renewals, modifications, or closure requests.
  • If the other institution has been designated the IRB of Record, you should correspond with the other institution and submit renewals, modifications, and closure requests in accordance with their local procedures. You must contact the University IRB if any of the following are true:
    • Change in risk level for the study
    • Subject complaint
    • Unanticipated problem involving risk to subjects or others
    • Suspension or termination of the research by the investigator, IRB or sponsor
    • Change in PI
    • Change in funding arrangements
    • Change in Montclair State University staff roles and responsibilities OR
    • Closure of the study

Do I have to get an IRB Authorization Agreement to just share de-identified data with researchers at another institution?

No. However, data sharing should be done in a manner consistent with your Montclair State University IRB approved study and any agreements made with research subjects about the use of their data.