IRB Authorization Agreements (IAA) FAQs

If the following FAQ’s do not address your concerns, please contact the IRB staff.

Who decides whether an IAA is appropriate?

Usually the directors of the human research protections programs in consultation with the researchers.

Who prepares IAAs?

IRB staff members prepare the documents with information provided by the researcher and coordinates with IRB staff and the collaborator's institution.

Are there collaborations for which IAAs are not appropriate?

Yes, if local review of each component of the collaboration is the best way to ensure that the rights and welfare of research subjects are protected

What limits does Duke have on the use of IAAs?

Duke will not agree to be the reviewing IRB in situations in which there are no reasonable means to monitor the research. Potential risks of harm to research subjects and the research site where the risks are incurred are factors in making the decision. Generally, Duke will not agree to be the reviewing IRB for research taking place abroad. An exception would be when Duke has an established presence at the foreign site and local review will also take place.

What if my research qualifies for exempt review?

IAAs are not intended for use when collaborators are engaged in exempt research. Researchers will have to secure approval from their home institutions.

What if my collaborator’s institution doesn’t enter into IAAs?

Some institutions do not enter into IRB Authorization Agreements as a matter of institutional policy. Researchers will have to submit request for protocol approval to their home institutions.

What if my collaborators want use a "SMART IRB" to execute the reliance agreement?

At this time, the Duke University Campus IRB is not subscribed to the SMART IRB platform. We use the IAA to enter into reliance agreements.

What if my role on 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.

Do I have to get an IAA to just share data with researchers at another institution?

No. However, data sharing should be done in a manner consistent with agreements made with research subjects about the use of their data.

What do I do if researchers from another institution allow me to use their facilities, but they are not involved in the research in any way?

Just get approval from the Duke IRB before beginning the research.

How long does it take to get an IAA?

The agreement consists of a short form that must be signed by institutional officials from both institutions. Duke’s institutional official is the Vice President for Research and Innovation.) It may take several weeks to obtain the necessary signatures and mail the agreements back and forth. Increasingly, universities are accepting scanned forms and that reduces the amount of time needed.

Do IAAs need federal approval?

No. Institutions just have to be prepared to produce the agreements upon request.

If I am conducting research with collaborators at another university, where should I submit amendments or continuing review requests?

If the research is being conducted under the auspices of an IAA, requests should be submitted to the reviewing IRB. It depends on which institution has agreed to be the reviewing IRB. If, for example, it is UNC, the UNC investigator should submit the requests to his or her IRB.

When may I put researchers from another institution on a Duke request for protocol approval?

Only if Duke has entered into an IAA with the other institution and Duke has agreed to be the reviewing IRB.

If non-Duke researchers are being added to an approved protocol, the request to amend the approved protocol must be limited to the IAA. Because IAAs are specific to an institution's FWA, the Campus IRB will be need a separate amendment for each institution involved.