Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. Today’s topic will cover Inter-Institutional Agreements and Non-Institutional Investigator Agreements.
What is an Inter-Institutional Agreement?
Occasionally a UNMC, The Nebraska Medical Center, or UNO principal investigator will request IRB approval to allow a clinical research study to be conducted by one or more participating investigator(s) at an off-site location. When UNMC IRB approved research, which is minimal risk or greater, is conducted at a hospital which is not an academic health science center, an Inter-Institutional Agreement (IIA) must be signed by the authorized official at the off-site. This agreement certifies that the external site authority is aware of the study and understands that the UNMC IRB has regulatory authority over the conduct of the study. Every participating investigator must be listed by name in the agreement. When an investigator is added to a study, a revised agreement must be completed.
What is a Non-Institutional Investigator Agreement?
Before an off-site participating investigator is authorized to enroll patients in a study covered by an Inter-Institutional Agreement, they must complete a Non-Institutional Investigator Agreement (NIIA) and be provided with a copy of HHS regulations 45 CFR 46 (the “Common Rule”), FDA regulations 21 CFR 50 and 56 (if the study is FDA regulated), and the Belmont Report.
Additionally, some subjects are enrolled and initially treated here at UNMC/The Nebraska Medical Center then return home to continue receiving the study medications or receive follow-up care by their private physician. The private physician must also complete the Non-Institutional Investigator Agreement.
The completed Non-Institutional Investigator Agreement should be sent to the UNMC IRB for co-signature. A copy of the agreement will be kept in the IRB. The original will be returned to the PI.
Why is this agreement necessary?
While the UNMC PI has overall responsibility for the conduct of the study regardless of location, participating investigators must certify that they fully understand the ethical principles and federal regulations governing all research involving human subjects, as well as the responsibilities of the participating investigator. Certification is provided by signatures on the NIIA document.
A private physician participates as a participating investigator in all of our clinical trials. Can the private physician sign only one agreement for all the studies?
No. This agreement needs to be re-negotiated and certified for each clinical trial that the private physician will serve as a participating investigator.
Where can I get these forms?
Both the Non-Institutional Investigator Agreement and the Inter-Institutional Agreement can be downloaded from the IRB Web site forms page.
Reminder
If an off-site has their own IRB, a copy of the IRB approval letter and consent document used to enroll subjects in the trial must be provided to the UNMC IRB to provide assurance that appropriate human subject protection is provided.
There may be other situations that do not quite fit in the examples listed above. If you are not sure what to do, call the IRB office for guidance at 559-6463.