IRB Approval

Each study using the Behavioral Lab space, resources, or subject pools must first receive Institutional Review Board (IRB) Approval.
The IRB must review and approval all research activity involving Human Subjects to protect the rights and welfare of research participants.

Is Your Study Human Subjects Research?
If
you are not sure whether or not your study qualifies as human subjects research, you are encouraged to complete the NU IRB Human Research Determination Form. Sections 1 and 2 of the form define human subjects research from the standpoint of DHHS and the FDA as well as provide some examples of common instances that are not considered human subjects research. Section 3 is meant to be filled out by researchers who would like the IRB to make a formal determination about whether or not their project is considered human subjects research based on these definitions.

  

“Human Research” (according to DHHS)
The definition includes two components:

“Research”: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

“Human Subject”: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

 

Upon completion of section 3, the researcher should submit this form to the IRB the same way a new study submission is completed---by logging into eIRB+ and starting a new study application. The Human Subjects Determination form should be uploaded in the protocol section in place of a protocol document.


HHS.Gov Human Subjects Decision Chart
HHS

Click Here For more HHS.Gov Decision Charts


Questions? Contact our Associate Director of Behavioral Research Support for IRB consultation & guidance: yekaterina.sigalova@kellogg.northwestern.edu