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IRB Guidance

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.


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.  

 

Definitions for Human Research

Review the following definitions to determine whether your activity is Human Research. Note that publication is not a determining factor for whether an activity is Human Research requiring review and approval by the IRB.

  1. “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.

      If your activity does not meet both of these components, then it is not Human Research according to DHHS. Please see below for the FDA definition. 

  2. “Human Research” (according to FDA)
    The definition includes two components:
    • “Research”: Any experiment that involves a test article and one or more Human Subjects, and that meets any one of the following:
      • Must meet the requirements for prior submission to the US Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
      • Must meet the requirements for prior submission to the US Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
      • Any activity the results of which are intended to be later submitted to, or held for inspection by, the US Food and Drug Administration as part of an application for a research or marketing permit.
    • “Human Subject”: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen a medical device is used.

If your activity is not research or is research that does not involve human subjects, then it is not Human Research according to FDA

If your activity does not meet either DHHS or FDA definitions for “Human Research”, then you do not need to submit anything to the IRB Office for review. Consult “WORKSHEET: Human Research Determination (HRP-310)” for further clarification if needed