Human Subjects Research Determinations

Do I need IRB Review?  Is This Human Subjects Research? 

Research projects meeting the regulatory definition of human subjects research require review and approval by an Institutional Review Board.  Federal regulations define Research as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."  (45CFR46.101(d)). 

The federal regulatory definition of a 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 (45CFR46.102(f))

There are three categories to be considered:

  • studies that are human subjects research
  • studies that may be considered human subjects research (gray area)
  • studies that do not qualify as human subjects research


"Do I need IRB Review? Is This Human Subjects Research? A Guide for Investigators" 

This guide provides a basic explanation of the regulations and provides examples of what may or may not constitute human subjects research.  As noted in this booklet, there are certain studies which may have the characteristics of human subjects research, but may not meet the regulatory definition. Studies which meet the definition require IRB review. 

HawkIRB Human Subjects Research Determination Form (HSRD)

Any investigator who is unsure of whether his/her proposal constitutes “human subjects research” may submit a HSRD form through HawkIRB. The IRB Chair and/or their designee will determine if their Human Subjects Research Determination request meets the definition of human subjects research.  

If a HSRD request form does not qualify as human subjects research, HawkIRB will issue a memo stating that the project does not require IRB review or approval. 

If the project is determined to meet the regulatory definition of research, the HawkIRB application will initiate a DRAFT new project application on your behalf based on the responses provided in the Human Subjects Research Determination (HSRD) request form.  It is the Investigator's responsibility to complete this DRAFT new project application and submit it to the IRB for review.  Research can not begin until formal IRB approval is granted! 

Frequently Asked Questions


For any questions or concerns regarding the information found on this page, please contact the Human Subjects Office at or (319) 335-6564.