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Office of Human Research Administration

Not Human Subjects Research and Exemptions

Not Human Subjects Research

  

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)).

 

A human subject is defined as a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information (45 CFR 46.102(f)). 

  • "Intervention" as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
  • "Interaction" as defined by DHHS regulations means communication or interpersonal contact between investigator and subject.
  • "Private information" as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
  • "Identifiable information" as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

 

When proposed activities do not meet the threshold definitions of human subjects research, IRB approval is not required; however, such determinations must be made by the IRB Chairperson or his/her designee by reviewing the Exemption/Not Human Subjects Research Request Form.  The Principal Investigator should not make these determinations.   

 

If you have questions about not human subjects research activities, please refer to our Departmental Assignments page to determine your department's contact.

    

Exemption

Under Federal regulations (45 CFR 46.101(b)(1-6)), certain categories of activity are considered human subjects research, but may be declared exempt from expedited or full board review.  These categories of activity do not require IRB approval.  Such determinations, however, must be made by the IRB Chairperson or his/her designee by reviewing the Exemption/Not Human Subjects Research Request Form.  The Principal Investigator should not make these determinations.   

 

If you have questions about exemptions, please refer to our Departmental Assignments page to determine your department's contact.

 

This page is maintained by the Office of Human Research Administration. For web-related suggestions, comments, and questions, please email the OHRA webmaster.

For any other questions, please contact OHRA.