Non Human Subjects Research

Before completing the application for determination of non-human subjects research, please contact the IRB.

Research that requires IRB review must meet the definition of human subjects research. The code of federal regulations provides the following definitions:

For purposes of the IRB, research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

Human subject means 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.

By these definitions, research undertaken on cadaveric tissues does not meet the regulatory definition of human subjects research, and if submitted, would receive a determination of non human subjects research. Another example of research that involves human beings or information about them but that does not meet the definition of human subjects is research on established cell lines. To qualify as non human subjects research, the investigator must receive the specimens without any of the following 18 identifiers:

Names	Account numbers
Geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code	Certificate/license numbers
All elements of dates (except year) for dates directly related to an individual (e.g., date of birth, admission)	Vehicle identifiers and serial numbers, including license plate numbers
Telephone numbers	Device identifiers and serial numbers
Fax numbers	Web Universal Resource Locators (URLs)
Electronic mail addresses	Internet Protocol (IP) address numbers
Social security numbers	Biometric identifiers, including finger and voiceprints
Medical record numbers	Full-face photographic images and any comparable images
Health plan beneficiary numbers	Any other unique identifying number, characteristic, or code.