All human subjects research (and all other activities, which in part involve human subject research), regardless of sponsorship, must be reviewed by the Human Subjects Research Office (HSR) and approved (administratively and/or by the IRB Committee) prior to initiation. This includes all interventions and interactions with participants for research, including advertising, recruitment, and/or screening of potential subjects. Please review the information below to understand what activities meet the definition of human subjects research.

Is this research?

Research is defined per 45 CFR 46 as a, “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.”

If the answer is “yes”, you need to determine if human subjects are involved.

Does this project involve human subjects?
  • Human subject has reference to two definitions by federal agencies.
    • Department of Health and Human Services (DHHS) defines human subjects as an individual about whom an investigator (whether professional or student) conducting research:
      • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
      • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
    • Food and Drug Administration (FDA) defines human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a health individual or a patient. When medical device research involves in virtro diagnostics and unidentified tissue specimens, the FDA defines the unidentified tissue specimens as human subjects.
  • Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
  • Interaction includes communication or interpersonal contact between investigator and subject.
  • Private information includes 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Identifiable private information is private information for which the identity of the subject is or may readily be associated with the information or ascertained by the investigator.
  • An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

If the answer to this question is also “yes”, then you need IRB approval to conduct research. Otherwise you need to ask the following questions.

Does the activity involve the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice?

(Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.)

If the answer to the above question is “yes,” then you need IRB approval to proceed.

Will data be submitted to the FDA or held for their inspection?

If the answer to the above question is “yes,” then you need IRB approval to proceed.

If you have any questions then please contact the HSR Office.