All UTD affiliated 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 as defined by the Department of Health and Human Services means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)). Research is considered synonymous with Clinical Investigation as defined by the FDA. The following activities are considered not research by DHHS:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance.
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

A systematic investigation is an activity that is planned in advance and that uses data collection and analysis to answer a question.

Generalizable knowledge is information that expands the knowledge base of a scientific discipline or other scholarly field of study.

Clinical Investigation, as defined by the FDA, is synonymous with “research” as defined by DHHS and means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA, or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

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 a living 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. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used.
      • When medical device research involves invitro 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.