What is Human Subjects Research?

What is Human Subjects Research?

Research is defined in the Code of Federal Regulations as “a systematic investigation that contributes to generalizable knowledge”.

In other words, for the most part, an investigator will:

  • be engaged in a research project that is
  • designed to test a hypothesis or assess a theory by
  • proposing or intending to explore a particular research topic that is “about” a living individual
  • by obtaining private information or identifiable biospecimens from that person through an intervention or interaction
  • that is used, studied or analyzed to generate identifiable private information or identifiable biospecimens
  • which will then develop or contribute to generalizable knowledge by drawing general conclusions (e.g., knowledge gained from a study may be applied to populations outside of the specific study population), or inform policy and then
  • either be published (e.g., in a journal) or presented at a professional conference beyond UMBC. This does not include oral presentations to classmates and the course instructor in a research methods course.

Please note:

An intervention includes physical procedures by which information or biospecimens are gathered; an interaction includes communication or interpersonal contact.

Identifiable private information is information for which the identity of a person can or may be readily ascertained by the investigator or associated with the information.

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