The Coordinated Science Laboratory
National Center for Principled Leadership & Research Ethics

Human Subjects Research

Definition of Human Subjects Research

Engagement in human subjects research includes any of the following for research purposes by an investigator, faculty member, post-doc, student, staff member, or agent in the research ("research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge):

  • Intervention for research purposes with any research participant by:
    • performing invasive or noninvasive procedures (e.g., drawing blood; MRIs; administering psychotherapy, drugs, other treatments).
    • manipulating the environment (e.g., controlling light; orchestrating environmental events or social interactions).
  • Interaction for research purposes with any research participant(e.g., engaging in protocol-dictated communication such as reading an IRB-approved script, asking IRB-approved screener questions, administering interviews, surveys). *see exception below
  • Obtaining the informed consent of a research participant.
  • Obtaining for research purposes identifiable private information or identifiable biological specimens from any source for the research. This includes but is not limited to: (1) observing or recording private behavior; and (2) using, studying, or analyzing for research purposes identifiable private information or identifiable specimens (a) provided by another institution or (b) already in the possession of the investigators.
  • Being the recipient of a contract or cooperative agreement directly from HHS for non-exempt human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution.

 

*EXCEPTION: If you perform procedures or interact with research participants as part of your standard duties (e.g., phlebotomist who draws blood all day; or receptionist who answers the phone in a research unit and takes only contact information to pass on to another person), you are not engaged in human subjects research.