Human Subjects Research Program Overview

While people typically view human subject research as biomedical and clinical studies that involve humans, the definition for human subject research is much broader than this. Areas that must be considered include:

  • Use of humans to test a device or product developed through research;
  • Use of data collected through interaction with people via a variety of communication styles (e.g., written or oral surveys) or intervention activities such as collection of bodily fluid samples or manipulation of the individual's environment;
  • Use of private information readily associated with individuals (even when the information was not collected for a specific study);
  • Use of bodily materials even if collected by someone other than the researcher; and

It is ORAU's policy that all research that falls under the above categories must be reviewed and approved by both the researcher's institution and the Institutional Review Board.

Purpose/Mission
A more detailed explanation of the purpose, mission, and history of the Human Subjects Research Program.

Legal Requirements
Defines all areas of research that are considered human subjects research and lists the researchers' and ORAU's legal responsibilities.