DOE Human Subjects Protection Program

Scope of Research

DOE’s research portfolio is unique among agencies supporting research because of its breadth (e.g., nuclear fission to human biology). Research on human subjects performed in accordance with the ethical and humanitarian principles allows experiments to be performed that provide medical and scientific benefits to individuals and to the nation.

Such research using human subjects encompasses a broader range of research than many investigators, program managers, and government officials often realize. In addition to traditional biomedical and clinical studies, human subjects research includes, but is not limited to, studies that use, create, or collect:

  • humans to test devices, products, or materials developed through research; to examine human-machine interfaces; or to evaluate environmental alterations;
  • bodily materials such as cells, blood, tissues, or urine that are identifiable with individuals even if the materials were not collected for the study in question;
  • private information readily identifiable with individuals, including genetic information and medical and exposure records, such as worker health studies, even if the information was not collected specifically for the study in question;
  • identifiable or high-risk data, including surveys, collected through direct intervention or interaction with individuals; and
  • studies conducted to gain generalizable knowledge about categories or classes of subjects (e.g., worker populations or subgroups).

Content reviewed: November 12, 2013