Human Subjects Research Program Overview

Purpose/Mission

The protection of human subjects in all of the research performed under the Department of Energy (DOE) authorities is of prime importance to the Department. All research conducted at DOE institutions, supported with DOE funds, or performed by DOE employees, including research that is classified and proprietary, whether done domestically or in an international environment, must comply with all federal regulations and DOE requirements that address the protection of human subjects.

Historical Background

In 1945, information came to light about unethical experiments conducted by Nazi physicians on concentration camp prisoners. In that same decade, a study in Tuskegee, Alabama, used disadvantaged rural black men to study the untreated course of syphilis. These subjects were not offered effective treatment until long after such treatment became generally available.

These issues heightened awareness of the need to protect human subjects and to ensure their informed voluntary consent to participate in human subjects research. The principles that underlie the protection of human subjects today are found in three main documents:

These three documents served as the cornerstone for the drafting of the Federal Policy for the Protection of Human Subjects (known as the Common Rule). The Common Rule was adopted in 1991 by 17 federal agencies that conduct, support, or otherwise regulate human subjects research.

For DOE, the Common Rule is implemented in Title 10 Code of Federal Regulations (CFR), Part 745.

For the U.S. Department of Health and Human Services (DHHS), the Common Rule is implemented at 45 CFR 46. Laws governing human subjects research are continuing to evolve rapidly.

Common Rule regulations are based upon the three ethical principles outlined in the Belmont Report:

  • Respect for Persons. This principal requires investigators to obtain informed consent and to protect the privacy of human research participants.
  • Beneficence. This principal requires researchers to maximize potential benefits to participants and to minimize the potential of harm.
  • Justice. This principle requires that the selection of human subjects should be fair and equitable and that the risks and benefits of research should be distributed among subjects in a fair and equitable manner.