About

Oversight of the Human Subjects Protection Program (HSPP) within DOE is assigned to the Associate Director of Science for Biological and Environmental Research (BER), who is the DOE Institutional Official for Human Subjects Research. The program is managed in collaboration with the Department’s semi-autonomous National Nuclear Security Administration (NNSA). DOE and NNSA each have an HSPP Manager, who reports functionally to the DOE Institutional Official. The HSPP managers work closely with DOE’s Headquarters and field organizations that fund and conduct human subjects research.

DOE has two central institutional review boards (IRBs) and multiple site IRBs. Each DOE site that conducts research involving human subjects is responsible for establishing and maintaining its own HSPP, in compliance with local, state, federal and DOE-specific requirements. While most sites have their own internal IRBs, some use one or both of DOE’s central IRBs or, alternatively, an external IRB. Research that is conducted by multiple DOE sites is reviewed by one of the two Central DOE IRBs.

Requirements

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies, including DOE, have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018 and June 19, 2018.

The revised Common Rule was effective July 19, 2018; note that from July 19, 2018 through January 20, 2019 institutions were not permitted to implement the entirety of the revised Common Rule.  This is explained in the transition provision (45 CFR 46.101(l), as amended June 19, 2018).  All projects initiated on or after January 20, 2019 must fully comply with the 2018 Requirements.  Studies that were ongoing as of that date may remain under the original (referred to as the Pre-2018 Requirements) Common Rule requirements or may be transitioned to the revised Common Rule.

All research involving human subjects 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, including:

Federal Requirements:

DOE-specific Requirements:

Note:  No human subjects research may be initiated without both a Federalwide Assurance (FWA) and approval by the cognizant Institutional Review Board (IRB) in accordance with 10 CFR 745.103 and DOE Order 443.1C, Section 4a(1). 

Background

DOE and its predecessor agencies (the Atomic Energy Commission (AEC) and the Energy Research and Development Administration (ERDA)) have traditionally considered the health of workers in its facilities to be a basic responsibility. From its inception during World War II, the U.S. nuclear program measured worker exposures and considered the impacts of those exposures on worker health. Post-World War II studies involving peaceful uses of atomic energy were governed by the ethical principles of medical and human research practices as set forth in the internationally accepted Nuremberg Code of 1949.

By 1970, the AEC required its national laboratories/contractors engaged in such work to comply with regulations then being developed by the National Institutes of Health (NIH) to protect human subjects involved in NIH-sponsored research. Contractor institutions set about establishing their own IRBs or making arrangements with existing IRBs to provide the necessary reviews of human studies protocols in order to ensure the physical protection and informed consent of research subjects.

The late 1970s and early 1980s was a period of rapid development of increasingly sophisticated technologies enabling detection of genetic patterns and aberrations known to be, or suspected of being, associated with existing disease or predictors of disease and others whose clinical significance was unknown or incomplete. With them, new and more complex ethical concerns continued to emerge in the 1990s. With the issuance of the Common Rule in 1991, DOE signed on to the new federal requirements and also increased internal efforts to ensure an adequate level of monitoring and protection of research volunteers.

The departments and agencies following the Common Rule identified a need to update the rule to reflect the changes in how research is conducted.  It will better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.  The revision is also an effort to modernize, simplify, and enhance the current system of oversight.  The revised Common Rule is designed to more thoroughly address the broader types of research conducted or otherwise supported by all of the Common Rule departments and agencies such as behavioral and social science research.  It also benefits from continuing efforts to harmonize human subjects policies across federal departments and agencies.

Scope of Research

DOE’s research portfolio is unique among federal agencies supporting research because of its breadth (e.g., nuclear fission to human biology to energy efficiency).

DOE 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, DOE-funded and conducted human subjects research includes, but is not limited to, studies that use, create, or collect data or information about:

  • humans in the testing of transformative energy technologies, devices, products, or materials developed through research; human-machine interfaces; or environmental alterations to a human environment;
  • bodily materials such as DNA, 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 data, including surveys, collected through direct intervention or interaction with individuals;
  • studies focused on Internet Research, Artificial Intelligence, Machine Learning and Big Data; and
  • epidemiologic and other studies conducted to gain generalizable knowledge about categories or classes of subjects (e.g., worker populations or subgroups).