80. Department of Energy (DoE) Regulations for Human Research

Updated June 24, 2021

Human research that is supported or conducted by the Department of Energy (DoE), including contracts, must comply with the following regulations: Common Rule (10 CFR 745); DoE Order 443.1C (Approved: 11-26-2019); DoE Order 206.1 (Effective date 11-1-2018); and their accompanying Contractor Requirements Documents (CRDs).

These requirements for human participant protections and the accompanying CRDs apply to all research conducted at DoE institutions regardless of funding source, or by DoE employees or contractor personnel regardless of funding source or location conducted, and whether done domestically or in an international environment, and including Human Terrain Mapping research (defined below). Requirements for human participant protections for classified research apply to all research conducted or supported by the DoE.

A DoE researcher form and review worksheet are used to assess DoE-supported research projects for the additional DoE regulations. In presenting the protocol to the IRB, the primary reviewer will address the additional DoE regulatory requirements.

In accordance with DoE regulations, the University maintains a Federal-wide Assurance (FWA) and requires review and approval by an appropriately constituted Institutional Review Board (IRB) of all human research conducted with DoE funding. Through its Quality Improvement Program, Research Integrity periodically conducts self-assessments to ensure compliance with regulatory requirements, State laws, and policies related to the protection of human research participants.

DoE Definitions

Under DoE regulations, “research involving human participants” includes studies of the intentional modification of the human environment.

Under DoE regulations, “generalizable” should be viewed in terms of the contribution to knowledge within a specific field of study and includes:

  • the study of tracer chemical, particles or other materials to characterize airflow;
  • studies in occupied homes or offices that involve manipulation of the environment to achieve research aims or to test new materials; and
  • studies in occupied homes or offices that involve the collection of information through surveys or focus groups related to occupants’ views of appliances, materials, or devices installed in their homes, or their energy-saving behaviors.

Human research includes “Human Terrain Mapping (HTM)”: Research and data gathering activities primarily conducted for military or intelligence purposes to understand the human terrain (i.e., the social, ethnographic, cultural, and political elements of the people among whom the U.S. Armed Forces are operating and/or in countries prone to political instability). HTM includes observations, questionnaires, and interviews of groups of individuals, as well as modeling and analysis of collected data, and may become the basis for U.S. military actions in such locations.

DoE Requirements for Protecting Personally Identifiable Information

The University IRB reviews all human research applications to ensure protections are sufficient to protect the confidentiality of research records. Human research conducted or supported by the DoE that utilizes personally identifiable information (PII) requires additional precautions to protect against breaches of PII. (According to the DoE, breaches of PII include loss of control, incorrect delivery, and theft of PII including PII stored electronically on servers or a DoE-operated web site.) The DoE additional protections are codified in two DoE documents:

  1. DOE Checklist for Use by Researchers Conducting Human Research That Utilizes Personally Identifiable Information (reflected in the DoE Research researcher form in IRBNet)
  2. DOE Institutional Review Board Template for Reviewing Human Research Protocols that utilized Personally Identifiable Information (PII) (reflected in the DoE Research Review Checklist in IRBNet)

DoE Requirements for Informed Consent

Consent document requirements specific to DoE research include:

  • The identity of the sponsoring agency, unless the sponsor requests that it not be done, because doing so could compromise intelligence sources or methods; the research involves no more than minimal risk to participants; and the IRB determines that by not disclosing the identity, the investigators will not adversely affect the participants.
  • When research is classified, consent documents must state the project is classified, and what it means for the purposes of the research project.

When conducting classified research, the IRB may not grant a waiver of the consent process or waiver of documentation of consent.

When the research is classified, the IRB must determine if participants need access to classified information to make a valid consent decision.

DoE Review Requirements

  • Experienced Research Integrity staff determine review levels with concurrence from the assigned reviewer. If uncertain, Research Integrity staff will confer with the IRB Chair to confirm the review level for DoE research.
  • As with all human research, the IRB assesses risks associated with DoE-funded research and the adequacy of informed consent processes and procedures to protect research participants.
  • IRB approval letters are electronically signed by the IRB Chair and published in IRBNet.
  • Human research involving vulnerable populations will be conducted in accordance with the relevant Subparts at 45 CFR 46: Subpart B for research involving pregnant women/fetuses (for Biomedical research only), Subpart C for research involving prisoners, or Subpart D for research involving children).
  • Employees and contractors are considered vulnerable participants. The IRB should consider if additional protections are required for research involving employees and contractors.
  • When conducting classified research, the use of exemptions is prohibited. The fact that research meets a particular exemption category may be noted, but review by a convened IRB is required.
  • When conducting classified research, the use of the expedited review procedure is prohibited.
  • When conducting classified research, the IRB must have a voting quorum of at least five members, which must include both a non-scientist and a non-affiliated member.
  • The non-affiliated member must be a non-governmental member with the appropriate security clearances. This individual cannot be a current federal employee or contractor.
  • Any IRB member can appeal a vote to approve research to the Institutional Official, Secretary of Energy, and Director of the Office of Science and Technology, in that order.

IRB approval letters for research conducted or supported by DoE must specify that the research was approved in accordance with DoE expectations and will be monitored and tracked by the IRB.

For research conducted at a DoE facility, the DoE Institutional Official is responsible for approving classified research conducted with DoE funding at its sites/laboratories and by its employees and contractors after IRB approval and prior to initiation.

For research conducted at a DoE facility, the DoE Human Subjects Protection Program Manager is responsible for:

  • Developing procedures for the classified research program in consultation with the National Nuclear Safety Administration Human Subject Protection Program Manager.
  • Conducting biennial performance reviews of all IRBs that review classified research involving human participants to assess compliance, in consultation with the National Nuclear Security Administration human participant protection program manager.
  • Reviewing and approving local plans to correct noncompliance or mitigate adverse events and unanticipated problems involving risks to participants or others.
  • Reviewing and approving statements of work for classified Human Terrain Mapping projects submitted by DoE’s Non-National Nuclear Security Administration sites or projects.
  • Making recommendations to the Secretary after concurrence from the organizational Official, on a project by project basis, regarding exemptions from the requirements for classified research.
  • Concurs on human participant provisions for classified research in interagency agreements, in consultation with the National Nuclear Security Administration, as appropriate.
  • Maintaining an unclassified list of classified projects.

DoE Reporting and Notification Requirements

Within 48 hours of discovery, researchers must report to the DoE Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) any significant adverse events, unanticipated risks, and complaints about the research; and a description of any corrective actions taken or to be taken.

Any suspected or confirmed data breach involving PII in printed or electronic form must be reported immediately in accordance with the requirements of DOE Order 206.1, DoE Privacy Program, and must include a description of corrective actions taken. The timeframe for immediately is defined as upon discovery.

NOTE: HRP concurrence will be sought for the plan for remaining corrective actions related to suspected or confirmed data breach.

The IRB will notify the DoE HSP Program Manager in writing within 48 hours of the following IRB determinations:

  • unanticipated problem including suspected or confirmed data breach involving PII,
  • suspension or termination of IRB approval of research, and
  • serious or continuing noncompliance.

Each notification will include a description of corrective actions taken, and the plan for any remaining corrective actions.