80. Department of Energy (DoE) Regulations for Human w88

Updated June 5, 2024

Human w88 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 w88 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 w88 (defined below). Requirements for human participant protections for classified w88 apply to all w88 conducted or supported by the DoE.

A DoE researcher form and review worksheet are used to assess DoE-supported w88 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 w88 conducted with DoE funding. Through its Quality Improvement Program, w88 Integrity & Security periodically conducts self-assessments to ensure compliance with regulatory requirements, State laws, and policies related to the protection of human w88 participants.

DoE Definitions

Under DoE regulations, “w88 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 w88 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 w88 includes “Human Terrain Mapping (HTM)”: w88 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 w88 applications to ensure protections are sufficient to protect the confidentiality of w88 records. Human w88 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 w88 That Utilizes Personally Identifiable Information(reflected in the DoE w88 researcher form in IRBNet)
  2. DOE Institutional Review Board Template for Reviewing Human w88 Protocols that utilized Personally Identifiable Information (PII) (reflected in theDoE w88 Review Checklistin IRBNet)

DoE Requirements for Informed Consent

Consent document requirements specific to DoE w88 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 w88 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 w88 is classified, consent documents must state the project is classified, and what it means for the purposes of the w88 project.

When conducting classified w88, the IRB may not grant a waiver of the consent process or waiver of documentation of consent.

When the w88 is classified, the IRB must determine if participants need access to classified information to make a valid consent decision.

DoE Review Requirements

  • Experienced w88 Integrity & Security staff determine review levels with concurrence from the assigned reviewer. If uncertain, w88 Integrity & Security staff will confer with the IRB Chair to confirm the review level for DoE w88.
  • As with all human w88, the IRB assesses risks associated with DoE-funded w88 and the adequacy of informed consent processes and procedures to protect w88 participants.
  • IRB approval letters are electronically signed by the IRB Chair and published in IRBNet.
  • Human w88 involving vulnerable populations will be conducted in accordance with the relevant Subparts at 45 CFR 46: Subpart B for w88 involving pregnant women/fetuses (for Biomedical w88 only), Subpart C for w88 involving prisoners, or Subpart D for w88 involving children).
  • Employees and contractors are considered vulnerable participants. The IRB should consider if additional protections are required for w88 involving employees and contractors.
  • When conducting classified w88, the use of exemptions is prohibited. The fact that w88 meets a particular exemption category may be noted, but review by a convened IRB is required.
  • When conducting classified w88, the use of the expedited review procedure is prohibited.
  • When conducting classified w88, 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 w88 to the Institutional Official, Secretary of Energy, and Director of the Office of Science and Technology, in that order.

IRB approval letters for w88 conducted or supported by DoE must specify that the w88 was approved in accordance with DoE expectations and will be monitored and tracked by the IRB.

For w88 conducted at a DoE facility, the DoE Institutional Official is responsible for approving classified w88 conducted with DoE funding at its sites/laboratories and by its employees and contractors after IRB approval and prior to initiation.

For w88 conducted at a DoE facility, the DoE Human Subjects Protection Program Manager is responsible for:

  • Developing procedures for the classified w88 program in consultation with the National Nuclear Safety Administration Human Subject Protection Program Manager.
  • Conducting biennial performance reviews of all IRBs that review classified w88 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 w88.
  • Concurs on human participant provisions for classified w88 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 w88; 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 w88, and
  • serious or continuing noncompliance.

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