Department of Energy

Purpose and Applicability

This webpage provides guidance for researchers, the UW IRBs, and HSD staff for research supported by the federal Department of Energy (DoE).

Research that is subject to DoE regulations includes research that is: (1) funded by DoE; and/or (2) conducted at DoE institutions or by DoE or DoE contract personnel (regardless of funding). This is true for domestic sites and in international settings.

Regulations

The DoE has signed onto the Common Rule with its interpretation of 45 CFR 46, Subpart A described in 10 CFR 745. The DoE regulations refer directly to 45 CFR 46, Subparts B-D to describe the regulatory requirements for protected populations.

Personally identifiable information collected and/or used in research must comply with the protections described in DoE Order 206.1 ^[9]. Researchers must attest that they will follow these protections in the SUPPLEMENT Department of Energy ^[10].

DoE employees are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is voluntary and that their research information remains confidential. The Central DoE IRB uses this checklist ^[11] to ensure the criteria for approval are met when DoE employees are enrolled in the research.

Projects involving modification of the human environment (e.g., testing energy-efficient devices in the home or offices and responding to surveys on such devices and personal energy use practices) require the IRB to consider several key factors, even if the research is exempt. The Central DoE IRB uses this checklist ^[12] to consider those factors.

Projects involving human terrain mapping (HTM) must be managed as human subjects research. HTM is research and data gathering activities primarily conducted for military or intelligence purposes to understand the human terrain – the social, ethnographic, cultural, and political elements of the people among whom the U.S. Armed Forces are operating on/or in countries prone to political instability. This work 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. The Central DoE IRB uses this checklist ^[13] to consider factors specific to HTM.

Definitions

Personally Identifiable Information (PII). PII is defined as any information collected or maintained about an individual including but not limited to, education, financial transactions, medical history and criminal or employment history, and information that can be used to distinguish or trace an individual’s identity, such as their name, Social Security Number, date and place of birth, mother’s maiden name, biometric data, and including any other personal information that is linked or linkable to a specific individual.

Note – PII is not the same as Protected Health Information (PHI) as defined by HIPAA regulations.

Human Subjects Research. DoE applies the standard Common Rule (45 CFR 46) definition of human subjects research (Does Your Research Involve Human Subjects? ^[14]) but supplements the definition by adding that:

• Generalizable means information/research findings that are intended to be applied to populations or situations beyond that studied/will have meaning and impact outside the single immediate activity itself.
• Human Terrain Mapping (HTM) projects are to be handled as human subjects research. More information under Regulations, above.

Procedures

Application materials. Researchers conducting DoE-supported research must submit the SUPPLEMENT Department of Energy ^[10] along with their Zipline application.

Reporting.

• Suspected or confirmed data breach involving PII.
  • The researcher must notify the DoE immediately as described in the SUPPLEMENT Department of Energy ^[10] in addition to any other reporting requirements described in DoE Order 206.1. Provide a description of corrective actions taken within 48 hours.
  • Notify HSD according to the requirements on the webpage, Guide to Reporting New Information ^[15].
• Serious adverse event.
  • The researcher must notify the DoE Human Subjects Protection Program Manager immediately and provide a description of corrective actions taken within 48 hours.
  • Notify HSD according to the requirements on the webpage, Guide to Reporting New Information ^[15].
• Unanticipated problems, significant adverse events, complaints about the research.
  • The researcher must notify the DoE Human Subjects Protection Program Manager within 48 hours.
  • Notify HSD according to the requirements on the webpage, Guide to Reporting New Information ^[15].
• Known or potential incidents of noncompliance with DoE regulations as well as suspension or termination of the research.
  • The IRB must notify the DoE Human Subjects Protection Program Manager within 48 hours.

Related Material

SUPPLEMENT Department of Energy ^[10]
WEBPAGE Guide to Reporting New Information ^[15]
WEBPAGE Step 2: Does Your Research Involve Human Subjects? ^[16]

Related Material

• 10 CFR 745 ^[17], DoE interpretation of 45 CFR 46, Subpart A
• 45 CFR 46, Subparts B-D
• DoE Directive O 443.1C ^[18], November 26, 2019
• DoE Order 206.1 ^[9], DoE Privacy Program, November 1, 2018
• DoE Human Subjects Protection Program website ^[19]
• DoE Checklist – Human Terrain Mapping ^[13]
• DoE Checklist – Modification of the Human Environment ^[12]
• DoE Checklist – Protecting Employees Who Participate as Research Subjects ^[11]

Version Information

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Keywords: Federal agencies