80. Department of Energy (DoE) Regulations for Human Subject Research
Updated Oct. 4, 2019
Human research that is supported or conducted by the Department of Energy (DoE) must comply with the Common Rule ( 10 CFR 745); DOE O 443.1B, Protection of Human Research Subjects (April 21, 2016); and DOE N 443.1, Protection of Human Subjects in Classified Research (January 21, 2016).
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 subject research conducted with DoE funding. Through its Quality Improvement Program, Research Integrity (RI) periodically conducts self-assessments to ensure compliance with regulatory requirements, State laws, and policies related to the protection of human research participants.
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 subject 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 subject 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.* The DoE additional protections are codified in two DoE documents:
- DOE Checklist for Use by Researchers Conducting Human Subjects Research That Utilizes Personally Identifiable Information (reflected in the DoE Research researcher form in IRBNet)
- DOE Institutional Review Board Template for Reviewing Human Subjects Research Protocols that utilized Personally Identifiable Information (PII) (reflected in the DoE Research Review Checklist in IRBNet)
*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.
DoE Review Requirements
- Experienced RI staff determine review levels with concurrence from the assigned reviewer. If uncertain, RI staff will confer with the IRB Chair to confirm the review level for DoE research.
- As with all human subject 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 subject 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.
- 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.
DoE Reporting and Notification Requirements
Within five business days of discovery (or 48 hours if the problem may be life-threatening or fatal), researchers must report to the IRB and 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 O 206.1, DoE Privacy Program, and must include a description of corrective actions taken.
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.