Additional Requirements for Department of Energy (DOE) Research

(See DOE Order 443.1C, Chg 1)

1. Research that involves one or more of the following must be submitted to the appropriate IRB for human subjects research (HSR)/not HSR review and determination:
   1. Study of humans in a systematically modified environment. These studies include but are not limited to intentional modification of the human environment:
      1. Study of human environments that use tracer chemicals, particles or other materials to characterize airflow.
      2. Study in occupied homes or offices that:
         1. Manipulate the environment to achieve research aims.
         2. Test new materials.
         3. Involve collecting information on occupants’ views of appliances, materials, or devices installed in their homes or their energy-saving behaviors through surveys and focus groups.
   2. Use of social media data and/or other publicly available data about individuals or publicly available biospecimens, even if the data or biospecimens appear(s) to be de-identified. Note: DOE follows the Health Insurance Portability and Accountability Act (HIPAA) and guidance issued by the National Institutes of Standards and Technology, as a minimum, in determining identifiability.
   3. Human Terrain Mapping (HTM), which is managed as HSR. HTM must be strictly limited to only those projects involving the analysis and modeling of de-identified data.
2. Ensure that final HSR/not HSR determinations for studies that may constitute HSR, including exempt HSR determinations, are made through the appropriate IRB and/or IRB office. For sites that use one or both Central DOE IRB(s) as their IRB(s) of record, the Central DOE office is the responsible office and coordinates with the site HSR leads, as appropriate, to discuss project specific information and convey study determinations.
3. If you submit studies to DOE central or DOE site IRBs, complete additional DOE-specific training that includes a module on recognizing and addressing bias in the design, review and conduct of Human Research.3. If you submit studies to DOE central or DOE site IRBs, complete additional DOE-specific training that includes a module on recognizing and addressing bias in the design, review and conduct of Human Research.
4. Personally identifiable information (PII) collected and/or used during HSR projects must be protected in accordance with the requirements of DOE Order 206.1, Department of Energy Privacy Program, current version. The Central DOE IRBs require submission of DOE’s HRP- 490- CHECKLIST-Reviewing Protocols that use Personally Identifiable Information (PII) if your research includes PII. Contact the CDOE at CDOEIRB@orau.org to obtain a copy.
5. The following must be reported in writing to the DOE human subjects research Program Manager (and, when a National Nuclear Security Administration (NNSA) element is involved, the NNSA HSP Program Manager), even for HSR that meets the regulatory definition of exempt HRS as outlined in 10 Code of Federal Regulations (CFR) Part 745.104.
   • Prior to initiation of the HSR portion of a new project, involving:
     1. An institution without an established Institutional Review Board (IRB);
     2. A foreign country;
     3. The potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups);
     4. Research subjects in a protected class (including the populations identified in Subparts B, C, and D of 45 CFR Part 46), as well as others such as individuals with impaired decision making capability, or DOE/NNSA Federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope; or
     5. The generation or use of classified information.
   • Immediately upon a finding of a suspected or confirmed data breach involving PII in printed or electronic form, report to the IRB, the DOE/NNSA HSP Program Manager(s), and the Integrated Joint Cybersecurity Coordination Center (iJC3), in accordance with the requirements of DOE O 206.1. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
   • Immediately upon learning of a serious adverse event, report to the IRB and the DOE/NNSA HSP Program Manager(s). The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
   • The IRB must be notified immediately and the DOE HSP Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager) must be notified within two (2) business days of learning of the following and consulted regarding planned corrective actions if any of the following occur:
     • Unanticipated problems, significant adverse events, and complaints about the research.
     • Any suspension or termination of IRB approval of research.
     • Any known or potential incidents of noncompliance with requirements of DOE Order 443.1C, Chg. 1, 10 CFR Part 745, or 45 CFR Part 46.
6. Requirements for human participant protections for classified research apply to all classified research conducted or supported by the DOE and its national laboratories, including contracts, and including Human Terrain Mapping research.
7. Researchers conducting human subjects research in any other country or on citizens or other individuals residing in that country must be cognizant of country-specific human subjects research requirements and consult the IRB regarding applicability of such requirements.
8. No human subjects research conducted with DOE funding, at DOE institutions (regardless of funding source), or by DOE or DOE contractor personnel (regardless of funding source or location conducted), whether done domestically or in an international environment, including classified and proprietary research, may be initiated without both a Federalwide Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) of compliance and approval by the cognizant Institutional Review Board (IRB) in accordance with 10 CFR §745.103.
9. Human subjects research involving multiple DOE sites (e.g., members of the research team from more than one DOE site and/or data or human subjects from more than one DOE site) must be reviewed and approved by one of the Central DOE IRBs prior to initiation, or if authorized by the DOE and/or NNSA HSP Program Manager, other appropriate IRB of record. In all cases, an IRB Authorization Agreement (IAA) or Memorandum of Understanding (MOU) must be in place between the organization(s) conducting the HSR and the organization responsible for IRB review.
10. Human subjects research that involves targeted inclusion of DOE Federal and/or contractor employees or their data must first be reviewed and approved by the appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the Federally assured DOE site or Headquarters, other appropriate IRB of record, in accordance with an IAA or MOU negotiated between the DOE site or Headquarters and the organization responsible for IRB review.
11. Classified and unclassified intelligence and intelligence-related HSR regardless of the funding source (including, but not limited to, Strategic Intelligence Partnerships Program (SIPP) funded studies, DOE Office of Intelligence and Counterintelligence (DOE-IN) funded studies, and/or studies funded by other DOE program offices that use intelligence datasets), must be reviewed and approved by the Central DOE IRB- Classified.
12. If applicable, federally funded HSR must comply with the requirements of the Paperwork Reduction Act.
13. If applicable, HSR involving visiting student researchers, researchers, and scholars from other countries as members of research teams must comply with Department of State requirements, e.g., those outlined in 22 CFR Part 62, Exchange Visitor Program, and U.S. Department of State Guidance Directive 2024-01, current version.
14. Equitable payment of human subjects participating in HSR is allowable.
15. Other specific requirements of the DOE research can be found in the “Additional Requirements for Department of Energy (DOE) Research” section in the IRB’s HRP-318 – WORKSHEET – Additional Federal Agency Criteria.