Additional Requirements for Department of Energy (DOE) Research

(See DOE Order 443.1C)

1. Research that involves one or more of the following must be submitted to the appropriate IRB for human subjects research 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.
   3. Human Terrain Mapping (HTM).
   4. All exempt HSR determinations must be made by the appropriate IRB and/or IRB office.
2. Personally identifiable information 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.
3. You must report the following to the DOE human subjects research Program Manager (and, when an NNSA element is involved, the NNSA HSP Program Manager) prior to initiation of any new human subjects research project, even if it meets the regulatory definition of exempt human subjects research as outlined in 10 CFR Part 745.104, 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 (prisoners, children, 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.
4. 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 48 hours and consulted regarding planned corrective actions if any of the following occur:
   1. Adverse events. Notify the IRB for all adverse events and the DOE/NNSA HSP Program Manager if the IRB determines them to be significant, as defined in DOE Order 443.1C.
   2. Unanticipated problems and complaints about the research.
   3. Any suspension or termination of IRB approval of research.
   4. Any significant noncompliance with HSP Program procedures or other requirements.
   5. Any finding of a suspected or confirmed data breach involving PII in printed or electronic form. Report immediately to the IRB, the DOE/NNSA HSP Program Manager(s), and the DOE-Cyber Incident Response Capability, in accordance with the requirements of the CRD associated with DOE O 206.1.
   6. Serious adverse events and corrective actions taken must be reported immediately to the IRB and the DOE/NNSA HSP Program Manager(s). The time frame for “immediately” is defined as upon discovery.
5. 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.
6. 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.
7. 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. 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.
8. Human subjects research that involves DOE Federal and/or contractor employees 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.
9. Classified and unclassified human subjects research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB- Classified.
10. If applicable, federally funded HSR must comply with the requirements of the Paperwork Reduction Act.