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DOE Requirements
Additional Requirements: Department of Energy (DoE)
- Last updated:
- 06/01/2025
- Guidance Contact:
IU Human Research Protection Program (HRPP)
irb@iu.edu
In addition to the requirements outlined in IU HRPP Policies, certain funding sources or federal agencies impose additional human subjects research requirements. When applicable, these agency-specific requirements must be followed to ensure compliance. The information below summarizes these additional requirements. Researchers are responsible for reviewing and adhering to all applicable requirements.
Department of Energy (DoE)
DOE has adopted the Common Rule at 10 CFR Part 745 and has published additional requirements for research it supports or conducts as described in DOE Order 443.1C, Protection of Human Research Subjects. For additional guidance, also review DOE-Specific Requirements.
DOE requirements apply to all 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.
No human subject research conducted with DOE funding, at DOE institutions, regardless of funding source), or by DOE contractor personnel (regardless of funding source or location conducted), and 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) and approval by the cognizant IRB in accordance with 10 CFR Part 745.103.
- Research that involves one or more of the following must be submitted to the appropriate IRB for human subjects research review and determination:
- Research that uses social media
- Research that involves the study of humans in a systematically modified environment
- Classified and unclassified human subject research that is funded through the Strategic Intelligence Partnership Program (SIPP) must be reviewed and approved by the Central DOE IRB-Classified.
- Human Terrain Mapping (HTM) is managed as research involving human subjects.
The informed consent document should 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 research involves no more than minimal risk to subjects; and the IRB determines that by not disclosing the identity, the investigators will not adversely affect the subjects.
- When conducting or reviewing classified research, exemptions (as per 10 CFR Part 745.104) will not be used. The fact that research meets a particular exemption category may be noted, but review by a convened IRB is required.
- When conducting or reviewing classified research, the use of the expedited review procedure is prohibited. The fact that research meets a particular expedited category may be noted, but review by a convened IRB is required.
- Informed consent may only be waived for classified research if the work meets one of the categories of the minimal risk human subject research addressed at 10 CFR Part 745.104.
- When research is classified, consent documents must disclose:
- The identity of the sponsoring agency, unless the sponsor requests it not be done. The only acceptable reason for non-disclosure is that disclosure could compromise intelligence sources or methods. Additionally, the research must be no more than minimal risk to subjects; and the IRB must determine that by not disclosing the identity the researchers will not adversely affect the subjects.
- That the project is classified, what it means for the purposes of the research project, and what part of the research that applies to.
- The IRB must determine if subjects need access to classified information to make a valid consent decision.
- Researchers are required to follow DOE requirements for the protection of personally identifiable information by completing and complying with the requirements of the “CHECKLIST-Reviewing Protocols that use PII" available at: https://science.osti.gov/ber/human-subjects/Regulations-and-Requirements/DOE-Specific-Requirements
- The IRB must verify compliance with the DOE requirements for protecting personally identifiable information (PII). Additional information can be found at: https://science.osti.gov/ber/human-subjects
- Research involving human subjects 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, unless review by another appropriate IRB of record is authorized by the DOE and/or NNSA HSP Program Manager.
- If authorized by the DOE and/or NNSA HSP Program Manager, research may be reviewed by 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.
- DOE and DOE site employees are considered vulnerable subjects when participating in research and additional care must be taken to ensure their participation is truly voluntary (e.g., by ensuring they do not report to members of the research team) and that data collected about them is kept confidential.
- 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.
The DOE Human Subjects Protection (HSP) Program Manager (and NNSA HSP Program Manager, if applicable) must be notified under the following circumstances:
- Prior to Initiation of Research: Must be notified in writing prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt HSR as outlined in 10 CFR Part 745.104, that involves:
- An institution without an established IRB.
- A foreign country.
- A potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups).
- Research subjects in a protected class (prisoners, children, individuals with impaired decision making, 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.
- The generation or use of classified information.
- Immediate Notification
- Upon learning of a serious adverse event. The HSP Program Manager(s) shall also be informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
- Within 48 Hours (with corrective action descriptions):
- Known or potential incidents of noncompliance
- Unanticipated problems
- Significant adverse events
- Complaints about the research
- Suspensions of IRB approval
- Terminations of IRB approval
- Any breach involving Personally Identifiable Information (PII) must be reported:
- Immediately upon a finding of a suspected or confirmed data breach involving PII in printed or electronic form, the incident must be reported to the DOE-Cyber Incident Response Capability in accordance with the requirements of DOE O 206.1.
- Within 48 hours the DOE or NNSA HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
- Additional Researcher Reporting (within 48 hours):
- Any significant adverse events, unanticipated risks; and complaints about the research, with a description of any corrective actions taken or to be taken.
- Any suspension or termination of IRB approval of research.
- Any significant noncompliance with HRPP procedures or other requirements.
- Any suspected or confirmed compromise of personally identifiable information, with a description of any corrective actions taken or to be taken. The incident must also be immediately reported to the DOE-Cyber Incident Response Capability.
- Any serious adverse event, with a description of any corrective actions taken or to be taken.