Title
Office of Human Research Ethics SOP 2401: Research Subject to US Department of Energy Regulations
1. Purpose
The purpose of this SOP is to establish written requirements to ensure compliance with U.S. Department of Energy (DOE) requirements regarding human subjects research. The DOE is a signatory to the 2018 Common Rule, codified at 10 CFR 745. Additional DOE requirements are specified in DOE Order 443.1C, Protection of Human Research Subjects, and DOE Order 206.1, Department of Energy Privacy Program.
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. The University of North Carolina at Chapel Hill (UNC-Chapel Hill) does not conduct classified research.
2. Responsibility
The UNC-Chapel Hill IRB and researchers conducting human subjects research supported by the DOE are responsible for ensuring compliance with this SOP.
3. Definitions
Human Subjects Research: DOE applies the standard Common Rule (45 CFR Part 46) definition of Human Subjects Research (see UNC-Chapel Hill HRPP SOP 6001 Definitions) but supplements the definition by adding that:
- Human Terrain Mapping (HTM) projects are to be handled as human subjects research.
- “Generalizable” means new information that has relevance beyond the population or program from which it was collected or information that is added to the scientific literature.
- Human subjects research includes:
- Use of humans to examine devices, products, or materials with the express purpose of investigating human-machine interfaces or evaluating environmental alterations when humans are the subjects being tested;
- Use of personally identifiable bodily materials such as cells, blood, tissues, urine, or hair, even if the materials were collected previously for a purpose other than the current research;
- Collection and use of personally identifiable information such as genetic information or medical and exposure records, even if the information was collected previously for a purpose other than the current research;
- Collection of personally identifiable or non-identifiable data, surveys, or questionnaires through direct intervention or interaction with individuals; and
- Search for generalizable knowledge about categories or classes of subjects (e.g., linking job conditions of worker populations to hazardous or adverse health outcomes).
Human Terrain Mapping: 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 and/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. In addition to HTM, such activities are often referred to as human social culture behavior (HSCB) studies. It is DOE policy that HTM activities are managed as human subjects research.
4. Procedures
4.1 No human subjects research subject to DOE requirements (as described above herein) may be initiated without both a Federalwide Assurance (FWA) or comparable assurance (e.g., DoD assurance) and approval by the cognizant IRB.
4.2 Human subjects research that involves 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 U.S. National Nuclear Security Administration (NNSA) Human Subjects Protections (HSP) Program Manager, other appropriate IRB of record.
4.3 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.
4.4 Research that uses social media data must be submitted to the appropriate IRB for review and determination.
4.5 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.
4.6 Research that involves the study of humans in a systematically modified environment must be submitted to the appropriate IRB for human subjects review and determination.
4.7 HTM is managed as human subjects research. UNC-Chapel Hill may conduct HTM human subjects research.
4.7.1 HTM projects conducted with DOE funding, at DOE sites/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, must be strictly limited to only those projects involving the analysis and modeling of de-identified data.
4.8 Personally identifiable information collected and/or used during human subjects research must be protected in accordance with the requirements of DOE Order 206.1, Department of Energy Privacy Program.
5. Notification Requirements
The Human Subjects Protection Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) must be notified in writing:
5.1 Prior to the initiation of the human subjects research portion of a new project, even if it meets the regulatory definition of exempt human subjects research as outlined in 10 CFR Part 745.104, that involves:
5.1.1 An Institution without an established IRB;
5.1.2 A foreign country; or
5.1.3 A potential for significant controversy (e.g. negative press or reaction from stakeholder or oversight groups).
5. 2 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. Immediately upon a finding of a suspected or confirmed data breach involving Personally Identifiable Information (PII) in printed or electronic form. Additionally, the incident must be reported to the DOE-Cyber Incident Response Capability in accordance with the requirements of DOE Order 206.1, Department of Energy Privacy Program. The appropriate HSP Program Manager must also be notified of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
5.3 Immediately upon learning of a serious adverse event. The appropriate HSP Program Manager must also be informed of any corrective actions taken and consulted regarding the plan for any remaining corrective actions.
5.4 Within 48 hours, with a description of corrective actions taken. The appropriate HSP Program Manager must also be consulted regarding the plan for any remaining corrective actions, following other incidents not described above:
5.4.1 Unanticipated problems, significant adverse events, and complaints about the research, as well as suspension or termination of IRB approval of research; and
5.4.2 Known or potential incidents of non-compliance with requirements of DOE Order 443.1C, 10 CFR Part 745, or 45 CFR Part 46.
6. Human Subjects Research Database Reporting
6.1 Human subjects research projects must be reported annually to the Human Subjects Research Projects Database (HSRD) in accordance with directions and schedules provided by the appropriate Human Subjects Protections Program Manager. Such reporting is also required when human subjects research is minimal risk or exempt.
Contact Information
Policy Contact
Name: Carley Emerson
Title: Director
Unit: Office of Human Research Ethics (OHRE)
Email: carley_emerson@unc.edu