Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
When working with certain governmental entities, there are additional steps and protections that PIs and IRBs must be aware of and execute, or risk complications with their funding.
All research conducted at DOE institutions, supported with DOE funds, or performed by DOE employees, including research that is classified and proprietary, whether done domestically or in an international environment.
DOE policy regarding the Protection of Human Subjects is established in the Federal Policy for the Protection of Human Subjects, adopted by DOE June 18, 1991 as Title 10 Code of Federal Regulations (CFR) 745, Protection of Human Subjects and expressed in DOE O 443.1B, Protection of Human Research Subjects.
The definition of “human subjects research” is expanded in 10 CFR 745 beyond the Common Rule. DOE considers the following additional criteria when considering whether or not Department of Energy supported research meets the requirements for review by an Institutional Review Board:
- Research involving human participants also includes studies of the intentional modification of the human environment; generalizable includes the study of tracer chemicals, particles or other materials to characterize airflow;
- Generalizable also includes studies in occupied homes or offices that: Manipulate the environment to achieve research aims. Test new materials. 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;
- Generalizable should be viewed in terms of the contribution to knowledge within the specific field of study.
Human Terrain Mapping (HTM) projects are covered under human subjects research. HTM is defined as “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 Human Terrain Mapping, such activities are often referred to as human social culture behavior (HSCB) and human terrain systems (HTS) studies.”
The management and oversight of the Human Subjects Protection Program within DOE is assigned to the Office of Biological and Environmental Research (OBER) within the Office of Science. OBER oversees the program in collaboration with the National Nuclear Security Administration (NNSA) Human Subjects Research manager(s) who have responsibilities for research involving defense elements within DOE.
Exemptions to this policy: “Any requests for partial or full exemptions from the requirements of this Order shall be submitted in writing to the Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager). An exemption may be recommended to the Secretary or the Secretary's designee by the HSP Program Manager (or by the NNSA HSP Program Manager when an NNSA element is involved) after concurrence by the DOE Institutional Official (see paragraph 7f). The basis for granting or denying exemption requests shall be set forth in writing.” (DOE O 443.1B.3(c))
No research involving human participants conducted with DOE funding, at DOE institutions, or by DOE personnel may be initiated without both a Federal-wide Assurance (FWA) and approval by the cognizant Institutional Review Board (IRB) in accordance with 10 CFR 745.103.
The IRB chair decides the level of review.
Personally Identifiable Information (PII) Checklist:
PII is different from Protected Health Information (PHI) – it includes PHI but adds additional, non-medical information to the list of data that must be kept confidential and protected using “reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure” (DOE checklist for researchers using PII). PII is defined as any information collected or maintained about an individual including but not limited to, education, financial transactions, medical history and criminal or employment history, and information that can be used to distinguish or trace an individual’s identity, such as his/her name, Social Security number, date and place of birth, mother’s maiden name, biometric data, and including any other personal information that is linked or linkable to a specific individual.
- Handling and marking documents containing PII as “containing PII or PHI”;
- Using two-factor authentication for logon access control for remote access to systems and databases that contain PII. (Two-factor authentication is contained in the National Institute of Standards and Technology (NIST) Special Publication 800-63 Version 1.0.2 found at: http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-2.pdf
Please refer to the checklist for a complete list of all requirements. The IRB must review and approve the researcher checklist to ensure compliance with the DOE requirements for the protection of personally identifiable information.
Researchers are required to ensure that the DOE HSR Program Manager (and, when an NNSA element is involved, the NNSA HSR Manager) is notified of any new HSR project involving:
- An institution without an established Institutional Review Board (IRB);
- A foreign country;
- The potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups);
- Research participants in a protected class; or
- The generation or use of classified or unclassified controlled information.
There are no additional funding requirements for DOE studies. Refer to the UW department of Research and Sponsored Programs website for guidance: https://www.rsp.wisc.edu/
There is no additional training required for DOE studies. Researchers and their study staff are expected to take human participants research training as required by the UW, and maintain this certification while participating on a DOE trial. (The UW uses the CITI program for this training, which is DOE’s preferred and supported system for expectations and requirements for IRB, management, and research staff education.)
Loss or suspected loss of PII must be reported immediately upon discovery to:
- The DOE Project Officer;
- DOE-Cyber Incident Response Capability (DOE-CIRC) at 866-941-2472 (email@example.com); and
- The applicable IRB(s).
Issues of noncompliance that do not involve PII should be reported to the DOE Project Officer (as well as the applicable IRB) along with a corrective action plan within 48 hours of becoming known to study staff. This includes but is not limited to significant adverse events, unanticipated problems, complaints about the research, and the suspension or termination of IRB approval of research.
Human Subjects Research Database (HSRD) – All DOE studies involving human subjects research will file a report with the HSRD in accordance with directions and schedules provided by the HSP Program Manager. This usually consists of an on-line questionnaire, completed annually.
There are no additional requirements for retention of ED study materials. Refer to UW IRB for recordkeeping guidance here:
10 CFR 745, Protection of Human Subjects - Sets out Federal requirements for DOE for the protection of human subjects involved in research activities.DOE Human Subjects Program
- DOE Human Subjects Resources
- Human Subjects Regulations, Orders, and Policies
- The Belmont Report
- Title 45 CFR 46: Protection of Human Subjects
- Policy guidance and documents
- OHRP Frequently Asked Questions
- 21 CFR Part 50 - Protection of Human Subjects
- 21 CFR Part 56 - Institutional Review Boards
- Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
- FDA Frequently Asked Questions
10 CFR 1008, Records Maintained On Individuals
Establishes the procedures to implement the Privacy Act of 1974 (PL. 93–579, 5 U.S.C. 552a) within the Department of Energy.
10 CFR 600, DOE Financial Assistance Rules
Provides the policies and procedures for administration and management of all DOE financial assistance activities.
10 CFR 602, Epidemiology and Other Health Studies Financial Assistance
Sets forth the policies and procedures applicable to the award and administration of financial assistance agreements and cooperative agreements for health-related research, education/training, conferences, communication, and related activities.
10 CFR 605, Office of Science Financial Assistance Program
Provides policies and procedures for the administration and management of basic and applied research financial award agreements awarded by the Office of Science.