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Human Subjects research supported by Department of Energy funds are subject to additional regulations found under 10 CFR 745.103 and DOE Directive DOE O 443.1B.
Rationale
In accordance with Department of Energy policy, no Human Subjects Research conducted with Department of Energy (DOE) funding, whether done domestically or in an international environment, shall be initiated without both a Federal-wide Assurance (FWA) and approval by the cognizant Institutional Review Board (IRB) in accordance with 10 CFR Part 745.103. Department of Energy funded research requirements go above and beyond those requirements outlined in 45 CFR 46.
The first extension the Department of Energy goes beyond the HHS 45 CFR 46.102 is the regulatory definition of human subjects research. 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.
Additional DOE requirements focus on two areas:
- Confidentiality and data security requirements on the protection of personally identifiable information.
- Reporting of any Unanticipated Problems
These DOE requirements must be met upon initial IRB approval and maintained throughout the course of the study. In order to ensure these requirements are met, the Human Subjects Office conducts a variety of quality improvement activities on an ongoing basis in order to provide the UI research community with timely IRB review of applications, educational resources and assistance in obtaining IRB approval, and ensuring compliance with federal regulations and UI policies for the protection of human subjects. Department of Energy requirements are reviewed using the “DOE Institutional Review Board Template for Reviewing Human Subjects Research Protocols that Utilize Personally Identifiable Information (PII).” For additional information on other quality improvement activities, see Chapter 11.G of the Guide for Human Subjects Research.