DOE Expectations Regarding Research Involving Intentional Modification of the Human Environment
Research involving the intentional modification or manipulation of human occupied environments has been inconsistently reviewed across DOE:
- Depending on the site Institutional Review Board (IRB)’s interpretation of the Federal Regulations, some projects have been reviewed as human subjects research (HSR) and some have not.
- Researchers have not brought such projects to the IRB for review because they were not aware that such research may be subject to human subjects protection requirements or they were told that it was not HSR.
The intent of the memo is to protect individuals included in such research and minimize variability across DOE by having such projects sent to the appropriate IRB for review and management as HSR./p>
DOE makes determinations about implementation of the Federal human subjects protection requirements across the DOE complex. The Federal regulations for the protection of human research subjects state [at 45 CFR Part 46.101(c)] that “the Department or agency heads retain final judgment as to whether a particular activity is covered by this policy.” In DOE Order 443.1B (DOE O 443.1B), the Secretary of Energy delegates this role to the Under Secretary, who, in consultation with the DOE National Nuclear Security Administration (NNSA), appoint the DOE Institutional Official (IO) to oversee and monitor implementation of this program. When there are inconsistencies in the way requirements are being implemented and/or interpreted by the affected DOE community, DOE issues clarifications through memoranda issued by the appropriate senior manager.
- Generalizable* studies in human environments (e.g., occupied homes and offices, classrooms, and transit centers like subway systems and airports) that use tracer chemicals, particles, and/or other materials, such as perfluorocarbons, to characterize airflow.
- Generalizable* studies in occupied homes and/or offices that:
- manipulate the environment to achieve research aims, e.g., increasing humidity and/or reducing influx of outside air through new energy-saving ventilation systems.
- test new materials (e.g., sequentially changing the filter materials in the HVAC system while monitoring the effects on air quality and energy use).
- 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. Some surveys may be online surveys administered through providers such as Amazon Mechanical Turk and Survey Monkey.
*Generalizable should be viewed in terms of contribution to knowledge within the specific field of study.
In all research potential risks must be evaluated and mitigated to the extent practicable. When:
(a) people are included in research or experiments, voluntarily or involuntarily* and/or
(b) people have their environment intentionally changed or manipulated for the purposes of the research, with or without their knowledge*, and/or
(c) research can only be validly conducted with people present (other than those conducting the research), regardless of whether personally identifiable information is collected about them, the potential risks to those individuals must be considered by the appropriate IRB.
*Typically researchers conduct the research and do not participate in HSR, but when they do, the potential risks to the researchers must also be considered by the IRB.
Even if the IRB does not view a project as meeting the literal definition of human subjects research as defined in 45 CFR Part 46, DOE requires initial review by the IRB of the application and supporting materials to determine whether the individuals included in the research will be properly informed and protected. Adherence to each specific requirement of 45 CFR Part 46 is not required in such a case, but DOE does require that:
- An application and supporting materials be submitted to the IRB;
- The Chair decide the level of review;
- During the review, the IRB assess risks associated with the research and whether the individuals to be included in such research will be properly informed and protected. SMEs should be used, as needed, in assessing risks and in determining whether risks have been mitigated to the extent practicable (to minimal risk).
- After the review, the Chair send a letter to the PI indicating that the project has been reviewed in accordance with DOE expectations and will be monitored and tracked by the IRB, which means that the PI will:
- Implement any IRB recommendations before the project begins;
- Notify the IRB of any proposed changes to the protocol in the future and ensure IRB review and authorization to proceed before implementing these changes;
- Provide an annual update to the IRB; and
- Follow the notification and reporting requirements in DOE O 443.1B for reporting adverse events, annual update of the DOE HSRD, etc.
An overview of this process is depicted in the flowchart.
Examples of Relevant Questions for the IRB to Consider During Initial Review:
- Is there is a compelling and credible case for anyone not on the research team to be present during the experiment? Are there other ways to achieve the research aims?
- Have all the risks and discomforts been identified and considered, e.g., have: a) chemicals/materials to be used been evaluated for potential human health and safety effects; b) all devices had appropriate safety testing; c) other potential risks been identified in the population group(s) to be exposed?
- Have appropriate mitigations been taken to minimize the risks, and are risks considered minimal for all involved?
- How will anyone who is involved in the study but not part of the research staff be informed of the research? Will consent forms be used? Are the key elements of informed consent included or the requirements for waiver of consent met?
- Is there a way for people to “opt out” if they wish without any repercussions?
- How will the PI monitor the research and measure outcomes?
- How and from what sources will data be collected? Will characteristics of the subject population be determined and/or required for the research?
Contact your local DOE site IRB manager or one of the DOE HSP Program Managers (see below).
DOE Central and Site IRBs
- Central DOE IRB: Lindsay Motz (Lindsay.Motz@orau.org)
- PNNL: Kathy Ertell (Katherine.firstname.lastname@example.org)
- LBNL: Chris Byrne (email@example.com) or Dianna Bolt (firstname.lastname@example.org)
- ANL: Gail Van Gorp (email@example.com)
- BNL: Darcy Mallon (firstname.lastname@example.org)
- ORISE: Lindsay Motz (Lindsay.Motz@orau.org)
- ORNL: Leigh Greeley (email@example.com)
- LLNL: Ann-Marie Dake (firstname.lastname@example.org)
- LANL: Donna Leshne (email@example.com)
- Sandia: Terry Reser (firstname.lastname@example.org)
- Fermilab: John Dawson (email@example.com)
- INL: Dena Tomchak (firstname.lastname@example.org)
- SRS: Karen Brown (email@example.com
- Thomas Jefferson Lab: Mary Logue (firstname.lastname@example.org)
DOE Headquarters Human Subjects Protection Program Managers