Human Subjects Research
What is Human Subjects Research?
A field test may involve procedures that are legally classified as human subjects research. Common examples in residential field testing include: usability testing of home energy management devices, focus groups and surveys to collect data on consumer opinions and preferences, and studies of human behavior based on detailed monitoring data. Human subjects research can apply to observational studies as well as experimental ones. Typically, human-subjects related programs in building science fall in the social sciences domain. Just because research plans do not include medical experiments on people, for example, does not necessarily clear them of human subjects testing considerations. For information about Department of Energy (DOE) funded human subjects research, please visit the DOE Human Subjects Protection Program website.
Is My Proposed Field Test Considered Human Subjects Research?
The laws governing human subjects research are outlined in Title 24 of the Code of Federal Regulations, Part 46 (45 CFR 46), "The Protection of Human Subjects." The laws are complex and difficult to interpret without experience, so the only reliable way to determine if a research project is human subjects testing is to have a member of an Institutional Review Board (IRB) review your test plan. Below are some things to consider for residential field tests. If you have any doubts ask your IRB.
Will this research involve...
- Using people as test subjects to evaluate the effectiveness and safety of devices, products or materials developed through research?
- Using people as test subjects to evaluate the effects of devices or environmental alterations on physiology, performance, behavior, or perception?
- Collection or analysis of data containing private information?
- Surveys, interviews, focus groups conducted for research purposes?
- Collection of personal images or voices for research purposes?
- Observation of humans, with or without their knowledge, for research purposes?
Note that answering "yes" to any of the above questions does not necessarily mean that your test plan is human subjects research, nor is the list of considerations comprehensive. The best way to make this determination is to talk to your IRB contact.
What is an Institutional Review Board (IRB)?
An Institutional Review Board (IRB) is a formal committee designated by an institution to monitor research involving human subjects. If you choose to engage in human subjects testing you must first apply for IRB approval. Your institution may have its own IRB that you can use (for example, research universities typically have IRBs). If your organization does not have its own IRB and you are working on a Building America project with the National Renewable Energy Laboratory (NREL), you can use the Central Department of Energy IRB (CDOEIRB) at no cost. Part of the mission of CDOEIRB is to provide services for U.S. Department of Energy (DOE) laboratories that do not have their own IRB.
Federal-Wide Assurance (FWA)
Any institution that conducts or oversees human subjects research using federal funds must first obtain a Federal-Wide Assurance (FWA), which is an institutional assurance to the Department of Health and Human Services (HHS), Office of Human Research Protection that the institution will comply with the federal regulations regarding the protection of human subjects. The HHS office maintains a Web page on IRBs and assurances with more information.
To conduct human subjects research, you should first complete the "Social and Behavioral Research" online training program. You will need to register on the site and you will be asked to affiliate with an institution. If your institution is not set up in the system or you are working with NREL on the particular field test, you can go to the Department of Energy drop-down list and choose "NREL." The course is in short modules and can be completed over several sessions. It will take you 2-3 hours to complete. When you have completed the entire course successfully, you will be able to print a completion certificate. The institution administrator is automatically sent a copy of the certificate upon completion.