Is Institutional Review Board (IRB) Approval Necessary for Usability Tests?

By Emilee Stanczyk

What is an IRB and what does a submission look like?  

An IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities. An IRB submission for human factors research consists of the research protocol, informed consent form(s), assent form(s) (if applicable), recruiting screeners and the principal investigator (PI)’s curriculum vitae (CV). Many IRBs also request that one or more forms be completed with additional information about study aspects such as the research locations, available resources and detailed device and/or drug information (if applicable). It is the IRB’s duty to evaluate the ethicality of the research based on all submitted information, confirming that the methods minimize participant risk, participants are fully informed of all research activities before voluntary participation and the PI is well-suited to manage the research.

Receiving approval via an “academic” (e.g., hospital or university) IRB for other human subjects research, such as a clinical trial, is typically a lengthy and tedious process because the complexity of the research might involve novel methodologies and the risk posed to participants is greater than that of a simulated-use usability test. However, seeking IRB approval for human factors research can be quick and easy, sometimes with researchers receiving approval in just one or two business days.

What is the purpose of submitting to IRB? 

Generally speaking, research involving human subjects requires pre-approval by an IRB before research may proceed. Pre-approval is particularly important when the research results will be submitted to a government agency such as the  U.S. Food and Drug Administration (FDA), which is part of the U.S. Department of Health & Human Services (HHS, the agency that created the IRB process). 

IRB approval is used to protect the participants of research activities from potential risks introduced by the research activities. For example, a usability test of an injection device involving needles introduces the risk of a needlestick, or a usability test of an adhesive electrode monitoring patch presents the opportunity for an adverse reaction/allergy to the adhesive. Both examples warrant IRB review to confirm the protocol considers human subjects’ (participants’) safety and that the researchers have implemented appropriate protection measures. 

Notably, given the often simulated-use nature of usability tests, most IRB submissions are eligible for an expedited review rather than a full-board review. An expedited review often only takes a few days and consists of a single reviewer, whereas a full board review can take longer and consists of multiple reviewers. Examples of usability tests that might warrant a full board review include those with test participants who are minors (i.e., adolescents or children) or who have pre-existing medical conditions or health risks (e.g., patients diagnosed with Cystic Fibrosis [CF]). 

Is there regulatory guidance on IRB submissions for usability tests?  

The IRB process is thoroughly described in the Code of Federal Regulations (CFR) policy: Title 45 (Public Welfare), Part 46 (Protection of Human Subjects). The CFR policy: Title 45, Part 46 defines the following terms: 

Human subjects are living individuals about whom a researcher (1) obtains information through intervention or interaction with the individual, and uses, studies or analyzes the information, or (2) obtains, uses, studies, analyzes or generates identifiable private information. 

Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. 

Per these definitions, usability tests qualify as "research" and involve "human subjects." 

Are there usability tests that do not warrant IRB submission? 

At Emergo by UL, we consider it a best practice to seek IRB review and approval before conducting any research involving human subjects, including usability tests. However, one might be able to make a compelling claim to forgo an IRB submission for a usability test that presents zero to low risk to human subjects as long as the organization conducting the test has implemented the appropriate protection measures. 

Contact our team to learn more about IRB submissions for usability tests. Or sign up for a complimentary account with OPUS, our team’s software platform that provides HFE training, tools and templates.

Emilee Stanczyk is a Managing Human Factors Specialist at Emergo by UL.