Dec 20, 2019

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 consists of:

·The research protocol;

·Informed consent and assent form(s);

·Recruiting materials, and

·the Principal Investigator’s (PI) CV.

Many IRBs also request that one or more forms be completed with additional information about research locations, available resources, detailed device and/or drug information (if applicable), etc. It is the IRB’s duty to evaluate the ethicality of the research based on all submitted information, ensuring that the methods minimize participant risk; participants are fully informed of all research activities prior to voluntary participation; and the PI is well-suited to manage the research.

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 US FDA, which is part of the U.S. Department of Health & Human Services (HHS, the agency that created the IRB process).

IRB submission is used to protect the participants of research activities from potential risks introduced by those 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 or allergy to the adhesive. Both examples warrant IRB review to ensure 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 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., people recruited because they routinely experience asthma attacks or patients diagnosed with Cystic fibrosis).

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 an investigator conducting research (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 generalizable knowledge.

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

Are there usability tests that do not warrant IRB submission?

We consider it 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 forego 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.

Allison Strochlic and Emilee Stanczyk are Research Director and Senior Human Factors Specialist, respectively, at Emergo by UL's Human Factors Research & Design division.

Learn more about medical device human factors engineering and usability issues at Emergo by UL:

  • Human factors design and prototype development support
  • HFE user research for medical devices and IVDs
  • Webinar: Methods for identifying potential use errors

 

Author

  • Allison Strochlic and Emilee Stanczyk

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