A Guide for Test Administrators and HFUE Managers

There are a lot of things to consider when creating a summative usability test. The first time can be overwhelming. What scenarios do I test? How do I identify a critical task? How many participants do I need? Do I need to test the training?

In this eGuide I will help you avoid common mistakes, like using a formative test structure for a summative usability test. I will also provide some tricks and tips to help you get the most out of your test participants and testing.

In general, the safest approach for research involving human subjects includes pre-approval by an Institutional Review Board (IRB) before research proceeds. Seeking prior IRB approval can be particularly important when the results are submitted the Food and Drug Administration (FDA). The FDA is part of the Department of Health and Human Services, which created the IRB process. IRB approval ensures that the research protects human subjects from undue risk.

An IRB approval is not always required. If the test is structured in such a way that participants are not exposed to physical hazards, it is acceptable to proceed without one. In this case, strict guidelines should be put in place to protect participants’ identities and ensure that all aspects of testing an IRB review would have independently checked are identified and addressed in an appropriate manner. Aside from physical hazards, an IRB approval protects the rights and welfare of human research subjects by ensuring that physical, psychological, legal, and/or social risks to subjects are minimized, and when present, they justified by the importance of the research, and agreed to by subjects (informed consent). Nothing can be left to the researcher’s judgment.