[Emergo, UL] Is Institutional Review Board (IRB) Approval Necessary for Usability Tests?
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.
Is IRB Approval Necessary for Usability Tests? | Emergo by UL
Is Institutional Review Board (IRB) Approval Necessary for Usability Tests?
Learn when and why IRB approval is necessary for usability tests in medical device development, including regulatory requirements and risk considerations.
www.emergobyul.com