Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
Shades of Gray in Human Research: 3 Steps to Determine if Human Factors & Usability Studies Need IRB Review
Deciphering U.S. FDA and HHS regulations and agency guidance regarding human research protection makes clear the need for protecting the safety and privacy of participants but leaves unclear whether Institutional Review Board (IRB) approval is needed for Human Factors and Usability Studies. Conservative organizations adopt a default position of seeking IRB approval for all human factors and usability research which they perform, but there are categories of such research that remain exempt from the requirement for IRB approval. In addition to interpreting the nuances of the regulations, determining the level of risk a study poses to participants is a determining factor in whether IRB approval is required as well as the type and extent of review and documentation required for the study. For this reason we have developed the following 3-step ‘Quick Start Guide’ for conducting research with human subjects.
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Posted on Jul 08, 2013