Ethool, a tool to enable legal decision-making in research involving humans using new technologies in Europe: design and usability validation

Abstract

AbstractHuman participation in technological research projects has become more frequent in recent years. However, most of the technological researchers who organize such experimentation are unaware about the various ethical and legal implications involved. Further, when it is a medical device prototype that is being evaluated, the ethical and legal implications may be even more complex. A review of the laws, standards and recommendations in Europe has been drawn up regarding human participation in new technology co-design, development and evaluation, focusing on technological research for assistive and medical devices. An easy-to-use tool, called Ethool, which acts as a guideline for European technological researchers has been designed and developed. In this manuscript, the iterative usability evaluation of Ethool is explained as well as the improvements made, following participants’ feedback. Ethool was rated as acceptable and usable by participants obtaining a SUS score of 93.0 in its last evaluation. The tool is currently available to be used by any interested parties with the aim of gathering additional feedback.