Ethool, a tool to enable ethical and legal decision-making in research involving humans using new technologies in Europe: design and usability validation-Reference-Cited by-同舟云学术

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

Published:2023-02-14 Issue: Volume: Page:
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Author:

Garzo Ainara¹,Garay-Vitoria Nestor²

Affiliation:

1. TECNALIA, Basque Research and Technology Alliance (BRTA)

2. Informatika Fakultatea (UPV/EHU)

Abstract

Abstract Human 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.

Publisher

Research Square Platform LLC

Reference37 articles.

1. International Organization for Standardization: ISO 9241 – 210: 2010 Ergonomics of human-system interaction – Part 210: Human-centred design for interactive systems. (2010)

2. Marcos Muñoz, M.J., Marijuan, M.: Investigación con personas fuera del ámbito sanitario: estudios de comportamiento, psicología, ciencias del deporte y otros. ¿Cómo la evaluamos en los CEI? In: Arribas, M.C.M. (ed.) VI Congreso ANCEI. pp. 39–41. Asociación Nacional de Comités de Ética de la Investigación (ANCEI), Tarragona (2019)

3. Garzo, A., Garay-Vitoria, N.: Ethical issues for user involvement in technological research projects: Directives and recommendations. In: Sethy, S.S. (ed.) Contemporary Ethical Issues in Engineering. pp. 251–269. IGI Global (2015)

4. Harvard University. Committee on the Use of Human Subjects: Required Ethics Training Overview, https://cuhs.harvard.edu/required-ethics-training, (2020)

5. UC Berkeley: CITI Training: Required Human Subjects Research Training for UC Berkeley Faculty, Staff, and Students, https://cphs.berkeley.edu/training.html, (2020)