Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research

Ainara Garzo; Nestor Garay-Vitoria

doi:10.1145/3471391.3471403

Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research

Ainara Garzo, Nestor Garay-Vitoria

Neuroengineering

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

2 Citations (Scopus)

Abstract

In recent years engineers developing new technologies with assistive or medical purposes have become aware that to create acceptable and usable solutions they need to involve final users, patients and stakeholders in the design, development and evaluation of systems as well as in the device certification processes. Involving stakeholders in such processes has several ethical and legal implications. It has become evident that it is still difficult for engineers in Europe to know which ethical and legal processes should be carried out as they have not been previously trained in these issues during their studies. This article is a review of the laws, standards and recommendations applicable in Europe concerning human involvement in new technologies research, with the aim of helping researchers in the region in question to identify the ethical and legal issues that could arise during those tasks. This review has been carried out in response to the identified need on the part of technological researchers. The design of a flowchart is presented as a summary of the interpretation of the documentation reviewed with the aim of helping the researchers to take the ethical and legal decisions that apply to research involving humans. The flowchart presented has been validated with various research projects in which the authors have participated. The proposed conceptual design can be used for taking decisions, but it is suggested that a tool based on this design be built with the aim of making decision taking easier for researchers in this area.

Original language	English
Title of host publication	Proceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021
Editors	Luis Molina-Tanco, Cristina Manresa-Yee, Carina Gonzalez-Gonzalez, Blanca Montalvo-Gallego, Arcadio Reyes-Lecuona
Publisher	Association for Computing Machinery
Pages	1-8
Number of pages	8
ISBN (Electronic)	9781450375979
ISBN (Print)	978-145037597-9
DOIs	https://doi.org/10.1145/3471391.3471403
Publication status	Published - 22 Sept 2021
Event	21st International Conference on Human-Computer Interaction, INTERACCION 2021 - Virtual, Online, Spain Duration: 22 Sept 2021 → 24 Sept 2021

Publication series

Name	ACM International Conference Proceeding Series

Conference

Conference	21st International Conference on Human-Computer Interaction, INTERACCION 2021
Country/Territory	Spain
City	Virtual, Online
Period	22/09/21 → 24/09/21

Funding

This work was supported by the Department of Education, Universities and Research of the Basque Government (grant-number IT980-16); and the DIH-HERO European project which has received funding from the European Union’s Horizon 2020 research and innovation programme (grant-number 825003). 1 EIT Health is supported by the European Institute of Innovation and Technology (EIT), a body of the European Union receives support from the European Union´s Horizon 2020 Research and innovation programme. MERLIN is a project that has received funding from EIT Health1 [48]. In this project a clinical evaluation was carried out using the MERLIN system, which consists of the ArmAssist robotic system based on serious games, merged with the Antari Home Care telecare platform [49]. The system has been evaluated by 9 post-stroke patients, at the Reina Sofia Hospital in Cordoba (Spain) [50] and by 12 patients at the University Medical Center in Groningen (The Netherlands) [51]. As the MERLIN system is considered a medical device prototype and thus did not have CE certification, the approval of the corresponding ethical committee and the competent authority was required, as stated on the presented flowchart. In this case, the approval was requested in both countries in which the trials were organized (Spain and the Netherlands) before starting patient recruitment.

Funders	Funder number
Department of Education, Universities and Research of the Basque Government	IT980-16
European Union´s Horizon 2020 Research and innovation programme
Horizon 2020 Framework Programme	825003
EIT Health
European Institute of Innovation and Technology

Keywords

competent authority
ethical committee
informed consent
privacy
User studies

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1145/3471391.3471403

Cite this

Garzo, A., & Garay-Vitoria, N. (2021). Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research. In L. Molina-Tanco, C. Manresa-Yee, C. Gonzalez-Gonzalez, B. Montalvo-Gallego, & A. Reyes-Lecuona (Eds.), Proceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021 (pp. 1-8). (ACM International Conference Proceeding Series). Association for Computing Machinery. https://doi.org/10.1145/3471391.3471403

Garzo, Ainara ; Garay-Vitoria, Nestor. / Ethical and legal implications for technological devices in clinical research in Europe : Flowchart design for ethical and legal decisions in clinical research. Proceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021. editor / Luis Molina-Tanco ; Cristina Manresa-Yee ; Carina Gonzalez-Gonzalez ; Blanca Montalvo-Gallego ; Arcadio Reyes-Lecuona. Association for Computing Machinery, 2021. pp. 1-8 (ACM International Conference Proceeding Series).

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title = "Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research",

abstract = "In recent years engineers developing new technologies with assistive or medical purposes have become aware that to create acceptable and usable solutions they need to involve final users, patients and stakeholders in the design, development and evaluation of systems as well as in the device certification processes. Involving stakeholders in such processes has several ethical and legal implications. It has become evident that it is still difficult for engineers in Europe to know which ethical and legal processes should be carried out as they have not been previously trained in these issues during their studies. This article is a review of the laws, standards and recommendations applicable in Europe concerning human involvement in new technologies research, with the aim of helping researchers in the region in question to identify the ethical and legal issues that could arise during those tasks. This review has been carried out in response to the identified need on the part of technological researchers. The design of a flowchart is presented as a summary of the interpretation of the documentation reviewed with the aim of helping the researchers to take the ethical and legal decisions that apply to research involving humans. The flowchart presented has been validated with various research projects in which the authors have participated. The proposed conceptual design can be used for taking decisions, but it is suggested that a tool based on this design be built with the aim of making decision taking easier for researchers in this area.",

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Garzo, A & Garay-Vitoria, N 2021, Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research. in L Molina-Tanco, C Manresa-Yee, C Gonzalez-Gonzalez, B Montalvo-Gallego & A Reyes-Lecuona (eds), Proceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021. ACM International Conference Proceeding Series, Association for Computing Machinery, pp. 1-8, 21st International Conference on Human-Computer Interaction, INTERACCION 2021, Virtual, Online, Spain, 22/09/21. https://doi.org/10.1145/3471391.3471403

Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research. / Garzo, Ainara; Garay-Vitoria, Nestor.
Proceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021. ed. / Luis Molina-Tanco; Cristina Manresa-Yee; Carina Gonzalez-Gonzalez; Blanca Montalvo-Gallego; Arcadio Reyes-Lecuona. Association for Computing Machinery, 2021. p. 1-8 (ACM International Conference Proceeding Series).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

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AB - In recent years engineers developing new technologies with assistive or medical purposes have become aware that to create acceptable and usable solutions they need to involve final users, patients and stakeholders in the design, development and evaluation of systems as well as in the device certification processes. Involving stakeholders in such processes has several ethical and legal implications. It has become evident that it is still difficult for engineers in Europe to know which ethical and legal processes should be carried out as they have not been previously trained in these issues during their studies. This article is a review of the laws, standards and recommendations applicable in Europe concerning human involvement in new technologies research, with the aim of helping researchers in the region in question to identify the ethical and legal issues that could arise during those tasks. This review has been carried out in response to the identified need on the part of technological researchers. The design of a flowchart is presented as a summary of the interpretation of the documentation reviewed with the aim of helping the researchers to take the ethical and legal decisions that apply to research involving humans. The flowchart presented has been validated with various research projects in which the authors have participated. The proposed conceptual design can be used for taking decisions, but it is suggested that a tool based on this design be built with the aim of making decision taking easier for researchers in this area.

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Garzo A, Garay-Vitoria N. Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research. In Molina-Tanco L, Manresa-Yee C, Gonzalez-Gonzalez C, Montalvo-Gallego B, Reyes-Lecuona A, editors, Proceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021. Association for Computing Machinery. 2021. p. 1-8. (ACM International Conference Proceeding Series). doi: 10.1145/3471391.3471403

Ethical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical research

Abstract

Publication series

Conference

Funding

Keywords

UN SDGs

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