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

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dc.contributor.authorGarzo, Ainara
dc.contributor.authorGaray-Vitoria, Nestor
dc.contributor.editorMolina-Tanco, Luis
dc.contributor.editorManresa-Yee, Cristina
dc.contributor.editorGonzalez-Gonzalez, Carina
dc.contributor.editorMontalvo-Gallego, Blanca
dc.contributor.editorReyes-Lecuona, Arcadio
dc.contributor.institutionMedical Technologies
dc.date.issued2021-09-22
dc.descriptionPublisher Copyright: © 2021 Owner/Author.
dc.description.abstractIn 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.en
dc.description.sponsorshipThis 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.
dc.description.statusPeer reviewed
dc.format.extent8
dc.identifier.citationGarzo , 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
dc.identifier.citationconference
dc.identifier.doi10.1145/3471391.3471403
dc.identifier.isbn978-145037597-9
dc.identifier.isbn9781450375979
dc.identifier.otherresearchoutputwizard: 11556/1184
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85113225204&partnerID=8YFLogxK
dc.language.isoeng
dc.publisherAssociation for Computing Machinery
dc.relation.ispartofProceedings of the 21st International Conference on Human-Computer Interaction, INTERACCION 2021
dc.relation.ispartofseriesACM International Conference Proceeding Series
dc.relation.projectIDDepartment of Education, Universities and Research of the Basque Government, IT980-16
dc.relation.projectIDEuropean Union´s Horizon 2020 Research and innovation programme
dc.relation.projectIDHorizon 2020 Framework Programme, H2020, 825003
dc.relation.projectIDEIT Health
dc.relation.projectIDEuropean Institute of Innovation and Technology, EIT
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subject.keywordscompetent authority
dc.subject.keywordsethical committee
dc.subject.keywordsinformed consent
dc.subject.keywordsprivacy
dc.subject.keywordsUser studies
dc.subject.keywordsCompetent authority
dc.subject.keywordsEthical committee
dc.subject.keywordsInformed consent
dc.subject.keywordsPrivacy
dc.subject.keywordsUser studies
dc.subject.keywordsSoftware
dc.subject.keywordsHuman-Computer Interaction
dc.subject.keywordsComputer Vision and Pattern Recognition
dc.subject.keywordsComputer Networks and Communications
dc.subject.keywordsSDG 16 - Peace, Justice and Strong Institutions
dc.titleEthical and legal implications for technological devices in clinical research in Europe: Flowchart design for ethical and legal decisions in clinical researchen
dc.typeconference output
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