Rezultaty
Implementation protocol to test and evaluate ProTransfer and ProBCF assessment tools with SEURO partners before main EIH and ISE trials
EAB Monitoring reportOutcomes from the EAB evaluation of how SEURO has met ethical legal and regulatory requirements across the project trial sites More specifically the deliverable will cover EC Ethics Summary Report findings and PostGrant Requirements GEN1 and GEN2 as outlined below1 Due to the severity of the ethics issues raised by the proposed research the Ethics Advisory Board must include independent expertise to monitor the ethics issues in this project and how they are handled This Board must be consulted in particular on the following points 1 how the consent strategy will be formed and revised taking into account the possibility that participants may lose their ability to sustain their consent and 2 how the ProACT system may impact clinical decisionmaking and the patientphysician relationship2 A report by the Ethics Advisory Board must be submitted as a deliverable after each reporting period
Data protection impact assessment (DPIA) reportThis document will provide an overview of the measures taken to ensure data protection including regulatory compliance has been achieved to the strictest levels in the development and implementation of SEURO tools and ProACT More specifically the deliverable will cover EC Ethics Summary Report findings and PostGrant Requirements POPD1 POPD2 POPD3 POPD4 POPD5 POPD6 and POPD7 as outlined below1 The beneficiary must check if special derogations pertaining to the rights of data subjects or the processing of genetic biometric andor health data have been established under the national legislation of the country where the research takes place and submit a declaration of compliance with respective national legal frameworks2 The host institution must confirm that it has appointed a Data Protection Officer DPO and the contact details of the DPO are made available to all data subjects involved in the research For host institutions not required to appoint a DPO under the GDPR a detailed data protection policy for the project must be submitted as a deliverable3 The beneficiary must explain how all of the data they intend to process is relevant and limited to the purposes of the research project in accordance with the data minimisation principle This must be submitted as a deliverable4 A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants must be submitted as a deliverable5 A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing must be submitted as a deliverable6 A description of the anonymisationpseudonymisation techniques that will be implemented must be submitted as a deliverable7 In case of further processing of previously collected personal data an explicit confirmation that the beneficiary has lawful basis for the data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects must be submitted as a deliverable
Ethical protocol and approval report for the SEURO trialsReport outlining the ethics protocols for all stages of SEURO FTs EIH and ISE trials Document will also contain copies of ethical approval letters across trial site regions More specifically the deliverable will cover EC Ethics Summary Report findings and PostGrant Requirements H1 H2 H3 H4 H5 and H6 as outlined below1 The procedures and criteria that will be used to identifyrecruit research participants must be submitted as a deliverable2 The informed consent procedures that include personal data and which will be implemented for the participation of humans must be submitted as a deliverable3 Templates of the informed consent forms and information sheets that include personal data in language and terms intelligible to the participants must be kept on file and submitted upon request4 In case adults unable to give informed consent are involved details on how the consent of the legal representatives and assisted consent when applicable will be acquired must be submitted as a deliverable5 Details on incidental findings policy must be submitted as a deliverable 6 Copies of opinionsapprovals by ethics committees andor competent authorities for the research with humans identified in this ethics evaluation must be submitted as a deliverable
SEURO management operations manual and quality management plan (QMP)This plan will outline the responsibilities and commitments of each partner as well as actions to be taken to ensure quality is delivered in all SEURO activities
SEURO dissemination and communication strategy manualThe deliverable will contain relevant information and guidance to the consortium partners to implement their dissemination and communication tasks
Report on outcomes from Friendly TrialsThis deliverable will outline the FT process the key findings and how these were fed into the refinement of the platform SEURO tools and protocols for the main trials
Dissemination and communication reportsThe reports will provide an overview of the different communication activities that have taken place during the time span including a list of academic publications
This document will provide the Data Management Plan DMP with Open Research Data Pilot ORDP for the SEURO project This document will beupdated over the course of the project whenever significant changes arise such as but not limited to new data changes in consortium policies eg new innovation potential decision to file for a patent changes in consortium composition and external factors eg new consortium members joining or old members leaving
Set up of ProACT website, social media & digital dissemination & communication tools.
Publikacje
Autorzy:
McAleer P., Doyle J., Dinsmore J
Opublikowane w:
Pervasive Computing Technologies for Healthcare, Numer vol 572, 2024, Strona(/y) 244-255
Wydawca:
Springer, Cham
DOI:
10.1007/978-3-031-59717-6_17
Autorzy:
Tighe S., Doyle J., Harvey S.
Opublikowane w:
Pervasive Computing Technologies for Healthcare. PH 2023., Numer vol 572, 2024
Wydawca:
Springer, Cham
DOI:
10.1007/978-3-031-59717-6_20
Autorzy:
Polak, S., van Leeuwen, C., Sillevis Smitt, M., Doyle, J., Cullen-Smith, S., Jacobs, A.
Opublikowane w:
Digital Human Modeling and Applications in Health, Safety, Ergonomics and Risk Management. HCII 2023. Lecture Notes in Computer Science, Numer vol 14029, 2023, Strona(/y) 123-137
Wydawca:
Springer
DOI:
10.1007/978-3-031-35748-0_9
Autorzy:
Leorin, C., Smith, S., Jacobs, A. & Ferrando, M.
Opublikowane w:
Association ICCHP, 2022, ISBN 9783950499780
Wydawca:
Association ICCHP
DOI:
10.35011/icchp-aaate22-p2-27
Autorzy:
Sheng, Y., Bond, R., Jaiswal, R., Dinsmore, J. Doyle, J.
Opublikowane w:
Journal of Medical Internet Research, 2024, ISSN 1438-8871
Wydawca:
Journal of medical Internet Research
DOI:
10.2196/46287
Autorzy:
Purpura A., Boschi T., Bonin F., Ordonez-Hurtado R., Mulligan N., Bettencourt-Silva J., Pascale A.
Opublikowane w:
Studies in health technology and informatics,, Numer Vol 310, 2024, Strona(/y) 1436-1437, ISSN 1879-8365
Wydawca:
IOS Press
DOI:
10.3233/shti231232
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