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Leistungen
The ethics risks related to the data processing activities of the proposal/project must be evaluated. This evaluation must include the support of a DPO throughout the project. Confirmation that a DPO will be appointed must be submitted as a deliverable.
OEI - Requirement No. 4 (öffnet in neuem Fenster)An ethics board, composed of external, independent members, free of any conflict of interest, must be appointed to oversee the ethics issues of the project, in particular those pertaining to the participation of humans and on data processing. This guarantees a trustworthy governance of the project and an effective check and balance. Furthermore, as it is mentioned in the proposal that there is risk of bio-surveillance at scale (p. 11), this must remain justified and proportionate based on the evidence-based risk. The proportionality of the project must be carefully examined. This relates to preventive awareness.
EPQ - Requirement No. 3 (öffnet in neuem Fenster)Details demonstrating that appropriate health and safety procedures conforming to relevant local/national guidelines/legislation are followed for staff involved in this project must be submitted as a deliverable before the start of the relevant activities.
H - Requirement No. 1 (öffnet in neuem Fenster)The informed consent procedures that will be implemented for the research participants must be submitted as a deliverable before the start of the relevant activities. This includes the procedures to ensure research participants' capacity to freely give/withhold consent without undue pressure.
Business plan for a commercialising the project results.
Appointment of DPO (öffnet in neuem Fenster)This deliverable will concern the appointment of a DPO. The DPO will support the evaluation of ethics risks related to the data processing activities of the project.
Project handbook, quality manual (öffnet in neuem Fenster)Project handbook and quality manual will raise understanding regarding project management and coordination activities.
Proceedings of the worldwide pandemic community-testing forum (öffnet in neuem Fenster)Recommendations will be collected from Worldwide pandemic community-testing forum and made public through proceedings.
A citizen’s guide to mass community testing (öffnet in neuem Fenster)The outcomes of and recommendations stemming from T2.2 will be reported here.
Pandemic Testing Playbook (öffnet in neuem Fenster)Development of a playbook written by expert contributors drawn from the WPCTF, which will include materials from our gap analysis T3.2., and other supporting WP 2 activity.
Protocols for detection of acute viral disease (öffnet in neuem Fenster)To provide methods for key personnel to make rapid decisions (minutes) on whether people are infected or not with a virus.
Ethical, legal and operational guidelines for mass community testing (öffnet in neuem Fenster)Investigation of jurisprudence, esp. the recent court decisions during the COVID19 pandemic on privacy issues will provide a contextual framework to consider for the project activities and developments.
Assessment and quality assurance of mobile laboratory operations (öffnet in neuem Fenster)A practical guide to the quality assurance requirements for mobile pandemic testing laboratories, including: (i) technical files for the laboratory modules we develop, (ii) a blank mobile laboratory technical file template; and (iii) an evaluation checklist to support the release of future iterations of our work, and the development of new approaches and components.
Analytical Target Profile / Target product profile /AQbD (öffnet in neuem Fenster)Digital, non-invasive or point-of-care diagnostics will be assessed in light of a selection tool (to be developed). Each diagnostic will be evaluated for its Technology Readiness Level (TRL) and usability.
Legal and ethical framework and data management plan (öffnet in neuem Fenster)This deliverable will concern the ethical issues and challenges that arise from the activities held within the project. It will also provide legal counsel and support, whenever it applies to project execution and results. Data Management Plan (DMP) will be prepared and updated, also a Data Protection Impact Assessment (DPIA) be implemented to identify and minimize privacy and related risks within the project.
Development of a diagnostic/prognostic target panel development workflow and pipeline.
Modular Laboratory RRML Platform (öffnet in neuem Fenster)Integrating the ONELAB modules into one mobile, versatile, robust, easily deployable and relocatable Rapid Response Mobile Laboratory (RRML) for the envisaged configurations, specified in the Analytical Target and Product Profile (defined in Task 3.3).
Data Map and integration (öffnet in neuem Fenster)A data model for information storage and exchange will be developed, to ensure that information can be aggregated and further shared with response partners and stakeholders.
Involves the development and content creation for ONELAB online presence which will include (but is not limited to) website and social media presence. The website will contain links to publicly available reports, deliverables and latest news, whilst also promoting events and workshops either as part of ONELAB or aligned to ONELAB’s objectives.
Veröffentlichungen
Autoren:
P Mochalski, J King, C A Mayhew and K Unterkofler
Veröffentlicht in:
Journal of Breath Research, Ausgabe 17, 2023, ISSN 1752-7163
Herausgeber:
IoP
DOI:
10.1088/1752-7163/acc964
Autoren:
Florentin Weiss, Anesu Chawaguta, Matthias Tolpeit, Valeria Volk, Arne Schiller, Veronika Ruzsanyi, Petra Hillinger, Wolfgang Lederer, Tilmann D. Märk, and Chris A. Mayhew
Veröffentlicht in:
J. Am. Soc. Mass Spectrom, Ausgabe 34, 2023, ISSN 1044-0305
Herausgeber:
ACS
DOI:
10.1021/jasms.3c00042
Autoren:
Florentin Weiss, Anesu Chawaguta, Tilmann D. Märk, Chris A. Mayhew, Arne Schiller
Veröffentlicht in:
International Journal of Mass Spectrometry, Ausgabe 488, 2023, ISSN 1387-3806
Herausgeber:
Elsevier BV
DOI:
10.1016/j.ijms.2023.117042
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