HORIZON EUROPE
Europeo
Specific Challenge:A large amount of high-quality health data is collected during clinical studies (interventional and non-interventional), but, beyond the immediate objectives of the study, these valuable data are not used to the extent they merit. Subject to appropriate legal grounds, these data could be used to enrich patients’ healthcare records to improve clinical decision-making and reduce duplication in procedures/investigations. In addition, returning clinical trial data to patients could allow them to contribute their data for additional scientific research (e.g. patient-powered research), in particular for rare diseases where treatments and data are scarce or unavailable. Finally, the lack of transparency and sharing of clinical trial data could contribute to the lack of patient willingness to be involved in studies, delays in clinical study set up and conduct, and delays in conducting health research in Europe to the detriment of vulnerable patients and public interest in general.
Please refer to Call topic text.
Scope:This project has two main objectives, which are equally important:
The first one is to align local and pan-...
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Specific Challenge:A large amount of high-quality health data is collected during clinical studies (interventional and non-interventional), but, beyond the immediate objectives of the study, these valuable data are not used to the extent they merit. Subject to appropriate legal grounds, these data could be used to enrich patients’ healthcare records to improve clinical decision-making and reduce duplication in procedures/investigations. In addition, returning clinical trial data to patients could allow them to contribute their data for additional scientific research (e.g. patient-powered research), in particular for rare diseases where treatments and data are scarce or unavailable. Finally, the lack of transparency and sharing of clinical trial data could contribute to the lack of patient willingness to be involved in studies, delays in clinical study set up and conduct, and delays in conducting health research in Europe to the detriment of vulnerable patients and public interest in general.
Please refer to Call topic text.
Scope:This project has two main objectives, which are equally important:
The first one is to align local and pan-European implementations and best practice for handling personal data protection regulations in order to foster the harmonisation of the legal framework applicable to medical research in the Member States;The second one is to deliver a pan-European prototype process to return clinical trial data to study participants, building on previous and ongoing EU-level activities on citizen-centric access to health records. This prototype process will be delivered as part of the project alongside a robust business plan to ensure its sustainability. To support these objectives, the project will:
Define harmonised rules for complying simultaneously with data protection regulations, regulatory requirements and ethical standards in Europe. These rules are to be endorsed by appropriate regulatory bodies and patients;Define which, when and how clinical trial data should be returned to study participants, including for integration in, or interconnection with, patients’ individual health records management files or applications and, where they exist, national and/or hospital EHR systems (for clarity, no ‘lay summaries’ or other expert analyses are within the scope of this project) and EHR standards such as EEHRxF;Define data governance models for cases where individual clinical trial data is (or can be) utilised for both healthcare decision making and future research, taking into account previous and ongoing EU-level activities on data governance in these fields;Ensure that the whole process, from collection of data to its destruction or anonymisation, including sharing of individual personal data, is aligned with the study participants’ expectations and the authorities and ethics committees’ standards and procedures, and documented in binding and/or approved standards or guidance documents. Please refer to Call topic text.
Expected Impact:In their proposals, applicants should describe how the outputs of the project will contribute to the following impacts and include, wherever possible baseline, targets and metrics to measure impact:
For patients: the project results should empower patients by returning their clinical trial data to them and to their medical records. Data acquired during clinical trials will aid better shared medical decision-making and reduce duplication in procedures/investigations; For healthcare professionals: enriched healthcare data obtained during clinical care should aid better clinical decision making and reduce duplication in patient procedures/investigations;For EU research: giving patients control of their clinical trial data will open possibilities for ethical data re-use e.g. if the patients opt in to donate their data to a common data sharing platform; For pharma: returning clinical trial data to study participants during study conduct has the potential to improve adherence to study procedures and improve overall patient retention. Facilitate conduct and setup of clinical studies as well as access to health data for research. Doing this in a meaningful way will further help to educate patients and in doing so empower them to be equal partners in the management of their disease;For regulators: it is an opportunity to exchange opinions with counterparts from other countries and researchers to propose informed workable aligned positions; From a societal perspective: the project will increase the transparency of clinical study and therefore increase the trust of patients in clinical research. At a time where clinical trials are increasingly complex, this may help with recruitment for studies and improve oversight by patients and regulators on clinical data re-use. In their proposals, applicants should outline how the project plans to leverage the public-private partnership model to maximise impact on innovation, research & development; regulatory, clinical and healthcare practices, where relevant. This could include a strategy for engagement with patients, healthcare professional associations, healthcare professionals, regulators, ethics committees, HTA agencies, payers etc., where relevant. In addition, applicants should describe how the project will impact the competitiveness and growth of companies, including SMEs. Moreover, in their proposals, applicants should outline how the project will:Manage research data and adhere to ethics requirements ;Disseminate, exploit, and sustain the project results. This may involve engaging with suitable biological and medical sciences research infrastructures .Support the improvement of the interoperability of EHRs by aligning with the EEHRxF.Communicate the project activities to relevant target audiences Please refer to Call topic text.
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Características del consorcio
:
La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
The IMI2 JU 23rd Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 23rd Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Standard evaluation form
Proposal templates are available after entering the submission tool
Proposal template stage 1
Proposal template stage 2
IMI2 Model Grant Agreement
Clinical trial template - The clinical trial template is required only at stage 2! Therefore, in the Proposal Submission Form at stage 1, the answer options to the question "Are clinical studies/trials/investigations included in the work plan of this project?” are disabled.
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
IMI2 Annual Work Plan 2020
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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