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TOPIC : International flagship collaboration with Canada for human data storage, integration and sharing to enable personalised medicine approaches

Topic identifier: SC1-BHC-05-2018
Publication date: 27 October 2017

Types of action: RIA Research and Innovation action
DeadlineModel:
Opening date:
single-stage
07 November 2017
Deadline: 18 April 2018 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

The EU has ample experience in building and running data repositories to support biomedical research. Notable initiatives are ELIXIR[1] and the European Genome-phenome Archive[2], storing many types of data up to the population-wide level. Similar expertise exists in Canada notably via IHEC (International Human Epigenome Consortium[3]) and its Data Portal[4] as well as PhenomeCentral, a repository for clinicians and scientists working on human rare disorders[5].

There is a recognised need for tools that allow researchers to manage, exchange and preserve their data efficiently. Data repositories are scattered around the world and often do not use compatible data standards. There is a pressing need for better integration of public repositories, coordinated data sharing and sustainable storage of high value data. Apart from hardware and maintenance costs, the cost of data curation, a necessary element to foster progress in biology and medicine, also needs to be considered.

Scope:

To build a collaboration of stakeholders in Europe and Canada in the domain of repositories storing and sharing human –omics data that will create a framework for long-term cooperation. In order to do so, this programme aims to enhance and standardise data deposition, curation and exchange procedures thus ensuring better data reuse and increased benefit to the scientific communities worldwide. The selected projects should build on the data quality metrics, standards and access policies developed by major international initiatives (e.g., IHEC, ICGC[6], IHMC[7], MME[8]).

Considering the existing data policies, projects should develop approaches that integrate data from disparate sources and include one or more of the following elements:

  • Data models that guarantee the interoperability of human health research data from different repositories and integrate different types of –omics data and, where relevant, clinical research and lifestyle data. The data models should take into account sex/gender differences where relevant. The projects should build on existing research infrastructures such as –omics repositories, biobanks and registries.
  • Reference architecture for data and process interoperability.
  • Technologies and methodologies for data harvesting, data access, data transfers, and archiving complex datasets.
  • Bioinformatics toolbox to support the analysis and management of data on diseases from a personalised medicine standpoint.
  • International ethical and legal governance model for a research data management and storage infrastructure and an associated data management plan compliant with the required level of data security and privacy that is aligned with the recent recommendations of the OECD Council on Health Data Governance[9].

This topic raises important issues of data sharing, privacy protection, informational right to self-determination and data security, which should be addressed from a legal, ethical as well as a social sciences perspective. It is important that proposals enable sustainable, collaborative projects and ensure cross-references with existing infrastructures (e.g., BBMRI-ERIC, ELIXIR) and other on-going initiatives (e.g., International Consortium for Personalised Medicine[10], European Open Science Cloud[11], IHEC, etc.). Synergies should be sought with other projects (e.g. calls under the Innovative Medicines Initiative (IMI)[12] and running IMI projects[13]). The proposals should take stock of the BBMRI-ERIC Code of Conduct for using personal data in health research. A multidisciplinary approach, i.e., involving clinicians, biologists, bioinformaticians, etc., is considered a key aspect of successful proposals. Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant from Canada.

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting different amounts. In addition to the EU/Associated Countries and Canada, the proposed project consortia may include other international partners. SME participation is encouraged.

Expected Impact:
  • Intensified sharing, reuse, collaboration and knowledge discovery in the health field, while ensuring legal safety on the use of the data.
  • Integration of various health and disease data in data-intensive fields such as personalised medicine.
  • More efficient research through reduced duplication of experimentation.
  • A network of research infrastructures and databases in the EU and Canada that build synergies between ongoing activities, contributing to delivering the backbone for new discoveries that address the Societal Challenges delineated in Horizon 2020[14].
  • Strengthened position of the EU and Canada in science and more collaboration between academia and industry resulting in more innovation, jobs and growth.
  • Contribute to the Digital Single Market through piloting IT health research solutions.
  • Further the “Open science” and “Open to the world” priorities and contribute to the Health Research and Innovation Cloud, one of the thematic clouds of the European Open Science Cloud.
Cross-cutting Priorities:

Open Science
Socio-economic science and humanities
International cooperation
Gender

[1]the pan-European infrastructure for life sciences data https://www.elixir-europe.org/

[2]https://ega-archive.org/

[3]http://ihec-epigenomes.org/ and http://ihec-epigenomes.org/about/policies-and-guidelines/

[4]maintained at the Montreal Neurological Institute http://epigenomesportal.ca/ihec/

[5]http://www.phenomecentral.org

[6]https://dcc.icgc.org/

[7]http://www.human-microbiome.org/

[8]http://www.matchmakerexchange.org

[9]https://www.oecd.org/health/health-systems/Recommendation-of-OECD-Council-on-Health-Data-Governance-Booklet.pdf

[10]http://www.icpermed.eu/

[11]https://ec.europa.eu/research/openscience/pdf/realising_the_european_open_science_cloud_2016.pdf

[12]https://www.imi.europa.eu/content/imi-2

[13]ETRIKS: https://www.etriks.org/, EMIF: http://www.emif.eu/, OPEN-PHACTS: https://www.openphacts.org/

[14]https://ec.europa.eu/programmes/horizon2020/en/h2020-section/societal-challenges

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme. 

Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant from Canada.

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
The same applies to the second stage of the two-stage call for topics SC1-BHC15-2018, SC1-BHC01-2019, SC1-BHC02-2019, SC1-BHC14-2019, SC1-BHC19-2019, SC1-BHC22-2019, SC1-BHC25-2019

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Research and Innovation Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

7. 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 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.

8. Additional documents:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

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