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Group of Senior Officials Framework for Global Research Infrastructures and how ELIXIR aligns e celerate Poster presented at the 12th GSO meeng in Oxford (UK), 05-07 November 2018 www.elixir-europe.org The socio-economic impact and knowledge transfer issues of Global Research Infrastruc- tures should be assessed not only in the begin- ning but during the lifecycle of the project. The GSO will refer also to the OECD Global Science Forum work on the socio-economic impact of Research Infrastructure. Research infrastructures underpin access to life science data and the various servic- es derived from them. These infrastructures are crical to bioinformacs research and its many applicaons in the fields of health (e.g. personalised medicine), food security (e.g. aquaculture) and the environment (e.g. polluon remediaon), which are of signifi- cant societal and economic benefits. Impact assessment, parcularly socio-economic im- pact, is an emerging and developing area of work across ELIXIR. One of the most acve ELIXIR members in this area of work is the European Instute for Bioinformacs (EBI), based in the UK, and part of the European Molecular Biology Laboratory (EMBL). In 2016, UK-based consultancy Charles Bea- grie Ltd published an in-depth analysis of the value and impact of EMBL-EBI, with the re- port valuing the benefits to users and their funders at £1 billion per annum worldwide - equivalent to more than 20 mes the direct operaonal cost of the instute. Further to this, the RI-PATHs project (“Research Infra- structure imPact Assessment paTHways”), funded by the European Union under the Horizon 2020 aims to develop a common methodology for assessing the socio-eco- nomic impact of research infrastructures, with ELIXIR as one of several case studies not restricted to life sciences. Finally, the ELIXIR Hub has been acvely informing the work of the Organisaon for Econom- ic Co-operaon and Development (OECD), in the context of their efforts to develop a methodology that can be applied to all re- search infrastructures, to assess their so- cio-economic impact. 14 Monitoring socio-economic impact This poster was created as part of the ELIXIR-EXCELERATE project. ELIXIR-EXCELERATE receives funding from the European Commission under the Research Infrastructures Programme of Horizon 2020, grant agreement number 676559. The sole responsibility for the content of this poster lies with ELIXIR. The content does not necessarily reflect the opinion of the European Union. The European Commission is not responsible for any use that may be made of the informaon contained therein. For further informaon, please contact: Dr Corinne Marn, ELIXIR External Relaons Officer [email protected] www.elixir-europe.org Global Research Infrastructures should develop policies with clear goals and strategies for the promoon of innovaon and technology trans- fer and the management of intellectual proper- ty. These policies should recognise the differing opportunies for innovaon at each lifecycle stage as well as the barriers and drivers appro- priate to the parcular GRI context. GRI’s are encouraged to regularly exchange informaon on good pracces regarding: (1) innovaon and intellectual property rights management; and (2) the sharing, exploitaon and ulisaon of data and technologies generated by usage of the GRI. ELIXIR’s Industry Strategy presents a com- prehensive overview of the current and fu- ture acons that ELIXIR aims to carry out to smulate innovaon and ensure indus- try uptake of ELIXIR’s services. This Strate- gy, which benefits from high-level strategic guidance from ELIXIR’s Industry Advisory Commiee, aims to increase industry us- age of ELIXIR resources, as well as foster- ing open innovaon of European Small and Medium-sized Enterprises (SMEs). Several communicaon channels including news- leers, online surveys, and industry-fo- cused events organised by ELIXIR are used to implement the Strategy, and monitor its impact. To further promote the use of pub- lic-funded data research infrastructures for data-driven innovaon, a report describing this entrepreneurial ecosystem, including success stories of companies in this sector, is regularly published. We acvely collaborate with the industry via Innovave Medicines Iniave (IMI) grants from the European Un- ion, in which ELIXIR Nodes typically help to make the industry-generated data “FAIR” (i.e. Findable, Accessible, Interoperable and Reusable), to help with making these data available to all ELIXIR has also established a Bioinformacs Supplier’s Forum, to allow for collaboraon between ELIXIR experts and industry providers of bioinformacs services such as High Performance Compung, hard- ware and soſtware. 13 Innovaon, Technology Transfer and Intellectual Property Measures to facilitate the internaonal mobility of sciensts and engineers to parci- pate in Global Research Infrastructures should be promoted. Since 2017, ELIXIR has been running a Staff Exchange Programme aiming to support capacity building in ELIXIR Nodes, and the exchange of best pracces in bioinformat- ics service provision. To date, a total of nine projects have been funded under the first call (2018), with approximately 30 mobilies. The programme is currently limited to Mem- bers of ELIXIR, hence only countries that join ELIXIR can take part. However, from 2019, there will be two calls per year, and eligibility will be expanded to allow for staff exchanges with industry. Addionally, many ELIXIR Nodes ulise the Marie Skłodowska Curie RISE (Research and Innovaon Staff Exchange) scheme - a dedicated European Union Horizon 2020 funding scheme for in- ternaonal staff exchanges - to allow them to exchange staff with internaonal part- ners. 12 Internaonal mobility Where clustering of complementary Research Infrastructures appears to be consistent with the mission of the Global Research Infrastruc- ture, schemes for access and mobility of re- searchers, engineers and technicians through the cluster should be acvely encouraged. ELIXIR collaborates closely with other Eu- ropean-wide research infrastructures and e-Infrastructures, in parcular research in- frastructures linked to ESFRI (European Strategy Forum on Research Infrastructures). These collaboraons are oſten facilitated by ELIXIR’s parcipaon in, and/or leadership of, European Union funded projects such as CORBEL (Coordinated Research Infrastruc- tures Building Enduring Life-science Servic- es). ELIXIR’s acvies and collaboraons of internaonal (i.e. beyond Europe) relevance are described in its Internaonal Strategy. In this context, ELIXIR has established formal agreements with many internaonal bioin- formacs-related iniaves. For instance, it collaborates with the Global Alliance for Genomics and Health (GA4GH) in devel- oping and promong standards and frame- works for the responsible sharing and reuse of genomics data. 11 Clustering of Research Infrastructures Many Global Research Infrastructures have rec- ognized that the data they produce are of value and ulity to thea broad scienfic community. Effecve data management and sharing has the potenal to increase the pace of interdiscipli- nary research and scienfic discovery, to inspire innovaon, and to promote more efficient and effecve use of research resources. Global Re- search Infrastructures that manage and main- tain research datasets in service to the scienfic community should have transparent and public data management policies for data preservaon and sharing that are mutually agreed to by the users. These policies are encouraged to consid- er: (1) long-term data curaon including meta- data; (2) data interoperability; (3) data access and re-use; and (4) alignment with community standards and pracces, including standards for openness, while respecng the “as open as pos- sible, as closed as necessary” principle. ELIXIR Nodes support life sciensts with their data management needs by providing advice, hands-on support, training and con- sultancy, along with running a number of services related to data management. For in- stance, ELIXIR has compiled a list of resourc- es that it recommends for the deposion of experimental data: the ELIXIR Deposion Databases; this list is referenced in guid- ance from the European Research Council. In terms of interoperability, ELIXIR helps users and machines to discover, access, integrate and analyse biological data, by encouraging the life science community to adopt stand- ardised file formats, metadata, vocabularies and idenfiers, in line with recommenda- ons from the Research Data Alliance and other internaonal iniaves. Addionally, ELIXIR has published a set of guiding prin- ciples on FAIR Data Management to help researchers to make published life-science data Findable, Accessible, Interoperable and Reusable. Finally, a dedicated working group on data management, to promote exchanges of best pracce across ELIXIR Nodes, is also in place. 10 Data management Global Research Infrastructure iniaves should recognize the ulity of the integrated use of ad- vanced e-infrastructures, services for accessing and processing, and curang data, as well as remote parcipaon (interacon) and access to scienfic experiments. ELIXIR is a virtual and distributed infrastruc- ture: its resources (from databases and soſt- ware tools, to training materials, cloud stor- age and supercomputers) are, by definion, available via web-based access and there- fore it could be described as an e-infrastruc- ture for the life sciences. ELIXIR’s acvies are divided into five areas called ‘Plaorms’: Data, Tools, Interoperability, Compute and Training. These Plaorms work in close col- laboraon with ELIXIR ‘Communies’, which bring together experts to develop standards, services and training within specific life sci- ence domains (e.g. Human Data, Rare Dis- eases, Marine Metagenomics, Plant Scienc- es, etc). 9 E-infrastructure The GRI policies should reflect the global-Ex- cellence-driven Access (gEA) paradigm through publicaon of a clear and transparent access goal. The goal should incorporate a peer-re- viewed process that recommends access based on the most promising emergent ideas, regard- less of the country of origin or the ability of the proposer to contribute financially. As an ‘Open Data’ infrastructure, ELIXIR’s resources are available to all users, regard- less of their locaon or sector, and via the virtual access modality (i.e. web-based ac- cess). There is no generic nor formal access review process whereby users apply for ac- cess to the ELIXIR’s resources. Rather, users anywhere on the globe typically go directly to the website of the resource which they wish to use (oſten this is known to them), or find a resource through one of the registries (e.g. the TeSS Training Portal for training ma- terials discovery; BioTools for finding soſt- ware and analysis tools). A full list of ELIXIR’s resources can be accessed at on a dedicated page of the web site. Notable excepons to the open access approach include “access controlled” databases of sensive human data for which a Data Access Commiee re- views the proposed experiment, or access to cloud facilies where users may need to submit a proposal to access the compung resource. 8 Access goal based on merit review Planning for terminaon or decommissioning of a Global Research Infrastructure iniave should be established early in the development of the facility where possible or relevant, by de- fining criteria for the conclusion of operaon, and establishing exit criteria and procedures for closing down and recognizing future termina- on liabilies or encumbrances on the sponsors at the conclusion of operaon. ELIXIR’s porolio of technical acvies scales with the organisaon’s membership size, as the acvies aim to coordinate and link naonal-level research infrastructures. More generally, ELIXIR will connue to op- erate a long as it brings value to its Mem- bers - demonstrang impact, especially so- cio-economic impact, underpins ELIXIR’s sustainability in the long-term. ELIXIR Mem- bers remain as such unless they withdraw from the ELIXIR Consorum Agreement. The mechanism for triggering the terminaon of ELIXIR is detailed in the ELIXIR Consorum Agreement, and we are currently working on draſting a decommissioning plan that will be incorporated to our Risk Management Plan. 7 Terminaon or decommissioning The scienfic output and strategic goals of Glob- al Research Infrastructures should be periodically evaluated and updated if needed throughout the enre lifecycle to ensure consistent excellence of the scienfic output. In addion, an assessment of the quality of the services offered to the sci- enfic communies is necessary to ensure the long-term usefulness and success of the infra- structure. Partnership agreements among fund- ing agencies must enable each naon to fulfil its unique stewardship responsibilies on behalf of its naonal government for oversight of contrib- uted funds. ELIXIR follows a “Hub and Nodes” model in which the Hub coordinates the work across ELIXIR, whilst each Member country hosts a Node made of a network of organisaons that provide the services accessed by us- ers. The individual resources run by Nodes are typically funded naonally, and hence have their own review processes, including through independent, internaonal scienfic advisory boards. The acvies that connect these services in the Nodes are regularly reviewed by the ELIXIR Scienfic Adviso- ry Board, firstly when a country joins and a Node applicaon is submied, and period- ically thereaſter. This ensures that ELIXIR reviews only focus on the acvies that are within the scope of ELIXIR. The upcoming ELIXIR Programme for 2019-2023 will in- clude a mid-term review, which will be car- ried out by independent and leading inter- naonal experts in bioinformac science, as well as research infrastructure operaons. In terms of external funding, all grants such as those under European Union’s Horizon 2020 Programme, require periodic and fi- nal reviews by external evaluators. Finally, ELIXIR’s accounts are monitored internally as part of the bi-weekly management team meengs, with correcve acons taken as necessary. Accounts are also externally au- dited and presented to the ELIXIR Board for yearly approval. 6 Periodic reviews The development of a Global Research Infra- structure should foresee a careful balance be- tween the minimum acceptable percentage of in-cash contribuons and the appropriate level of in-kind contribuons. The in-kind contribu- ons have to be effecvely evaluated regarding quality and schedule. ELIXIR is funded via (1) Ordinary Contribu- ons from Member States in line with Net Naonal Income, and (2) compeve, fixed- term grants such as from the European Un- ion’s Horizon 2020 Programme and the In- novave Medicines Iniave. A proporon of ELIXIR’s income is spent on administrave costs (staff me, travel and other expenses, overheads, ad-hoc consultancy support), but the majority of the ELIXIR Budget is allocat- ed to technical acvies delivered by Nodes via Commissioned Services. Hence, the costs of ELIXIR are mainly operaonal, rather than related to the construcon and maintenance of a physical infrastructure. The ELIXIR Budget excludes in-kind contribuons (e.g. in terms of staff me) from sciensts who are implemenng the Scienfic Programme - Ordinary Contribuons to the Hub can only be “cash” contribuons via the ELIXIR membership fee. The individual services (e.g. databases, tools, etc) that ELIXIR helps con- nect and which are run by ELIXIR Nodes are, however, principally funded through naon- al contribuons, so represent addional, ma- jor ‘in-kind’ contribuons to ELIXIR. These naonal investments vary in size, ming, du- raon and scope, and are oſten granted on a compeve basis, so do present challenges in coordinang effort across Members. 5 Funding management Appropriate management structures and pro- fessional top level management should be es- tablished, consistent with best pracces derived from exisng recommendaons and experience at the internaonal level, to ensure rigorous project management. The ELIXIR Handbook of Operaons pro- vides informaon on the governance struc- ture of ELIXIR, as well as its procedures and policies, notably in terms of project management. The ELIXIR Hub has a team of expert project managers which manage the internally-funded porolio of projects (called Commissioned Services), as well as the porolio of externally-funded projects (for instance funded by the European Union), in close collaboraon with key technical and administraon personnel from the Hub. Key Project Management Knowledge Areas, as defined by the Project Management Body of Knowledge (i.e. integraon, scope, me, cost, quality, human resources, communi- caon, risk, procurement and stakeholder management), are hence taken into consid- eraon. Professional development plans for employees of the Hub are collaboravely defined with their respecve line managers, to ensure that work objecves are clear and, where relevant, adequate training is provid- ed. The ELIXIR Hub currently parcipates in a Joint Masters in Research Infrastructure management through the RITrain project. 4 Project management Stakeholders should agree upon a shared under- standing of the foreseen scope, schedule (including a metable) and cost, addressing inherent uncertaines and any external con- straints, and define processes to effecvely address deviaons. To frame the scope of ELIXIR’s acvies, the ELIXIR Board, comprising of representaves from the Members, adopts a five-year Scien- fic Programme and accompanying Financial Plan, seng out the scope and high-lev- el objecves to be achieved in that period. Annual Work Plans and Budgets, within the framework of the Financial Plan and Scien- fic Programme, then set out in more detail the exact acvies that will be carried out by ELIXIR partners, including the Commis- sioned Services that will be undertaken. The ELIXIR Board meets twice a year to receive a technical and financial update (including on externally funded projects), and to de- cide on acons to be taken to address devi- aons. As Membership in ELIXIR is stable, and the budget provided by countries is cal- culated on the basis of their Net Naonal Income, planning the cost of acvies within the five-year period or annually is relave- ly straighorward. There is less certainty in terms of externally-funded projects as these are dependent on successful peer review and the value of compeng proposals. 3 Defining scope, schedule, and cost Global Research Infrastructures iniaves should explicitly and clearly define, as early as possible, the roles and responsibilies of the partners through the different phases of a pro- ject’s full lifecycle: planning, construcon, oper- aon, upgrading, and terminaon or decommis- sioning. Rules for future parcipaon should be defined to allow the inclusion of new partners. The ELIXIR Consorum Agreement is the le- gal framework behind ELIXIR, and describes its governance structure, along with roles and responsibilies of its Members. ELIX- IR has been a legal enty since December 2013, and is currently implemenng its first five-year Programme (2014-2018), whilst preparing the next one (2019-2023). There are currently 21 countries which are Mem- bers of ELIXIR, plus the European Molecu- lar Biology Laboratory (EMBL). Cyprus is an Observer. Eligibility and procedure for new countries to join are detailed in the ELIXIR Consorum Agreement and in other prac- cal documentaon held by the ELIXIR Hub. Any country in the world can apply to the ELIXIR Board to become a Member or Observer; the Board reviews applicaons against a set of objecve criteria before making a final decision. The ELIXIR Collabo- raon Agreement is the legal document that es together the ELIXIR “Hub” (i.e. Secretar- iat) with the naonal Node in each Member country. This allows the ELIXIR Hub to run Commissioned Services across its Members, in support of implemenng ELIXIR’s work programme. 2 Defining project partnerships for effecve management Global Research Infrastructures should address the most pressing global research challenges, i.e. those froners of knowledge where a glob- al-crical-mass effort to achieve progress is required. Science, technology, innovaon, and advanced research training goals should be fully integrated throughout the infrastructure plans from their early development. ELIXIR is an intergovernmental iniave that unites Europe’s leading life science organ- isaons in managing and safeguarding the increasing volume of data being generated by publicly funded research. It coordinates, integrates and sustains bioinformacs re- sources across its member states, and ena- bles users in academia and industry to ac- cess services that are vital for their research. These bioinformacs resources include da- tabases, soſtware tools, training materials, cloud storage and supercomputers. The goal of ELIXIR is to coordinate these resources so that they form a single linked infrastruc- ture, thereby enhancing the value of naon- al-level bioinformacs infrastructure and reducing effort duplicaon. This distributed pan-European infrastructure makes it easier for sciensts anywhere on the globe to find and share data (via virtual access), exchange experse across borders, and agree on best pracces (e.g. standards for interoperability). 1 Core purpose of Global Research Infrastructures

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Page 1: Group of Senior Officials Framework for Global Research ......data management policies for data preservation and sharing that are mutually agreed to by the users. These policies are

Group of Senior Officials Framework for Global Research Infrastructures and how ELIXIR aligns

e celeratePoster presented at the 12th GSO meeting in Oxford (UK), 05-07 November 2018

www.elixir-europe.org

The socio-economic impact and knowledge transfer issues of Global Research Infrastruc-tures should be assessed not only in the begin-ning but during the lifecycle of the project. The GSO will refer also to the OECD Global Science Forum work on the socio-economic impact of Research Infrastructure.

Research infrastructures underpin access to life science data and the various servic-es derived from them. These infrastructures are critical to bioinformatics research and its many applications in the fields of health (e.g. personalised medicine), food security (e.g. aquaculture) and the environment (e.g. pollution remediation), which are of signifi-cant societal and economic benefits. Impact assessment, particularly socio-economic im-pact, is an emerging and developing area of work across ELIXIR. One of the most active ELIXIR members in this area of work is the European Institute for Bioinformatics (EBI), based in the UK, and part of the European Molecular Biology Laboratory (EMBL). In 2016, UK-based consultancy Charles Bea-grie Ltd published an in-depth analysis of the value and impact of EMBL-EBI, with the re-port valuing the benefits to users and their funders at £1 billion per annum worldwide - equivalent to more than 20 times the direct operational cost of the institute. Further to this, the RI-PATHs project (“Research Infra-structure imPact Assessment paTHways”), funded by the European Union under the Horizon 2020 aims to develop a common methodology for assessing the socio-eco-nomic impact of research infrastructures, with ELIXIR as one of several case studies not restricted to life sciences. Finally, the ELIXIR Hub has been actively informing the work of the Organisation for Econom-ic Co-operation and Development (OECD), in the context of their efforts to develop a methodology that can be applied to all re-search infrastructures, to assess their so-cio-economic impact.

14 Monitoring socio-economic impact

This poster was created as part of the ELIXIR-EXCELERATE project. ELIXIR-EXCELERATE receives funding from the European Commission under the Research Infrastructures Programme of Horizon 2020, grant agreement number 676559. The sole responsibility for the content of this poster lies with ELIXIR. The content does not necessarily reflect the opinion of the European Union. The European Commission is not responsible for any use that may be made of the information contained therein.

For further information, please contact:Dr Corinne Martin, ELIXIR External Relations Officer [email protected] www.elixir-europe.org

Global Research Infrastructures should develop policies with clear goals and strategies for the promotion of innovation and technology trans-fer and the management of intellectual proper-ty. These policies should recognise the differing opportunities for innovation at each lifecycle stage as well as the barriers and drivers appro-priate to the particular GRI context. GRI’s are encouraged to regularly exchange information on good practices regarding: (1) innovation and intellectual property rights management; and (2) the sharing, exploitation and utilisation of data and technologies generated by usage of the GRI.

ELIXIR’s Industry Strategy presents a com-prehensive overview of the current and fu-ture actions that ELIXIR aims to carry out to stimulate innovation and ensure indus-try uptake of ELIXIR’s services. This Strate-gy, which benefits from high-level strategic guidance from ELIXIR’s Industry Advisory Committee, aims to increase industry us-age of ELIXIR resources, as well as foster-ing open innovation of European Small and Medium-sized Enterprises (SMEs). Several communication channels including news-letters, online surveys, and industry-fo-cused events organised by ELIXIR are used to implement the Strategy, and monitor its impact. To further promote the use of pub-lic-funded data research infrastructures for data-driven innovation, a report describing this entrepreneurial ecosystem, including success stories of companies in this sector, is regularly published. We actively collaborate with the industry via Innovative Medicines Initiative (IMI) grants from the European Un-ion, in which ELIXIR Nodes typically help to make the industry-generated data “FAIR” (i.e. Findable, Accessible, Interoperable and Reusable), to help with making these data available to all ELIXIR has also established a Bioinformatics Supplier’s Forum, to allow for collaboration between ELIXIR experts and industry providers of bioinformatics services such as High Performance Computing, hard-ware and software.

13 Innovation, Technology Transfer and Intellectual Property

Measures to facilitate the international mobility of scientists and engineers to partici-pate in Global Research Infrastructures should be promoted.

Since 2017, ELIXIR has been running a Staff Exchange Programme aiming to support capacity building in ELIXIR Nodes, and the exchange of best practices in bioinformat-ics service provision. To date, a total of nine projects have been funded under the first call (2018), with approximately 30 mobilities. The programme is currently limited to Mem-bers of ELIXIR, hence only countries that join ELIXIR can take part. However, from 2019, there will be two calls per year, and eligibility will be expanded to allow for staff exchanges with industry. Additionally, many ELIXIR Nodes utilise the Marie Skłodowska Curie RISE (Research and Innovation Staff Exchange) scheme - a dedicated European Union Horizon 2020 funding scheme for in-ternational staff exchanges - to allow them to exchange staff with international part-ners.

12International mobility

Where clustering of complementary Research Infrastructures appears to be consistent with the mission of the Global Research Infrastruc-ture, schemes for access and mobility of re-searchers, engineers and technicians through the cluster should be actively encouraged.

ELIXIR collaborates closely with other Eu-ropean-wide research infrastructures and e-Infrastructures, in particular research in-frastructures linked to ESFRI (European Strategy Forum on Research Infrastructures). These collaborations are often facilitated by ELIXIR’s participation in, and/or leadership of, European Union funded projects such as CORBEL (Coordinated Research Infrastruc-tures Building Enduring Life-science Servic-es). ELIXIR’s activities and collaborations of international (i.e. beyond Europe) relevance are described in its International Strategy. In this context, ELIXIR has established formal agreements with many international bioin-formatics-related initiatives. For instance, it collaborates with the Global Alliance for Genomics and Health (GA4GH) in devel-oping and promoting standards and frame-works for the responsible sharing and reuse of genomics data.

11 Clustering of Research Infrastructures

Many Global Research Infrastructures have rec-ognized that the data they produce are of value and utility to thea broad scientific community. Effective data management and sharing has the potential to increase the pace of interdiscipli-nary research and scientific discovery, to inspire innovation, and to promote more efficient and effective use of research resources. Global Re-search Infrastructures that manage and main-tain research datasets in service to the scientific community should have transparent and public data management policies for data preservation and sharing that are mutually agreed to by the users. These policies are encouraged to consid-er: (1) long-term data curation including meta-data; (2) data interoperability; (3) data access and re-use; and (4) alignment with community standards and practices, including standards for openness, while respecting the “as open as pos-sible, as closed as necessary” principle.

ELIXIR Nodes support life scientists with their data management needs by providing advice, hands-on support, training and con-sultancy, along with running a number of services related to data management. For in-stance, ELIXIR has compiled a list of resourc-es that it recommends for the deposition of experimental data: the ELIXIR Deposition Databases; this list is referenced in guid-ance from the European Research Council. In terms of interoperability, ELIXIR helps users and machines to discover, access, integrate and analyse biological data, by encouraging the life science community to adopt stand-ardised file formats, metadata, vocabularies and identifiers, in line with recommenda-tions from the Research Data Alliance and other international initiatives. Additionally, ELIXIR has published a set of guiding prin-ciples on FAIR Data Management to help researchers to make published life-science data Findable, Accessible, Interoperable and Reusable. Finally, a dedicated working group on data management, to promote exchanges of best practice across ELIXIR Nodes, is also in place.

10 Data management

Global Research Infrastructure initiatives should recognize the utility of the integrated use of ad-vanced e-infrastructures, services for accessing and processing, and curating data, as well as remote participation (interaction) and access to scientific experiments.

ELIXIR is a virtual and distributed infrastruc-ture: its resources (from databases and soft-ware tools, to training materials, cloud stor-age and supercomputers) are, by definition, available via web-based access and there-fore it could be described as an e-infrastruc-ture for the life sciences. ELIXIR’s activities are divided into five areas called ‘Platforms’: Data, Tools, Interoperability, Compute and Training. These Platforms work in close col-laboration with ELIXIR ‘Communities’, which bring together experts to develop standards, services and training within specific life sci-ence domains (e.g. Human Data, Rare Dis-eases, Marine Metagenomics, Plant Scienc-es, etc).

9 E-infrastructure

The GRI policies should reflect the global-Ex-cellence-driven Access (gEA) paradigm through publication of a clear and transparent access goal. The goal should incorporate a peer-re-viewed process that recommends access based on the most promising emergent ideas, regard-less of the country of origin or the ability of the proposer to contribute financially.

As an ‘Open Data’ infrastructure, ELIXIR’s resources are available to all users, regard-less of their location or sector, and via the virtual access modality (i.e. web-based ac-cess). There is no generic nor formal access review process whereby users apply for ac-cess to the ELIXIR’s resources. Rather, users anywhere on the globe typically go directly to the website of the resource which they wish to use (often this is known to them), or find a resource through one of the registries (e.g. the TeSS Training Portal for training ma-terials discovery; BioTools for finding soft-ware and analysis tools). A full list of ELIXIR’s resources can be accessed at on a dedicated page of the web site. Notable exceptions to the open access approach include “access controlled” databases of sensitive human data for which a Data Access Committee re-views the proposed experiment, or access to cloud facilities where users may need to submit a proposal to access the computing resource.

8 Access goal based on merit review

Planning for termination or decommissioning of a Global Research Infrastructure initiative should be established early in the development of the facility where possible or relevant, by de-fining criteria for the conclusion of operation, and establishing exit criteria and procedures for closing down and recognizing future termina-tion liabilities or encumbrances on the sponsors at the conclusion of operation.

ELIXIR’s portfolio of technical activities scales with the organisation’s membership size, as the activities aim to coordinate and link national-level research infrastructures. More generally, ELIXIR will continue to op-erate a long as it brings value to its Mem-bers - demonstrating impact, especially so-cio-economic impact, underpins ELIXIR’s sustainability in the long-term. ELIXIR Mem-bers remain as such unless they withdraw from the ELIXIR Consortium Agreement. The mechanism for triggering the termination of ELIXIR is detailed in the ELIXIR Consortium Agreement, and we are currently working on drafting a decommissioning plan that will be incorporated to our Risk Management Plan.

7 Termination or decommissioning

The scientific output and strategic goals of Glob-al Research Infrastructures should be periodically evaluated and updated if needed throughout the entire lifecycle to ensure consistent excellence of the scientific output. In addition, an assessment of the quality of the services offered to the sci-entific communities is necessary to ensure the long-term usefulness and success of the infra-structure. Partnership agreements among fund-ing agencies must enable each nation to fulfil its unique stewardship responsibilities on behalf of its national government for oversight of contrib-uted funds.

ELIXIR follows a “Hub and Nodes” model in which the Hub coordinates the work across ELIXIR, whilst each Member country hosts a Node made of a network of organisations that provide the services accessed by us-ers. The individual resources run by Nodes are typically funded nationally, and hence have their own review processes, including through independent, international scientific advisory boards. The activities that connect these services in the Nodes are regularly reviewed by the ELIXIR Scientific Adviso-ry Board, firstly when a country joins and a Node application is submitted, and period-ically thereafter. This ensures that ELIXIR reviews only focus on the activities that are within the scope of ELIXIR. The upcoming ELIXIR Programme for 2019-2023 will in-clude a mid-term review, which will be car-ried out by independent and leading inter-national experts in bioinformatic science, as well as research infrastructure operations. In terms of external funding, all grants such as those under European Union’s Horizon 2020 Programme, require periodic and fi-nal reviews by external evaluators. Finally, ELIXIR’s accounts are monitored internally as part of the bi-weekly management team meetings, with corrective actions taken as necessary. Accounts are also externally au-dited and presented to the ELIXIR Board for yearly approval.

6Periodic reviews

The development of a Global Research Infra-structure should foresee a careful balance be-tween the minimum acceptable percentage of in-cash contributions and the appropriate level of in-kind contributions. The in-kind contribu-tions have to be effectively evaluated regarding quality and schedule.

ELIXIR is funded via (1) Ordinary Contribu-tions from Member States in line with Net National Income, and (2) competitive, fixed-term grants such as from the European Un-ion’s Horizon 2020 Programme and the In-novative Medicines Initiative. A proportion of ELIXIR’s income is spent on administrative costs (staff time, travel and other expenses, overheads, ad-hoc consultancy support), but the majority of the ELIXIR Budget is allocat-ed to technical activities delivered by Nodes via Commissioned Services. Hence, the costs of ELIXIR are mainly operational, rather than related to the construction and maintenance of a physical infrastructure. The ELIXIR Budget excludes in-kind contributions (e.g. in terms of staff time) from scientists who are implementing the Scientific Programme - Ordinary Contributions to the Hub can only be “cash” contributions via the ELIXIR membership fee. The individual services (e.g. databases, tools, etc) that ELIXIR helps con-nect and which are run by ELIXIR Nodes are, however, principally funded through nation-al contributions, so represent additional, ma-jor ‘in-kind’ contributions to ELIXIR. These national investments vary in size, timing, du-ration and scope, and are often granted on a competitive basis, so do present challenges in coordinating effort across Members.

5 Funding management

Appropriate management structures and pro-fessional top level management should be es-tablished, consistent with best practices derived from existing recommendations and experience at the international level, to ensure rigorous project management.

The ELIXIR Handbook of Operations pro-vides information on the governance struc-ture of ELIXIR, as well as its procedures and policies, notably in terms of project management. The ELIXIR Hub has a team of expert project managers which manage the internally-funded portfolio of projects (called Commissioned Services), as well as the portfolio of externally-funded projects (for instance funded by the European Union), in close collaboration with key technical and administration personnel from the Hub. Key Project Management Knowledge Areas, as defined by the Project Management Body of Knowledge (i.e. integration, scope, time, cost, quality, human resources, communi-cation, risk, procurement and stakeholder management), are hence taken into consid-eration. Professional development plans for employees of the Hub are collaboratively defined with their respective line managers, to ensure that work objectives are clear and, where relevant, adequate training is provid-ed. The ELIXIR Hub currently participates in a Joint Masters in Research Infrastructure management through the RITrain project.

4Project management

Stakeholders should agree upon a shared under-standing of the foreseen scope, schedule (including a timetable) and cost, addressing inherent uncertainties and any external con-straints, and define processes to effectively address deviations.

To frame the scope of ELIXIR’s activities, the ELIXIR Board, comprising of representatives from the Members, adopts a five-year Scien-tific Programme and accompanying Financial Plan, setting out the scope and high-lev-el objectives to be achieved in that period. Annual Work Plans and Budgets, within the framework of the Financial Plan and Scien-tific Programme, then set out in more detail the exact activities that will be carried out by ELIXIR partners, including the Commis-sioned Services that will be undertaken. The ELIXIR Board meets twice a year to receive a technical and financial update (including on externally funded projects), and to de-cide on actions to be taken to address devi-ations. As Membership in ELIXIR is stable, and the budget provided by countries is cal-culated on the basis of their Net National Income, planning the cost of activities within the five-year period or annually is relative-ly straightforward. There is less certainty in terms of externally-funded projects as these are dependent on successful peer review and the value of competing proposals.

3Defining scope, schedule, and cost

Global Research Infrastructures initiatives should explicitly and clearly define, as early as possible, the roles and responsibilities of the partners through the different phases of a pro-ject’s full lifecycle: planning, construction, oper-ation, upgrading, and termination or decommis-sioning. Rules for future participation should be defined to allow the inclusion of new partners.

The ELIXIR Consortium Agreement is the le-gal framework behind ELIXIR, and describes its governance structure, along with roles and responsibilities of its Members. ELIX-IR has been a legal entity since December 2013, and is currently implementing its first five-year Programme (2014-2018), whilst preparing the next one (2019-2023). There are currently 21 countries which are Mem-bers of ELIXIR, plus the European Molecu-lar Biology Laboratory (EMBL). Cyprus is an Observer. Eligibility and procedure for new countries to join are detailed in the ELIXIR Consortium Agreement and in other prac-tical documentation held by the ELIXIR Hub. Any country in the world can apply to the ELIXIR Board to become a Member or Observer; the Board reviews applications against a set of objective criteria before making a final decision. The ELIXIR Collabo-ration Agreement is the legal document that ties together the ELIXIR “Hub” (i.e. Secretar-iat) with the national Node in each Member country. This allows the ELIXIR Hub to run Commissioned Services across its Members, in support of implementing ELIXIR’s work programme.

2 Defining project partnerships for effective management

Global Research Infrastructures should address the most pressing global research challenges, i.e. those frontiers of knowledge where a glob-al-critical-mass effort to achieve progress is required. Science, technology, innovation, and advanced research training goals should be fully integrated throughout the infrastructure plans from their early development.

ELIXIR is an intergovernmental initiative that unites Europe’s leading life science organ-isations in managing and safeguarding the increasing volume of data being generated by publicly funded research. It coordinates, integrates and sustains bioinformatics re-sources across its member states, and ena-bles users in academia and industry to ac-cess services that are vital for their research. These bioinformatics resources include da-tabases, software tools, training materials, cloud storage and supercomputers. The goal of ELIXIR is to coordinate these resources so that they form a single linked infrastruc-ture, thereby enhancing the value of nation-al-level bioinformatics infrastructure and reducing effort duplication. This distributed pan-European infrastructure makes it easier for scientists anywhere on the globe to find and share data (via virtual access), exchange expertise across borders, and agree on best practices (e.g. standards for interoperability).

1Core purpose of Global Research Infrastructures