Research Ideas and Outcomes :
Grant Proposal
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Corresponding author: Natalie Evans (n.evans@amsterdamumc.nl)
Received: 07 Oct 2021 | Published: 09 Nov 2021
© 2021 Natalie Evans, Marc van Hoof, Laura Hartman, Ana Marusic, Bert Gordijn, Kris Dierickx, Lex Bouter, Guy Widdershoven
This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation:
Evans N, van Hoof M, Hartman L, Marusic A, Gordijn B, Dierickx K, Bouter L, Widdershoven G (2021) EnTIRE: Mapping Normative Frameworks for EThics and Integrity of REsearch. Research Ideas and Outcomes 7: e76240. https://doi.org/10.3897/rio.7.e76240
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Background: The areas of Research Ethics and Research Integrity (RE+RI) are rapidly evolving. In the EU and internationally, new legislation, codes of conduct and good practices are constantly being developed. New technologies (e.g. gene editing), complex statistical methods (e.g. biostatistics), pressure to publish and obtain grants, and growing emphasis on stakeholder driven science (e.g. public-private partnerships) increase the complexity of conducting science. In this complex and dynamic environment, researchers cannot easily identify the correct rules and best tools for responsible conduct of research. This also increasingly constitutes a challenge for RE+RI experts.
Aim: Our aim is to create a platform that makes the normative framework governing RE+RI easily accessible, supports application in research and evaluation, and involves all stakeholders in a participatory way, thus achieving sustainability. The platform will foster uptake of ethical standards and responsible conduct of research, and ultimately support research excellence and strengthen society’s confidence in research and its findings.
Vision: Our vision is that in order to make the normative framework governing RE+RI accessible, a dynamic online Wiki-platform, owned by the community of RE+RI stakeholders, is needed. The value of this platform will lie in the availability of practical information on how to comply with EU, national and discipline-specific RE+RI standards and legislation, including information on rules and procedures, educational materials, and illustrative cases and scenarios. Adopting open science (open source and open data) approaches, the platform will be easy to use, by applying novel techniques for data collection and comparison, enabling users to navigate quickly and intuitively to appropriate content. In order to keep the platform up-to-date and sustainable, it will be based upon active involvement of the RE+RI community, and will contribute to further development of this community by providing a podium for reflection and dialogue on RE+RI norms and practices.
Objectives: EnTIRE’s work packages (WP) will: undertake an in-depth stakeholder consultation across EU countries exploring RE+RI experiences and practices in order to define the boundaries of data to be collected, and developing a mapping structure adapted to user needs (WP 2); assemble the relevant normative elements, including RE+RI rules and procedures, educational materials, and illustrative casuistry, and identify relevant institutions across EU countries (WP 3-5); develop a user-friendly Wiki-platform and online resources to foster and facilitate responsible research practices and to promote compliance amongst European researchers with RE+RI standards and pertinent legislation and regulations (WP 6); and foster further development of the RE+RI community, that will support the platform and be supported by it, will keep the information up-to-date, disseminate the project’s findings and develop innovative strategies for maintaining the platform and building relationships to relevant organisations for further dissemination, including sustainable funding (WP 7).
Relevance to the work programme: The proposed project responds directly to the core requirement of call SwafS-16-2016 to ‘provide a dynamic mapping of the RE+RI normative framework which applies to scientific research conducted in the EU and beyond’. Our proposal does this by using a participatory approach, stimulating knowledge transfer regarding codes and regulations, resources and institutions, and cases, by applying innovative ICT solutions and open science approaches, and by further developing a community of active users, to enable sustainability after the end of the project.
Research ethics, Research Integrity, Responsible Conduct of Research, Research Policy
Consortium partners are listed in Table
Participant no. |
Part. short name |
Participant organisation name |
Country |
1 (Coordinator) |
VUmc |
Stichting VUmc |
The Netherlands (NL) |
2 |
GI |
gesinn.it |
Germany (DE) |
3 |
KUL |
Katholieke Universiteit Leuven |
Belgium (BE) |
4 |
MEFST |
Sveuciliste U Splitu, Medicinski Fakultet |
Croatia (HR) |
5 |
DCU |
Dublin City University |
Ireland (IE) |
6 |
UEM |
Universidad Europea De Madrid Sl |
Spain (ES) |
7 |
UNIDEB |
Debreceni Egyetem |
Hungary (HU) |
8 |
UiO |
Universitetet I Oslo |
Norway (NO) |
9 |
UNIMAN |
The University Of Manchester |
United Kingdom (UK) |
10 |
EUREC |
European Network of Research Ethics Committees |
Germany (DE) |
Responsible research conduct seems under increasing pressure: recent cases of scientists falsifying (
This project will develop a platform that makes the normative framework governing RE+RI easily in Europe accessible. Before describing how this will be acheived, it is important to define what is meant by RE+RI and the associated normative framework.
Defining research ethics and research integrity (RE+RI), and their mutual relationship
In describing the study of research behaviour, Steneck (2006) proposes definitions of ‘research ethics’ and ‘research integrity’: research ethics is described as the ‘critical study of the moral problems associated with or that arise in the course of pursuing research’, whereas research integrity is said to entail ‘possessing and steadfastly adhering to professional standards, as outlined by professional organizations, research institutions and, when relevant, the government and public’.(
Normative framework governing RE+RI
The normative framework governing RE+RI consists of explicit rules, formulated in laws, regulations, codes, and guidelines, and implicit rules, which structure local RE+RI practice, and influence the application of explicitly formulated rules. Mapping the normative framework requires making accessible explicit rules (assembling them, and comparing them through normative analysis) and showing how they can be applied in local practice (which is an object of, for instance, teaching and training programmes, fostering practical insight and experience, and which is supported by assembling cases, analysing them and building scenarios). Thus, the mapping of the normative framework should pay attention to both explicit elements (laws, regulations, codes, guidelines) and implicit elements (addressed in teaching programmes, cases and scenarios).
The overall aim of the project is to create a platform that makes the normative framework governing RE+RI easily accessible, supports application in research and evaluation, and involves all stakeholders in a participatory way, thus achieving sustainability. The platform will foster uptake of ethical standards and responsible conduct of research, and ultimately support research excellence and strengthen society’s confidence in research and its findings.
To achieve this aim, the EnTIRE project will address the following objectives:
Developing such a platform comes with a specific set of challenges, including:
To address these, EnTIRE will build upon the following principles:
Our approach has three unique features
Feature I: Stakeholder participation and community engagement
The key unique feature of this proposal is the iterative, ‘bottom up’ approach, making explicit normative experiences of local stakeholders and principles embedded in local rules and practices, and enabling the structuring of data in a way that fits in with research and evaluation practice, providing useful, accessible information for local users Fig.
This participatory approach will provide the basis for the dynamic mapping of the relevant norms, processes, resources and institutions, which will entail the collection of:
Stakeholders will also be involved in the evaluation and improvement of the ease of use of the platform. Like the stakeholder consultation, the mapping will be carried out in two phases: a pilot phase in three countries, followed by a scale up phase in all European countries. The lessons learnt during the pilot phase will enable a more rapid data collection during the second, scale-up phase.
Stakeholder participation will provide the basis for community engagement, necessary to secure continuity of the platform and further development of the content. The platform will be owned by the RE+RI community, preventing a vendor lock-in by the ICT firm. All relevant parties will be involved in the process of developing the platform and in gathering its content. The community will perform periodic critical content review, in order to keep the platform up-to-date and involve (other) users actively in fostering awareness of and debate on RE + RI. The basis for the community will be the participants in the European Network of Research Ethics and Research Integrity (ENERI), and the participants in the online focus groups. In order to expand the community, we will perform a stepwise scaling-up procedure, inviting selected researchers in the different regions and other stakeholders to become reviewers and moderators/editors. We will invite RE+RI committees to curate their own page. Further cooperation with other established bodies, many of which include RE+RI working groups, will be explored e.g. the European University Association (EUA - www.eua.be/), the League to European Research Universities (LERU - www.leru.org/), Science Europe - www.scienceeurope.org/, the European Network of Research Ethics Committees - www.eurecnet.org/ - or the European Network of Research Integrity Offices - www.enrio.eu/).
Community engagement will provide the basis for dissemination. Dissemination activities will be two-part: dissemination for awareness and understanding (amongst RE+RI followers, that is stakeholders interested in information on RE+RI issues) and dissemination for continuity (amongst RE+RI leaders, that is members of the RE+RI community who actively contribute to the development of RE+RI norms). Dissemination for continuity includes embedding RE+RI in teaching curricula and including adherence with standards and regulations in research funding and publication criteria. This will necessitate active involvement of learned societies (such as All European Academies (ALLEA - www.allea.org/) and LERU), organisations involved in research publication (such as the Committee on Publication Ethics (COPE - publicationethics.org/), European Association of Science Editors (EASE - www.ease.org.uk/), the World Association of Medical Editors (WAME - www.wame.org/), and the Council of Science Editors (CSE - www.councilscienceeditors.org/)) and research funding organisations (such as Science Europe). Indeed,
Feature II Focus on (diversity of) RE+RI practices
The second unique feature of our project is acknowledging the substantial and essential diversity of practices within and between countries and disciplines (
Feature III Interactive self-sustainable Wiki-platform
The third unique feature consist of the techniques we propose to develop the EnTIRE platform which will be hosted on www.embassy.science (ownership obtained). The main ICT challenge lies not in performing the mapping as such, but performing it in such a way that it creates an online platform that is dynamic, customer-tailored, up-to-date and self-sustainable. Through a commitment to open source and open data approaches we aim to develop an online platform that is sustainable, user-friendly, low cost, and designed by and for the target RE+RI community. For this purpose, a Wiki-platform is the most suitable basis. The online platform will support the user with unique content analysis features. This entails, amongst other things, ‘Birds Eye View Dashboards’ which use semantic and data mining approaches to allow quick comparisons and easy extraction of information by researchers, policy makers and governmental bodies to find overlaps and differences between countries and topics in legislations and policies, find related case reports etc. Combining novel data mining approaches with conventional hierarchical approaches will allow researchers to perform analyses more easily – greatly enhancing the ability to perform cross-country comparative research with low effort and cost. We will adopt an open source approach to address the challenges of maintaining the relevance of platform data and minimizing recurrent costs. The Wiki-platform is open access and will be adapted to the specific needs of the project. Commitment to an open science and Wiki-approach, involving stakeholder expertise, makes the platform dynamic, user-friendly, up-to-date and self-sustainable.
The platform will incorporate several novel ICT techniques (e.g. full content search, data mining, semantic analysis) to ensure that users can find relevant, reliable and up-to-date information efficiently. Recent innovations in ICT, which, for example, drove the commercial success of companies such as Spotify and Netflix, will enable the user to navigate the content on the platform dependent on the profile and previous searches of the user. The use of such techniques in itself implies ethical issues, that will explicitly be addressed on the platform. The dynamic and efficient nature of our website will allow and promote the development and improvement of RE+RI practices across the EU, ultimately strengthening the regulatory process and researchers’, regulators’ and society’s confidence in scientific research and its findings. Through an open and interactive platform, the project will improve the effectiveness and efficiency of both institutional and national RE+RI committees and RE+RI activities of other stakeholders, like scientific journals, funding agencies and professional associations. Effectiveness will be enhanced by providing region and domain specific standards, legislation, regulations and procedures and by providing access to best practices which may serve as examples. Furthermore, the platform will include a continuous improvement cycle; an interface will allow users to provide feedback on areas of RE+RI that are not clearly covered – providing institutional and national committees and other stakeholders with the impetus to clarify ‘grey areas’ and develop inclusive, anticipatory RE+RI governance. Efficiency will be enhanced as greater transparency will enable institutional and national committees and other stakeholders to identify similarities and differences in approaches - thus stimulating shared learning and communication. Efficiency will also be improved indirectly because better informed and trained researchers will produce more appropriate research proposals – saving RE+RI committees time and resources.
The EnTIRE consortium has the necessary expertise to develop an interactive platform. The partner gesinn-it holds the specific expertise of knowledge management and is a specialist in Wiki-software development. The three unique features described above are clearly linked to the project’s objectives and Work Packages (WP). The bottom-up stakeholder and community approach is the basis for meeting Objective 1 and 4, and are exemplary for the activities in in WP 2 and 7. The focus on diversity is related to Objective 2, and crucial for the gathering of data in WP 3-5. The interactive Wiki-platform, to be created in WP 6, will enable reaching Objective 3. (See Fig.
Successful knowledge management – the Wiki approach for the EnTIRE platform
Wikimedia Foundation, Inc. (WMF) is an non-profit organization founded in 2003 by Jimmy Wales. It hosts sites such as Wikipedia [https://en.wikipedia.org/wiki/Wikimedia_Foundation]. Wikipedia is an international online project which attempts to create free encyclopedias in multiple languages. Within three years, the world’s largest open content project has achieved more than 1.500.000 articles, outnumbering all other encyclopaedias.
1.2.1. Relation to the general objectives of Horizon 2020 and to the Work Programme 2016-2017 Horizon 2020 has general objectives of supporting excellent science and addressing the great societal challenges of our age. The ‘Science with and for Society’ (SwafS) programme specifically aims to build effective cooperation between science and society, to recruit new talent for science and to pair scientific excellence with social awareness and responsibility. In order to meet the general aims and objectives of Horizon 2020 and the SwafS programme our proposal contains all the necessary elements. It enables further awareness of the relationship between science and societal responsibility, both among researchers and the general public, and is innovative by making use of novel ICT techniques. Specifically EnTIRE’s vision, aims and approach:
1.2.2. Relation to the specific topic: SwafS-16-2016: Mapping the Ethics and Research Integrity Normative Framework
One of the eight activity lines of the ‘Science with and for Society’ programme 2016-2017’ is ‘developing inclusive, anticipatory governance for research and innovation’ which includes the current topic ‘Mapping the Ethics and Research Integrity Normative Framework’. The topic’s aim is directly reflected in EnTIRE’s overall aim. In Table
EnTIRE Objectives and Approach in Relationship to the Scope of the Topic:
Scope of SwafS-16-2016 | EnTIRE strategic approach |
The action aims at providing a dynamic mapping of the ethics/integrity normative framework which applies to scientific research conducted by European research teams, in the EU and beyond. | The RE+RI normative framework is understood to encompass more than just the rules and regulations, but also the normative experiences of stakeholders and learning processes during the application of rules and regulations. Experiences, values, norms and priorities will be explored during the stakeholder consultation (WP 2). The findings from the consultation will help define the focus and the boundaries of content to be collected in the mapping exercise (WP 3-5) and structure the information on the website according to stakeholders’ concerns; enabling the collection, provision and presentation of data sensitive to stakeholder needs. The mapping is considered ‘dynamic’ as the open source/open data approach for the online platform will enable the RE+RI community to keep the content and platform up-to-date (WP 6 and 7). |
The work undertaken shall primarily aim at supporting the work of researchers and ethics/integrity review committees. | The participatory approach ensures that the online platform will be sensitive to the priorities and preference of various types of users. We distinguish RE+RI leaders (who are highly committed to RE+RI norms and contribute to their development), and RE+RI followers (who are eager to comply, but require easy access). RE+RI leaders will be supported by the platform by continuously staying up-to-date and having possibilities for dialogue and deliberation. RE+RI followers will be enabled to disentangle complexities in rules and regulations and in applying them to daily practice. |
The action shall design the most appropriate mapping methodology, the processes and institutions to be mapped and produce appropriate process maps, indicating the criteria/dimensions (geographic scope, thematic coverage, stakeholder involvement, etc.) and enable comparative analysis. | A bottom-up, participatory approach is the most appropriate to capture the diversity of explicit and implicit RE+RI rules across the EU (WP 2). Data collection (WPs 3-5) encompasses the following processes, resources and institutions: WP 3 - EU, country and domain specific policies, guidelines, standards and legislation and legislative bodies; WP 4 - RE+RI resources, including training courses for researchers and RE+RI review committees, contact details of RE+RI review committees and RE+RI experts for advices; WP 5 - Cases, derived from literature, published by RE+RI committees, and presented and discussed during focus group meetings. WPs 2-5 will start with a pilot phase, followed by a process of scaling up to all EU countries, and will include normative analysis and case analysis. Data mining features, which allow for searchability, will be combined with more conventional, hierarchical data organization approaches (e.g. by geography or discipline), allowing researchers to perform analyses more easily – greatly enhancing their ability to perform cross-country comparative research with low effort and cost. |
The outcome of the mapping action shall stimulate knowledge transfer and ultimately promote the uptake of the highest ethical standards. In order to facilitate this role, English summary/abstract of the normative elements (e.g. legislation, code, etc.) focusing on the main practical requirements/recommendations should be made available. | Knowledge transfer will be stimulated through widespread dissemination. EnTIRE includes a WP dedicated to dissemination in recognition of the importance of knowledge transfer to the project’s success (WP 7). The stakeholder and community approach provide an excellent basis for dissemination. Activities will be two-part: 1) dissemination for awareness and understanding, involving RE+RI followers, by offering easily accessible information; and 2) dissemination for continuity, engaging RE+RI leaders, offering up-to-date information and the possibility for contributing to platform development. This will be based on extensive cooperation with ENERI and other relevant EU projects/organisations. It also requires commitment and action to change current practices amongst journal editors and research funding and publishing associations. English summaries of the main normative elements of research ethics and integrity will, of course, be easily accessible via the online platform. |
Researchers shall also be helped to distinguish between the legislation that must be applied (highlighting the practical obligations) and the soft laws and best practices that must be taken into account (illustrating them with concrete examples) in the research design and implementation to guarantee the compatibility with the highest ethical standards. | The innovative, user-friendly open acces and open source WIKI-platform developed by WP 6 will allow RE+RI followers to become aware of the legislation and regulations that must be applied, and of cases and scenarios embodying best practices; RE+RI leaders will be involved in developing and deliberating upon norms guiding responsible research conduct, thus creating preconditions for scientific excellence. |
The resulting mapping shall be made available online and include beyond the constitutive elements of the normative framework information on the available trainings and education activities as well as on where to find appropriate ethics/integrity expertise | In collaboration with partner gesinn-it, an innovative online Wiki- platform will be developed (WP 6). Novel elements include: the participatory mapping of data sensitive to stakeholders priorities and preference; the data mining features which will support the discovery of actionable insights; and community engagement to ensure the platform’s long term sustainability. As mentioned previously, the online platform will identify relevant training courses, resources and where to find appropriate expertise. |
Practical information on how to comply with the legislation and standards should be provided | Practical information and best practice examples will be collated by WPs 3-5. |
In addition, the work must rely on a real case and scenario building approach based on existing literature, court cases etc. | There is a dedicated WP to the collection of cases (WP5). Cases come from existing sources (literature, websites, court cases) and stakeholder focus groups. Also, methods of analysis will be assembled and applied, resulting in illuminating scenarios. This process will extend beyond the duration of the project, based upon community engagement in the Wiki-platform. |
The mapping shall also include contact details of the ethics and research integrity committees/bodies and other relevant authorities (e.g. for personal data protection) which shall deliver the necessary approvals/authorisations. | The contact details of the ethics and research integrity committees/bodies and other relevant authorities that deliver the necessary approvals/ authorisations are included in the initial processes, resources and institutions to be mapped, they will be available through the online platform and, in the future, updated by users via the open editing feature. RE+RI committees are invited to participate in the platform and create and maintain their own pages. |
The construction and update of this online database must be done in close cooperation with the "European Ethics and Research Integrity Network" which is supported by Horizon 2020 | ENERI will serve as an important source in the processes of stakeholder consultation and community building. Close cooperation already exists between partner members and ENERI, and will be further developed during the project. ENERI has offered to participate substantially in the analytic part of EnTIRE and to provide network, expertise, website and communication channels for dissemination of EnTIRE’s activities. The EnTIRE platform will benefit from expertise gathered in ENERI and provide a tool for ENERI to foster further cooperation in the RE+RI community. |
This cooperation shall notably ensure positive synergies and guarantee the long term continuity/sustainability of the resulting output | The unique combination of EnTIRE’s innovative, sustainable vision for the online Wiki-platform and the active involvement of the RE+RI community, many of whom are involved in ENERI, will result in long term continuity. Since sustainability forms such an important aspect of this project, one workpackage (WP 7) is specifically dedicated to dissemination and continuity. Sustainability is based upon the stakeholder and community approach, the Wiki-platform and the ICT innovations fostering searchability and user friendliness. Moreover, additional steps to ensure the project’s long-term continuation include: 1. Developing an adequate infrastructure for teaching and higher education organisations (such as ALLEA, LERU and EUA) to embed RE+RI in teaching curricula. 2. Providing support to national and European research funding organisations to include adherence with RE+RI standards and regulations in research funding criteria, such as the requirement of adherence to data management standards in Horizon2020 projects. 3. Providing support to journal editors and publishing associations (such as COPE, EASE, WAME and CSE) to include, promote and emphasize adherence with RE+RI standards and regulations in publication criteria. 4. Building links with local, national and EU wide RE+RI websites to enable coupling to maintain the website content with the website with the help of ICT partner gesinn-it (WP6) 5. Developing a long-term continuity plan – in collaboration with the private ICT partner gesinn.it (WP 7) |
In addition to the above cited network and in order to avoid duplication of work already undertaken, it is essential to ensure that the publicly available results from relevant EU funded research projects (from FP7 and Horizon 2020) are taken into account. | Publicly available results from relevant EU funded research projects (ENERI, SATORI, PRINTEGER, RRI Tools and HEIRRI) will be included in the mapping process. The partners in these projects are important RE+RI leaders who will be addressed in the community approach, ensuring that output of these projects will immediately be visible on the EnTIRE platform. |
International cooperation is encouraged | Although the project focuses on mapping the RE+RI framework in Europe, it is clearly international. The kick-of will be during the World Congres on Research Integrity, organized by the Dutch lead partner in Amsterdam 2017. The Advisory Board includes international RE+RI expert Ray de Vries. This will ensure that the approach used in the project meets international standards. International contacts of EnTIRE partners will provide the basis for scaling up to other regions of the world (after the end of the project). |
The Commission considers that proposals requesting a contribution from the EU of the order of EUR 3.8 million would allow this specific challenge to be addressed | The project stays within the budget. See section 3.4. for a specifaction of the allocation of the recourses. |
The current situation: researcher behavior
Confidence in research is severely undermined by evidence of violations, misbehaviours and poor judgement (
The current situation: online ethics databases
A number of US based projects have started with similar goals in the past, but all have considerable limitations, which are outlined below:
The current situation of researchers needing accessible information whereas websites are too static and limited to serve researchers’ needs can only be solved by creating an interactive platform, enabling users to navigate quickly and intuitively to appropriate content, developed and kept up-to-date by a community of active users. EnTIRE will create an online platform that is neither a repository nor a database, but rather a platform that supports the development of a RE+RI community where the content can both stimulate and follow the development of the field. The platform will harbour all relevant content (laws, regulations, procedures, policies, views, opinions, casuistry) for RE+RI in a structural way that enhances the ability to find what the user seeks in an efficient manner. As there are several types of users (RE+RI leaders and RE+RI followers), different levels of information will be used. Information content will be organised in a way that it will guide the user through applicable resources, but will also allow the expert to find the content which is relevant to him or her. The platform will also account for the relevance and importance of the information content. For example; a law which is highly relevant will be prioritized over a case report when searching the full content of the platform. External search engines will be given full access to ensure that the platform becomes widely known to the target audience. EnTIRE is inspired by a project which has already succeeded in addressing the main failings of past projects (keeping content up-to-date, searchable and appropriate content, building a community): Wikipedia. Wikipedia’s framework is completely free to use because it is open source. It provides open source applications that can be tailored to specific projects and which allow for content editing from users and speedy and efficient data retrieval and processing. Furthermore, we will additionally develop an extension for the most appropriate information analysis for the site (data mining). The goal of EnTIRE is not to replace either current available search engines or Wikipedia itself. Both initiatives serve a general audience. EnTIRE will harbor specialty content and contains information which is not of relevance to the general audience. The future user of the EnTIRE platform (www.embassy.science) will only frequent the platform if the information is visibly reliable and up-to-date. Therefore, in contrast to the conventional Wikipedia approach, review and moderation/editing of pages or information content which is essential to RE+RI will be performed by researchers, monitored by RE+RI leaders. All the information content is publicly available (‘open data approach’) allowing researchers across Europe and beyond, to study RE+RI issues and find relevant information. This will be further enhanced by a data mining approach. An extension to the platform will be developed which allows the users in a ‘birds eye view’ dashboard to compare relevant information content between countries (e.g. compare legislation between countries and easily find gaps and overlaps). From a risk perspective, one of the strongest arguments for this approach is that the Wiki approach has been very successful in the past in achieving distributed, international and accurate knowledge management. An investment of the EU in this project prevents that a new platform is developed, decreases the (recurring) maintenance costs, allows future EU projects to benefit from the investment in this platform and thus ensures that the funds have a maximum impact. Combining the Wiki approach with new assets, such as datamining, may result in new and economically viable technologies. This is an incentive for partner gesinn-it to contribute to developing ICT products which are not directly profitable because of the open source formula.
In addition to the US based projects discussed above, a number of EC funded projects and networks are of particular relevance. These include ENERI, PRINTEGER, SATORI, HEIRRI, FOSTER, RRI-TOOLS and EnRRICH. They often have higher level aims focusing on the harmonization of values and standards within EU. These aims are positively supported by the more practical, applied ambitions of the EnTIRE project. Furthermore, many have involved the collection of data such as training courses and ethics experts contact details which are publically available and will be fed directly into the EnTIRE project. Finally, these projects and networks embody the RE+RI community, which EnTIRE aims to engage and support. The relations between EnTIRE and other research and innovation activities are listed below:
The aim of EnTIRE is to map the normative framework governing RE+RI, paying attention to both explicit and implicit elements. To get insight into implicit elements of the normative framework, focus groups with stakeholders will be organized, aimed to elucidate experiences and cases from practice (WP 2). Next, explicit elements of the normative framework, including laws, regulations, codes and guidelines will be assembled and analysed (WP 3). Also, practical resources, especially teaching programmes, focusing on implicit elements will be collected (WP 4). Furthermore, we will collect and analyse cases and build scenarios, again embodying implicit elements of the normative framework (WP 5). The results of WP 3-5 will be used as content for the platform (WP 6). In order to make the platform sustainable, the RE+RI community will be engaged (WP 7), in line with the stakeholder approach (WP 2). For WP 2-5, we will use a pilot phase, to get data from an limited number of EU countries, followed by a scale-up phase, extending the data collection to all EU countries. See, for more information on the timing and planning, the GANTT chart in section 3.1.
EnTIRE adheres to the underlying H2020 gender equality objectives:
Firstly, the EnTIRE project strives for gender equality at all levels (researchers, advisory board, management team, stakeholder consultation participants, and managing of the Wiki-platform). WP 1 will be responsible for monitoring the gender distribution of the project participants and taking any necessary remedial actions. EnTIRE includes women who are early, mid, and late career researchers. Women are WPs leads or have a managing role in three of the seven WPs: WP 1 Laura Hartman (partner 1. VUmc, managment), WP 2 Natalie Evans (partner 1.VUmc), WP 5 Ana Marusic (partner 4.MEFST). Secondly, EnTIRE takes gender into account in the RE+RI mapping process itself. As EnTIRE acknowledges the importance of implicit rules and contextual factors, it will address the gendered aspects, as well as the socio-cultural, political, economic and institutional factors implicit in the RE+RI normative framework. Examples include the effects of women being less likely to be promoted to top positions, low proportion in decision-making roles and gender pay-gap. By making such implicit elements explicit and allowing for reflection and dialogue, EnTIRE will contribute to making research practice more gender equal, as well as more equal concerning socio-economic factors.
It is the ultimate aim of the EnTIRE consortium to promote responsible research conduct by stimulating awareness of, and reflection and deliberation on, formal and informal RE+RI rules and practices. We will do this by developing an interactive platform sensitive to user needs, that makes the RE+RI normative framework, containing explicit elements (laws, regulations, codes, guidelines) and implicit elements (practical experience addressed in teaching programmes and embodied in cases), easily accessible. We consider our efforts (within and beyond this project) successful when:
Table
Short-term impact (during project) | Mid-term impact | Long-term impact | |
(< 5 years after project) | (> 5 years after project) | ||
Scientific community | The interactive platform, providing open access to rules and regulations, resources and cases, will support 1.6 million European researchers by making RE+RI information available. Increased awareness of and sensitivity towards formal and informal rules governing RE+RI. Case-based learning through instructive cases and methods of analysis. | Novel tools, based on the EnTIRE platform, help researchers to understand and apply formal and informal rules governing RE+RI in day-to-day research. Novel insights and ideas to improve research culture for the benefit of RE+RI, for example concerning open access, research funding, work load and responsibilities and responsible publication practice will be available. | Provide confidence amongst European researchers (and beyond) that they comply with formal and informal RE+RI rules, which are normatively adequate and serve to guarantee scientific quality and foster excellence. Compliance will be fostered by harmonisation of rules and guidelines. |
Policy makers | Mapping of rules and regulations, elucidating regional differences and detecting 'white spots'. | More effective RE+RI review mechanisms. Increased consensus between policy makers and researchers, leading to more effective policies. | Harmonisation of policies across scientific fields and countries and regions. The EnTIRE platform will also be the appropriate medium to publish harmonized rules in the future, since it will be well known in the research community. |
Researchers in ethics | Improved accessibility to data for comparative studies and increased contacts with engaged members of the platform community for more than 1000 researchers in ethics. Its open access nature will contribute to a level playing field in ethics research. | Boosting European ethics research excellence through increased innovation capacity from the EnTIRE platform, evidenced by novel policies with significant input from ethics expertise. | Joint endeavour between ethics researchers and other stakeholders to ensure improvement of RE+RI rules and practices that stimulate compliance of researchers . |
Industry | Better access to guidelines on how to do responsible research and how to cooperate with scientific research organisations, including sponsorship, in a responsible way. | Novel tools, based on the EnTIRE platform, helping to understand and apply formal and informal rules governing RE+RI in day-to-day research. | With laying the foundations for a harmonization of and improvement of the rules and guidelines regulating the conduct of responsible science, there will be less need to invest in bureaucratic efforts to map and comply with different regulations per organisation, per region and per European country. (also contributing to a level playing field among research bodies in Europe and a favourable research climate). |
Society | Growing awareness of the importance of RE+RI issues and policies and a better understanding of research conduct and output. | Growing interest in and engagement with further development of rules and resources of responsible research practice. | Widely supported trust in scientific communities and results. |
Expected impact according to the call: The proposed action will facilitate the work of researchers to comply with research integrity and ethics standards and legislation while improving the effectiveness and efficiency of committees and competent national bodies. Consequently, the excellence of public and private research in the European Research Area will be promoted. As described in Section 1, this project will lay the foundations for these expected impacts through:
Table
External barrier | Mitigation |
Lack of priority amongst researchers | We will foster debate between leading researchers on relevance of RE+RI issues for the quality of research (through platform design and community action) and will explicitly target the “peace of mind” that can be established through proactive discussion of RE+RI and its challenges. |
Lack of political interest in improvement and harmonisation of policies on EU scale | We will integrate policy makers as stakeholders in the process of stakeholder consultation and community engagement, making them experience the value of exchange of practices and deliberation on RE+RI issues. |
Abundance of issues other than RE+RI asking attention of researchers in ethics | We will put RE+RI issues on the agenda of relevant societies for ethical researchers in Europe and highlight the EnTIRE platform as an attractive source of information for research and communication. (See 2.2.3 for the participation in relevant societies of our consortium members.) |
Lack of interest in industry in RE+RI issues and improvement of rules | We will foster debate on relevance of RE+RI issues for responsible cooperation between science and industry (through platform design, community action and presentations at conferences such as EuroScience Open Forum (ESOF). |
Doubts in society about normative attitude of scientists and results of research | We will leverage the active involvement of researchers in the platform to show the surplus value of a community of stakeholders assembling and editing information (compare confidence of the public in Wikipedia) |
Delays and lack of interest in the political arena to changes of policies that contribute to an improvement of RE+RI rules | Through the involvement of policy makers and regulatory bodies in EnTIRE, we have laid a foundation for a supportive network and support to change policies and keeping RE+RI high on the political agenda. |
Dissemination strategy The consortium recognises the importance of awareness regarding the EnTIRE project and its outcomes across sectors to reach the goals listed above. Therefore, the partners are dedicated to reaching all stakeholders involved before, during and after the project. The main goal of the dissemination strategy is to:
In addition, dissemination promotes transfer of knowledge and expertise between consortium partners and other stakeholders. The dissemination strategy will be developed, monitored, evaluated and continuously improved in WP7 by all partners under coordination of partner VUmc and in close collaboration with ENERI, which has offered to participate substantially in the analytic part of EnTIRE and to provide network, expertise, website and communication channels for dissemination of EnTIRE’s activities. The EnTIRE platform will benefit from expertise gathered in ENERI and provide a tool for ENERI to foster further cooperation in the RE+RI community. The people involved in WP7 will also be responsible for developing a dissemination policy that has to be signed by all consortium participants and which will be included in the consortium agreement.
Dissemination policy principles Dissemination activities are conducted by all partners but directed by the WP7 team. However, prior to distributing information there must be final approval from the whole consortium in order to be sure that every partner is aware when dissemination of results takes place and that it does not have sensitive information which is important for the partner. Finally, the final approval will be provided by the Project Coordinator to prevent any leak of sensitive information.
Stakeholder Analysis Our dissemination strategy builds upon targeted communication to, and involvement of, all groups in society with a vested interest in EnTIRE's results and groups that are affected by the results of the project (stakeholders). EnTIRE is based in stakeholder participation from the very start. Understanding the interests and motivations of all stakeholders will allow the consortium not only to make the platform meet user needs, but also to effectively reach and inform them in the most optimal way about the outcomes of EnTIRE. Table
Stakeholder Overview, Envisioned Effect, Specific Message and Dissemination Channel.
Stakeholder | Intended effects | Message | Targeted dissemination methods |
Scientific community | Awareness of and compliance with rules governing RE+RI. | “We have a simple, accessible system that allows for searching relevant information, learning, and discussion.” |
• Alerts when content relevant for researchers (further specified in research disciplines) is added to the EnTIRE platform, invitation to add and edit information. • Making the platform visible in common search engines, such as Google (using pushing strategies such as adwords). • Making animation videos of key learning points on the website for easy transfer. |
Policy makers | Improved policy making, based on relevant information and stakeholder participation. | “Our platform, through advanced searching techniques, enables easy comparison of regulations, and provides a basis for better policy making.” |
• Relevant journals. • Alerts when content relevant for policymakers is added to the EnTIRE platform, invitation to add and edit information. • Relevant conferences, e.g. WCRI 2017 Amsterdam. |
Ethics researchers | Active use of platform, involvement in editing, participating in the community. | “Our platform provides accessible data for comparative research and normative analysis and serves as a basis for active involvement in furthering normative deliberation and improving policies.” |
• Relevant journals. • Alerts when content relevant for ethics researchers is added to the EnTIRE platform, invitation to add and edit information. • Conferences of societies of ethics researchers. |
Industry | Awareness of and compliance with rules governing RE+RI. | “We have a simple, accessible system that allows for searching relevant information, learning, and discussion concerning (multinational) research.” |
• Alerts when content relevant for industry is added to the EnTIRE platform, invitation to add and edit information. • Making the platform visible in search engines, such as Google (using pushing strategies). |
General public | Awareness of importance of RE+RI issues and policies. | “Responsible research requires addressing RE+RI issues, we foster this by proving support for researchers and policy makers, thus contributing to trustworthy research.” |
• Mass media news items. • Alerts when content relevant for the general public is added to the EnTIRE platform, invitation to add and edit information. • Social media. • Flyers/brochures. • Participation in public debates. • Develop animation video’s to capture the main points of the scientific system to educate the public. |
Stakeholder Involvement A unique feature of EnTIRE is stakeholder consultation and community engagement. We will involve all stakeholder groups in two face-to-face focus groups in three countries (Croatia, Spain, the Netherlands) and in a cross-country focus group. In the scale-up phase, online focus groups will be organized in all European countries. Results will be used to define the boundaries of the data to be collected and to adapt the platform to stakeholder needs. Stakeholders will also be involved in evaluating the platform. Community engagement will entail approaching al relevant stakeholders in the RE+RI community to actively participate to the EnTIRE platform with new ideas, reflections and practice examples.
This project will support research and innovation in a number of ways and can lead to a number of commercial and non-commercial spin-offs.
As this is a CSA project, communication is a corner stone of the project. EnTIRE will communicate to stakeholders via several communication channels at major milestones of the project. The following dissemination resources will be used:
Events and conferences | |
Event | Timing |
Kick-off during 5th World Congress of Research Integrity in Amsterdam | May 2017 |
EuroScience Open Forum (ESOF) | July 2018 |
7th World Congress of Research Integrity | May 2019 |
International Center for Academic Integrity (ICAI) | February 2020 |
National data integrity conference | June 2020 |
EuroScience Open Forum (ESOF) | July 2020 |
End conference EnTIRE | 2021 (to be decided) |
Outreach
Public confidence in the scientific community has been challenged by research integrity scandals, including the Stapel case, the Poldermans case, and the Penkowa case. This makes public outreach more important than ever. Therefore, we have implemented several special outreach measures, including:
In this way, the project and its spin-off will contribute to restoring the public trust in the scientific community.
In order to achieve the objectives that are described in Section 1.1, the project is structured into 7 WPs. These WPs involve stakeholder consultation (WP2), data gathering and synthesizing (WP3-5), the development of the EnTIRE platform (WP6), dissemination (WP7) and project management and data management (WP1) (see Fig.
The timing of workpackages and the planning of tasks and activities of the EnTIRE project are presented in Table
GANTT Chart Showing the Timing of Work Packages and the Planning of Tasks and Activities of the EnTIRE project.
Project year and month | Year 1 | Year 2 | Year 3 | Year 4 | |||||||||||||
3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 27 | 30 | 33 | 36 | 39 | 42 | 45 | 48 | ||
T1.1 | Scientific coordination | x | X | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
T1.2 | Administrative coordination | x | X | X | x | x | x | x | x | x | x | x | x | x | x | x | x |
T1.3 | Financial coordination | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
T2.1 | Preparation of the stakeholder consultation | x | |||||||||||||||
T2.2 | Pilot: face-to-face focus groups withs takeholders | x | |||||||||||||||
T2.3 | Defining the boundaries of the data to be collected | x | x | x | |||||||||||||
T2.4 | Scale -up: Online focus groups with stakeholders | x | x | x | |||||||||||||
T2.5 | Assessing the acceptability of the online platform | x | x | x | x | x | x | x | x | x | x | x | |||||
T3.1 | Preparation of data-collection on normative documents | x | x | ||||||||||||||
T3.2 | Pilot collection of data on normative documents | x | x | ||||||||||||||
T3.3 | Scale up: Collecting normative documents in all EU countries | x | x | x | x | x | x | x | |||||||||
T3.4 | Analysis of the normative documents | x | x | x | x | x | x | x | |||||||||
T3.5 | Testing, updating and optimizing online platform | x | x | x | x | x | x | X | x | x | x | x | |||||
T4.1 | Preparation of data collection on resources | x | x | ||||||||||||||
T4.2 | Pilot collection of data on resources | x | x | ||||||||||||||
T4.3 | Scale-up: Inventory database on resources for European countries | x | x | x | x | x | x | x | x | ||||||||
T4.4 | Testing, updating and optimizing the online platform | x | x | x | x | x | x | x | x | x | x | x | |||||
T5.1 | Preparation of data collection on cases | x | x | ||||||||||||||
T5.2 | Pilot collection of data on cases | x | x | ||||||||||||||
T5.3 | Scale up: Collecting and categorizing RE+RI cases | x | x | x | x | x | x | x | |||||||||
T5.4 | Identifying and applying appropriate case analysis methods and building RE+RI scenarios | x | x | x | x | x | x | x | x | x | x | x | x | ||||
T5.5 | Testing, updating and optimizing online platform | ||||||||||||||||
T6.1 | Development of the platform | x | x | x | x | ||||||||||||
T6.2 | Content structure organisation of the platform | x | x | x | x | x | x | x | x | x | x | x | x | ||||
T6.3 | Publish open source software modification on online repositories | x | x | x | x | x | x | x | x | x | x | x | x | ||||
T6.4 | Platform adaptation to the feedback from stakeholders | x | x | ||||||||||||||
T6.5 | Develop and employ a tool to search in and compare relevant topics across countries on the platform | x | x | x | x | x | x | x | |||||||||
T6.6 | Evaluation of efficiency of information retrieval on the platform | x | x | x | x | x | |||||||||||
T6.7 | Steady-state maintenance of the platform | x | x | x | x | x | |||||||||||
T7.1 | Structuring community development | x | x | x | x | ||||||||||||
T7.2 | Fostering community awareness of the platform | x | x | x | x | x | x | x | x | x | |||||||
T7.3 | Creating platform endorsement | x | x | x | |||||||||||||
T7.4 | Extended platform development and community engagement | x | x | x | x | x | x | ||||||||||
T7.5 | Fostering long term sustainability | x | x | x | |||||||||||||
3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 27 | 30 | 33 | 36 | 39 | 42 | 45 | 48 |
All consortium members have an extensive track-record in their respective fields and have collaborated successfully in many national and international research projects before. Members of the team have extensive knowledge in the fields of RE+RI and a large experience with collecting and analyzing relevant data. The consortium has access to the technology needed to develop the EnTIRE platform, including WikiMedia and datamining; the consortium has a sound methodological background and experience with participatory approaches and community engagement. Therefore, the consortium is well-equipped to complete the project successfully and on time. See Fig.
Work package 1: Project Co-ordination
Start date M1, end date M48
Lead beneficiary: VUmc
Participants: VUmc (25.8 PM); GI (1 PM); KUL (1 PM); MEFST (1 PM); DCU (1 PM); UEM (1 PM); UNIDEB (1 PM); UiO (1 PM); UNIMAN (1 PM); EUREC (1 PM).
Objectives
The main aim of WP 1 is to ensure the day-to-day project co-ordination activities and to provide scientific, administrative, and financial direction to the EnTIRE consortium and all WPs.
This aim will be achieved by pursuing the following objectives, to:
Description of work
The project coordination structure will contain a General Assembly, Executive Board and Advisory Board. This is further described in section 3.2. The EnTIRE project will be coordinated by VUmc, who will coordinate the project’s day-to-day activities and chair the Executive Board. As designated by the EC, the coordinator (VUmc) will be responsible for legal, ethical and gender issues, contractual management (Grant Agreement, amendments and Consortium Agreement, incl. handling of IPR issues), processing EC audits and reviews and management of EC payments.
The project coordination WP will achieve the above objectives by conducting the following tasks:
Task 1.1. Scientific coordination (M 1-48, VUmc)
Task 1.2. Administrative coordination (M 1-48, VUmc)
Task 1.3 Financial coordination (M 1-48, VUmc)
Work package 2: Stakeholder Consultation
Start date M1, end date M48
Lead beneficiary: VUmc
Participants: VUmc (32 PM); GI (2 PM); KUL (2 PM); MEFST (4 PM); DCU (1 PM); UEM (3.5 PM); UNIDEB (3 PM); UiO (1 PM); EUREC (1 PM).
Objectives
This work package is responsible for meeting overall objective 1: to undertake an in-depth stakeholder consultation across EU countries exploring RE+RI experiences and practices, define the boundaries of data to be collected, and developing a mapping structure adapted to user needs (WP2).
WP sub-objectives include to:
Background
A central element of the EnTIRE project is the inclusion of stakeholders’ priorities and perspectives both in relation to the boundaries of the data to be collected and in the design and development of the online platform. Indeed, buy-in and intensive participation of a diversity of stakeholders from across Europe is key to the project’s success; a sense of ownership amongst stakeholders and their associated networks will result in an online community that will make the platform self-sustainable.
The stakeholder consultation will be conducted through a questionnaire, followed by a focus group methodology (
The focus groups will investigate experiences of participants, clarifying how rules and regulations function in practice and identifying information needs. Also, cases from practice will be solicited and discussed. The focus groups will be analysed, taking into account the literature on RE+RI, in order to optimize interaction between practice and theory (
Description of work
Task 2.1. Preparation of the stakeholder consultation (M1-3, VUmc, UEM, MEFST, UM)
Task 2.2. Pilot: face-to-face focus groups withs takeholders (M4-8, VUmc, UEM, MEFST, UM)
Task 2.3. Defining the boundaries of the data to be collected (M8-12, VUmc, UEM, MEFST, UM)
Task 2.4.Scale -up: Online focus groups with stakeholders (M9-18, VUmc, all partners)
Task 2.5. Assessing the acceptability of the online platform (M18-48, VUmc)
Iteratively assess the acceptability and usability of the platform developed in WP 6 with stakeholders using the online community developed through the platform.
Work package 3: Guidelines and regulations on RE & RI in the European Union
Start date M1, end date M48
Lead beneficiary: KUL
Participants: VUmc (2 PM); GI (2 PM); KUL (48.9 PM); MEFST (2 PM); DCU (2 PM); UEM (2 PM); UNIDEB (5 PM); UiO (2 PM); EUREC (1 PM).
Objectives
This WP will be responsible for the collection of data on the diversity of guidelines, codes, legislations, and standards that have been created in the EU.
WP sub-objectives include:
Background
The work package will offer a detailed mapping and analysis of the normative documents on research ethics and research integrity that are available within the European Union. Our previously published overview of guidelines, standards, laws, and codes in European countries, regions and institutions (
Description of work
Task 3.1. Preparation of data-collection on normative documents (M1-6, KUL)
Task 3.2. Pilot collection of data on normative documents(M6-12, KUL, UEM, MEFST)
Task 3.3. Scale up: Collecting normative documents in all EU countries (M12-36, KUL, all partners)
Task 3.4 Analysis of the normative documents (M11-32, KUL)
Task 3.5. Testing, updating and optimizing online platform (M18-48, KUL and GI)
Work package 4: Resources for RE & RI
Start date M1, end date M48
Lead beneficiary: MEFST
Participants: VUmc (2 PM); GI (2 PM); KUL (2 PM); MEFST (30 PM); DCU (5 PM); UEM (2 PM); UNIDEB (2 PM); UiO (2 PM); UNIMAN (2 PM); EUREC (1 PM).
Objectives
This work package is responsible for collecting and synthesizing the information about:
WP sub-objectives include:
Background
WP4 will focus on systematic and comprehensive inventory of RE+RI committees, currently available training resources, and experts across Europe. This is crucial for creating a functional platform, as there is little information or harmonization of RE+RI structures in Europe (
Based on the information from other EU projects, such as RRI Tools and HEIRRI, and available literature on RE+RI (
In parallel with data collection, we will work on the best model for sharing the information on the OA platform developed by WP6, to ensure participation of stakeholders and commitment to full sustainability of the platform beyond the project.
Description of work
Tasks
Task 4.1 Preparation of data collection on resources(M1-6, MEFST and DCU, UNIMAN)
Task 4.2 Pilot collection of data on resources(M6-12, MEFST, VUmc, UEM)
Task 4.3 Scale-up: Inventory database on resources for European countries (M12-39, MEFST, and all members)
Task 4.4 9. Testing, updating and optimizing the online platform (M18-48,MEFTS and GI)
Iteratively assess the usability, interactives and sustainability of the platform developed in WP 6 with the regard to collected data on RE+RI committees, training opportunities and experts.
Work package 5: Cases, casuistry and scenarios
Start date M1, end date M48
Lead beneficiary: DCU
Participants: VUmc (2 PM); GI (2 PM); KUL (2 PM); MEFST (5 PM); DCU (27 PM); UEM (2 PM); UNIDEB (19 PM); UiO (2 PM); UNIMAN (2.5 PM), EUREC (2 PM).
Objectives
This work package is responsible for gathering and make available cases, methods of case analysis, and to present actual case analyses as well as a set of scenarios.
WP5 sub-objectives include:
Background
Work package 5 “Cases, casuistry and scenarios” contains all tasks that provide for a comprehensive selection of RE+RI cases and case analysis methods as well as the presentation of actual case analyses. Moreover, a selection of prominent RE+RI cases will be analysed with different case analysis methods. Finally, a set of scenarios will be developed. The purpose of making the cases, case analysis methods, actual cases analyses and scenarios available is to foster structured analysis and thorough debate about RE+RI cases, which in its turn might serve as the bedrock for responsible future RE+RI regulation and practice.
The RE+RI cases to be uploaded onto the EnTIRE platform will result from searches in different potential sources, e.g. academic literature, reports of RE+RI committees, professional regulators, grey literature, media outlets and the blogosphere. In addition, the focus groups sessions, both the face-to-face and the online focusgroups, in WP2 will be used to generate, as well as to reflect and deliberate on, cases from local practice. The cases resulting from the searches within these different sources will be tagged and categorized, with the purpose of enhancing the indexing of cases in the EnTIRE platform. Both traditional methods of categorisation – e.g. using well-known concepts such as misconduct, falsification, fabrication, plagiarism - as well as more innovative ways of categorisation, such as using the ethical principles within the RE+RI normative framework, will be applied and a thesaurus developed. In addition, case analysis methods suitable to the analysis of RE+RI cases will be identified through a systematic literature review and made available on the online platform. Moreover, a selection of prominent RE+RI cases will be analysed thereby showcasing relevant case analysis methods. Finally, a set of scenarios will be built for educational purposes and in order to stimulate strategic thinking about RE+RI.
Description of work
Task 5.1. Preparation of data collection on cases (M1-6, DCU, UNIDEB, Manchester)
Task 5.2. Pilot collection of data on cases (M6-12, DCU, UNIDEB, Manchester)
Task 5.3. Scale up: Collecting and categorizing RE+RI cases (M12-36, DCU, UNIDEB, VUmc)
Task 5.4. Identifying and applying appropriate case analysis methods and building RE+RI scenarios (M12-48, DCU, UNIDEB)
Task 5.5. Testing, updating and optimizing the online platform (M18-48, DCU and GI)
Work package 6: Platform development and maintenance
Start date M1, end date M48
Lead beneficiary: GI
Participants: VUmc (4 PM); GI (46 PM); KUL (1 PM); MEFST (1 PM); DCU (1 PM); UEM (1 PM); UNIDEB (1 PM); EUREC (1 PM).
Objectives
This work package is responsible for meeting overall objective 3: to develop a user-friendly platform, including a website and online resources, to facilitate access to RE+RI knowledge and experience and support application in research and evaluation, thus fostering uptake of ethical standards and responsible conduct of research.WP sub-objectives include to:
Background
The main aim of this WP is to develop the EnTIRE platform (www.embassy.science) and allow the EnTIRE consortium to deliver, structure, review, edit and analyse content on the platform. The platform should have a high level of user-friendliness (intuitiveness) that allows any user to start working on it immediately without further instructions. The platform will use publically funded, open source, freely available software: (Semantic) MediaWiki (
Description of work
Task 6.1. Development of the platform (M1-12, GI)
Task 6.2. Content structure and organisation of the platform (M12-48, All partners, GI)
Task 6.3. Publish open source software modification on online repositories (M12-48, GI)
Task 6.4. Platform adaptation to the feedback from stakeholders (M30-36, GI)
Task 6.5. Develop and employ a tool to search in and compare relevant topics across countries on the platform (M30-48,VUmc, GI)
Task 6.6. Evaluation of efficiency of information retrieval on the platform (M36-42, VUmc, GI)
Task 6.7. Steady-state maintenance of the platform (M36-48, GI)
Work package 7: Community engagement, communication and dissemination
Start date M1, end date M48
Lead beneficiary: VUmc
Participants: VUmc (30 PM); GI (5 PM); KUL (2 PM); MEFST (1 PM); DCU (2 PM); UEM (2 PM); UNIDEB (2 PM); UiO (2 PM); UNIMAN (2 PM), EUREC (1 PM).
Objectives
This work package is responsible for meeting overall objective 4: to foster the further development of the RE+RI community, that will support the platform and be supported by it, disseminate the project’s findings, apply innovative strategies for maintaining the platform through stakeholder participation, and relate the platform to relevant organisations for further dissemination fostering sustainability.
WP sub-objectives include to:
Background
The main objective of WP 7 is to engage the RE+RI community, that will disseminate the project’s findings, apply innovative strategies for maintaining the platform (WP 6) through stakeholder participation, and relate the platform to relevant organisations for further dissemination fostering sustainability (
Description of work
Task 7.1. Structuring community development (M1-18, VUmc)
Task 7.2. Fostering community awareness of the platform(M4-36, VUmc, all partners, ENERI)
Task 7.3. Creating platform endorsement (M24-32, VUmc)
Task 7.4. Extended platform development and community engagement (M32-48, VUmc, GI)
Task 7.5. Fostering long term sustainability (M40-48, VUmc, Aall partners, ENERI)
A descriptive overview of the work packages is provided in Table
Work package No | Work Package Title | Lead Participant No | Lead Participant Short Name | Person-Months | Start Month | End month |
1 | Project Coordination | 1 | VUmc | 34.8 | 1 | 48 |
2 | Stakeholder consultation | 1 | VUmc | 49.5 | 1 | 48 |
3 | Guidelines and regulations on RE & RI in the European Union | 3 | KUL | 66.9 | 1 | 48 |
4 | Resources for RE+RI | 4 | MEFST | 53.5 | 1 | 48 |
5 | Cases, casuistry and scenarios | 5 | DCU | 65.5 | 1 | 48 |
6 | Platform development and maintenance | 2 | GI | 56 | 1 | 48 |
7 | Community engagement, communication and dissemination | 1 | VUmc | 50 | 1 | 48 |
Total months | ||||||
376.2 |
Deliverable (number) | Deliverable name | Work package number | Short name of lead participant | Type | Dissemination level | Delivery date |
D.1.1 | Project management and quality assurance plans | WP1 | VUmc | R | CO | (Month 2) |
D.1.2 | Document providing the logo and templates for a uniform corporate look | WP1 | VUmc | DEC | PU | (Month 3) |
D.1.3 | Data management plan | WP1 | VUmc | OTHER | PU | Month 6 |
D.1.3 | Partner-specific templates for collecting input for internal reporting and monitoring and required EU documents | WP1 | VUmc | OTHER | PU | (Month 12) |
D. 1.4 | Reports for the EnTIRE consortium | WP1 | VUmc | R | CO | (after General Assembly, Executive Board and Advisory Board meetings and when required) |
D.1.5 | Reports for the EC | WP1 | VUmc | R | PU | EC according to funding requirements) |
D.2.1 | Protocol for the phased multi-country stakeholder consultation | WP2 | VUmc | OTHER | PU | M3 |
D2.2 | Definition of the boundaries of data to be collected for the mapping exercise (WPs 3-5): | WP2 | VUmc | OTHER | PU | M12 |
D2.3 | Report of results from the stakeholder consultation | WP2 | VUmc | R | PU | M33 |
D.2.4 | Work package report: project end | WP2 | VUmc | R | PU | M48 |
D.3.1. | Template for the collection of guidelines, codes, laws: | WP3 | KUL | OTHER | PU | M7 |
D.3.2 | First online content for OA web platform | WP3 | KUL | OTHER | PU | M15 |
D.3.3 | A report containing the most significant similarities and contradictions (at level of content and approach) within the different guidelines in the member states | WP3 | KUL | R | PU | M38 |
D.3.4 | Report on functionality of OA resource | WP3 | KUL | R | PU | M40 |
D.3.5 | A report containing all the documents ranked per member state, enforceability, level ((intra)national, PU regional, institutional), web links, etc | WP3 | KUL | R | PU | M48 |
D.3.6 | Final WP report | WP3 | KUL | R | PU | M48 |
D.4.1 | Content framework for data collection | WP4 | MEFST | OTHER | PU | M6 |
D.4.2 | Protocol for literature and country resources search and data collection | WP4 | MEFST | OTHER | PU | M9 |
D.4.3 | Online content for OA web platform | WP4 | MEFST | OTHER | PU | M15 |
D.4.4 | Report on functionality of OA resource | WP4 | MEFST | R | PU | M40 |
D.4.5 | Final WP report | WP4 | MEFST | R | PU | M48 |
D.5.1 | Protocol for systematic searches and tagging of RE+RI cases: | WP5 | DCU | OTHER | PU | M7 |
Delivery of the first tagged RE+RI cases as input for the platform | WP5 | DCU | OTHER | PU | M18 | |
D.5.3 | Delivery of the entire set of case deliberation methods and case analyses as input for the platform | WP5 | DCU | OTHER | PU | M24 |
D.5.4 | Delivery of the first RE+RI scenario as input for the platform | WP5 | DCU | OTHER | PU | M30 |
D.5.5. | Report on functionality of OA resource | WP5 | DCU | R | PU | M40 |
D.5.6. | Work package report | WP5 | DCU | R | PU | M48 |
D.6.1 | EnTIRE platform | WP6 | GI | DEC | PU | M12 |
D.6.2 | Publication of the adapted platform software in a public open source software repository | WP6 | GI | DEC | PU | M12 |
D.6.3 | Report of the evaluation and graphical user interface of the platform | WP6 | GI | R | PU | M23 |
D.6.4 | Publication of the extensions to the platform in a public open source software repository | WP6 | GI | OTHER | PU | M40 |
D.6.5 | Report of the efficiency evaluation of the platform | WP6 | GI | R | PU | M42 |
D.6.6 | Report for future plans of the platform | WP6 | GI | R | PU | M48 |
D.7.1 | Communication and dissemination plan | WP7 | VUmc | DEC | PU | M6 |
D.7.2 | Platform community management plan | WP7 | VUmc | DEC | PU | M12 |
D.7.3 | Report of platform endorsements, usage statistics and an analysis | WP7 | VUmc | R | PU | M36 |
D.7.4 | Final and future Community management, Communication and Dissemination Plan: | WP7 | VUmc | DEC | PU | M46 |
D.7.5 | Plans of the newly formed consortium to sustain the platform beyond the end of this grant | WP7 | VUmc | OTHER | PU | M48 |
Milestone number | Milestone name | Related work package(s) | Estimated date | Means of verification |
M1.1. | Kick-off meeting | WP1 | M4 | Conference website |
M2.1 | Elements of the normative framework defined: | WP2 | M 12 | Table |
M2.2 | Stakeholders’ experiences, priorities and preferences established: | WP2 | M32 | Report |
M3.1 | Format for collecting normative documents constructed | WP3 | M7 | Format |
M3.2 | First input for EnTIRE platform created | WP3 | M16 | Screenshot |
M3.3 | Content analysis available on the website | WP3 | M40 | Screenshot |
M4.1 | Content framework constructed | WP4 | M9 | Table |
M4.2 | Data from pilot data collection finalized and discussed with consortium members and Advisory Board | WP4 | M13 | Report |
M4.3. | First input for OA platform created | WP4 | M16 | Screenshot |
M5.1 | First tagged RE+RI cases available on the platform | WP5 | M18 | Screenshot |
M5.2 | Case deliberation methods available on the platform | WP5 | M24 | Screenshot |
M5.3 | First RE+RI case analyses available on the platform | WP5 | M24 | Screenshot |
M5.4 | First RE+RI scenario available on the platform | WP5 | M30 | Screenshot |
M6.1 | The EnTIRE platform (www.embassy.science) is brought online for stakeholders | WP6 | M12 | Website |
M6.2 | The EnTIRE platform (www.embassy.science) is brought online for the general public | WP6 | M24 | Website |
M7.1 | EnTIRE community taskforce initiated | WP7 | M3 | Report |
M7.2 | New consortium composed to sustain the EnTIRE platform beyond the end of this grant | WP7 | M48 | Report |
The success of the EnTIRE project and its anticipated achievements will to a large extent be dependent on the management of the project and the structure and procedures to enable this. Prof. Dr. Guy Widdershoven (Project leader of WP1) has extensive experience in managing large collaborative projects, for instance a Dutch national project concerning reduction of seclusion in psychiatry and a large project funded by the Dutch funder NWO on empirical ethics. As former scientific director of the Care and Public Health Research Institute of Maastricht University (400 fte) and as current head of the department of the medical humanities (30fte) of the coordinating beneficiary, the VUmc, he has been successful in scientific supervision and financial management. He will be supported by Laura Hartman MA, who was a project leader on several large research projects at this department The VU medical centre (VUmc) is highly experienced at hosting the coordination and management of large collaborative research projects. From this experience, an extensive set of structures and procedures have been put in place to ensure the successful management and delivery of the project, the scientific quality of the research, and make sure that dissemination and stakeholder engagement deliver the expected impacts.
The management structure and procedures in EnTIRE are designed to:
A schematic overview of the intended management structure of EnTIRE is presented in Fig.
As will be further detailed in the CA, three levels of management are distinguished. Each of these levels has different authorities and responsibilities as described in the following sections.
The General Assembly’s (GA) main responsibility is to advise and review the project results in accordance with the GA and the CA. It consists of one representative of each project partner. The GA will meet face-to-face, preceding and preparing the contractual reporting obligations to the European Commission (EC). These meetings will be used to review the progress of EnTIRE discuss problems and formulate advice on future directions. As such, the GA is the appropriate internal advisory body in the following issues:
In addition, the GA has specific decision-making responsibilities in the following issues:
The GA is chaired by the principle investigator Prof. Guy Widdershoven: PI of the coordinating beneficiary, the VUmc. Extraordinary meetings can be convened at any time, following a written request by (or via) the Executive Board. At other times, communication between the GA members and the consortium will take place via means of postal mail, e-mail and telephone. The CA will address further details of above mentioned issues including voting procedures, veto rights, representations and agreed procedures on distribution of meeting documents.
The Executive Board (EB) acts as the central management team of EnTIRE, and is responsible for overall monitoring of the scientific and financial progress of the project activities towards the main objectives of the project. The activities of the EB are based on agreed deliverables and associated milestones, within the budgetary limits. It consists of the work package leaders of WP3, 4 and 5 (Prof. Kris Dierickx, Prof. Anna Marušić, Prof. Bert Gordijn respectively and is chaired by Prof. Guy Widdershoven (PI). The EB is responsible for and has decision-making authority in the following issues:
The EB will meet at least twice a year; one of these meetings will be a telephone conference, whereas the other meeting precedes the annual GA meeting. Additional meetings can be convened at any time following a written request by any member of the EB to the chairman. All decisions in the EB will be taken by majority voting.
By means of the external Advisory Board (AB), EnTIRE will seek regular external advice on relevant issues. The AB will provide expert advice on the quality of the deliverables, in order to oversee that the project will develop in accordance to the appropriate legal, ethical and social issues, general philosophy and direction of the project. It will also advise on corrective measures in the content of the work if necessary and the dissemination and exploitation of the projects results. The AB has no formal decision power within the project. The members of the AB are independent and therefore no budget is reserved for AB consultations. The members of the advisory board are be selected for:
Persons will be invited when necessary and in consultation with the EC representative. The following persons and/or organisations are committed take seat in the AB (Table
Representative on AB | Organisation / affiliation | Expertise relevant to the project |
Prof. Ray de Vries, | University of Michigan | Professor Emeritus in the Department of Learning Health Sciences and the Department of Obstetrics and Gynecology at the University of Michigan. Prof. de Vries has a long-term interested in the regulation of science and the production of scientific knowledge and has published extensively on research misbehaviours. |
Dr. Maura Hiney | Health Research Board, Science Europe, ALLEA | Head of Post-Award Management and Evaluation at Health Research Board (HRB) and Chair of ALLEA Task group on research integrity and Chair of Science Europe Working Group |
Dr. Nicole Foger | European Network of Research Integrity Offices & Austrian Agency for Research Integrity | Chair of European Network of Research Integrity Offices (ENRIO) |
Dr. Elizabeth Moylan | BioMed Central, Committee on Publication Ethics (COPE) | Senior Editor for Research Integrity on the BMC open access-series journals, Council Member for COPE |
In compliance with the GA and consistent with the CA, the coordinating institute, or Coordinator (CO) VUmc, will be the intermediary for any communication with the Commission and any partner. As such, the CO will be responsible for:
The CO employs a dedicated Project Office (PO) that acts as central day-to-day management office. The PO is located at the premises of partner 1 and consists of the PI, a project manager, a financial controller/administrator and a project secretary. The main duties of the project office include the activities allocated to WP1: Project management. This includes the preparation of the EB meetings, preparation and timely distribution of the agendas as well as supporting documents and minutes of the meetings. If necessary, the Project Office can be expanded with a legal and/or financial and/or valorisation expert to support the PI. Under responsibility of the coordinating PI Prof. Guy Widdershoven, the project manager will execute all daily administrative, legal and financial issues concerning the whole project and will be in direct contact with the representatives of the European Commission. The financial controller will assist the project manager in monitoring the budget and financial reporting to the EC and is available to the consortium partners for financial or budgetary questions during the implementation of EnTIRE. Furthermore, the Project Office has dedicated support offices at its disposal to provide expert legal, administrative, financial and project management advice and support to the project management team. These services include a Technology Transfer Office, the Grants Desk VU/VUmc, and Project Control and Administration Office.
At the operational level, the task of Work Package Teams (WP Teams) is to ensure an effective and efficient implementation of the activities within their WP. WP Teams consist of the WP Leader and other key investigators that are participating in that specific WP.
WP leaders are responsible for developing detailed WP implementation plans on the basis of the current proposal, and for the efficient and effective implementation of these plans. More specifically, the Work Package leaders are responsible for:
Extraordinary reporting to the Coordinator will be provided by the WP leader particularly in cases of a specific milestone or deliverable of the WP being in danger of being delayed or unattainable relative to the schedule. This shall include a suggestion for remedies or solutions regarding the apparent shortcoming to keep the project on schedule and to minimize unfavourable consequences for other WPs and the project as a whole. Related decisions to be taken will be brought to the attention of theEB and decision-making of the EB will be assured in a short time – either by a regular or – if appropriate – an extraordinary meeting or email.
Work Packages (WP) will be implemented by the WP partners, each of which will be led by a WP leader. Each WP has been divided into tasks with clearly defined activities and outputs. Tasks are led by a Task leader who will be responsible for management of the research within the task. This structure provides WP leaders with support in the execution of their WP duties however the final responsibility for implementation of all tasks remains with the WP leader. The Coordinator will support the WP leader in the implementation of all WPs stepping in to ensure the work plan is adhered to. The Coordinator will organize regular conference calls (at least once in two months as necessary more frequently) with WP leaders, and – as necessary - partners involved in each WP. Progress reporting by each WP leader will be made at General Assembly meetings.
Each participant appoints one formal contact (the Principle Investigator, PI) for the GA. This partner contact is the first spokesperson for his/her institute vis-à-vis the GA and the Project Office on issues (a.o.) related to:
The PO will implement standard quality procedures, to ensure smooth management and monitoring of the project progress and to ensure the quality of all outputs of the project in particular deliverables. The procedures include, amongst other things, the establishment of meeting and communication procedures, guide on reporting procedures, standard procedures for data collection and procedures on conflict mediation and corrective actions.
Before submission to the EC, the quality of all deliverables will be checked with a system of academic peer review and also quality control. Each deliverable will be subject to a peer review either by the external advisors or by two scientific experts from the across the project consortium. The overall quality and delivery against the Description of Work will then be checked at two at three levels by:
Any issues with quality will be resolved before final approval and submission to the EC.
To be effective as a large collaborative consortium, sound internal communication is essential. To that end, EnTIRE will implement a communication strategy aimed at efficient and effective communication with all relevant stakeholders. The EnTIRE platform will be instrumental with this, maintained by our partner 2. GI. A collaborative working platform will be set up in order to provide the appropriate tools for distributing information internally in an effective and user friendly way. WP7 will be responsible for the public part of dissemination and will take the lead in drafting the communication strategy (as part of the dissemination plan).
For all meetings, the chair (the Coordinator for the GA and EB and the WP Leaders for the WP Teams) is responsible for preparation, planning and if necessary a follow-up of the meetings. Table
Body | Frequency | Preparation | Method and scope |
General Assembly | Every year | EB | Face to face - formal accord on progress reporting to EC, decisions affecting CA and/or EC contract, knowledge dissemination and exploitation, dispute resolution. |
Executive Board | Every 6 months | EB | EB meetings are alternating between interim meetings that will be held through telephone conferencing, and face to face meetings that precede the annual GA; coordination, overall progress of the WPs to the project objectives, inter WP alignment, scientific discussions and associated decisions, financial reporting, reporting to the GA. |
Advisory Board | Every 12 months | EB | Regular contact, Face to face & teleconference. For external advice on relevant issues. |
WP Teams | Frequently | WP Leaders | Face to face & teleconference; WP progress, intra WP alignment of tasks, financial monitoring. |
All members of the consortium | Every 12 months + 1 kick-off meeting | EB | Face to face - exchange of scientific data with a special focus on junior staff and bench workers with the aim to share information between WPs, and accelerate implementation of information. |
In addition to regular periodic reports, a final report will be submitted, within 60 days after the end of the project. This final report shall comprise:
The final report, cost certificates (audit certificates) and other deliverables foreseen will be sent to the EC representative by the deadline given in the contract.
The CA will detail all other project specific reporting procedures. Each report will have a defined frequency, format and list of topics to be covered. All reports will be distributed within a set time-limit which as agreed upon in the GA or CA, before the respective meeting. The reports listed above cover the formal reporting obligations to the EC. Other scientific and/or technical documentation to be circulated amongst the various consortium partners as a result or part of scientific and/or technical activities within the project is not included. In addition, the lead investigators from each of the consortium partners will be held responsible for providing the Coordinator with relevant and necessary input (e.g. Forms C or certificate of costs) towards the obligatory formal EC reporting. Financial reporting will be done through the Participant Portal. Towards this end, each partner will appoint a Financial Statement Authorised Signatory (F-SIGN). An overview of reporting is provided in Table
Report | Delivery date (month) |
Periodic Report | M 18 |
Periodic Report | M 36 |
Final Report | M 48 |
3.2.11 Critical Risks
No project is without its risks. Critical risks identified by the consortium, and possible mitigation measures, are outlined in Table
Description of risk | Work package(s) involved | Proposed risk-mitigation measures |
Lack of communication, lack of respect for planning and deadlines, or partner underperformance | WP1 | An adequate management structure has been designed, which will be carried out by management-skilled academics and experienced consultant companies. Frequent (teleconference) meetings will be held. Most partners already know each other in their respective fields. |
Organisational financial problems require reducing project budget | WP1 | All partners will monitor audit certificates and financial problems and will report to the EB on a regular and planned basis. |
Partner leaves the consortium | WP 1 | Consortium partners have a large mutual drive to work together. In the unlikely event a partner leaves the consortium, all partners will be responsible for seeking a new partner that has similar capabilities and is able to finish the work. All participants have an extensive network to tap into. For other parts, the remaining partners will finalise the work. |
Lack of integration of results of partners leading to underperformance | WP 1 | An adequate management structure has been conceived. The consortium partners will organise dedicated site visits and exchange of personnel if needed. |
A potential risk is the lack of willingness of stakeholders to participate in the face-to-face focus groups. | WP 2 | The partners involved in the identification and invitation of stakeholders for each country know the field very well and are able to address relevant individuals and organisations personally if interest is low. |
A potential risk is the large number of elements in the normative framework. | WP 2 | The partners involved in analysing the focus groups have experience in clustering data and determining core concepts. By organizing two rounds of focus groups, the stakeholders will be included in this process. Results will also be discussed with the Advisory Board. |
A potential risk is the lack of willingness of stakeholders to participate in the online focus groups. | WP 2 | The partners in the project together know relevant colleagues in all European countries which will be asked for assistance in identifying and inviting participants. |
Based on our experience with the collection of national guidelines and legislation in EFTA member states it is clear that most of these (at that time national) documents are not always easy to find, although one would expect otherwise. A possible risk is that the period of the project will not be sufficient to collect all the relevant documents in the EU member state. | WP 3 | We expect that the expertise and experience of our consortium, and the existing network of national contact persons will be able to limit this risk. |
A potential risk is the lack of willingness of stakeholders to contribute to data collection. | WP 4 | The partners involved in the identification and invitation of stakeholders for each country know the field very well and are able to address relevant individuals and organisations personally if interest is low. |
A potential risk is the systematization of possibly very heterogeneous data from different countries. | WP 4 | We will use the normative framework developed in the stakeholder consultation and experience from other organizations (such as World Health Organization country statistics, http://www.who.int/gho/countries/en/) to construct the information so that it includes general indices of RE+Ri plus individual country specificities. |
A potential risk is the language barriers, particularly for information from the South-East Europe. | WP 4 | The lead partner for the WP (MEFST) has excellent contacts in the countries of the region and speaks similar language to many of the countries in the region. |
A potential risk is the number of RE+RI cases that are found, which may be either too small or too large. If the number is too small, further search strategies will be applied, making use of expert knowledge of partners and other RE+RI leaders. If the number is too large, methods of limiting the number of cases will be deployed in the search strategies such as exclusively focusing on a recent time period. | WP 5 | It has to be kept in mind that a community will be established, dedicated to the project’s long-term continuity of the online forum. So the platform will be interactive and sustainable, meaning that additional cases can be gathered, added and analysed after the EnTIRE project has been completed. Hence, aiming to be exhaustive is not pivotal. |
The project becomes dependent on the ICT supplier through the use of proprietary software. | WP6 | This risk is fully mitigated as we will only work with open source software and will publish the entire platform online together with sufficient documentation. This ensures that any other ICT firm (and the open source community) can continue to work with the platform. The platform is created by and for the community and will become an entity (non-profit organisation) independent from the ICT partner and the consortium by using this approach. |
The platform will be attacked by computer hackers | WP6 | We will ensure the latest versions of relevant software packages to mitigate this risk. Also adequate infrastructure to prevent common security attacks will be used. Moreover, a back-up of the platform will be created on a daily basis. |
The vastness of (different types of) content on the platform inhibits efficiently finding what is relevant. | WP6 | As mentioned in Section 1, several similar attempts in the US have succumbed to this risk. In this project it will be actively mitigated by using a software platform which was designed to handle large and different types of content (Wiki-software). The advisory board includes professor Ray de Vries from the University of Michigan in the US who, based on the prior experience in the US, will advise about what is relevant. |
Lack of volume of users (‘critical mass’) | WP7 | Approaches include but are not limited to giving stakeholders an active role, distributing the benefits of an open access platform, active lobbying of research organisations and tailoring the incentives (taking into account any cultural differences). |
Not achieving an elaborate community and stable long-term committed user base. | WP7 | The EnTIRE platform allows for effective community management by design. Moreover, the lead of WP 7 has experience in open source community management, the overall lead of the project has an elaborate network in RE+RI and has invited other WP leads with similarly sized RE+RI networks which mitigates this risk. |
Lack of budgets and external investments for long-term sustainability. | WP7 | The community approach will mitigate this risk, because financial needs will be comparatively limited and community members will include organisations which can act as lead and partners in the future consortium. |
The EnTIRE consortium consists of 10 partners from 9 different institutions, located in 9 different countries, within and beyond the EU. Each partner has been carefully chosen to reflect leading expertise in the tasks and WPs they will participate in. Consequently, there are many complementarities, for example. The scientific partners are all leading experts in research ethics and research integrity. Partner 2 (GI) is a specialist in building an open access interactive Wiki-platform.
The lead partner 1 (VUmc) has a track record in addressing normative issues and providing normative support by fostering stakeholder participation through qualitative research, both nationally (in developing networks for clinical ethics support and for patient participation in healthcare, and internationally (for instance the European Clinical Ethics Network). Other partners, especially 6 (UEM), 9 (UNIMAN), and 10 (EUREC),are also experts in the field of stakeholder research. The participatory approach, focusing on stakeholder consultation and community engagement, is endorsed by all partners.
The partners who are responsible for the collection of data (WP3-5) have much experience in assembling and analyzing large data sets. Partner 3 (KUL) has made an inventory of European Laws, regulations, codes and guidelines, published in The Lancet. Partner 4 (MEFST) has a broad overview of resources, such as teaching materials and contact persons. Other partners, especially 9 (UNIMAN) and 7 (UNIDEB) will assist, bringing in their expertise. Partner 5 (DCU) has experience in collecting cases, and is an expert in case analysis and making scenarios. The other scientific partners are also experienced in gathering RE+RI normative documents, resources and cases, and will assist in collecting and analyzing data. The distribution of partners over various European regions ensures that the consortium will be able to reach all EU countries (see Section 3.3.3).
The platform will be built by partner 2 (GI), who has expertise in WikiMedia, and has experience in making a platform in interaction with key-users. In order to make the platform sustainable, the RE+RI community will be engaged. Partner 1 (VUmc) has large experience in fostering community engagement in large projects aimed at reforming healthcare practice (in primary healthcare and mental healthcare), using a stakeholder approach. All partners are active in several relevant networks and communities, including ENERI, PRINTIGER, HIERRI, FOSTER, RRI-TOOLS, EnRRICH, COPE, and others. Thus, the consortium is firmly rooted in the RE+RI community and will be able to engage this community in the process of making the platform sustainable.
Through a joint commitment to stakeholder participation and community engagement, a shared awareness of the importance of (differences in) RE+RI practices, and the conviction that making accessible RE+RI information requires an interactive and open access platform, the EnTIRE consortium members will effectively work together with a clear focus, contributing their expertise in a complementary way.
Lastly, the consortium posits an Advisory Board that consists of experts from different countries within and beyond the EU. These experts will consistently provide advice on the deliverables of the EnTIRE project (Table
In all, the consortium is balanced over the objectives and is efficient, primarily aimed at achieving synergy and excluding any unnecessary overlap in expertise and resources. These complementarities are maximised by the inclusion of well in depth knowledge, expertise and experience with collaborating in large consortia.
Excellence is a prerequisite for achieving impact. The EnTIRE partners individually and in partnership have demonstrated their contribution to academic advances across and within relevant disciplines more than once. For example, partner 1 (VUmc), 3 (KUL), 5 (DCU), and 10 (EUREC) have provided significant advances in our understanding of the relation between empirical science and bioethics, developed innovative research methods such as interactive empirical ethics, and contributed to the development of the theory on empirical bioethics.
Besides this evidence of having academic impact, the partners individually were involved in the uptake and usage of their academic results by healthcare professionals and institutions. A compelling examples is the implementation of Clinical Ethics Support (especially Moral Case Deliberation) in Europe, with a leading role for partner 1 (VUmc) and 8 (UiO).
Another important prerequisite for achieving impact is to have excellent communication capacities. As various the track records of the involved partners show, this consortium is well equipped to engaging in societal debates, to communicate scientific results to a wider public and with that, to create support and engagement to ensure a sustainable impact.
All partners are highly active in their respective context and have access to and active participation in relevant networks and organisations. Some examples are: the central role of partners 1 (VUmc) , 3 (KUL), 4 (MEFST), 5 (EDC), 6 (UEM), 7 (UNIDEB) , 8 (UiO), 9 (UNIMAN) and 10 (EUREC) in national and international bioethics organisations, and the central role of partners 1 (VUmc), 3 (KUL), 4 (MEFST), 8 (UiO), 9 (UNIMAN), and 10 (EUREC) in RE+RI networks.
Measured by current and previous participation in national, European and global networks and their active relations with important stakeholders, EnTIRE ensures capitalisation on current networks and knowledge available throughout the EU.
The EnTIRE consortium consists of 10 partners from 9 different EU Member States and 1 Associated Country (Fig.
EnTIRE project (Mapping Normative Frameworks for EThics and Integrity of Research) has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement N 741782. EnTIRE aims to create an online platform that makes RE+RI information easily accessible to the research community. The EnTIRE Consortium is composed by AmsterdamUMC, gesinn.It Gmbh & Co Kg, KU Leuven, University of Split School of Medicine, Dublin City University, Central European University, University of Oslo, University of Manchester, European Network of Research Ethics Committees.