Data Monitoring Board
The Data Monitoring Board (DMB) has advisory functions for research projects in which privacy issues arise in the computerized management of sensitive data or that adhere to the "open access to research data" pilot action of the European Horizon 2020 program.
The processing of personal data and the protection of personal data must be carried out in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), available at eur-lex.europa.eu/eli/reg/2016/679/oj.
Moreover, it is necessary to take into considerations the laws and regulations of the EU Member State where the data processing activity is performed. With regard to the processing of personal data in Italy, the main applicable law is d. lgs. n. 196/2003 - Codice in materia di protezione dei dati personali – as amended by d. lgs. n. 101 del 2018, available at www.garanteprivacy.it/codice. The University has created the FAQ on research and protection of personal data to support research projects in complying with the above mentioned legislation.
When personal data is collected outside the European Union, it is required to comply with the domestic law and regulations of the country where data is collected
The University, in applying the legislation, has identified as a competent body the Data Monitoring Board, to which the researchers must submit a Data Management Plan (DMP) related to the collection and production of research data and the methodology with which they will be managed. Data management plans are an indispensable component of the data lifecycle because they define what actions are necessary to ensure accessibility during each phase of the project. DMPs follow the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) to ensure maximum efficiency, use and reuse of data.
The members of the Data Monitoring Board are appointed by the Chancellor and hold office for 3 academic years.
Issued by decree of the Rector n.112 10/02/2017
1. Establishment and functions
At the Ca 'Foscari University of Venice, the Data Monitoring Board (hereinafter also DMB) is established with advisory functions for research projects that raise ethical issues regarding the collection and management of information with sensitive data or adhere to the "open access" management regarding the final and intermediate products of the research, among which the "open access to research data" pilot referred to in art. 29.3 and 34.2 of the Model Grant Agreement of the Horizon 2020 program.
The DMB consists of seven members within the University and an external member, appointed by Decree of the Chancellor. The DMB holds office for three academic years and its components are immediately renewable for once. Of the internal members, four are chosen among the teaching staff and three among the technical administrative staff of which: an expert in information and telecommunication services, an expert in the field of research and an expert in the field of digital librarianship.
To pursue its goals, referred to in the previous art. 1, the DMB can also avail itself of the collaboration of qualified experts in the specific topics dealt with.
During the first meeting, the DMB appoints the Coordinator, chosen from among the four professors who are internal to the University, who are assigned - as a non-exhaustive indication - the following functions: representing the DMB both within the University and outward, implement the resolutions, convene and chair the meetings.
4. Support structure
The technical, administrative and secretarial support structure of the DMB is identified by the Decree of the General Manager. In particular, the secretariat collects and keeps the relevant documents for the meetings of the DMB and sends the minutes to the competent offices of the central administration of the University, when necessary. A Secretary, chosen by the Coordinator, participates in the meetings and take minutes.
The purpose of the Data Monitoring Board is to express, in light of the current legislation and the prior opinion of the University Ethics Committee, in case it is required, on the correct management with computer tools of the data collected and produced by the projects and on open access (in the case of pilot "open access to research data") regarding the following aspects:
- the nature of existing or intended data, their origin, type and size, as well as the reason for the creation of new data sets and their added value;
- the reason for creating new data, in terms of content and quality, as well as metadata and accompanying dataset documentation, with reference to standards of discipline, interoperability and legislation;
- the processes adopted for the management, documentation, care and conservation of data, as well as the estimate of costs associated with the management and maintenance of data;
- the methods for collecting, storing, protecting and disseminating personal and sensitive data;
- the policies for access (open or not) to the repository, transmission and circulation of data;
- the correct and exhaustive formulation of the Data Management Plans of the projects that envisage it, such as those that adhere to the "open access to research data" initiative.
6. Financial allocation
The activity of the DMB is funded with a specific budget chapter of the University Library System. The component outside the University is entitled to reimbursement of expenses related to participation in meetings, pursuant to art. 2, paragraph 2, lett. a) of the University Missions Regulations. As far as the expenditure ceilings are concerned, those provided for in Table 1 - class 1 of the same University regulations are applied.
The meetings of the DMB are convened electronically by sending an e-mail with a return receipt to the institutional e-mail addresses of the individual members, containing the date, time and place set for the meeting and the related agenda. The convocation must be sent with notice of at least five consecutive natural days, which can be reduced to three in the event of an emergency call. Where possible, together with the call, and in any case in good time, all the documents to be examined at the next meeting will be made available to the various members of the Board.
The sessions can also take place using telematic methods.
8. Meetings in video-conference, audio-conference or e-mail
The meetings of the DMB are also valid when they are held electronically via video-conferencing, audio-conferencing or e-mail, provided that the members of the Board are allowed to follow the discussion and participate in real time, and in any case within the duration of the meeting, to the discussion of the topics and to exchange documents related to these topics and that all of the above is acknowledged in the relative minutes. If these conditions are met, the meeting of the DMB is considered to be held in the place where the Coordinator-Chairman of the meeting is located and where the meeting secretary must also be present, in order to allow the drafting and signing of the minutes.
In the event of an electronic meeting, the meeting will begin by sending to the members, by e-mail, the text of the resolutions to be taken and the related preliminary documentation that will constitute the minutes of the meeting, asking to report observations, requests for clarifications, proposals for changes or of integration - to be sent at the same time to all the members - in order to reach the approval of the definitive text of the deliberations and of the minutes by the end of the meeting, which must be indicated in the letter of convocation.
Requests related to each project must be communicated to the DMB secretariat, for its assessments, adequately in advance, usually 15 working days with respect to the project deadlines, accompanied by all the necessary documentation needed by the DMB to express its opinion (as a non-exhaustive example: deliverable, requests from the European Commission, Data Management Plan, University Ethics Committee report, etc.). The results of the DMB will be sent to the project manager and to the Research Office, which will transmit them to the European Commission.
10. Minutes of meetings
A report signed by the Coordinator and the Secretary is drawn up for each meeting. The draft of each report will be sent to the members of the DMB by e-mail in time for approval at the next meeting.
11. Reference standard
For anything not expressly provided for in this Regulation, reference should be made to the legislative, statutory and regulatory provisions in force.
12. Issue and entry into force
This Regulation is issued by decree of the Rector and enters into force on the seventh day following its publication in the University register, subject to approval by the Board of Directors.
Data Management Plan (DMP)
From January 2017 all projects supported with funds from the European Commission and funding bodies (H2020, ERC, etc.) require that the data produced during the research process and the related metadata must be:
- made accessible with the least possible number of restrictions, unless a reasoned decision is made. "Open Access by default with some opt out / as open access as possible / as closed as necessary"
- subordinated to the drafting of a Data Management Plan (DMP)
Beneficiaries of funded projects must:
- prepare a DMP
- deposit the data and related metadata in the chosen data repository
- make every effort to ensure that the data are accessible (for data mining, exploitation, reuse, dissemination, reproduction) using licenses that allow the free use and at the same time protect the intellectual property of the author (eg Creative Commons-CC-BY [ITA])
- provide, when possible, information on the tools used to validate the results
The opening of data does not mean making them all accessible, but encouraging their good management, understood as an essential element for a better science.
What is DMP
The DMP is a tool that allows researchers to plan the collection, storage, description and dissemination of their data and research metadata from the beginning of the activity; it therefore represents a framework for responsible management of the data collected and produced, according to FAIR good practices:
- Findable - Accessible - Interoperable - Reusable / Replicable
The management of research data is a very complex process, but if correctly organized from the beginning on the basis of a Data Management Plan (structured in the form of tools) it can be easier because it allows the researcher to plan in a synthetic way (in the first version) and in more detail (later versions) the research phases: planning, creation, organization, sharing and security.
Indeed, the DMP represents the entire life cycle of data, allowing traceability, availability of authenticity, citability, appropriate conservation and adherence to clear legal parameters and appropriate safety standards. The DMP is considered in all respects by the European Commission a mandatory living document and deliverable, to be drawn up within 6 months from the approval of the project.
- as living document it can have various versions
- as deliverable it must be accompanied by a "unique identifier", a sort of bar code assigned automatically (in the form of a handle) at the time of loading in ARCA
- as machine actionable for now it foresees that the DMP is in pdf format, but in the future further formats are suggested for evaluations, analyzes, controls, projections, KPIs (Key Performance Indicators)
Who must prepare the DMP
Researchers that must draw up the Data Management Plan (DMP):
- extended DMP: researchers who are recipient of project grants funded by the European Community's H2020 program;
- simplified DMP: researchers who are recipient of project grants funded by the European Community's H2020 program or from other funding bodies in case the computerized data management required by the project entails ethical issues related to privacy.
In any case, beneficiaries of all funded projects that collect or generate data.
The European Commission does not require researchers to submit the DMP when proposing the project.
Why manage and share data
- increase the impact of research: making data available to other researchers means increasing the knowledge and relevance of your research
- save time: preparing the DMP in time allows you to plan your needs, define the costs to be incurred in the research, saving time and resources
- protect data: the storage of your research data in certified infrastructures (ARCA, Zenodo or others identifiable in re3data [ENG]) safeguards your work and your time
- maintain data integrity: DMP helps you plan how to manage and document the life cycle of data produced during the search for future availability and use
- to comply with the requests of funding bodies: many agencies require the filing of data (and related metadata) as an integral part of the funded research project
- promote new discoveries: exposing and sharing your data with other researchers can lead to the development of new research as well as helping non-funded projects
- access data processed by other researchers: the open sharing of information allows you to see what has been done by other researchers
Possibility of opt-out
Not all data can be opened.
The European Commission provides for the possibility of exercising the opt-out during any phase of the project (both before and after the signing of the grant agreement) if the following conditions are met:
- in case the project does not generate or collect data
- in case of need for data protection for possible economic exploitation
- in case of incompatibility with data protection for security reasons
- in case of incompatibility with the obligations to protect sensitive data
- in the event that making data open is a risk for achieving the main objective of the project
- other legitimate reasons to describe and motivate
It is also possible to open only a subset of data.
How the DMP is structured
The DMP is structured as a checklist and mainly concerns:
- Administrative plan details
General information on the research project
- Dataset description
Description of existing or intended data. Motivating the creation of new datasets and explaining their added value
- Standards and metadata
Motivate the creation of new data. Describe the metadata and the documentation of the datasets with reference to disciplinary standards, interoperability and legislation
- Data Management, documentation and curation
Describe the processes adopted for the management, documentation, care and conservation of data. Estimate of the relative associated costs
- Data security and confidentiality of potentially disclosive information
Description of the procedures adopted with regard to the security, storage, transmission and exchange of sensitive data
- Data sharing and access
Description of the data that will be shared and made available. Policies of access to repositories, transmission and circulation of data
- Responsibilities and resources
Explicate responsibilities at the project / University level for data and metadata regarding: collection, creation, quality, security, archiving. Possible additional resources, compatibility with policies, legal and ethical aspects
- Relevant institutional policies on data sharing and data security
Refer to the University policies and to the legislation where applicable
Data and metadata
The data is almost never separated from the metadata.
The data and related metadata that must be evaluated and included in the DMP are either:
- produced during the research and needed for its validation in scientific publications (underlying data)
- other data (for example raw data).
It is important to carefully evaluate the type and quantity of data that will be produced because the costs associated with management during their life cycle are eligible during the project and will be included in the DMP.
To treat data and related metadata, researchers can access the following services:
- for temporary and secure storage of your data you can use the Google Drive storage space included with every @unive account. This storage can be used for every kind of data except for those with strict limitations on storage location
- for the final storage of data and metadata: ARCA [ITA] (Ca 'Foscari Research Archive), a publishing platform compliant with OpenAIRE, which provides for the metadata to be delivered to OpenAIRE according to FAIR good practices
- for the storage of the DMP (in all possible versions) in a machine actionable format: ARCA, which at the time of storage automatically assigns a persistent identifier to the DMP
Alternatively, you can store data and metadata in another data repository. Verify that it is both certified as reliable (Zenodo or re3data), defined as a Trustworthy Digital Repository (TDRs) and compatible with the main standards: Data Seal of Approval, Nestor Seal, ISO (the latest standard is No. 16363, produced in 2012), ICSU-WDS.
In all cases, follow the instructions on the OpenAIRE website: How to select a Repository.
Simplified DMP and full DMP
The Ca' Foscari Data Monitoring Board provides 2 specific Data Management Plan models, structured as templates, depending on the type of data processed:
Some research projects involve the management of sensitive data or in any case problems related to the privacy of the persons involved in the research. The European Commission therefore contemplates the possibility of keeping such data confidential and protected.
In this case it is necessary that the DMP has a prior approval on these aspects, by the Ethics Commission. In this regard, the Data Monitoring Board, before giving a congruency opinion on the DMP, requests that the University Ethics Commission decides on the part of its competence. At the moment it is advisable to send the project to the individual Commission Members.
The researchers who have obtained the opinion of the University Ethics Commission are asked to forward it to the Data Monitoring Board secretariat at firstname.lastname@example.org.
Open Data are "Data that can be used, modified and shared by anyone for any reason, as long as the origin and the openness are preserved (Open Definition [ITA]).
Their accessibility is a fundamental step towards Open Science.
In order for data to be open, the Guidelines on FAIR Data Management state that they must be FAIR (Findable - Accessible - Interoperable - Reusable / Replicable).
In practice, the application of the FAIR principles requires the data to be:
- Findable: traceable and described, using persistent identifiers (ie "stable codes" formed by numeric / alphanumeric strings of characters that must be associated in a UNIQUE and PERMANENT way to the data, for example: DOI https://www.medra.org/it/faq.htm, Handle), rich and high quality metadata, possibly ontologies and standardized taxonomies (Dubin Core, ADS Guides and Guidelines for metadata, DCC guides for Metadata standards, etc.) and registered repositories
- Accessible: open access, available for sharing and reuse. Thus data should be accessible with the least number of restrictions, unless a reasoned decision is made. Open Access by default with some opt outs / as open access as possible / as closed as necessary
- Interoperable: research data should be interoperable, capable of being processed by machines using vocabularies which follow FAIR principles
- Reusable: with descriptive metadata conforming to the relevant EU regulations; they must be released under a use license and accompanied by information on their collection and processing.
The correct design of the Data Management Plan guarantees the compatibility of the data produced by the research with the FAIR principles.
Researchers with projects included in this case must draw up the complete DMP to be sent to the Data Monitoring Board secretariat at email@example.com.
Last update: 12/10/2021