Ethics Committee

The Ethics Committee is a body of Ca' Foscari University with the following functions:

  • advisory, propositional, research, investigation, promotion and dissemination functions in the field of ethics
  • investigation functions, as part of the procedure for ascertaining violations of the University's Code of Ethics and Conduct
  • ex ante evaluation functions of ethical aspects relating to research projects and evaluation of the Data Management Plan (DMP), relating to the collection, production, dissemination and reuse of research data and the methodology with which they will be managed.
Contatti

Technical-administrative support platform: University Library System

In order carry out this specific function, the Research Ethics Subcommittee (in a restricted composition) has been set up.

The Committee focuses its activities on issues relating to ethics, the protection of privacy and sensitive data linked to research projects. For this reason, it operates according to adequate technical timeframes for the analysis and in-depth study of the submitted projects.

Advisory functions, research, investigation, promotion and dissemination in ethics (art. 25 of the Ethical Code for the University):

  • Prof. Agar Brugiavini - Curriculum
  • Prof. Daniela Meneghini - Curriculum
  • Dr. Michela Del Bono - Curriculum
  • Dr. Esterita Vanin - Curriculum
  • Dr. Alessandro Bernes - privacy, data protection and law expert - Curriculum
  • Dr. Stefano Calzavara, computer science expert - Curriculum
  • Prof. Lucetta Scaraffia, research ethics expert 
  • Dr. Chiara Da Villa, expert in Data Management
  • Dr. Silvia Zabeo, euro-planning expert - Curriculum
  • Mr. Cesare Bulegato, appointed representative by the Student Representatives Assembly 
  • Dr. Rachele Svetlana Bassan, appointed representative by the Doctoral Students Council - Curriculum

It is necessary to submit DMPs, ethical deliverables, requests and inquiries in pdf format via Moodle, with all the relevant documents needed to put in context the requested opinions/approvals (abstract, objectives, methodology, expected impact...), according to the following timelines:

  • Data Management Plan (DMP)

    • by the 20th day of the month preceding the meeting of the Ethics Committee (scheduled in the first ten days of each month, except August)

  • Ethic deliverables which require a mandatory opinion from the EC

    • by the 20th day of the month preceding the meeting of the Ethics Committee (scheduled in the first ten days of each month)

  • Inquiries, requests

    • at least 15 days before the meeting of the Ethics Committee (scheduled in the first ten days of each month, except August)

The Ethics Committee reserves the right to request integrations to the projects.
Requests received after this deadline will be evaluated in the following session.

Research Ethics Subcommittee (SER)

The Research Ethics Subcommittee (Sottocommissione Etica per la Ricerca, SER) was established within the Ethics Committee. SER deals with the evaluation of ethical aspects relating to research projects and the evaluation of the Data Management Plan (DMP), relating to the collection, production, dissemination and reuse of research data and the methodology with which they will be managed during the project.

The Subcommittee is composed by:

SER has advisory functions for research projects focusing on ethical issues and privacy in the field of the computerised management of personal data, including "sensitive" data (or particular categories of personal data, i.e., those revealing one’s racial or ethnic origin, religious, philosophical beliefs, political opinions, trade union membership, health or sex life information).

Personal data

The processing and protection of personal data must take place in full compliance with the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of individuals with regard to the processing of personal data, as well as the free circulation of such data and repealing Directive 95/46/EC (General Data Protection Regulation, better known as GDPR) available at https://eur-lex.europa.eu/eli/reg/2016/679/oj in different languages.

The scientific representative must also take into account the regulations in force in the Member State of the European Union in which the processing of personal data takes place. As regards Italy, the reference is the legislative decree. No. 196/2003 - Code regarding the protection of personal data - as amended by legislative decree. No. 101 of 2018, available at https://www.garanteprivacy.it/codice. Finally, please note that for data collected in non-European Union states, it is also necessary to comply with local legislation.

The University provides FAQs relating to Research and Protection of Personal Data to support the implementation of the legislation in the context of research projects.

The tool identified by the research funders for data management during the project and also after its ending is the Data Management Plan (DMP) which defines the actions necessary to ensure accessibility compatibly with FAIR (Findable, Accessible, Interoperable, Reusable) principles.

Data Management Plan (DMP)

All projects supported with funds from the European Commission other funding bodies provide that the data produced during the search process and the related metadata must be:

  • made accessible with as few restrictions as possible, unless there is a reasoned decision to the contrary (Open Access by default with some opt outs/as open access as possible, as closed as necessary)

  • subordinated to the drafting of a Data Management Plan (DMP)

Beneficiaries of funded projects shall:

  1. develop a DMP
  2. deposit the data and related metadata in "trusted repositories" such as Zenodo or others identifiable in re3data
  3. make the data accessible (for data mining, exploitation, reuse, dissemination, reproduction) using licenses that allow free use and at the same time protect the author's intellectual property (for example the Creative Commons-CC-BY)
  4. provide, when possible, information on the tools and instruments used to validate the results

Opening data does not mean making it all accessible, but encouraging good management, meant as an essential element for better science.

The DMP is a tool that allows researchers to plan the collection, storage, description and disclosure of their research data and metadata from the very beginning of their activity; it therefore represents a reference framework for responsible management of the data collected and produced, according to FAIR best practices:
Findable - Accessible - Interoperable - Reusable / Replicable.

The management of research data is a very complex process, but if set correctly from the beginning on the basis of a Data Management Plan (in the form of a tool) it can be easier, since it allows the researcher to plan synthetically (in the initial version) and gradually in more detail (subsequent versions) the research phases: planning, creation, organisation, sharing and security.

In fact, the DMP represents the entire life cycle of data, allowing its traceability, availability, authenticity, citability, appropriate storage and adherence to clear legal parameters and appropriate security standards. The DMP is considered in all respects by the European Commission to be a mandatory living document and deliverable, to be drafted within 6 months of the approval of the project and its conclusion.

The DMP, as:

  • living document can have several versions
  • deliverable must be accompanied by a "unique identifier", a sort of barcode assigned automatically (in the form of a handle) upon loading on the trusted repository
  • machine actionable it must be transformable as a PDF to be read by computers as well.

Researchers who are beneficiaries of all funded research projects that collect or generate open data in which ethical or privacy issues emerge in relation to computerised data management must draw up the Data Management Plan (DMP).

In order to:

  • increase the impact of research: making data available to other researchers means increasing the knowledge and relevance of your research
  • save time: drafting the DMP in time allows you to plan your needs, define the costs incurred during the research, saving time and subsequently resources
  • protect data: storing your research data in "trusted repositories" (Zenodo or others identifiable in re3data) safeguards your work and your time
  • maintain data integrity: the DMP helps planning how to manage and document the life cycle of the data produced during the research for their future availability and use
  • comply with the requests of the funders: many agencies require the filing of data (and related metadata) as an integral part of the funded research project
  • promote new discoveries: exposing your data and sharing it with other researchers can lead to the development of new research, as well as helping projects that are not funded
  • support open access: your open access data is valuable to the scientific community
  • access data processed by other researchers: the open sharing of information allows you to see what other researchers have done
Name Symbol You can You cannot You must
Attribution https://www.unive.it/pag/fileadmin/user_upload/SBA/img/Per_chi_pubblica/CC_BY.jpg use, modify, distribute Mention the author, indicate the changes
Share alike https://www.unive.it/pag/fileadmin/user_upload/SBA/img/Per_chi_pubblica/CC_BY_-_SA.jpg use, modify, distribute Mention the author, indicate the changes, use the same license
No derivatives https://www.unive.it/pag/fileadmin/user_upload/SBA/img/Per_chi_pubblica/CC_BY_-_ND.jpg use, distribute modify Mention the author
Non commercial https://www.unive.it/pag/fileadmin/user_upload/SBA/img/Per_chi_pubblica/CC_BY_-_NC.jpg use, modify, distribute use for commercial purposes Cite the author, indicate the changes
Non commercial-Share alike https://www.unive.it/pag/fileadmin/user_upload/SBA/img/Per_chi_pubblica/CC_BY_-_NC_-_SA.jpg use, modify, distribute use for commercial purposes Cite the author, indicate the changes, use the same license
Non commercial-No derivatives https://www.unive.it/pag/fileadmin/user_upload/SBA/img/Per_chi_pubblica/CC_BY_-_NC_-_ND.jpg use, distribute modify, use for commercial purposes Mention the author

The Creative Commons (CC) licenses allow you to communicate in a simple and standardised way which rights the author of the work reserves and which he/she renounces for the benefit of users.

Three actors are involved in the usability of the publications:

  • author vs editor (in the case of copyright. For more information, see the page on Copyright)
  • author vs reader (in the case of open access and Creative Commons licenses).

The latter specify to the reader how they can use the materials freely made available by the publisher and what rights are granted to them.
Creative Commons licenses combine an image with the specific right.

CC licenses are periodically updated and universally used to share content on the internet because they are easy to understand and graphically identified.
For further information, visit CreativeCommons.

Not all data can be opened; even just a subset of data can be made open.

The European Commission provides for the possibility of exercising the opt-out if the following conditions are met:

  • 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 protection obligations of sensitive data
  • in the event that making the data open is a risk for the achievement of the main objective of the project
  • other legitimate reasons to describe and justify

The DMP mainly concerns the following aspects:

  1. Data summary
    This section describes the data that may be collected, stored, produced, reused and disseminated during the research: knowing exactly and precisely the type of data, the Research Ethics Subcommittee will be able to formulate an opinion on the technical, organisational and security measures that the project will have to adopt and whether these are adequate for data management. The information presented here will also help other researchers understand the data.
    Please note that not all research data should be considered personal data.
  2. FAIR Data
    This section presents the measures to ensure that the data is:

    • Findable = equipped with unique identifiers, keywords, metadata standards and other practices that optimise their identification and reuse;
    • Accessible = deposited in certified and reliable digital platforms for long-term storage; accessible as data (including open access), with access protocols and any restrictions; accompanied by rich metadata that allow their discoverability. In the event that certain data or metadata cannot be shared, adequate justification is required.
    • Interoperable = described using vocabularies, standards, formats or methodologies that will allow their exchange, reuse and interoperability.
    • Re-usable = therefore the researcher will provide information on the required documentation (e.g., explanatory methodology, codes, variables).

  3. Other research outputs
    This section deals with the management of other research products generated/reused in the course of the project (e.g., software, models, new materials) and, where appropriate, details their compliance with FAIR principles.
  4. Allocation of resources
    This section discusses the costs associated with compliance with FAIR principles and accountability in data management.
  5. Data security
    It is the most important section for research projects that collect personal data.
    It deals with security, storage and conservation, data recovery. 
  6. Ethics
    In this section the researcher presents all ethical or legal issues that may have an impact on data sharing. Also, when the research uses personal data, refer to aspects such as informed consent.
  7. Other issues
    Indicate whether other data management procedures or practices are relevant to the project.

Data is almost never separated from metadata.
Metadata describes data containing specific information such as type, length, text description and other features.
Considering the scope of data (document files, images, videos, etc.) and their exponential increase, it is not surprising that understanding and managing metadata has become a priority.

Metadata serves a variety of purposes, one of the most common being resource discovery for example:

  1. Facilitate interoperability and integrate resources.
    Using metadata to describe resources allows humans and machines to understand it. This allows for more effective interoperability, i.e., how data is exchanged between many systems with heterogeneous operating platforms, data structures and interfaces.
  2. Facilitate digital identification through standard numbers that uniquely identify the asset defined by the metadata.
    Combining metadata with sets of unique data identifiers enables differentiation of objects and resources.
  3. Protect resources and their future accessibility.
    We know the problem of data longevity, the fragility of digital information and its susceptibility to corruption or alteration. For the purposes of archiving and conservation, metadata are required to trace the origin of the object and describe its physical features and behaviour, so that it can be replicated by technologies in the future.

To preserve and store data and related metadata, researchers can use various platforms:

  • for temporary and secure archiving, you can use the Google Drive space associated with each University account. This space can be used for any type of data, with the exception of those with explicit limitations on the storage location
  • for the definitive deposit of data and metadata you can use a repository after verifying in re3data that it is certified as reliable and compatible with the main standards: ZenodoTrustworthy Digital RepositoryData Seal of ApprovalNestor SealISO (the latest standard is No. 16363, produced in 2012), ICSU-WDS
  • for the definitive deposit of publications, you can use the ARCA (Ca' Foscari Research Archive) publication platform, which provides for the harvesting of metadata towards OpenAIRE according to FAIR best practices.
  • for the deposit of the DMP in a machine actionable format, ARCA automatically assigns a persistent identifier

Social platforms such as Academia.edu or Researchgate are not trusted repositories.

Ca' Foscari Data Management Plan

SER provides a Data Management Plan model, which the researcher will use in funded research projects that collect or generate data:

  • closed because they are personal/sensitive or in any case linked to the privacy/confidentiality of the subjects involved in the research;
  • open if the project provides for their accessibility and dissemination according to the principles of Open Science.

Closed data

In the case of research projects that provide for the management of personal/sensitive data (or in any case problems related to the privacy of the people involved in the research), the European Commission foresees the possibility of keeping such data confidential and protected.

The DMP provides a series of ideas and indications to help the researcher manage them correctly: we invite you in particular to pay attention to the "Personal data" section.

Open data

In the case of projects that involve the production of open data, i.e. "Data that can be used, modified and shared by anyone for any reason, as long as its origin and openness are preserved" (Open Definition), the correct processing of the Data Management Plan ensures its compatibility with the FAIR principles (a fundamental step towards Open Science).

In concrete terms, the application of the FAIR principles requires that data is:

  • Findable: traceable and described, using persistent identifiers (i.e., "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 quality metadata, possibly standardised ontologies and taxonomies (Dublin CoreDCC guide for Metadata standards etc.) and registered repositories
  • Accessible: open access, available for sharing and reuse. Therefore, made accessible with the least number of restrictions, unless a reasoned decision to the contrary is justified Open Access by default with some opt outs/as open access as possible, as closed as necessary
  • Interoperable: able to be processed by operating systems with languages compliant with FAIR principles

  • Reusable: Data and Metadata must be well described to allow the data to be used and processed. They must be issued with appropriate licenses (e.g., CC, GNU) and accompanied by information on how they were collected and processed: detailed information on the origin of the data is essential for their correct reuse.

 

 

 

The correct elaboration of the Data Management Plan guarantees the compatibility of the data produced according to FAIR principles.

Ethical aspects

Research projects: conception phase

If a research project raises one or more ethical aspects, it is necessary to carry out a self-assessment of the same when drafting the proposal. The main ethical issues concern the following areas (the categories indicated are those highlighted by the European Union):

  1. Human embryonic stem cells and human embryos
  2. Humans
  3. Human cells or tissues 
  4. Personal data 
  5. Animals 
  6. Non-EU countries (all EU Programmes) 
  7. Environment, health and safety (all EU Programmes) 
  8. Artificial intelligence (all EU Programmes)
  9. Other ethics issues
  10. Cross-cutting issue: potential misuse of results

When designing the proposal, in projects financed by the European Union - it is a good practice that can also be applied to other types of research projects - it is necessary to present a description of the ethical issues that arise and a description on how it is intended to address them (Ethics Self-Assessment) in order to ensure compliance with European, national and institutional provisions. The reference support document is the EU guide attached below.

What to do:

  • Project proposals submitted in the context of competitive calls: the self-assessment of the ethical aspects must be carried out at the time of preparing the project proposal to be presented to the funding body, and the support of the Ethics Committee is not required at this stage.
  • Other project proposals in the context of university projects, degree or PhD theses: in case there are doubts regarding possible ethical aspects that could arise, it is possible to send an inquiry via the Moodle of the Ethics Committee, contextualising the request in an appropriate way by presenting objectives, methodology, expected impact and specific information on the activities for which opinion/approval is requested

Research projects: implementation phase

When a project is funded, the funding body provides the scientific managers with a specific document (for example, for Horizon Europe, the Ethics Summary Report) in which, after a screening carried out by experts, the main ethical aspects are highlighted and have to be addressed before or during the implementation of the activities and specific requests indicated, in addition to what is indicated in the proposal phase in the Ethics Self-Assessment.
Any clarifications to be provided and/or a list of ethical deliverables are indicated in the Ethics Summary Report; a deadline is associated with each of them.

  • If the deadlines are different, the scientific representative will have to produce different documents and upload them to the portal at different times, within the set deadline.
  • If, on the other hand, the deadlines coincide, it will be possible to produce a single document for ethical aspects (separate from the Data Management Plan, which has an ad hoc structure - see dedicated section).

Particular ethical issues could also arise during the implementation of other research activities in the context of university projects, degree or PhD theses: again, it is advisable to send an inquiry to the EC Moodle, contextualising the request in an appropriate way, presenting objectives, methodology, expected impact and specific information on the activities for which opinion/approval is requested.

Reference documents:

  • "EU Grants - How to complete your ethics self-assessment” Guide (available in the attachment in the previous section "Research projects: conception phase"), which provides useful information that can be applied to all research projects and, for each thematic area, it indicates in-depth reference documents
  • Informed consent models approved by the University (upon authentication)

Last update: 29/07/2022