Protech Ethics

Ethics management

Ethics management within Protech is of high importance for quality assurance, therefore the Protech Consortium carries out the project actions in compliance with ethical principles and applicable international, EU and national laws. Paying special attention to ethical issues, the Protech Consortium has developed guidelines that aim to support the ethical aspects of data collection and defined procedures and measures to secure their compliance. An Ethics Management Plan (EMP) has been created that describes all the fundamental ethical issues relevant to the Protech project and defines the procedures to be followed by all Consortium partners working on the project.

The EMP contains the procedures to be followed by all the project participants that are included in the delivery of Protech project. The objective of ethical guidelines is to ensure that all Protech Consortium partners work in an ethically acceptable way with respect to involving participants in any of its actions in the project. This plan specifies how the Consortium will maintain security, privacy, and confidentiality norms, as well as common values of autonomy, independence, beneficence, non-maleficence, and justice will be respected. Furthermore, it will advise all partners in the consortium, both EU and non-EU, on how to work with participants, respecting the combined ethical standards of the consortium members, as well as the national regulations. 

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General Rules on Ethics in Research

Ethical rules must be applied throughout the project in its implementation and esecially in relation to research activities. Good research practices are based on fundamental principles of research integrity. Such principles serve as a guide for researchers in their work as well as in their engagement with various challenges inherent in research.

These fundamental principles are the following:

  • Reliability in ensuring the quality of research, reflected in the design, the methodology, the analysis, and the use of resources.
  • Honesty in developing, undertaking, reviewing, reporting, and communicating research in a transparent, fair, full, and unbiased way.  
  • Respect for colleagues, research participants, society, ecosystems, cultural heritage, and environment.  
  • Accountability for the research from idea to publication, for its management   and organisation, for training, supervision, and monitoring, and its wider impacts.

Besides the above-mentioned principles, all researchers have an ethical obligation to protect participants’ rights including dignity, autonomy, privacy, welfare, and safety, as well as physical and mental integrity, and must ensure that the participants are treated fairly and with respect.  

The rights of the research participants are anchored in the Conventions, regulations, and declarations at the international, European, and national levels. The key sources of EU and international law are the Chapter of Fundamental Rights of the European Union and the European Convention of the Human Rights, as well as the UN Declaration of Human Rights and the UN Convention on the Rights of Persons with Disabilities (UN CRPD). Additional central policies and declarations that codify principles of research ethics and ethical treatment of research participants include the Nuremberg Code, the Helsinki Declaration, and the Belmont Report.

The principles based on these instruments are the following:  

  • Respecting human dignity and integrity.
  • Ensuring honesty and transparency toward research subjects.  
  • Respecting individual autonomy and obtaining free and informed consent.
  • Protecting vulnerable individuals.  
  • Ensuring privacy and confidentiality (e.g., through use of pseudonymization and anonymization techniques).
  • Promoting justice and inclusiveness.  
  • Minimising harm and maximizing benefit.
  • Sharing the benefits with disadvantaged populations, especially if the research is being carried out in developing countries.  
  • Respecting and protecting the environment and future generations.

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Guidance on Ethics in Practice: Informed Consent for Participation in Research and Ethical Committee Clearance

Protech will include several research activities involving human participants. Whenever Protech partners want to involve human participants in their research (e.g., conduct surveys, questionnaires, interviews, recordings) they must ensure that participation is entirely voluntary and that they have obtained and documented the participants’ informed consent in advance. Consent must be voluntary, free, and informed. The validity of consent is (among other points) determined by the legal capacity of the person concerned to provide their consent.

Furthermore, consent is also one of the grounds of legitimacy for the processing of personal data under the General Data Protection Regulation. Usually, informed consent in research covers both the research consent that must always be obtained and consent under the GDPR as a legal ground legitimizing the processing activity.  

Research participants must provide their consent for participation in the research activity and the processing of their data:

  • Consent must be a freely given, specific, informed, and unambiguous indication of the data subject's wishes by which he or she, by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her as per GDPR guidelines.
  • In order to make sure that informed consent is given freely, all relevant circumstances which might influence the decision of a potential subject to participate in Protech research activities, should be taken into account, in particular whether the potential subject belongs to an economically or socially disadvantaged group or is in a situation of institutional or hierarchical dependency that could inappropriately influence her or his decision to participate.
  • When obtaining consent to participate in Protech research, the partner must assess whether the prospective participant does not have the mental faculties to provide a freely given, specific, informed, and unambiguous indication of their wishes. If the participant is a person with insufficient mental faculties, their personal data may only be used in Protech with the additional consent of their holders of parental responsibility, legal guardians, or other legal representatives.  
  • Prior to obtaining informed consent, the potential participant should receive an information sheet with all relevant information about the Protech research activity in a language which is easily understood by him or her.
  • The information sheet should describe the aims, methods and implications of the research, the nature of the participation and any benefits, risks or discomfort that might ensue. Information should be clear and understandable and adapted to the audience.
  • Additional methods of information (video, infographic, etc.) must be considered in addition to a paper trail and there must always be an oral explanation and the opportunity to ask questions.  
  • The information sheet should also state what procedures will be implemented in the event of unexpected or incidental findings (in particular, whether the participants have the right to know, or not to know, about any such findings).

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Protech partners must obtain the consents of the research participants in writing and store them for a minimum of 5 years or in line with each partners retention period after the end of the project. Separate storage possibilities that strengthen a strong pseudonymization approach should be considered. When the subject is unable to write, it may be recorded through appropriate alternative means, for instance through audio or video recorders, but this should be a last resort.

For every research activity, the GDPR’s rules and principles and the ethical rules and principles mentioned above must be implemented. This requires a dedicated research design and in particular the implementation of safeguards, e.g., pseudonymization techniques.

For many research activities, ethical committee clearance will be needed. This depends on national and local rules and research partners must ascertain whether they need such clearance and what the time frame is for obtaining any clearance.

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Procedures on Ethical issues and Self-Assessment

The project sets up rules to guarantee that all activities address security, ethics, and individuals’ personal data. The project will enable mechanisms to avoid any intentional or unintentional use of information that can bring any harm to any participant or being misused in other contexts. All partners performing research will act according to national and European legislation, and in line with national data protection provisions and the European data protection rules. They will also be required to follow agreed rules for the recruitment of participants, the implementation of activities, recording, analysis, and storage of data collected in the project. The guidelines on these issues are applied by all partners and periodically reviewed by the General Assembly, Ethics Committee and Ethics advisors of the project.

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Ethics Self-Assessment

Based on European Commission’s guidance for ethics self-assessment it is significant to have information on the participants’ specific vulnerable characteristics, the research must be relevant to both source and host communities, and its objectives must not be harmful or prejudicial to participants.  

Protech is committed to ensure that the general benefits of its activities will warrant the involvement and efforts of their participant individuals. The project will be based on deliberative co-creation of activities and representatives of all interested stakeholders will be involved in these field activities. The project will enable mechanisms to avoid any intentional or unintentional use of data that can bring any harm to any participant or being misused in other contexts.  

All partners will act according to national and European legislation, and in line with national data protection provisions and the European data protection rules. They will be required to follow agreed rules for the recruitment of participants, the implementation of activities, recording, analysis, and storage of data collected in the project. Any survey, interview, or workshop participation will happen on a voluntary basis with sufficient information to all parties.

Agreement will be reached with organisations that provide information through documents or interviews, on the disclosure of that information and the protection of confidentiality. All data will be stored anonymously on secure servers that has restricted, password-protected access and data encryption where possible.. The storage and transferring of data across borders, and from institution to institution, will adhere to national, institutional and EU policies, such as the FAIR Data Management guidelines, concerning safe storage and transfer of data. The use of data for analyses will not breach confidentiality. The project will carry out periodic evaluation meetings to ensure that ethical issues are followed by all partners in the research. If ethical issues arise unexpectedly during the research process, the Ethics Committee would contact the Commission/Agency immediately to receive appropriate help and guidance.

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Ethics Committee

An Ethics Committee will provide guidance and a neutral perspective on the approach of Protech research, particularly concerning the provision of fundamental human rights and the preservation of privacy. The Ethics Committee will achieve this through meetings at critical ethical points in the project, engagement in relevant events, and guidance to partners when required. They will also scrutinise several of the project's key outputs from an ethical perspective - ensuring the project adheres to guiding frameworks and recommendations. In addition to individuals with expertise in ethical guidance, representatives of key stakeholder groups will also be integrated into the Ethics Committee, such as: users, victim/survivor advocates and data management experts.