DigiCare4You Ethics Compliance

Importance of Ethics Compliance in DigiCare4You

DigiCare4You is a research project with the main objective to develop intersectoral innovation digital tools for early screening, prevention, and management of type 2 diabetes (T2D) and hypertension (HTN). The project research will conduct an implementation study targeting more than 10,000 families in two Middle-Income Countries (Albania and Bulgaria) and two High-Income Countries (Greece and Spain). The focus is on vulnerable groups of people and in particular on elementary and high-school students. Thus, schools will be used as an entry point to the research sample (community). It is needed to build an existing procedure for children’s periodic growth assessment, parents/caregivers through the development of a non-invasive self-reported digital screening tool.

The project has been funded by the European Commission via the Horizon 2020 program. Subject of strict ethics compliance rules, this project received a Conditional Clearance and Ethics Requirements as part of the Ethics Appraisal Process. The project activities must be carried out in accordance with strict ethics requirements and standards. This text provides details on the ethics requirements and action points taken (or they will be taken) in order to ensure that DigiCare4You satisfies ethics principles and relevant laws.

DigiCare4You - Ethics Compliance & Ethics Requirements

As a result of the successful realization of the ethics appraisal process, the project has received several ethics requirements categorized into three groups – requirements related to the participation of humans in the project, protection of personal data, and general ethics requirements.

Concerning the participation of humans in the research activities, there are the following requirements:

  • The procedures and criteria that will be used to identify and recruit the different types of research participants must be developed and submitted as the project deliverable.
  • The informed consent procedures that will be implemented for the participation of humans, including data protection, must be developed and submitted as the deliverable. This must include all different types of research participants.
  • Templates of the informed consent/assent forms and information sheets (in language and terms intelligible to the participants) must be submitted as a deliverable. This must include all different types of research participants.
  • Copies of opinions/approvals by ethics committees and/or competent authorities for the research involving all different types of research participants must be submitted as a deliverable.

With regard to the protection of personal data, the following ethics requirements were received:

  • The host institution must confirm that it has appointed a Data Protection Officer (DPO) and the contact details of the DPO are made available to all data subjects involved in the research. For host institutions not required to appoint a DPO under the GDPR a detailed data protection policy for the project must be kept on file and submitted upon request.
  • A description of the technical and organizational measures that will be implemented to safeguard the rights and freedoms of the data subjects/research participants must be submitted as a deliverable.
  • A description of the security measures that will be implemented to prevent unauthorized access to personal data or the equipment used for processing must be submitted as a deliverable.
  • The beneficiary must evaluate the ethical risks related to the data processing activities of the project. This includes also an opinion if data protection impact assessment should be conducted under art.35 General Data Protection Regulation 2016/679. The risk evaluation and the opinion must be submitted as a deliverable.
  • As the research involves profiling, the beneficiary must provide an explanation of how the data subjects will be informed of the existence of the profiling, its possible consequences, and how their fundamental rights will be safeguarded. This must be submitted as a deliverable.

Finally, there are general ethics requirements, and they refer to the establishment and work of the Ethics Advisory Board. Namely, the project beneficiary must confirm that an external independent Ethics Board has been established which includes relevant independent expertise to monitor the ethics issues in the project and how they are handled.   

Ethics compliance – an integral part of project management

The project consortium has reviewed ethics issues and the received requirements. The structured approach has been taken to identify, assess and dispose of any ethical and data protection issues as well as to organize the managerial way to deal with them. All project partners are responsible for the ethical and legal requirements in the context of the work they undertake in the project. Ultimately, the project coordinator is responsible for ensuring that all project activities are done in a compliant way. However, Privanova as a legal and ethical manager manages the internal monitoring of the implementation of the ethics requirements by the consortium. In this way, the ethical issues that might be raised by DigiCare4You are continuously addressed during the project’s life cycle.

Project partners involved in DigiCare4You are familiar with the ethical challenges associated with research involving humans, given their training and previous experience in research methodology. Also, Privanova is well experienced and trained in research ethics, ethical and societal impact assessment and data protection aspects. Therefore, cooperation among Privanova, the coordinator, and project partners results in the identification of any ethical issues during the project.

Addressing ethics requirements in DigiCare4You

The project consortium takes all possible measures to ensure there is no discrimination or harm from the recruitment, exclusion, or inclusion process. Factors such as the purposes of the research, whether participants may be susceptible to coercion or undue influence, selection criteria, including gender balance, and consent management are taken into consideration. Detailed information on the procedures and criteria that are used to identify/recruit research participants has been developed. Particular attention has been given to the informed consenting mechanism and how a potentially vulnerable group of participants should provide their consent to participate in the research activities.  

The project partners aim to reach all families within the targeted societies following the project requirements in order to avoid any possible stigmatization of the participating families. Participation in the project activities is on a voluntary basis so there is no obligation to participate. Also, any participant can withdraw at any moment without any adverse consequences. 

The project partners advise external project participants including those involved in the research sample that their participation is entirely voluntary. The consortium has developed and documented the informed consent and information sheet in a language fully understandable to them. These describe the aims, methods, and implications of the research, the nature of the participation, and any benefits or risks (e.g., to privacy) that might be involved. The relevant contact points are also provided. The information explicitly states that participation is voluntary and that participants have the right to terminate the interview or refuse to participate as well as to withdraw their participation, or data at any time without any consequences. The signed consent form is used as the legal ground for lawful data processing, actually, it allows responsible examination and inspection of the data collected during the study.

DigiCare4You relies on the processing of personal data for research purposes, especially concerning contact details and opinions of those participating in the interviews, workshops, and pilots. The research complies with EU and national data protection laws. The project partners collect and process data only if, and insofar as, it is necessary for its research. In practice, this means that data processing activities fully adhere to the data minimization and purpose limitation principles. In addition, appropriate technical and organizational measures are applied to secure data, and all rights laid down by the GDPR are granted to the participants. The Data Management Plan contains a clear overview of the data as well as a clarification of data processing activities in accordance with FAIR principles. 

Finally, the Ethics Advisory Board as an external, independent body composed of ethics experts provides oversight of the ethical implementation of the projects and helps in efforts to prevent problems and propose possible solutions. The EAB is a valuable instance that addresses any ethical issues that arise in projects.


Ethics has transversal nature and prevails over all project activities, work packages, and tasks.  Therefore, it is a matter of the highest importance in any research project including those supported by the European Commission such as DigiCare4You. The firm plan of implementing ethical principles in practice and within the research context proves the strong dedication of the project consortium to realize the project in accordance with ethical standards. In other words, principles are often perceived as abstract and general guidelines for what should be done. However, the skillful staff is needed to transfer the principles into concrete organizational measures that should ensure the ethical dimension of the project and bring a new quality layer concerning the project implementation and deployed results.