Introduction
Dear Sir/Madam,
You are asked to take part in a scientific study. Participation is voluntary and requires your written consent. Before you decide whether you want to participate in this study, you will be given an explanation about what the study involves. Please read this information carefully, and ask the investigator for an explanation if you have any questions. You may also discuss it with your partner, friends or family.
1. Research objectives
The DataCom Project aims at building a new framework to facilitate an ethical secondary use of health data held by public bodies, with the aim of improving accountability and enhancing responsible re-use. To build it, I will develop and test in intersectoral practical environments the innovative concept of “Ethical Commodification”: the possibility of exploiting personal data in an ethical way for the public good, in accordance with citizens’ expectations and needs and taking into account the risks associated with the exploitation of anonymized data sets, focusing on 3 Member States, Italy, Spain, and the Netherlands. In order to reach this objective, DataCom has a strong interdisciplinary and intersectoral approach, bridging law, ethics, and computer science, taking into consideration the needs of the public sector and those of citizens.
2. Surveys, interviews, and focus groups
This research involves the participation of human subjects as survey and interview respondents and as participants in a focus group.
Interviews and the focus group will be conducted in person and, when not possible, online or via telephone, while the survey will be conducted online. Interviews and the survey will be essential to complement document analysis, as they will allow evidence of the cause-effect relationship for the understanding of public servants’ processing of health data, while the focus group will be essential for the testing of the new framework, in order to comprehend if the guidelines provided to public servants are effective and if they match citizens’ expectations and needs. They will additionally be employed to provide further contextualization of findings.
I do not explicitly target vulnerable groups, but greater care will be employed in the case of patients, who might be among participants to the survey and focus group, as DataCom is about health data and how citizens perceive the processing of their sensitive information. In case my research involves vulnerable groups, for example, patients or adults with learning disabilities, I will make sure that secure, freely given informed consent is provided from the participants. I will actively make sure that they have the time and opportunity to access support in their decision-making, for example, by being supported by a trusted friend or relative, and I will provide specific explanatory materials (e.g., leaflets). Throughout the whole research Project, the Advisory Committee, which will have a prominent Ethics expert among its selected members, will closely advise me and help me in dealing with ethical issues.
The survey will be administered to 300 public servants directly involved in health data handling and to citizens.
The interviews will involve 30 public servants in each Member State, of which 10 in public research institutions, 10 in hospitals, and 10 in non-academic public institutions, such as municipalities and EU institutions. The aim is to investigate how public servants in different countries handle the re-use of health data, how they apply the legal (e.g., privacy by design, compatibility assessment for further purposes) and ethical principles (e.g., expectations of citizens, possible adverse effect of data re-use), what techniques they employ to anonymize data sets in their everyday job and what measures they adopt to mitigate risks. When analyzing the implementation of ethical principles, I will check whether ethical assessments concerning specific subgroups (e.g., immigrants, women, LGBT+ people) are more likely of being performed than others.
I will also interview 30 citizens in the 3 selected MS, 15 who voluntarily donated their data to public institutions, and 15 who did not, to understand their expectations towards the re-use of their data.
3. Duration
The project has a duration of 2 years, starting on the 1st of July 2023.
The interviews will have a duration of one hour maximum, while the focus group will last 2 hours.
4. Principal Investigator
The project is conducted by Dr. Chiara Gallese under the supervision of Prof. Ugo Pagallo at the University of Turin, Italy. It will be also conducted at the Universitat Polytecnica de Catalunya in Barcelona, Spain, and at the Eindhoven MedTech Innovation Center in Eindhoven, the Netherlands.
You can contact us at chiara.gallese AT unito.it
5. Importance of this research
The societal impact of the project is related to the protection of rights and freedoms of millions of individuals, including those of vulnerable groups (such as patients): understanding how responsibly re-using health data also means giving them broader protection, by safely handling their personal data and avoiding the unnecessary exploitation and monetization of their sensitive information. In addition, it will be beneficial to public institutions, including European ones, as they will gain a better understanding of the legal vacuum and of the needs of citizens, potentially leading to new reforms and to an update of the law, as well as representing the starting point for a technical standardization of data anonymization in the public sector. In particular, the EU Health Data Space will directly benefit from the new insights brought by this project. Last but not least, it will have a positive impact on legal professionals and medical researchers, who will have a guide on the complex legal landscape which is relevant to their profession.
6. Risks and benefits
The research has no risks for participants. The benefits are the possibility of having an impact on decision-making regarding the exploitation of health data in the EU.
7. Funding bodies
This Project no. 101108151, “DataCom – A new EU Framework for an Ethical Re-use of Health Data”, is funded by the European Union under the HORIZON-MSCA-2022-PF-01 Action.
8. Data storage
The data will be kept in the servers of the University of Turin, Italy, for 10 years, to allow the audit for research integrity.
I will follow both data protection law and UT internal policies regarding technical and organizational measures to protect personal data. Following the principle of data minimization, I will record the video of interviews only if it is necessary for the research project and relevant to my research, for example, in the case that participants share their screen to show slides, documents, or other relevant information which cannot be understood solely through an audio recording. If audio recording is sufficient, I will not record the video. If all I need is the transcription, I will delete the audio as soon as I can get the transcription (principle of storage limitation). To perform the transcription, if I cannot do it manually due to lack of time, and I employ software or an external company (data processor), I will arrange the appropriate data agreements and security measures. If the tool I am using is a tool that records both video and audio (such as MS Teams), but I will not need the video, I will ask participants to turn off their cameras. I will not employ a personal phone, notebook or portable recorder to perform the recordings, but only the encrypted equipment provided by UT. When I do not need the video or audio recordings anymore, I will delete them immediately. Regarding software employed in my research, I will make sure that appropriate safeguards are in place: for example, I will ensure that no data is transmitted outside the EU, that a data processing agreement is in place, and that a privacy assessment of the tool has been performed. I will also make sure that the tools I am employing are compliant with privacy by design and by default principles. Students, research assistants, and staff in general will be trained and educated on data protection and internal procedures regarding data handling. All necessary organizational measures will be in place at UT and during secondments.
9. Withdrawal from the study
It is up to you to decide whether or not to participate in the study. Participation is voluntary.
If you do participate in the study, you can always change your mind and decide to stop, at any time during the study. You do not have to say why you are stopping, but you do need to tell the investigator immediately. Stopping will not have any negative consequences for you. The data collected until that time will still be used for the study unless you indicate that you do not want this.
If there is any new information about the study that is important for you, the investigator will let you know. You will then be asked whether you still want to continue your participation.
10. Follow-up
Participants can request information to be sent by email at the end of the project and a copy of published results.
CONSENT FORM
I declare that I have fully understood the information provided above by Dr. Chiara Gallese
Yes ☐ No ☐
I agree to participate in the research:
Yes ☐ No☐
________________ ________________________
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