Summary of the i-CONSENT’s conversations on informed consent in the context of the COVID-19 last session
The last intervention took place December 15th and was conducted by Prof. Assuntina Morresi. It revolved around the ethical issues and implications for informed consent of COVID-19 contact tracing apps.
In any pandemic context, isolating infected subjects and avoiding the spread of the contagion are two main priorities in terms of public health. In this perspective, contact tracing is crucial.
The primary indicator of the effectiveness of contact tracing (CT) is the number of secondary cases identified and isolated. Traditional CT has been widely practiced so far by the Prevention Departments and consists in interviewing cases and contacts (by telephone or with home visits) and using other methods to identify all contacts, performing laboratory tests, monitoring contacts for symptoms and making sure that they are following quarantine/isolation and other preventive measures.
Digital Contact Tracing (CT)
Digital CT makes full use of technological solutions based on digital health and, in particular, of two components: electronic health (e-health) and mobile health (m-health), drastically limiting personal contacts between public health operators and citizens and using technologies for accessing telematic databases and proximity tracing with Bluetooth or GPS. Through digital implementation, contact tracing takes place through computer applications on mobile media.
From the point of view of public health, the apps have been introduced just as another way of applying the procedures of traditional contact tracing. From an ethical and bioethical point of view, it should be emphasized that technology is not a neutral tool.
Ethical issues and implications for informed consent
Prof. Morresi highlighted two levels of analysis:
1. The relational nature of traditional contact tracing is crucial in order to fully grasp the ethical issues related to CT apps:
- The heart of contact tracing is the dialogue between the tracker and the index person. The main purpose of this dialogue is to identify the subject’s contacts;
- Risk assessment can take place fully if all aspects relating to the contact with the positive person are asked/shared; the interview turns out to be all the more effective the greater the trust is between the tracker and the interviewed person;
- The tracker has also to deal with the problems of the person interviewed. Trackers must ensure that the person’s living conditions allow for isolation. If needed, he must identify whether the person to be isolated or quarantined needs to take care of other people. Ultimately the tracker has to take charge of the positive/possible positive.
Definitely, the tracker undertakes a relationship of care that has to take into account thoroughly the needs of the interviewed subject. To protect community health, operators must take care of the individual.
2. Ethical evaluation regarding the application implemented in the Italian context («Immuni«).
The application was designed with the aim of alerting people who have a risk of contagion through proximity tracking via Bluetooth technology. Also, it was designed indeed to protect the privacy of the subject (in fact it uses a «decentralized» data collection, i.e. the data does not leave the single mobile device). In sum, in the Italian context, the application did not work as it was supposed to replace fully traditional contact tracing.
Prof. Morresi highlighted further ethical implications:
- Cybersecurity issues, relating to data protection;
- High amount of personal and health data entered; new and large datasets created by the app; collection of data not only on health but also e.g. on mobility;
- Non-identifiability of the tracker
In-person consent as a complement
Prof. Morresi discussed the implications for informed consent which should include an in-person explanation to accompany the use of the digital application. Each subject must be able to give consent to the use of the Apps, even after downloading them to their smartphone (or mobile support), and also differentiated with respect to the different modules that make them up. It must be ensured that consent is given in full awareness: the information to users must be clear and understandable, taking into account that an important segment of the population, especially the elderly, is not yet familiar with computer media.
It would be advisable especially for these groups of users to provide explanations in the presence of the operators in the App start-up phase, or at least make videos or tutorials available. Furthermore, at the time of installation, the possibility of uninstalling must be clearly communicated, and the procedure for carrying out it must be simple and unhindered.
Assuntina Morresi is Associate Professor of Phisical Chemistry, University of Perugia; member of Committee on Bioethics of the Council of Europe (DH-BIO); Member of the Italian Committee for Bioethics. She is also a member of the ISS Bioethics COVID-19 Working Group. Within this working group, she authored the report «Digital support for contact tracing during the pandemic: ethical and governance considerations”.