Legal and ethical implications

Work Package 9 of the CISC project, titled ‘Ethics requirements’, was drafted and submitted as a first step in the launch of the CISC project (year 1), in order to anticipate all the legal and ethical issues that may arise throughout the project, and to put a plan in place to either avoid or address them as swiftly as possible. Complementarily, an internal ethics board was established specifically for the purpose of this project involving expertise in the law and ethics of research design, and in data management.

The requirements that were initially identified included the elaboration of consistent procedures to recruit a diverse and representative sample of research participants, the justification of the data collected in accordance with the data minimisation principle, the drafting of clear and informative consent forms for all participants, and the creation of an incidental findings policy. Furthermore, it was deemed necessary to devise a risk minimisation plan for vulnerable research participants, to appoint a Data Protection Officer (DPO), and to craft a Data Management Plan (DMP) to ensure all data collected is kept safe, confidential and GDPR-compliant, with special attention to Recital 53 (on the processing of sensitive data) and Chapter V (covering data transfers from outside the EU), given that one of the LIVE LABs is partially located in Serbia. Furthermore, it was specified that all this information would be kept for the duration of the project in a shared folder with a strict authentication process, along with the ethics applications to each researcher’s relevant university and the eventual approvals by their ethics committees.


Summary of the current status of the LIVE LABs’ ethics approval

All researchers but one working on the LIVE LABS have secured ethical approval from their respective universities’ ethics boards. The bodies in charge of providing said ethics approval were TU Dublin’s Ethics and Integrity Board or REIC (Ireland), Politecnico di Torino’s Comitato Etico (Italy), and the Ethics Committee of the University of Kragujevac’s Faculty of Medical Sciences (Serbia). Aside from submitting their ethics application to their respective university’s board, the researchers also submitted their project to the internal ethics board to solicit independent advice, and to have a point of contact for issues that may emerge during the project.

In the case of LIVE LAB 1, there are three different research sites, one per university involved in the project. The approval of the University of Kragujevac’s Ethics Committee was secured the first year of the project. The rest of researchers gained approval for their project in the second year of their research, after one or two rounds of revisions and their respective adjustments in line with both the REIC and the CISC internal ethics board.

Regarding LIVE LAB 2, part of the leading research team works uniquely with synthetic data already in the possession of the project’s industry partners (IVECO), collected according to their own rules and regulations. In this case, after submitting an application to TU Dublin’s ethics self-assessment tool, the research was deemed to entail minimal risk and invasiveness, hence it is believed to be exempt from the regular procedure of research ethics applications. On the other hand, the researcher who aims to collect physiological data submitted the relevant documents to PoliTo’s Comitato Etico, which made a few suggestions for improvement. The documents have been adjusted accordingly, and will be re-submitted in the near future, as soon as the Comitato is back in place (as it is momentarily inoperative, due to some internal reconfiguration). The documents have also been translated from Italian into English and submitted to the CISC internal ethics board. Following approval the researcher will proceed with the final agreement with IVECO, in order to kickstart the research on the plant that hosts Live Lab 2, located in Mantova (Italy).

As per LIVE LAB 3, the CISC internal board provided an expert opinion on several matters prior to the submission to TU Dublin’s board, which served to improve their chances of a swift approval. After enacting the relevant adjustments, the leading researchers sent the updated documents to the internal project ethics board to request if there were any further comments, which they also received and incorporated. Complementarily, the submission was made to TU Dublin’s board, which provided feedback earlier last month (September 2023). After having adopted it, the updated documents have been submitted to the university’s board again.

There are two ESRs (6 and 9) whose research is based on synthetic data, and thus ethical approval is not required at present by their respective universities. Finally, ESR10, in charge of the legal and ethical perspective of the project, and whose data collection method are interviews and focus groups, has obtained the REIC’s full approval to proceed with the data collection.


Ethical issues of importance in each respective CISC LIVE LABS

One of the differential factors of LIVE LAB 1’s ethics application is its focus on providing reassurance to the participants regarding their freedom to withdraw. It also invites participants to not feel self-conscious about their own performance, given that the researchers are unable to deduce anything from the information they are exposed to during the experiment or after its completion. Moreover, the application clarifies the breaks the participants are allowed (since the experiment is quite lengthy), and the kind of data that will be collected during it (since the number of data-gathering devices involved and the variables they can record is considerably high). It is also made clear up to which point participants will be able to ask for their data to be removed from the study, which is until it is merged with the rest of the participants’ data in an anonymised form.

Some of the most relevant suggestions made by the ethics boards were to clarify the professional responsible for the ethical oversight of the experiment (who was confirmed to be CISC’s PI), and to justify the number of participants (which was adjusted due to time constraints, but remains similar to other comparable peer-reviewed research projects). The REIC’s response also asked to identify the specific sensors that would be used during the experiment and to provide a comprehensive list of the questions that would be asked in the survey, which the researchers did. The internal ethics board asked to clarify the samplying criteria for including participants, with emphasis on excluding people with certain prior conditions such as epilepsy. Finally, the research team was asked to clarify the anonymisation process and how it interacts with the EU’s best practices for open research and, more specifically, open access repositories.

In the case of LIVE LAB 2, the researcher in charge of data collection elaborates on the steps that will be followed to ensure the safety of the data gathered which, given its status as ‘health data’, is considered highly sensitive according to the European regulation on data privacy (GDPR Recital 53: Processing of Sensitive Data in Health and Social Sector). Therefore, the data requested is appropriately justified and deemed relevant within the scope of the project, and it is explicitly stated that it will be treated with the lawfulness and confidentiality required under GDPR, by applying the principles of purpose limitation, anonymisation, limited access, encryption, etc.

Moreover, the application includes information regarding the software used for the experiment, i.e. Empatica EmbracePlus. Most relevantly, it stores the data uniquely on the device in question (which serves to protect it from third party access), encrypts the data during transmission and storage, requires credentials for access, and allows to destroy the data after the project’s completion.

The application also makes explicit mention and recognition of the possibility of injury, but qualifies its risk as being low and of temporary nature – nonetheless, a series of safety precautions are foreseen in order to further minimise it, ensuring the appropriate conditions and warm-up and the close and constant supervision by the researcher in charge. The active request to the participant to express their perceived fatigue in a document made for this purpose ensures their level of strain can be recorded and monitored in an unequivocal and straightforward way (including a colour scale and drawings for greater clarity), so the responsible researcher can know whether to watch any of the participants closely after the exercise has been completed. The document consists of a modified version of the Rating of Perceived Exertion (RPE) Scale (Borg, 1962).

The suggestions made by PoliTo’s ethical board were to improve the drafting of the proposal itself (since it had to be done in Italian, a language that the leading researcher doesn’t speak natively), to add a Covid protocol into the submission, and to provide further detail of the data to be collected by the smartwatch. Further feedback will come after the CISC internal ethics board has looked into it, and possibly after the submission is made again to PoliTo’s Comitato Etico – once the latter is fully functioning again.

Finally, some of the main issues highlighted in the LIVE LAB 3 application regard the importance of a clear consent form and participant information sheet, all drafted in lay language, given that some of the devices used during the experiment (mBrainTrain Smarting Mobi, Tobii Glasses 3, EmpaticaPlus CareLab) could be perceived to be invasive or intimidating. The application also emphasises the mechanisms in place to ensure a fair, unbiased and non-coercive recruitment process; the allocation of several breaks during the experiment, and the commitment to provide thoughtful guidance and training to the participants (for the success of the experiment but also to ensure they are comfortable and at ease).

In its reply, TU Dublin’s REIC asked at which stage the consent form would be signed, to which the researchers replied by adding the clarification that signing the consent sheet would be the first step in the process. At the petition of the board, the researchers also clarified that the experiment does not compromise participants’ health in any way other than any risks that may arise from the ordinary use of a computer. However, the clarification that the first aid protocol will be followed in case of any incident was added. Given that the researchers will not need to request information about any of the participants’ medical conditions, they will be able to follow the GDPR principle of data minimisation, and specifically of sensitive data minimisation.

Upon request of the REIC, the researchers also clarified which of the questions in the questionnaire are to be answered by the participant and which ones are meant for the researchers themselves. Similarly, they also transitioned from Qualtrics into the more secure option of Microsoft Forms, as offered by TU Dublin’s SharePoint, for the purposes of data collection. They also clarified, added and updated several aspects of their data management plan; most saliently, about the location, retention period and degree of anonymisation of the data stored, as well as on the interaction (or lack thereof) between the data gathered in Italy and Ireland.

On the other hand, one of the main suggestions made by the internal board was to clarify the demographic terminology, as some documents referred to biological sex, while others referred to gender diversity. The CISC board also asked to clarify which parties would be allowed to access the health data collected; and to add a disclaimer at the end of the information sheet stating that all participants are welcome to contact the university’s ethics committee if they are not satisfied with their experience taking part in the research or would like their data to be dismissed and/or destroyed.