Carelink is developing a smart location and tracking solution that will allow Persons with Dementia (PwD) the freedom to walk out of their front door with the knowledge that there is a safety net (Carelink), which warns their carer, if they are showing signs of a ‘wandering’ event about to occur, or if they are heading towards/away from, predefined unsafe/safe zones. At this stage of the development process, we are moving towards the trialling of our solution, and this opens up a number of ethical questions which need to be considered.
In any research that involves human participants, the project team is responsible for the wellbeing of the end-users, and so it is important to consider all the ethical consequences of their inclusion. When carrying out end-user trials it is vital to obtain voluntary participation, and therefore informed consent must be sought, either from the participants themselves or from their designated carer. There are a number of ethical considerations that must be respected when dealing with human participants, and these include but are not limited to privacy, autonomy and obtrusiveness, which will ensure that the participants are represented well, their personal information is protected and they are not inconvenienced in any way.
The EU General Data Protection Regulation (GDPR) has been in legal effect across Europe since 25th May 2018 and is used to protect and inform EU citizens on the use of their data. From a data protection perspective, the use of Artificial Intelligence (AI) raises a number of concerns. We need to ensure that the data that is collected is protected and only used for the purposes that it has been gathered for, and that even while the collected data is anonymised there is no way to infer personal data from supplementary gathered data. These laws along with the recent proliferation of wearable technology that is used to capture data, store data and ultimately process and analyse this data has resulted in a whole new tranche of privacy questions that need to be considered when dealing with technology in end-user trials.
Along with the matter of privacy and data protection (referenced here in an earlier blogpost by partner and privacy specialist Opensky Data Systems) from the technology perspective, we must also look to the humanity and social side with regards to the ethical principles. One of the most important and challenging ethics issue with regard to research involving older or vulnerable people is how to obtain properly informed, and freely given consent. This consent must be obtained from those who: (i) may be some way dependent on family carers, professional carers or others, (ii) might live in an institutional setting with care being provided and, most especially, (ii) may have diminished cognitive capacity.
Therefore, there is a large duty of care responsibility on the Carelink partners towards their end-user participants. Each partner participating in our trials will recruit participants through recognised Alzheimer Associations, elderly homes or in some cases through personal contacts. Our potential study participants will be informed of the potential benefits, risks, inconveniences or requirements to carry out these field trials, in order to allow them to make a fully informed decision on their willingness to participate. All of the principles of anonymity and data confidentiality that we are taking on board within the project will be made clear to participants as a key part of gaining their informed consent. After being informed about our project, the potential study participants will be given sufficient time in order to consider the decision to take part in the trials or not. As we are dealing with PwD and their carer, it is expected that both are required to sign our Informed Consent form. If it turns out that the PwD is unable to sign the informed consent due to a lack of legal capacity, then it must be signed by his or her legal representative. Only after the informed consent form has been submitted will we screen end users for suitability. The potential study participants will be evaluated for inclusion or exclusion based on a specific screening checklist that has been created for the project and will be strictly adhered to.
With all this in mind, and taking the above considerations on board we have designed our Carelink user trials with the participant’s wellbeing at the centre.
- No end users will be able to participate without the appropriate Informed Consent form being completed, which requires the participant to sign-off on the fact that they understand fully the process and are interested in continuing.
- All information relating to the participants will be collected with the proper measure to guarantee their confidentiality and with respect to the data protection laws.
- No data will be shared beyond the project boundaries, and even within the project only to the partners requiring access.
All of which will lead to a successful engagement with participants, with them safe in the knowledge that their personal an private information are protected and they are helping us to build towards our solution.
Would you like to be considered for participation? Please email firstname.lastname@example.org.