Ethical and social implications

Ensuring that dementia research is conducted in an ethical manner

Ethical behaviour in relation to interactions with people with dementia is more than a question of rights and duties.

It is important to consider in addition the lived experiences of people with dementia and their carers (for example in relation to care giving, care receiving, being a fellow member of society, vulnerability, and dignity) which are embedded in people’s everyday lives. This also applies to the participation of people with dementia in research. Abstract principles cannot be considered in strict isolation of the context and the people involved but may form a useful starting point for a broad ethical consideration.

All research must be worthwhile, effective, and conducted in an ethical manner. Throughout history, this has not always been the case, and this has led to the publication of various guidelines as well as the obligation for researchers to obtain ethical approval from research ethics committees to carry out their research.

Whilst much of the early emphasis was on protection from harm and respect for autonomy, behaving in an ethical manner towards people with dementia participating in research is also about empowerment, rights, respect, equity, and wellbeing.

Article 31 of the United Nations Convention on the Rights of Persons with Disabilities (CRPD), states that appropriate information, including statistical and research data, must be collected to formulate and implement policies. Under the CRPD, people with disabilities include

This applies to dementia. Consequently, reasonable accommodation (appropriate adaptations) (Article 2) must be made to ensure that people with dementia have the same opportunities to take part in research as other people. 

It is necessary to look critically at existing guidelines and for research ethics committees, researchers and funders to consider novel ways to involve people with dementia in research, balancing their needs and interests with requirements for good quality research. This should at best promote and at least not hinder the ethically sound involvement of people with dementia in a broad range of research settings and domains.

Many people with dementia continue to be excluded based on measures designed to protect them from harm, on the basis of structural discrimination or inadvertently through lack of awareness of their needs, interests, circumstances or difficulties. This is unfortunate as they have important knowledge and data to share that could benefit other members of society in the future.

Ethical reflection in the PREDICTOM study

Regulatory ethics approval

All scientific research involving people or animals must be approved by a research ethics committee (by a regional or national research ethics committee and/or by a university). PREDICTOM therefore applied for research ethics approval in all the countries where there are clinical partners conducting research requiring research participants. This helps ensure that the researchers have reflected on important issues covering the safety, welfare, and rights of participants, but also that the study has societal and scientific value, a sound methodology and is fair.

It is nevertheless important for research partners to continue to reflect on ethical issues that are specific to the topic of the research and to how various tools, methods and procedures are implemented. 

Ongoing reflection about relevant ethical issues

The various concerns, assumptions and expectations that lay people but also healthcare professionals have about the use of the AI-based risk prediction and screening processes may affect the successful implementation of the tools/platform being developed. It is therefore important to reflect on such issues during the development stage, testing and implementation in terms of ethics because ethical research, by definition, also means methodologically sound, robust, meaningful and in keeping with the needs, concerns, wellbeing and rights of participants (and also carers and researchers), bearing in mind how the results may impact on people’s lives in the future and on society as a whole.

Alzheimer Europe will conduct a rapid review of literature of ethical issues surrounding screening, shared decision making and the use of artificial intelligence in the context of cognitive decline and dementia. This will include articles that have been published in peer-reviewed academic journals as well as relevant reports (e.g. from associations, institutions, and government bodies). This will enable researchers to consider important factors when administering tests, interacting with participants, and handling their data.

However, it is important to ensure that ethical reflection is not limited to researchers. Lay people, especially people with cognitive difficulties and their carers, also need to be involved. The literature review will therefore be accompanied by Public Involvement work in the form of a series of consultations with lay people, including informal carers, a person with dementia, people with concerns about their cognition, people with no such concerns and people with an interest in brain health.

Alzheimer Europe will lead this work and all the members of the PREDICTOM PI team will be involved.  This will lead to the development of a strategy for the trustworthy and ethical use of AI-based screening platforms.

Examples of some of the issues we will be exploring

A key goal of PREDICTOM is to make the detection and diagnosis of dementia timelier and more accessible to people. To do so, a platform will be developed to help identify people (from the general population) who are at a higher risk of developing dementia. This includes people who currently do not have cognitive impairment (e.g. memory problems) or just have mild issues but who may have a greater likelihood of developing dementia in the future.

Regarding ethics, this raises issues about what constitutes a timely diagnosis. As people are being diagnosed, or in some cases identified as having a high risk of developing dementia, much earlier than in the past, the question arises as to when this is beneficial and meaningful to them, and to society (e.g. to the public health system). There are also issues related to

• different screening processes, how and where they are conducted, how risk status is communicated and which, if any, information participants should be entitled to receive during the study about their health and risk status.

• the use of artificial intelligence in the screening processes such as how people feel about its use, whether they understand it, whether it is reliable for everyone or excludes people from some groups.

• data protection (e.g. how samples are handled, with whom they are shared, whether people understand the potential risks and how they feel about that).