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2019: Overcoming ethical challenges affecting the involvement of people with dementia in research


What is research and why is dementia research important?

Research consists of a systematic, organised inquiry to find answers to worthwhile questions, using predefined methods or procedures which are clearly documented. The answers to such questions should contribute towards a body of knowledge or theory and it should be possible for other people to understand exactly what researchers did to arrive at their conclusions and any limitations there may have been to the study.

Research into the care, treatment and support of people with dementia is essential for the lives and wellbeing of millions of people who have or at some point will develop dementia. Such research often provides a means to develop new drugs and treatments, promote good health, find out what kinds of services and care people want, explore the needs and experience of professional and informal carers, and better understand what it means to live with dementia. Very often, research provides a basis for government policies, the development of guidelines and the creation or improvement of products, services, support, medication and procedures.  

This discussion paper is about all kinds of research involving people with dementia. Involvement in research should be understood as including ‘Public Involvement’ and involvement as a research participant (formerly known as a research subject). Both forms of involvement are equally important and raise ethical issues, which are the focus of this discussion paper.

The relevance of different research paradigms for inclusive research

For quite some time, there were two main research paradigms[1], namely the positivist/post positivist paradigm (linked to quantitative research) and the constructivist (or interpretivist) paradigm (linked to qualitative research). A few decades ago, there were huge methodological debates as to which of the two paradigms was ‘right’. These debates were based on disagreements about ontology (the nature of knowledge and what counts as knowledge or fact), epistemology (the source of knowledge and how knowledge is determined) and axiology (the aims of research and how researchers’ own values are understood in relation to the research process). Some researchers argued that only the positivist/post positivist paradigm was ‘real science’.

Others argued that it was not suited to the study of complex human and social phenomena. This debate came to be known as the paradigm wars[2] and some posited that the two approaches were irreconcilable due to their very different underlying philosophies.

Researchers have largely moved beyond this dispute, adopting a more pragmatic approach. This recognises the strengths and limitations of each and accepts that it is the type of question that determines/justifies which method is appropriate and valid. Pragmatists emphasise that the focus should be on the research problem and that pluralistic approaches should be adopted to derive the necessary knowledge about it (Creswell 2009). Nevertheless, perspectives and concerns reminiscent of these early debates are still sometimes evident amongst researchers, funding bodies and research ethics committees and may sometimes hamper efforts to render research more inclusive with regard to people with dementia.  The reason for this is that the definition of science and hence of scientific research was, historically, developed within a positivist context and even now, some definitions still reflect positivist assumptions. Methods used to make research more inclusive, on the other hand, tend to draw on qualitative research methods (i.e. reflecting assumptions from the constructivist paradigm), which are still considered by some as not being ‘scientific’. Hence, attempts to be more inclusive may be met by resistance from researchers, funders and research ethics committees who have a narrow perspective of research.   

Another important issue of relevance to the promotion of inclusive research is that some researchers feel that the two key paradigms mentioned above do not adequately or appropriately address social injustice or do not go far enough in advocating for marginalised groups. The two key paradigms have been criticised for not actively pursuing the interests of minority groups with the result that members of such groups all too easily fall through the net and consequently are underrepresented in research. There was also a criticism that lay people were involved in research solely as ‘subjects’ or ‘participants’ and that they could be involved throughout the research process so as to ensure that their needs and preferences were taken into consideration.

This has led to the development of the advocacy and participatory research paradigm in which researchers are often guided by a theoretical perspective (e.g. racialised or disability-based, feminist, critical or queer theory) and seek to engage people from marginalised groups actively in the whole research process as collaborators in research as well as research participants. The key issue is not whether a particular method is used but whether there is a shared commitment to bringing about social change and an emphasis on participants (usually from marginalised communities) benefiting in some way from having participated, particularly if this is not the norm, and from accessible findings (Pyett 2002). Whilst the participatory aspect of this paradigm shares certain goals with Public Involvement (see Part 1 of this paper), the advocacy and participatory paradigm is based on the premise that “research inquiry needs to be intertwined with politics and a political agenda”, should address issues such as inequality, oppression, domination, suppression, and alienation, create political debate and bring about social changes (Creswell 2009, p.9). These are not necessarily aims shared by all researchers who nevertheless strive for a greater involvement of people with dementia in research.  

Different research paradigms, types of research and research methodologies represent opportunities to develop an understanding of issues of relevance to the lives and wellbeing of people with dementia. They also come with certain challenges, an important one being how to ensure the ethical involvement of people with dementia in research. Such challenges may be greater with regard to certain issues or to the involvement of minority or marginalised groups. One paradigm is not better or worse than another. The key challenge is to ensure that the research is carried out ethically and in accordance with established procedures, standards and principles, whilst challenging and adapting these if and when necessary in order to involve a diverse set of people with dementia in research.  

FWhat springs to mind when you think of the term ‘scientific’?

FWhat is your world view about research and about what counts as ‘knowledge’?

FDo you think this has any impact on your approach to inclusive research?

What is meant by the ethical involvement of people with dementia in research?

The involvement of people with dementia in research is part of a more global aim to ensure that researchper seis ethically sound. All research must be worthwhile, effective and conducted in an ethical manner. Throughout history, there have been numerous examples of this not happening 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 in order to carry out their research. The Nuremberg Code (1948) was the first internationally agreed set of guidelines on the good conduct of research. It was published shortly after the end of the Second World War, mainly in response to public outcry over medical research carried out under the Nazi regime on people, by force and/or involving a lack of due concern for their wellbeing. However, unethical studies were not limited to the war period and did not stop with the Nuremberg Code. Other cases eventually came to light such as the Tuskegee syphilis study (1932 – 72), the human radiation experiments (1945–72), the Jewish Chronic Disease Hospital New York Study (1963), the Willowbrook study (1956) and several hundred others which were identified in reports by Beecher and Pappworth published in the 1960s (Savelescu and Hope 2010). The protective measures for research participants, laid out in the Nuremberg Code, were later incorporated by the World Medical Association into the Declaration of Helsinki (1964). These protective measures were also incorporated by the Council of Europe into the European Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (the Oviedo Convention) and supplemented in its Additional Protocol on the Convention of Human Rights and Biomedicine concerning Biomedical Research (2005).

Whilst much of the early emphasis was on protection from harm and respect for autonomy, behaving in an ethical manner towards people with dementia engaged in research is also about empowerment, rights, respect, equity and wellbeing. The biomedical ethical principles described by Beauchamp and Childress (2012) are now widely used by researchers from many disciplines and contexts. These principles represent an important means to help ensure the ethical involvement of people with dementia in research, emphasising not only respect for persons (their autonomy and dignity), beneficence (which could also cover the promotion of wellbeing and empowerment) and non-maleficence (i.e. protection from harm), but also the need for justice/equity, which is particularly important with regard to the issue of equal inclusion. A possible drawback to this ‘principlist’ approach is that more than one principle may be relevant and that the four principles do not necessarily capture all moral concerns. However, as suggested by Hunter (2010), such moral decision making on the basis of principles can also be supported by people with different ethical perspectives (e.g. derived from consequentialism or duty-based ethics). 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 incorporating, for example, elements of:

  • virtue ethics (which focuses on the character of the person carrying out an action),
  • ethics of care (which focuses on people within a complex net of relationships and the importance of empathy and solidarity),
  • communitarism (which focuses on the maintenance of the community based on recognition that people are embedded within culture and society) and
  • discourse ethics (which emphasises the need to ensure that moral norms are established through a fair dialogue in which everyone’s perspectives and viewpoints are heard and taken seriously).[3] 

The ethical criteria for clinical research described by Emanuel et al. (2000) are also widely cited and provide guidance to help ensure that clinical research is robust, has value and is meaningful, providing society with accurate answers to questions that were worth asking. They cover: 1. value (linked to the enhancement of health or knowledge), 2. scientific validity (methodologically rigorous), 3. fair subject selection (guided by scientific objectives not vulnerability or privilege, with a fair distribution of risks and benefits), 4. a favourable risk-benefit ratio, 5. independent review (with the possibility to approve, amend or terminate studies), 6. informed consent and 7. respect for enrolled research participants (protection of privacy, possibility to withdraw and monitoring of participants’ wellbeing). Emanuel et al. (2000) claim that the requirements are universal but that they must be adapted to the health, economic, cultural and technical conditions in which research is conducted.

Alzheimer Europe promotes a rights-based approach to the involvement of people with dementia in its work and subsequently in all research in which it involves people with dementia. This falls within the scope of a deontological approach based on the notion that there is something morally important about being human, that this gives rise to certain rights shared by all humans and that other people have a duty to respect those rights (Hunter 2010). Article 31 of the United Nations Convention on the Rights of Persons with Disabilities (CRPD)[4], states that appropriate information, including statistical and research data, must be collected to formulate and implement policies. In keeping with the guiding principle of the Convention, which is that of inclusion, a broad range of people with dementia should be involved. Moreover, reference to the right of people with disabilities[5] to reasonable accommodation (Article 2) means that appropriate adaptations must be made to ensure that people with dementia, for example, have the same opportunities to take part in research as other people.  Under the CRPD, people with disabilities include “those who have long-term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others” (Article 1). Ethical involvement of people with dementia in research can also be linked to the PANEL principles of Participation, Accountability, Non-Discrimination and Equality, Empowerment and Legality, to the International Ethical Guidelines for Biomedical Research Involving Human Subjects[6] and to the EU Clinical Trials Directive[7].

The ethically sound conduct of research is further regulated and monitored by national, local and university ethics committees throughout the world in relation to medical and non-medical research involving human participants. Members of research ethics committees are likely to have different approaches and this is important in ensuring that some ethical issues are not overlooked as a result of an over-emphasis on a single approach to ethical decision making (Hunter 2007). Guidelines at national level may also apply in specific or multiple research domains, such as the Code of Human Research Ethics of the British Psychological Society (2014)[8] or the Code of Ethics for Scientific Research in Belgium (2009)[9].

Ethically sound involvement in research is also about who sets the research agenda, who is involved, at what stage and in what capacity. These issues have been influenced by broad historical developments such as the feminist, disability, intellectual disability and black civil rights movements, and consumerist debates (Gradinger et al. 2013). According to Beresford (2019), feminists and disabled people in particular challenged some of the deeply engrained foundations of positivist research such as distance, neutrality and objectivity, and questioned the independence of mainstream research with regard to funding often based on commercial priorities and reflecting the values of healthcare systems. Awareness of the need to involve people affected by various medical conditions in decisions related to the research agenda has led to some initiatives, such as the James Lind Alliance (funded by the National Institute for Health Research in the UK), which bring together people directly affected by the condition, carers and clinicians to influence the choice of issues to be addressed and where possible to influence the funding of such research[10]. The aim of the James Lind Alliance is to create Priority Setting Partnerships (PSPs) to identify and prioritise key unanswered questions in a wide range of medical conditions, thereby ensuring that health research funders are aware of the issues that matter most to the people likely to be affected by research in their everyday lives. This corresponds to the ethical goal of ensuring that research addresses worthwhile questions (including questions that are worthwhile to people with dementia).

Any research involving human participants should have anticipated social value for society. In relation to clinical research, this is defined as being “the nature and magnitude of the improvement [that]the intervention is expected to have on the wellbeing of patients, individuals in society or society” (Habets, van Delden and Bredenoord 2014, p.3). However, the necessity to involve people with dementia in decisions related to priority setting for research should not deny or undermine the importance of researchers’ right to scientific curiosity. As pointed out by Flinterman, Broerse and Bunders (2007), basic research initiated on this basis with no direct reflection about its relevance to the current interests of patients has sometimes led to important breakthroughs in knowledge development and innovations. Important knowledge gained from research does not have to have immediate practical ramifications for it to be deemed to have value (Emanuel et al. 2000).  In a series of articles on increasing value and reducing waste in biomedical research published in the Lancet[11], Chalmers et al. (2014) suggest that it is in keeping with the nature of science to study things that are uncertain and which do not always result in worthwhile achievements for patients. They add, however, that funders should be more transparent about how they prioritise important uncertainties and how they take into account the needs of people for whose lives the findings of research may be relevant.  

The ethically sound involvement of people with dementia in research needs to be considered in relation to Public Involvement (see Part 1 of this paper) and in relation to people who are research participants, stretching from the very beginning of the research process (e.g. during the conceptualisation and design phase) up to and even beyond the end of the research project when the findings are disseminated (see Part 4 of this paper). The people involved should be respected and treated as equals. This means that their input should be taken into consideration and valued, and measures should be taken to empower, where possible, and promote the wellbeing and safety of all involved (i.e. people with dementia and researchers alike). The ethically sound involvement of people with dementia in research is not limited to the protection of vulnerable research participants but also to the empowerment of people with dementia based on a reciprocal relationship of respect. In this discussion paper, we will be looking at such involvement both in the context of Public Involvement (PI) and as research participants.

Why is further reflection on the ethical involvement of people with dementia in research needed?

Much of the widely used ethical guidance on research was developed in the context of biomedical and clinical research. The various documents have influenced the actions and thoughts of researchers, research ethics committees and funding bodies for several decades and have been meaningfully applied in numerous other research contexts and domains.  However, research is constantly evolving, along with knowledge, understanding of dementia (as a medical condition and a personal experience) and attitudes and practices linked to the involvement of people with cognitive difficulties, such as people with dementia, in research.

Research ethics committees also have a key role to play in promoting the ethically sound involvement of people with dementia in research but concerns about promoting wellbeing and avoiding harm are not always conducive to the effective and meaningful participation of people with dementia in research. Many people with dementia continue to be excluded on the basis of measures actually 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 to share.

Consequently, it is important to be open to different ways of interpreting and applying ethical guidance to new situations, challenges and goals. 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.

In accordance with the principle of justice, the benefits of research should be equally distributed amongst all members of society (Smith 2008). Research findings must correspond to the needs and interests of everyone with dementia in order to ensure an equal chance of good health, well-being and quality of life for people with dementia from minority groups in Europe. This should also help ensure that the strengths and valuable contribution of people from minority groups to societies are visible and acknowledged. Research findings are used either directly (e.g. in health care professionals’ daily practice) or indirectly (e.g. in policy or education). However, people from minority ethnic groups, as well as other people in socially vulnerable situations, are underrepresented in research, both in the context of shaping and conducting research, and as research participants. Their lack of involvement in research cannot be dismissed on the grounds that they are not interested in research, would not have the capacity to take part or are ‘hard to reach’.

There are numerous factors which hinder inclusive research such as invitations which are full of complex sentences and difficult words, proposing meetings in unfamiliar places, certain inclusion criteria and complicated consent procedures. Even when people are included, research materials, data collection tools and procedures may be culturally inappropriate and not validated, thus reducing the potential value of the involvement of people from some groups. Many of these factors can be addressed directly by researchers, research ethics committees and funders. Some may require a more substantial effort over time (e.g. being inherent in existing structures and procedures of organisations and deeply engrained in attitudes and perceptions).  

People with dementia do not form a homogeneous group. They come from all walks of life and may have different needs and experiences based on the underlying conditions and causes of their dementia (e.g. the underlying disease or condition, whether they have early onset, familial or late onset), how far advanced their condition is and different symptoms related to their condition. There are also numerous sub-groups of people with dementia whose experiences and needs should be viewed as the result of dynamic intersections between different shared characteristics and collective experiences (Jubany, Güuell and Davis 2011). Vertovec (2007) highlights the “super diversity” of minority ethnic populations, drawing attention to the rising diversity within groups in relation to country of origin, socio-economic status and religious and cultural traditions. Such differences can, according to Uppal, Bonas and Philpott (2014), impact on defining individual norms, values and experiences. The diversity of the experience of dementia needs to be reflected in research.

About this discussion paper

Purpose, authors, contributors and target group

The purpose of this discussion paper is to promote reflection about the ethical involvement of people with dementia in research. The paper was drafted in 2019 by a group of researchers with expertise in inclusive dementia research and ethics (hereafter referred to as ‘the ethics working group’), some of whom also have experience as members of research ethics committees. This working group was set up and chaired by Alzheimer Europe.  Please see Appendix 1 for a brief bio of each of the co-authors of this paper and a list of the names of external experts who commented on the paper.

The European Working Group of People with Dementia (hereafter referred to as the EWGPWD) supported the ethics working group by providing input on various sections of the discussion paper and reviewing the recommendations.  There were group discussions before and during the drafting of the text which influenced the issues addressed and the recommendations made. This method of involvement was chosen by the members of the EWGPWD. It consisted of a bottom-up approach whereby people with dementia were not provided with a summary of the issues considered as important to the ethics working group but rather were asked about the issues that they considered important. Their views were then fed back to the ethics working group who added their own contribution, debated these and additional issues and reviewed the relevant scientific and grey literature. In view of the length and complexity of the resulting paper, different members of the EWGPWD were invited to contribute further to different parts of the text.

The two groups agreed that in order to promote inclusive research, it was important to reach those who plan, conduct, evaluate and fund research. This discussion paper is therefore targeted at researchers, research ethics committees and funders.

The members of the ethics working group and the EWGPWD recognise that we, like many researchers, people with dementia, funders and members of research ethics committees, are looking at the issue of the ethical involvement of people with dementia in research through a particular research paradigm or a lens. This reflects to some extent dominant Western-orientated values, assumptions and priorities and risks blinding us to the experience of many people with dementia from minority groups. For this reason, we have tried to be objective, to put ourselves in the shoes of other people and to be reflexive about our own influences, assumptions and attitudes. Part 3 of this paper addresses the issue of reflexivity and positionality and questions for reflection have been included at various points throughout the text. We have also included testimonials from members of the EWGPWD who provide a personal perspective on some of the key issues addressed, which they highlighted in discussions prior to and during the drafting of this paper.


In order to avoid duplication of effort and for the ethics working group to be able to address the many possible issues related to the ethical involvement in research within the timeframe of the project, the scope of this discussion paper has been deliberately limited to people who have dementia. We will therefore not be addressing issues linked to the involvement of people with normal cognition, pre-clinical Alzheimer´s disease or mild cognitive impairment in dementia research. This should not in any way be interpreted as overlooking the important contribution that people from these groups who do not have dementia make to dementia research. However, a considerable body of reflection has and is still being carried out into ethical issues linked to the involvement of people from these three groups in dementia research by  ethics working groups in the context of recent and current European projects (e.g. EPAD, AMYPAD and ROADMAP, to name but a few[12]). Similarly, the issue of data protection (covering privacy, confidentiality and other issues relevant to the ethical management of personal data) will not be addressed in this discussion paper as considerable reflection on these topics is currently underway in the context of a 3-year, IMI-funded project called ‘Neuronet’.[13]

The paper is about the involvement of people with any kind of dementia in research, not just Alzheimer’s dementia. It is relevant to researchers, funders and research ethics committees involved in any kind or branch of research and in any discipline (e.g. quantitative, qualitative, mixed methods, clinical etc.). Whilst much of the focus will be on dementia research, it should not be assumed that the involvement of people with dementia should be limited solely to dementia research.

Frequent reference will be made to minority groups. This should be interpreted as referring to groups of people having one or more characteristics in common which puts them at risk of exclusion in the context of research. This might, for example, be based on age, ethnicity, health status, gender identity, complex support needs, level of education, socio-economic status, disability, intellectual disability, difficulties with language, learning or literacy (including computer literacy and health literacy), place of residence (including care homes, prisons, being homeless and being a member of traveller communities) and communication issues such as having combinations and degrees of deafness and blindness. The list is not exhaustive. Other terms are occasionally used such as marginalised and disadvantaged (in this paper mainly in relation to discussions about intersectionality), both of which have slightly different connotations. Marginalised, for example, suggests that people are living on the boundaries of or outside society, and this may sometimes be through choice. As Pyett (2002) points out, they are still members of society and may actually consider mainstream society as marginal to their values and lives and there are some powerful minority groups who are not disadvantaged[14].  

Finally, we recognise that most people live within a social web of interdependent relationships with others (e.g. relatives, friends and wider communities). They are not isolated entities. For many people, the views and experience of others are important to them. Moreover, their participation in research may have a psychological, emotional, financial or other impact on close friends and family. Relatives of people with dementia often play an important role in research as participants in their own right, in the context of PI and through the support they provide, which enables people with dementia to participate in research. It is important that they are also engaged in research in an ethical manner. The emphasis of this paper is on the involvement of people with dementia in research, but respect for individuals and families from different ethnic groups also entails recognition of the importance for many people of the family (e.g. in decision making and supporting involvement).

Structure of the discussion paper and how to use it

This discussion paper is divided into four sections:

  1. issues related to Public Involvement (PI)[15]
  2. issues surrounding the recruitment of research participants and the informed consent procedure
  3. issues surrounding participation in research once recruited
  4. issues related involvement after the end of research studies

The paper addresses a large number of issues and refers to the situation of a broad range of people with dementia. Examples are provided about the experience of people with various characteristics or from specific minority groups. This should not be interpreted as implying that only these groups are concerned. It was not possible to mention every minority group or person affected by non-inclusive research practices. It is nevertheless possible that we (i.e. the authors) have overlooked a particular issue that is important to the topic of this paper. We would welcome feedback from readers about specific issues of relevance to the promotion of inclusive research with people with dementia, which have not been addressed.

Readers may not read each part of the discussion paper or all the sections and sub-sections with the same level of interest and attention. Some may prefer to dip in and out of the different parts of the discussion paper. With this in mind, we have included several summaries as well as cross references in the text, partly to avoid repetition and partly as readers may have missed the initial discussion of an issue which is revisited later in the text.  On the other hand, and in keeping with the concepts of reflexivity and positionality (see Part 3), the lack of interest in particular issues is perhaps revealing in itself and may have some relevance to the issue of inclusive research. 

Throughout the text, readers will find testimonials from people with dementia and a few questions to encourage reflection. A glossary can be found in Appendix 2 containing some of the key concepts covered in the paper and there are recommendations interspersed throughout. These are, where appropriate, separated into recommendations for researchers, recommendations for research ethics committees and recommendations for research funders

[1] “constellation of beliefs, values, techniques and so on shared by members of a given community” (Kuhn 1970, p. 175)

[2] See Baumgarten M (2012).Paradigm Wars - Validity and Reliability in Qualitative Research. Grin Verlag and Tashakkori and Teddlie (1998).Mixed methodology. Combining qualitative and quantitative approaches. London: Sage Publications

[3] A clear overview of different ethical perspectives of relevance to the ethics of research can be found in Chapter 1 of the European Textbook on Ethics in Research (European Commission 2010).

[4] Please see:

[5] For a discussion about dementia as a disability, please see Alzheimer Europe’s 2017 report on this topic:

[6] Council for International Organizations of Medical Sciences (2002)

[7] This will be replaced by the Clinical Trials Directive which will come into application in 2020, following a delay caused by difficulties with the IT system. See: 



[10] In America, the Patient-Centred Outcomes Research Insititute (PCORI) promotes ‘PCOR’ research. This identifies evidence gaps with patients, researches issues which matter to patients and uses the findings to improve healthcare in a constant cycle in which research and practice constantly inform each other. See

[11] These documents can be found at:

[12] See for information about these projects and links to their respective websites.

[13] The Neuronet project will run  until 2022, will consolidate the ethics work from 15 IMI-funded neurodegeneration projects, specifically relating to patient privacy, data protection and confidentiality.

[14] Our focus is not on powerful minority groups as they are unlikely to be excluded from research.

[15] Please see Part 1 for a discussion about this term.



Last Updated: Friday 13 November 2020