The necessity to obtain informed consent
Before anyone participates in a study, they should have given their informed consent to the researchers in charge of the study. Giving informed consent involves more than just accepting to take part as the decision must be based on a full understanding of what is involved. The information concerning the study should be provided by the researchers and be understandable to potential participants who should be given time to take in the information, discuss with other people if they wish to do so and ask any questions. For this reason, informed consent should be seen as a process rather than simply a document to be signed.
For studies involving medical treatment or drugs, the consent procedure is a medico-legal requirement covered by laws and codes of medical ethics. Depending on the country in which the research is being carried out, there may be additional specific laws on research which lay down conditions for obtaining consent. People with limited mental capacity or who lack the capacity to consent may still participate in research under certain conditions (which may be fairly strict).
People who are considering taking part in a study are sent detailed information and a formal document to sign. They are usually invited to a meeting with the researchers to discuss their possible participation and are free to bring along another person (e.g. their doctor, a social work, a legal representative, a close friend, relative or another trusted person) and to ask questions. Sometimes, the researchers have brochures or DVDs which people can take home and look at before making a final decision. This gives them the time to make sure that they fully understand what is involved, to discuss the matter with friends and family and to think about any additional questions they may have.
It is the researchers’ responsibility to ensure that potential participants fully understand what is involved as this is the basis for informed consent. Once the study is underway, the researchers may acquire additional information which might affect whether some participants would want to continue or would prefer to withdraw. The researchers should share such information with participants.
For questionnaires or surveys, the situation is sometimes different as the researchers do not necessarily have direct face-to-face contact with the participants e.g. in the case of random postal surveys. Participants’ consent is implied by their action in returning the completed questionnaire as invited. However, the researchers should have provided background information about the study and how the information obtained will be used either on the questionnaire or in a cover letter.
The fact that a person has consented to a face-to-face interview does not necessarily imply that they have also consented to being filmed or recorded. It is therefore important that researchers ask additional consent to use recording equipment during an interview.
Most research ethics committees require written consent (i.e. with a real signature) for any research involving direct contact with participants (e.g. one to one or in a group) conducted by telephone, in person or virtually. More recently, perhaps especially due to the COVID-19 situation when people were unable to go out (e.g. to post letters), some research ethics committees accepted various forms of virtual consent. It is important to develop new and innovative approaches to informed consent that are appropriate for people with dementia and taken into consideration the challenges they face. For some approaches, participants may need additional support.
The ability and right to decide whether to participate in research
The aim of informed consent is to protect research participants from harm whilst respecting their right to decide for themselves whether they would like to take part in a particular study. The informed consent procedure should give people the opportunity to weigh the possible benefits against the burden and risk of participating in research. It must ensure that any consent given is voluntary (i.e. people have not been forced or pushed into participating against their will). Participants must also have the capacity and the legal right to make that decision (i.e. decision-making capacity and legal capacity).
People may have varying degrees of decision-making capacity. This may fluctuate not only because of dementia but also due to a range of psychosocial, emotional, situational, medical, psychiatric and neurological factors. Researchers need to determine whether a potential participant has the capacity to consent to participation in a particular study. Lack of such capacity does not automatically result in a person’s exclusion from research. Many people with dementia are able to give informed consent if appropriate adjustments are made and necessary support provided.
Many people who are in the early stages of dementia have the capacity to consent to participation in research. However, it is important that researchers understand that people with dementia may have certain difficulties with comprehension, attention span, memory and communication. For this reason, researchers need to take extra care to ensure that the information they have given has been understood and to respect each person’s pace. Printed information can be helpful as a support to memory and going back over what has been said can help the person remember what is involved. Involving a someone of the person’s choice can also be helpful provided that the person with dementia agrees to this.
Assessment of the capacity to consent
Informed consent should not be understood as a signed piece of paper or a one-off requirement at the beginning of a study. Rather, it is a process based on verbal, non-verbal and behavioural cues, which needs to be revisited regularly throughout the research. A range of approaches can be used to obtain informed consent for participation in research such as clinical interviews, discussions and measures of capacity, including neurological test batteries (Beattie 2009). The MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR) (Appelbaum 2007, Appelbaum and Grisso 2001) is sometimes described as the ‘gold standard’ for the assessment of capacity to consent to clinical research, although not necessarily on its own (Howe 2012). It covers understanding, appreciation of the nature of the situation, reasoning and expressing a choice.
Examples of other instruments include the University of California San Diego Brief Assessment of Capacity to Consent (UBACC) and the Evaluation to Sign Consent (ESC) (Beattie 2009). The Mini Mental Status Exam (MMSE) is not generally considered as a suitable or reliable measure of the capacity to consent to research. Care should be taken when drawing conclusions about capacity to consent using instruments which have not been validated for people from various minority groups.
Being informed vs understanding
Information provided to potential research participants with dementia should cover various issues related to a particular study (e.g. what the study is about, why the person is being asked to participate, what participation would involve, potential risks and possible benefits if any, who is responsible for the study, the timeframe of the study and whom to contact for more information, further explanation or in case of complaints) and general issues related to participation in research (e.g. the voluntary nature of participation, the right to withdraw at any time, confidentiality and privacy issues). Participants must be able to comprehend the information provided, demonstrate that they have understood, assess the relevance of information to them and make a reasoned decision.
Voluntariness and the therapeutic misconception
Participation in research of any kind must be voluntary. There are different degrees of lack of voluntariness ranging from being subjected to research without having had any choice in the matter, being forced to participate on the basis of some kind of threat or deciding to participate on the basis of undue influence. Pressure to participate can be quite subtle and may be unintentional. An example would be someone being asked by a healthcare professional or staff in a residential care setting and fearing upsetting that person due to a feeling of dependency on them, respect for their position or not wanting to jeopardise an existing positive relationship with them.
People’s voluntariness could also be influenced by their interpretation of what they are being asked to do and why. The decision about whether or not to participate in research may depend on how research is understood and most importantly, whether a person understands the difference between research and treatment or care. This might not always be as obvious as it first seems, especially in situations where a person is informed about a study by a healthcare professional in a healthcare setting (Lewens 2006). The provision of treatment and care is generally consented to on the basis of an assumption that it is necessary and will hopefully in some way be personally beneficial. If this distinction is not clear, it cannot be said that a person has given informed consent to research. Medical researchers should try to ensure that potential participants realise that the overall aim of research, including biomedical research, is not to improve their health or contribute to their personal wellbeing. The overall aim is to generate new knowledge that will be beneficial to society.
Consent with and on behalf of people with dementia: shared, supported and proxy decision making
There has been a move away from the concept of proxy (i.e. substituted) decision making towards supported decision making. Supported decision making is about providing the necessary support to enable a person to make a decision, including one that is legally recognised.
In their recommendations on research (and data sharing) involving people with dementia, Thorogood et al. (2018) point out that research ethics guidelines generally promote supported or shared decision-making. They suggest that this might include “simplifying consent forms, providing visual or memory aids, taking interactive or educational approaches (where persons with dementia are asked to explain their understanding of consent elements), re-explaining misunderstood information, or involving familiar carers to facilitate explanation and communication of a decision” (Thorogood et al. 2018, p.1338). Such measures could perhaps be further extended to address any barrier experienced by people with dementia, regardless of whether it is linked to a health condition (e.g. such as having a lower level of literacy or being a member of group that is stigmatised etc.).
In situations where a person has been appointed who is authorised to decide on behalf of a person with dementia about participation in research (i.e. a ‘proxy’ or ‘substitute’ decision maker), it is increasingly excepted that that person should base their decisions on the known will and preferences of the person with dementia and not on the basis of ‘best interests’ or ‘welfare’ (Thorogood et al. 2018). Where possible, people with dementia should, as far as possible, be included in the decision-making process. In addition, even people evaluated as unable to give consent for research may preserve the capacity to appoint a research proxy (Kim et al. 2011).
It is increasingly recommended, if not stipulated (European Directive 2001), that proxy consent should represent the person’s presumed will. In reality, this is often not the case. Proxies often do not know a person’s will and preference and make decisions that the person appointing them would not have made (Kim et al. 2013, Thorogood et al. 2018). Proxies may sometimes be too restrictive, thus depriving people with dementia of the opportunity to be involved in research or, on the contrary, involve people with dementia in research when this does not correspond to their wishes, values and interests (Jongsma 2016).
Proxies can be very beneficial in combination with advance directives because they may be well-placed to help interpret the kinds of studies a person might have wanted to participate in, drawing on the information provided in an advance directive, their knowledge of the person and possible information about his/her wishes and interests. Some people with dementia grant their proxies the power to override their previously expressed wishes (e.g. in the light of scientific advances which result in unanticipated consequences for participation or on significant changes in the person’s situation). Others may want their advance directives to be followed, without leaving leeway for their proxy to decide.
Substitute decision makers (whether they be healthcare proxies, legal guardians or relatives) could also discuss the issue of research with the person with dementia, speak to the researchers about interpretation of the advance directive, monitor the research process and signal any problems. However, it must be borne in mind that their views about research may differ to those of the person they are representing. They may be over-protective or simply unaware of what the person with dementia would have wanted. Moreover, they are supposed to act in the person’s best interests or at least not act against them, which would be problematic in the case of non-therapeutic research involving more than minimal risks and/or burdens (as they may consider any risk or burden as not being in the person’s best interests). For this reason, it is important that when people designate a health care proxy, they discuss their preferences and feelings about different types of care with him/her, and any views about participation in research.
Consent by means of advance directives for research
Whilst it is often not possible to obtain consent to research from people in the late stage of dementia, there is a need to balance their protection with their right to choose to participate in research, should they wish to do so. One solution is to encourage people in the early stages of dementia to consider this issue and record their wishes in an advance directive. Alternatively, they could record their wish not to take part in research. In most countries, such statements about research would not be legally binding but, as an example of previously expressed wishes, could be taken into account in any discussions about possible participation.
Writing an advance directive for care/treatment is more straightforward than writing one for research. For the former, the person can refer to specific known interventions or use more general terms such as “all life-saving interventions” whereas for the latter, it is difficult to give consent for a future experiment which has not yet been devised and which by the nature of research is likely to be innovative. Furthermore, it would be difficult to formulate wishes in terms that are neither too vague nor too restrictive. In view of the amount of time that could pass between making the advance directive and the research starting, it is difficult for someone to have a clear idea of what they might be letting themselves in for.
Several ethical concerns have been raised about the use of advance directives in the context of dementia (in general, not necessarily for research). These are mainly linked to arguments about personal identity and changing interests. There is a broad and complex philosophical debate surrounding personhood and dementia. An issue of particular concern and of relevance to the debate about advance directives for research is whether the person who wrote an advance directive is the same person as the one for whom it may later be applied, and if not, why the advance directive should be respected. This is a complex philosophical debate. For further reflection on this issue, please see Alzheimer Europe’s 2019 report on Overcoming ethical challenges affecting the involvement of people with dementia in research.
Consenting to future research in an advance directive is also problematic because, as pointed out by Berghmans (1998), it is difficult to give consent for a future experiment which has not yet been devised and which, by the very nature of research, is likely to be innovative. Researchers may find it easier to accept a negative advance directive for research as this does not raise issues about the ambiguity surrounding the risks and burdens people might be exposing themselves to. The risks of research as well as the potential burdens and benefits can only ever be estimated but in the case of decisions made for research that might occur several years later, procedures and methods may have advanced beyond what was initially imaginable. The ‘informed’ aspect of consent is therefore missing in the case of advance directives for research. However, people can be informed about and helped to understand the implications of this lack of prior knowledge and then make as informed a decision as possible. Those who have a trusted person could be encouraged to appoint and allow the involvement of a proxy in future decisions about participation in research.
People participating in research are entitled to confidentiality even if the results of research are made public. Information should not be divulged to anyone outside the research team unless prior authorisation has been obtained. In most cases, anonymity is guaranteed and participants may be assigned code names or numbers. This enables the researchers to quote people without revealing their true identity. Moreover, any personal/private information that researchers learn of in the course of the study, which is not related to the study, should not be disclosed to anyone. There is a difference between anonymisation and pseudonymisation. With anonymisation, participants are assigned a number or code which is linked to the data that they provide but the code cannot be traced back to them (e.g. to their name and address), whereas with pseudonymisation, it is stored and could at some point be traced back to them (even though it usually isn’t).
In some studies, particularly small-scale qualitative studies or action research, researchers may decide to show the preliminary results to the participants and invite them to comment. This gives them the opportunity to confirm or query anything that has been written about them as well to be more fully involved in the study. This is very important in studies which have involved very personal contact or with participants who have shared very personal information about themselves. It is also important from a scientific perspective as a means for researchers to check that they have fully understood the information that was communicated to them.
For a comprehensive overview and discussion of ethical issues linked to the involvement of people with dementia in research, please see our 2019 report on Overcoming ethical challenges affecting the involvement of people with dementia in research.
Most countries have research ethics committees to which researchers must apply for approval before starting their research. Research ethics committees may be governmental, independent, linked to local health authorities or linked to educational institutions. Depending on the kind of research being carried out and the participants involved, researchers may have to seek approval from more than one committee. The approval is usually granted on the basis of a detailed description of the planned research, containing details of the methods to be used, the people to be involved, the kind of analysis to be carried out, evidence of the scientific justification for the study, ethical issues envisaged and methods to be adopted so as to avoid participants or even researchers coming to any physical or psychological harm. The committee may also invite the researcher to a meeting to discuss certain issues. Increasingly, research ethics committees include a person with dementia.
In some cases, ethical approval is a legal requirement, whereas in others it is an academic requirement. Some researchers would not have access to such research ethics committees but would nevertheless be expected to have considered relevant ethical issues and to have obtained informed consent from all participants.