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Issues of Informed Consent from Persons with Dementia When Employing Assistive Technologies



The use of Assistive Technologies (ATs) in the provision of healthcare promises to provide novel opportunities to protect, empower and extend the autonomy of persons with dementia (PwDs). However, it also poses autonomy-related challenges, especially regarding informed consent. Traditional informed consent procedures, aimed at the protection of the autonomy of research participants and patients undergoing treatment, are not readily applicable to PwDs, when it comes to deciding about ATs. This chapter analyses the ethical challenges of obtaining informed consent from PwDs for research and development, and the use of ATs. The analysis reviews both traditional informed consent procedures, as well more innovative ones. The chapter will conclude with a list of recommendations, based on the findings of the ethical analysis.
novitzky,peter chen,cynthia
smeaton,alan f.verbruggen,renaat
The use of Assistive Technologies (ATs) in the provision of healthcare promises to
provide novel opportunities to protect, empower and extend the autonomy of per-
sons with dementia (PwDs). However, it also poses autonomy-related challenges,
especially regarding informed consent. Traditional informed consent procedures,
aimed at the protection of the autonomy of research participants and patients un-
dergoing treatment, are not readily applicable to PwDs, when it comes to deciding
about ATs. This chapter analyses the ethical challenges of obtaining informed con-
sent from PwDs for research and development, and the use of ATs. The analysis
reviews both traditional informed consent procedures, as well more innovative ones.
The chapter will conclude with a list of recommendations, based on the findings of
the ethical analysis.
Keywords: Informed Consent, Assistive Technologies, Ambient Assisted Living, Competency,
1 introduction
Informed consent is one of the cornerstones and requirements sine qua non of modern
medical research and clinical practice. It developed relatively quickly to gain great
importance, despite initial setbacks. The requirement of informed consent applies to
all subjects of medical research and therapy, including persons with dementia (PwDs),
whose impaired competence to provide valid informed consent poses particular chal-
lenges. While Assistive Technologies (ATs)1provide opportunities for better care with
This is a draft of a chapter that has been accepted for publication by Oxford University Press in the forthcom-
ing book Assistive Technology for Dementia, edited by Bernice Elger et al., due for publication in November
1The term Assistive Technologies (ATs) in this chapter is defined as “any item, piece of equipment, or
product system, whether acquired commercially, modified, or customized, that is used to increase, maintain,
or improve functional capabilities of individuals with disabilities” [1, p. 134]. They are also referred to as
novel techniques for obtaining informed consent, many of the ethical challenges need
further consideration and deeper ethical analysis in order to be addressed satisfactorily.
This chapter, firstly, describes the purpose of informed consent, with a short historical
overview. Secondly, it defines and specifies the requirements of informed consent, high-
lighting the issues of obtaining valid informed consent from PwDs. Thirdly, this chapter
reviews traditional and innovative methods of obtaining informed consent from PwDs.
Fourthly, it summarises outstanding ethical issues that may emerge during research or
application of ATs with PwDs. Finally, it proposes recommendations on how to tackle
key ethical issues of informed consent with PwDs.
1.1Purpose of Informed Consent
It may be argued that the requirement for informed consent is a logical consequence
of the requirement of respecting every person’s autonomy to make and be responsible
for decisions [7, Art. 5]. Both these requirements are founded on the concept of human
dignity, stipulated by The Universal Declaration of Human Rights [8, Art. 1] and the Uni-
versal Declaration on Bioethics and Human Rights (UDBHR) [7, Art. 3], applicable to every
human being.
This origin of the requirement for informed consent in UDBHR [7] defines its three
main purposes: (1) protection against undue paternalism by physicians, (2) avoidance
of undue or uninformed influence from others (e.g. authorities, etc.), (3) provision of a
voice to the person concerned, to facilitate their self-determination [9].
1.2Historical Milestones of Informed Consent
Informed consent was first mentioned in response to public outcry over injuries inflicted
upon human participants through non-therapeutic interventions in 1891 in Germany.
Later, in 1900, a German ministerial directive requiring informed consent was issued, as
a result of the Neisser case, where a clinical trial was conducted on people who were
not asked for consent [10].
The informed consent standard was first internationally recognised in The Nuremberg
Code [11], a response to Nazi research conducted on concentration camp prisoners. The
first paragraph stipulates that voluntary consent from participants in any type of med-
ical experiment is absolutely essential. The rigorous phrasing of the Code delegitimised
research with humans incapable of providing consent.
Thus, the strict standard of the Code obstructed research and development (R&D)
of novel therapies for people affected by some of the most serious conditions. Con-
sequently, it needed to be liberalised. This occurred in two stages. Firstly, the Declar-
ation of Helsinki [12] distinguished therapeutic from non-therapeutic research, allowing
therapeutic research on incompetent persons (albeit under special circumstance), while
Digital Assistive Technologies [2], and Welfare Technologies [3]. Both terms involve intelligent computing,
with elements of pervasiveness and ubiquity, the characteristics of Ambient Intelligence (AmI) [2,4,5].
A subgroup of AmI comprise Ambient Assisted Living (AAL) technologies, which refer to innovative
technologies, intelligent systems of assistance that help elderly people (including PwDs) in all stages of
their life in order to extend their stay in their preferred environment, and support systems that maintain
people’s health and functional capabilities by promoting a healthier lifestyle, allowing active and creative
participation in the community, and improving quality of life [6].
still prohibiting non-therapeutic research. However, early phase research, i.e. where dir-
ect benefits to the participant are uncertain, remained excluded. Further liberalisation
occurred in the 1990s. With strict safeguards,2the possibility of research without direct
benefit to incompetent participants was gradually accepted [13].
Later bioethical documents, such as the International Ethical Guidelines For Biomedical
Research Involving Human Subjects [14], the Convention on Human Rights and Biomedi-
cine [15], and the UDBHR [7] reflect this development.
2 general problems of consent from persons with dementia
Beauchamp and Childress categorise the traditional requirements of informed consent
into three groups [16]:
1. Consent threshold elements – including competence and voluntariness
2. Information elements – disclosure of relevant information, provision of recommend-
ations, understanding
3. Consent elements – decision,authorization
PwDs may have issues with all these elements. Their competence may be diminished,
e.g. by cognitive impairment. The voluntariness of PwDs may also be negatively affected
in research studies because PwDs tend to want to please researchers and are afraid of
offending them [17].
The information elements represent a group of issues in their own right. One key
issue is that it is generally difficult to ascertain whether a patient or research parti-
cipant has sufficiently understood the information disclosed [9].3It is the professional’s
duty to find a correlation between the information to be disclosed and the background
knowledge of the participant. Comprehensible language must be used to help ensure
understanding. Information disclosed to PwDs may not be fully understood if the lan-
guage used is too technical [18]. Furthermore, participants should not be overloaded
with information or under-informed [19]. When in doubt regarding the understanding
of the information provided about the objectives, risks, benefits, etc., of the interven-
tion, a mediator (e.g. independent adviser, responsible for protecting the safety, welfare
and interests of the PwDs) can be employed to assist the person in understanding the
information [20].
The understanding of information by PwDs cannot be fully ascertained in the same
way as with competent patients/research participants. Thus, the issue of understanding
by PwDs remains unresolved.
The situation is similar with the consent elements. Due to cognitive impairment,
PwDs become increasingly unable to provide consent, either as an ultimate decision
or a formal authorisation for research participation or treatment. As such, the three
2These safeguards usually extend to circumstances where such research must significantly contribute to
either a better understanding of the individual’s condition, or to the overall knowledge about that disease
or disorder. Furthermore, research without direct benefit must pose only minimal risk and minimal burden
to the research participant. Finally, the research participant must provide valid consent for participating in
such a study [13].
3E.g. an engineer will understand the information much more easily if it is presented using terminology
and metaphors from engineering.
essential elements of valid informed consent may pose problems for PwDs, who may
fulfil some but rarely all of the necessary requirements.
As a person’s competence deteriorates, the chances of obtaining explicit and express
consent reduce. Therefore, other forms of consent may become relevant, such as substi-
tuted consent (as with the terminally ill), or presumed consent (as in emergencies [21]).
The case of PwDs is, however, very specific. Although progressive cognitive impair-
ment eventually renders PwDs incompetent, their capacity to provide informed consent
may not be completely diminished during the early stages of this condition. Compet-
ence is usually understood as a legal term, where the loss of competence refers to the
loss of the legal right to decide in important matters [13]. The bioethical interpretation
of loss of competence is much more nuanced. It still refers to the inability of a person to
make decisions but without “artificial binary certainty” [22, pp. 5152]. This means that
for PwDs, competence to provide informed consent is not necessarily an “all-or-nothing
‘on-off’ switch” [23, p. 72] but rather, a fluctuating state. Thus, capacity is a continuum,
dependent on external variables that have the power to alter, diminish or enhance the
PwD’s capacity to consent [22].
The capacity of a person is usually described as a capability in two domains: cognit-
ive and volitive. For informed consent, the assessment of volitive capability, which also
assesses the capacity to make judgements (capacité de discernment) is decisive [24]. The
instrument currently considered the most valid for assessing PwDs’ capacity [25] is the
MacArthur Competence Assessment Tool (MacCAT) [2628]. The MacCAT is available
for both research and clinical application,4and shows good validity and reliability. How-
ever, it is time-consuming (3060 minutes), and requires prior training and familiarity. It
and other assessment instruments are also unable to measure moral and/or emotional
capacity to make a meaningful decision consistent with one’s life history [25]. There-
fore, Vorm and Rikkert [25] recommend using the MacCAT in combination with specific
questions regarding the hopes, beliefs and personal history of the patient/research par-
In addition, the proportionality principle should be applied, as a criterion of the ca-
pacity to consent in research with PwDs. The riskier and more burdensome the trial,
the higher the level of capacity for consent needed from research participants and the
higher the standards required for consent [25].
As the disease progresses, PwDs may be considered incompetent and yet retain some
decision-making capacity. This state introduces a ‘grey zone’ into informed consent.5
It is notable that not long ago, physicians believed that a diagnosis of dementia auto-
matically rendered PwDs incompetent in expressing their advance directives (approx-
imately 72 % in a US survey [29]). It is important to determine specific dementia sub-
types [29].6Different dementia subtypes affect different areas of the brain, and therefore,
4E.g. MacCAT-CR, where CR means clinical research; and MacCAT-T, where T means treatment.
5Bowman [22] mentions the “grey hinterland” (e.g. somewhere in between capacity and incapacity), where
PwDs may sometimes have decision-making capacity [22, p. 73].
6A study by Fazel et al. [29] suggested that only 20 % of PwDs were competent enough to complete their
advance directives, compared with a group of relatively healthy elderly volunteers, whose capacity rate
was approximately 78 %. They concluded that only a relatively small proportion of diagnosed PwDs are
competent enough to complete advance directives (those with higher premorbid intelligence). Moreover,
they found that competence was affected by aspects of higher intellectual functioning, which are not fully
assessed by the MMSE test [29].
different functions. Knowing which functions are affected helps professionals identify
which PwDs may be considered competent [23].
3 specific problems of consent from persons with dementia and ats
3.1Specific Consent Problems in Clinical Research with Competent Persons with Dementia
To enhance research participants’ understanding of the nature, elements, and goals of a
research study, it is advisable that the researchers repeat the information several times,
and, if appropriate, in smaller, more digestible portions [20]. The disclosure of inform-
ation is a particularly interactive process. The condition for repeated provision of in-
formation has also been proposed during the drafting process of the UDBHR articles [7]
concerning informed consent. The rationale behind this reiterative step is the general
recognition that informed consent, by focusing on the fulfilment of its essential elements,
is a procedural concept [9]. Aspects of this interpretation of informed consent are also
noticeable in one of the first drafts of Art. 6of UDBHR [7], where the committee inter-
preted informed consent as an “ongoing participation” [21, p. 9]. Ongoing participation
in research necessitates a more active role on the part of the participants, where the dis-
closure of information is no longer a one-step uni-directional requirement but rather a
continuous and mutual effort to communicate and understand the information through-
out the duration of the research participation [21].
Additional ethical challenges regarding clinical research with ATs are presented by
issues with data-ownership, data-handling, and the re-use of previously collected data.
Ethical issues from the context of biobanks and genetic data research may be relevant
to research with ATs. It is commonly accepted that the owners of genetic data gathered
from participants are the institutions that host databanks. These institutions are ac-
countable for the proper management of this data. However, the research results are the
property of individual researchers, unless otherwise specified in the consent forms [18].
Similarly, questions regarding data ownership and management also arise during the
R&D of ATs, when vast amounts of private, confidential, medical data are collected. The
R&D process may involve many researchers and different research institutions, often in
multiple countries with different legislative frameworks. This can be further complic-
ated in geographic regions that have ‘tiers’ of legislative frameworks; such as Europe,
where European and national legislative frameworks interact, or in the United States,
where both federal and state laws must be respected. These conditions increase the
complexity of data-ownership and data-handling, both key issues for researchers and
participants, which are scrutinised when considering consent.
New technologies also offer a great opportunity for re-using samples and data in
new research studies. The requirement to re-contact previous participants for informed
consent is an issue that is still not completely resolved [18]. A similar issue may be en-
countered with the data gathered from PwDs with ATs, after they have been anonymised.
For genetic data in databanks, a specific authorisation model has been developed by
Caulfield et al. [30], which enables participants to preserve a certain amount of control
over their data for future analysis [18]. Similar or alternative frameworks may emerge
in the future regarding recorded data of PwDs by ATs.
3.2Specific Consent Problems in Clinical Practice with Competent Persons with Dementia
The challenges related to ongoing participation and understanding of information by
PwDs also apply in clinical practice, because PwDs are free to refuse treatment. Stanton-
Jean et al. highlight that a refusal of one particular treatment does not automatically
mean a refusal of all treatments. Therefore, reasonable alternatives should always be
communicated and explained in detail [18].
3.3Specific Consent Problems in Clinical Research with Incompetent Persons with Dementia
Clinical research with incompetent persons such as PwDs, requires special justification.
Such justification is usually based on the premise that it would be unjust and unaccept-
able to abandon certain groups that are unable to provide informed consent. Exclusion
from research studies also means the exclusion from the potential benefits of research
studies [24].
Alzheimer Europe7and the European Dementia Consensus Network (EDCON) sup-
port the involvement of PwDs in research [25,31]. Naturally, such research must fulfil
certain conditions.
Art. 7b of the UDBHR [7] requires – as a general rule – that research studies should
have a direct health benefit for the participants, although it permits exceptions to that
rule. Research without direct health benefit is only permitted when the risk is min-
imal. Also, incompetent participants should only be included in studies where there
are no alternatives of comparable effectiveness with competent participants.8In ex-
ceptional cases, the UDBHR [7] allows research studies with incompetent participants
without direct benefit for the participants. Such studies should, however, contribute to
the health benefit of persons with the same condition, while exposing participants to
minimal risks and burdens. As neither the UDBHR [7] nor the Explanatory Memorandum
on UDBHR [21] define minimal risk, the definition of minimal risk used in the Addi-
tional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical
Research [32] may be applicable. It defines minimal risk as a “very slight and temporary
negative impact on the health of the person concerned” [32, Art. 17.1]. This includes
procedures such as taking saliva, small tissue samples, blood, one X-ray exposure, or
undergoing an MRI without contrast medium [13].
Groves [33] highlights that research conducted with PwDs, in search of pathophysiolo-
gical foundations of the disease, often offers no therapeutic benefit for the research par-
ticipant.9The author warns that there might be a “conspiracy of silence” [33, p. 20]
about the phenomenon where the research results favour, to some extent, the interests
of the researchers rather than those of the participants. Moreover, if participants and
proxies were consistently to be informed about the lack of therapeutic benefits (e.g. in
Phase I studies), there might be a decline in enrolment rates. This contributes to the
controversial nature of clinical research on cognitively impaired adults [33].
8Vorm and Rikkert [25] advise that PwDs who are incompetent most of the time should not be included in
9For example, Phase I studies in particular involve the administration of investigational medication to par-
ticipants in increasing dosages, in order to test the drug’s toxicity. Although, these drugs may carry a
potential for benefit (recognition for researchers, profit for drug companies, etc.), the participants receive
no direct health benefit (beyond the fulfilment of their altruistic motivations [33]).
3.4Specific Consent Problems in Clinical Practice with Incompetent Persons with Dementia
In Art. 7of the UDBHR [7], the term “medical practice,” with regard to informed consent
and incompetent persons, is mentioned only in relation to research authorisation. An
incompetent person incapable of consent may provide assent, and should be involved
as much as possible in the decision-making process. For legally incompetent persons
(children, etc.), the institution of assent is widely applied. While giving consent refers
to an “agreement to a proposal,” assent indicates only “agreement with a proposal” [34,
p. 313]. The former is a normatively-transformative act (in a sense of action), and the
latter is a state of mind or attitude (in a form of feelings or thoughts; [34]). Assent is
different from consent because it reflects the limitations of understanding in a person.
The process of obtaining assent should consider the mental capacities, levels of maturity
and overall development of the person concerned. Assent is also accepted by the Declar-
ation of Helsinki [35] as a valid way of including a person into the consenting process [18].
The fact that full competency has not been acquired yet (children), or has been lost (de-
mentia), seems to be morally irrelevant for the process of assenting. In both cases the
UDBHR [7] requires the greatest possible involvement of the incompetent person.
With PwDs of limited decision-making capacity, Vorm and Rikkert [25] favour the
dual consent procedure. Dual consent involves acquiring consent from the authorised
representative, followed by the assent (or consent, if the participant is capable to provide
it) from the PwD.
Regarding refusal or withdrawal of treatment, the requirements for intellectual ca-
pacity, including judgement, are generally less strict than those required for providing
consent to clinical treatment. However, small signs of opposition (e.g. gestures, weeping,
fear of hospitals, etc.) should not immediately be considered as refusals. As a guiding
rule, it should be borne in mind that the more adverse the effect of withdrawing treat-
ment, the stricter the requirements should be toward the capacity of judgement of the
individual concerned. Any failure to respect autonomy, no matter how limited the auto-
nomy, should be minimised. Consideration of the patient’s whole situation (history,
circumstances, previous care) should determine the best way of preserving the person’s
integrity, health, and dignity [24].
4 informed consent procedures for persons with dementia
This section presents various methods of acquiring informed consent from PwDs. Rolling
informed consent and advance directives represent more traditional methods, while
delayed consent and dynamic consent are new methods that are currently under devel-
4.1Rolling Informed Consent
Rolling informed consent is a method of obtaining informed consent adjusted to the
conditions of PwDs [36]. The method involves three aspects:
1. Repeatedly providing information (i.e. not only when requested), and asking for
consent during various stages of treatment or research
2. Listening to the content and nuances of the speech of the PwD and continuously
assessing whether participation is voluntary and not subject to coercion, persua-
sion, manipulation, or simple distress, which if so, should be sufficient reason for
the researcher to end the session, without needing the expressed request of the
participant [37]
3. Repeatedly communicating the possibility of opting-out or withdrawing from treat-
ment or research at any given stage.
Rolling informed consent has the potential to reflect the specific conditions of PwDs,
by ensuring that consent is regularly checked and confirmed, while also regularly mon-
itoring the cognitive functions of the PwD. However, this method may be considered
burdensome and time-consuming by professionals.
4.2Advance Directives
A key issue with advance directives of PwDs is that of ruptures between previous desires
expressed in advanced directives and current wishes expressed during times of limited
competency. Healthcare professionals can choose between two extremes. One is the
application of the pure ‘best interest’ standard10 in every case with PwDs. However,
doing this could bring negative consequences. One such consequence may be on PwDs
who rely on caregivers to help them implement their decisions, whereby the caregivers
may only help implement the decisions that they consider in the PwD’s best interests.
As such, PwDs would be a class of people that would be unable to occasionally make
a reckless decision. Moreover, the PwD’s assessment of her best interest would always
be considered less valuable than an assessment made by other ‘competent’ people. This
may result in the coercion of PwDs, which is unlikely to restore (or, in the case of PwDs,
maintain) one’s sense of self except for the sense of a powerless self [39].
The other extreme solution is to always follow the advance directive of the patient.11
This would be based on the respect for the human dignity of the person, and her auto-
nomy to make decisions. This translates into invariably following the previously ex-
pressed decisions to the full extent. The problem now is that the present interests of
PwDs might conflict with earlier wishes expressed in advance directives [38].12
Both solutions offer satisfactory results in only a limited number of cases. In lucid
states, PwDs may be competent enough to express genuine wishes that might overcome
their advance directive and vice versa. Moreover, consistent guidance of any of these two
standards would overburden caregivers. A possible resolution of such cases has been
provided by Huxtable [43] in the form of principled compromise.
4.3Delayed Consent
Art. 67of the UDBHR [7], other international documents, and recommendations from
expert groups suggest that direct consent from the patient/research participant should
always be preferred over any form of substituted judgement. PwDs who experience
10 Muramoto [38] refers to this as the Pure Beneficence Argument (PBA).
11 Also called the Pure Autonomy Argument (PAA, [38])
12 A similar discussion occurred between the philosophers, Dworkin [40], Dresser [41], and Shiffrin [42].
bouts of transient incapacity and temporary lucidity are in a ‘grey zone,’ where they are
at times able to provide informed consent. For situations like this, which can occur dur-
ing ongoing research, researchers have two possible options. The first is of temporarily
interrupting the research and waiting until the person recovers lucidity. However, this
might impede the continuity of the research, causing gradually increasing delays. The
second option is to use a form of ‘retrospective consent’ (used in the case of life-saving
treatments of mature minors [34], which involves seeking consent after the research
activity has been performed (without prior consent), when the person recovers from the
incapacitated state (e.g. [44]). This method is used in cases where the research could
not be performed with competent participants, either because of time constraints or the
permanent condition of the participant [45].13
It may be argued that in the case of PwDs and in non-emergency circumstances, re-
searchers may delay the process of obtaining (rolling) informed consent from PwDs
until they regain lucidity. This argument may be based on the likelihood that some
PwDs have temporary non-lucid states (e.g. mild dementia). Delayed consent may in
such cases respect the autonomy of the PwD to a greater extent than the substituted
consent of a proxy. There is, however, a dearth of academic literature providing any
further insight into the possibilities of retrospective or delayed consent specifically in
relation with PwDs.
The issue with delayed consent for PwDs is that there is no way of knowing in ad-
vance whether the non-lucid state is temporary. Moreover, delayed consent may signific-
antly and unpredictably extend the timeframe needed for obtaining consent from PwDs.
Therefore, it would be prudent to define an upper limit for the timeframe.
4.4Dynamic Consent
Dynamic consent is currently developed and investigated in biobank projects. Kaye et
al. [47], however, propose using this approach or concept more widely within clinical
research or other fields. It is defined as “a new approach for engaging individuals
about the use of their personal information . . . [by] an interactive personalised interface
that allows participants to engage as much or as little as they choose and to alter their
consent choices in real time” [47, p. 2]. The consent of an individual is enclosed in
an encrypted information container. Employing asymmetric cryptography, the consent,
together with other personal information, can be publicly shared with a trusted research
centre through a trusted authority. Thus, it is also ensured that the research centre has
access only to the information that it has approval for ([47] and the documentation of
the EnCoRe Project).14 The research centre thus gains access to the most recent consent
and other necessary sensitive medical information of the participant, relevant for the
study, while preserving the privacy of the participant. The flexibility and relative ease
of receiving information is also beneficial for the participant. She may easily alter or
13 The protocol of the NICE Study [46] in ICU environment allows the possibility of a form of retrospective
consent (i.e. delayed consent) where the respondents who provided delayed consent were less likely to
delegate the decision-making to another person or an organisation [45]. However, the NICE Study [46] did
not focus on PwDs.
14 EnCoRe – Ensuring Consent & Revocation Project:
html (visited on 31/09/2015). The details of the process are described in deliverable D2.3Third En-
CoRe Technical Architecture:
D2_3_EnCoRe_Architecture_V1.0.pdf (visited on 31/09/2015).
withdraw her consent, follow-up on the use of her data and the results of the study,
or be available for subsequent contact for data re-use [47]. Eventually, other personal
preferences or advance directives may also be included in this information container.
The container would then serve as a logbook of information over the lifespan of a person.
When used in relation to research with PwDs, dynamic consent may introduce more
data into the process of obtaining consent. Having more data may be beneficial by
providing a record of the PwD’s former wishes as either a form of advanced directive or
to inform decisions made with substituted consent. Having more data may also generate
more issues and unresolvable complexities in the decision-making process. Therefore,
even such long-term record of the preferences and evolution of a PwD’s advance direct-
ive provided by the dynamic consent framework is unlikely to provide solutions for the
specific issues with PwDs already described.
Dynamic consent may be interpreted as a merger of rolling informed consent and ad-
vance directives with the utilisation of modern technologies. The benefit of using tech-
nology is that it may alleviate some of the burdens of healthcare professionals. However,
the use of technology always involves the danger of unidirectional information disclos-
ure and consent, without the presence of a trained professional. This may generate
additional issues in relation to the cognitive impairment of PwDs.
5 outstanding informed consent issues
This section highlights some further ethical issues related to informed consent from
PwDs that need more attention and analysis in future medical research and clinical
practice with ATs.
5.1Informed Consent of Third Parties
ATs with recording abilities have boosted research with participant-created data, allow-
ing the shift from researcher-created datasets to more automated participant-created
datasets. ATs deployed in the dwellings of research participants may also capture data
on visitors or other persons who have not consented to participate in a research study.
The presence of third parties (e.g. family, cohabitants, friends, etc.) is an issue because
these people are not given the opportunity to provide informed consent before their
presence is captured within the dwelling of the research participant, where the research
is being conducted. In cases like these, third parties may not be fully aware of the on-
going recording. Kelly et al. [48] concede that this might pose serious ethical and legal
issues. However, a distinction is often applied regarding the focus of the research, which
is on the participant and not on any third parties incidentally recorded. Kelly et al. [48]
note that, nevertheless, the ethical standard of respect for autonomy directs that the pri-
vacy of third parties must be protected. Even if the study is designed to investigate the
influence on the research participant by third parties (e.g. behaviour in group settings),
the anonymity of these third parties should be preserved [48].
To tackle such unwanted recordings, Kelly et al. suggest that participants must be
given the chance to review and delete unwanted recordings before the researcher views
them [48]. However, PwDs may unavoidably become ignorant about the lack of con-
sent from third parties, or may forget to review the recordings. The lack of additional
literature on this issue suggests that further investigation is needed into alternative ap-
proaches to solving the problem of informed consent from third parties in research using
data capture.
5.2Autonomous Technology
One of the crucial attributes of certain ATs, especially AAL technologies, is their ability
to disappear into the background of the environment. Sensor technologies may collect
data and respond to certain events or states in an automated manner. PwDs using
ambient technologies may forget their presence, during which time, ATs may perform
undesirable tasks.
The automated and autonomous nature of these technologies poses ethical risks to
the PwDs [49]. They might expose PwDs, due to their inability to fully comprehend
the extent of the data collection and transmission by ICT, to misuse, criminal activities,
privacy breaches, or dehumanising treatment [49]. In addition, PwDs could be stripped
of their freedom to make decisions, making them the only group of people without this
right [39]. Undesired activity by ATs may also be detrimental in dementia management,
as it could cause anxiety in PwDs (e.g. issues of ‘false alarms’ [50], ICT’s ‘life of their
own’ [51], etc.).
Even if ATs were to require consent from the PwD, the danger persists that, within
a shared dwelling, consent is provided illegitimately by somebody else (e.g. carer, etc.).
Thus, an unobtrusive authentication of the PwD for consent will be needed.15 Even
by introducing these precautionary measures, the question of autonomous ICT and the
requirement for consent remains unresolved. Therefore, further research is required for
more focused and detailed insight into the extent to which the needs of PwDs can be
served by autonomous decisions made by ICT. The research should target the use of
autonomous devices in particular contexts, i.e. when such activity is acceptable for the
person compared with when it is not, e.g. when it results in disturbing the person. Also,
more research is needed to establish valid proportionality between the need for (and the
degree of) autonomous ICT and the requirement of informed consent from PwDs for
certain actions. Such research should also seek to identify how often consent should be
sought from PwDs during research and/or clinical practice.
5.3Information Overload
PwDs are more vulnerable to information overload [52,53], which may occur during
the acquisition of informed consent. Information overload might be addressed to some
extent by the division of information into smaller, more digestible blocks, distributed
across a longer timeline. However, despite all these efforts, information overload cannot
be completely avoided, due to the condition of PwDs. One consequence of information
overload may be the problem of routinisation [54]. Studies show that even healthy vo-
lunteers often provide or refuse informed consent as a result of an unreflective, habitual
act performed on electronic devices [5456].
15 Achieving this may be challenging because of the possible forgetfulness of PwDs. For this reason, authen-
tication by fingerprint-reading, voice- or face-recognition may be preferable.
Therefore, during the acquisition of informed consent, there needs to be an appropri-
ate, and personalised, balance of information, tailored to every individual PwD. Such
a requirement also means that the information should be interactively and dynamically
adjusted to the actual state of the PwD, taking into consideration their competence and
other faculties, in order to successfully and ethically obtain informed consent.
More research is needed into how routinisation affects PwDs. Further research is also
required to more precisely determine what represents under-information and informa-
tion overload for PwDs.
5.4The Seemingly Infinite Memory of Lifelogs
ATs may also function as lifelogs.16 Lifelogs, due to their ‘seemingly infinite memory’
capabilities, are not only perfect for logging information about health status, physiolo-
gical data, or other relevant health information, but are also useful for storing the con-
sent and previously expressed wishes and preferences of individuals. While one might
expect this to be especially beneficial for forgetful PwDs, this may not be necessarily so.
Generally, forgetting is an intrinsic form of controlling one’s memory [57]. With the
utilisation of lifelogs, this control may be lost. As an intrinsic part of human nature, one
might prefer to forget certain memories. However, lifelogs may prevent people from
forgetting. This might result in distress, depression and/or anxiety. Analogously, if
the previous consent of the PwD is always remembered and recorded, it may not be
easily changed in cases of diminishing competency. Therefore, it would be important
to regularly renew the consent of PwDs. Regular requests for consent can reinforce the
PwD’s feeling of control over the ATs, and their own care, and reaffirm their feeling
of security. However, seeking consent too often may be burdensome and upsetting
for PwDs. Therefore, an individually tailored approach that strikes the right balance
needs to be developed for the consent-seeking process, with the emphasis on avoiding
causing anxiety, routinisation, or reducing acceptability. These conditions impose high
requirements on researchers and developers of ATs.
More research is required on how an adequate amount of relevant information can be
provided by ATs, while respecting the PwD’s personal needs and condition.
5.5Compelling Security Upgrades and Remote Updates
Recent developments in ICT revealed other issues related to consent, the level of control
of ICT devices, and the security of their users. A series of recently discovered security
issues (i.e. bugs, security vulnerabilities)17 forced operating system developers to en-
courage their users to upgrade to newer systems. These newer operating systems come
with higher security protection, official support, upgraded user-interfaces, new function-
alities and different behaviours compared with their previous versions. These changes
require study and adjustments of workflows for users, which PwDs cannot perform.
Being single rather than corporate users, PwDs lose the official support from IT com-
panies by not upgrading their systems. Due to their inability to upgrade the systems on
their devices, they also lose control over their private and medical data that are stored
16 Lifelogs are a form of pervasive computing, which consist of unified, digital records [57].
17 For example, most of the systems were affected by the security exploit, FREAK (Factoring RSA Export
Keys): (visited on 28/10/2015).
in these devices, thus exposing these to hackers. These issues should be included in
consent forms when offering treatment with ATs.
Moreover, there is the issue of autonomous technology. To provide end-users with the
strongest security protection possible, companies offer remotely controlled automatic
updates to their operating systems.18 A PwD, unaware of the differences introduced
by the new system into her workflow, may face extreme difficulties after such pseudo-
intentional consent. Although the PwD may have ‘consented’ to such an upgrade (in
hope of greater security), in the end she may find herself so unfamiliar with the up-
graded system that it becomes unusable. This may result in increased anxiety, poorer
dementia management, a greater digital divide and the loss of computer-using function-
ality in PwDs. The support behind ATs must, therefore, include the need for long-term
and system-wide support of the ICT devices deployed to PwDs.
More research is needed into the provision of ICT for PwDs, including how to address
the digital divide. This should involve the investigation of how to better provide security
updates and long-term ICT support, maintain the PwD’s familiarity with ICT systems,
and the development of easy-to-use technologies for cognitively impaired persons.
5.6Placebo-effect of ATs
Informed consent is closely related to the issue of using placebos in research. Placebos
are inert substances or treatments, used both in treatment and clinical research [58]. The
term placebo-effect is the result of all verbal, non-verbal communication, and rituals of
therapy, where the efficacy is not derived from any pharmacological or physiological
intervention [59]. Despite the fact that the UDBHR [7] does not explicitly specify the
role of informed consent in the use of placebo during treatment or research, studies
involving ATs may have outcomes that could be identified as placebo-effects.
One example may be the well-publicised robotic harp seal, PARO (comPAnion RObot),
which interactively responds and expresses emotions to a patient, just as a real animal
does during animal-assisted therapy [60]. These therapies have demonstrated reductions
in emotional, behavioural, and psychological symptoms, lowering agitation levels and
improving the mood of PwDs [60]. However, the validity of these treatments may be
questioned because they are assumed to have placebo-effects or novelty-effects, demand
characteristics, experimenter expectancy effects, or informant bias [60].
There is a dearth of literature investigating the placebo-effect of ATs. Research is
needed to determine whether ATs have placebo effects and if so, what consequences
this would introduce into the care of PwDs using ATs.
6 recommendations
As a result of the analysis presented in this Chapter, the following recommendations are
proposed. Informed consent interpreted solely on the basis of legal requirements should
be avoided, especially with PwDs. The diagnosis of dementia should not automatically
imply lack of competence to provide informed consent. Incompetent PwDs, in the ‘grey
18 Such automatic upgrade, with minimal need for user input, has been recently advertised: upgrades-now- automatic/ (visited
on 30/10/2015).
zone’ of informed consent may retain sufficient capacity to provide consent or assent.
Strict adherence to regulations can result in harmful and unethical consequences.
If research can be conducted with healthy, or at least competent, volunteers instead of
vulnerable populations, such as PwDs, it should be. In accordance with the UDBHR [7],
research with persons who lack the capacity to consent should only be allowed if there is
direct health benefit to those participants, and if no comparable study can be undertaken
with participants able to consent.
Traditional (rolling informed consent, advanced directives) and alternative methods
(delayed informed consent, dynamic informed consent) should be used to obtain in-
formed consent from PwDs. Combining informed consent methods (and modern tech-
nologies) may prove helpful in recording the preferences of PwDs over a longer period
of time, e.g. in clinical practice, the recording of an advance directive at the time of
diagnosis may be combined with the application of delayed consent, to extend the auto-
nomy of PwDs without the need for substituted consent. Similarly, consent of PwDs
in clinical research obtained by rolling informed consent may be combined with data
obtained with dynamic consent. Combined methods are more likely to reflect the spe-
cial conditions and needs of PwDs, and may also improve the validity of the informed
consent obtained. In general, the development of better consent methods and proced-
ures should be encouraged, in order to achieve the highest ethical standards possible for
informed consent from PwDs.
It is the responsibility of the researcher(s) to assess whether the PwD’s competency
has changed during the research study, and to conduct the research in compliance with
the requirements of the UDBHR [7]. This should also be reflected in the study design.
It would be advisable to appoint an independent adviser or mediator, to support the
PwDs and be responsible for the protection of their safety, welfare and interests during
the research study.
ATs do not essentially alter the criteria of informed consent; however, the issues of
consent of third parties, partial or full autonomy of ATs, information overload, infinite
memory of lifelogs, safety and security while preserving the usability of ATs for PwDs
will need to be investigated further. Similarly, research studies investigating the poten-
tial placebo-effect of ATs should be established.
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As geographers, we often work with personal data, meaning that the European Union’s General Data Protection Regulation (GDPR) can have a major impact upon our research. The GDPR is a set of legal requirements that serves to ensure the protection of personal data. In this paper, we reflect on our experiences of how the GDPR impacts upon the planning and conduct of (international) geographical research; and develop good data protection practices for geography. In so doing, we explore the Data Protection Impact Assessment (DPIA) as a method to explore data protection and privacy issues and discuss three relevant issues for geographers in relation to the GDPR: (1) informing research participants; (2) data management; and (3) international collaboration. Although it is time-consuming to make a project ‘GDPR proof’, the process helps researchers to thoroughly think through its privacy implications at an early stage. Thus, the GDPR does not make geographical research impossible, but rather contributes to making it more effective and fairer.
Edited by four leading members of the new generation of medical and healthcare ethicists working in the UK, respected worldwide for their work in medical ethics, Principles of Health Care Ethics, Second Edition is a standard resource for students, professionals, and academics wishing to understand current and future issues in healthcare ethics. With a distinguished international panel of contributors working at the leading edge of academia, this volume presents a comprehensive guide to the field, with state of the art introductions to the wide range of topics in modern healthcare ethics, from consent to human rights, from utilitarianism to feminism, from the doctor-patient relationship to xenotransplantation. This volume is the Second Edition of the highly successful work edited by Professor Raanan Gillon, Emeritus Professor of Medical Ethics at Imperial College London and former editor of the Journal of Medical Ethics, the leading journal in this field. Developments from the First Edition include: The focus on 'Four Principles Method' is relaxed to cover more different methods in health care ethics. More material on new medical technologies is included, the coverage of issues on the doctor/patient relationship is expanded, and material on ethics and public health is brought together into a new section.
The SAGE Handbook of Healthcare Ethics is an influential collection of work by leading scholars on the fundamental and emerging themes which define healthcare ethics. This authoritative Handbook brings together experts with backgrounds in philosophy, sociology, law, public policy and the health professions and reflects the increasing impact of globalization and the dynamic advances in the fields of bioscience and genetics, which keep ethics at the centre of debates about the future direction of healthcare. Combining international and interdisciplinary perspectives, the Handbook provides a cutting-edge account of debates in five key areas: Health Care Ethics in an Era of Globalization; Beginning and End of Life; Vulnerable Populations; Research Ethics and Technologies; Public Health and Human Rights.
The doctrine of informed consent is now recognized worldwide through several international guidelines and normative instruments. Based on respect for the dignity and autonomy of patients and research participants, it has been the subject of numerous publications for quite some time. In a globalized world where a variety of spiritualities and cultures are in close contact, the subject is discussed at length with respect to how it can be applied in all contexts, particularly in the context resulting from recent scientific and technological developments, especially in genetics and genomics. More specifically, the meaning and scope of the word “informed” is questioned more and more depending on the individual, group, or country to which it applies. This chapter examines the various challenges raised in the literature related to the use of this concept in a globalized world. It postulates that the answers to questions are not definitive, and that each possible solution must be based on the dialogue between all involved and on the respect and autonomy of the individual, even if the decision-making process may vary depending on the context in which research and medicine are practiced.
This contribution describes how the compendium is ordered and structured in presenting the major issues and controversies in current-day global bioethics. After briefly explaining the emergence of global bioethics as well as the growing involvement of international organizations, it is pointed out how the United Nations Educational, Scientific and Cultural Organization (UNESCO) is active since more than two decades in the field of bioethics. These activities have led to the unanimous adoption in 2005 of the first international legal document in global bioethics, the Universal Declaration on Bioethics and Human Rights. The Declaration presents 15 ethical principles for global bioethics. It is the framework of these principles that provides the structure of the compendium. The main question addressed in this volume (Compendium of Global Bioethics) is whether and how these global principles are applied within the heterogeneous contexts of different countries with various religions and traditions.
A conflict arises in the clinic over the care of a critically ill, incapacitated patient. The clinicians and the patient’s family confront a difficult choice: to treat or not to treat? Decisions to withdraw or withhold life-sustaining treatment feature frequently in the courts and in the world's media, with prominent examples including the cases of Charlotte Wyatt, in the UK, and Terri Schiavo, in the USA. According to legislation like the Mental Capacity Act 2005, the central issues are the welfare (or ‘best interests’) of the patient, alongside any wishes they might have conveyed, via an ‘advance directive’ or through the appointment of a ‘lasting power of attorney’. Richard Huxtable argues that the law governing both welfare and wishes frequently fails to furnish clinicians and families with the guidance they require. However, he finds this unsurprising, given the competing ethical issues at stake. Huxtable proposes that there is a case for ‘principled compromise’ here, such that the processes for resolving principled disputes take precedence. He argues for greater ethical engagement, through a reinvigorated system of clinical ethics support, in which committees work alongside the courts to resolve the conflicts that can arise at the limits of life. Providing a comprehensive account of the law pertaining to children and adults alike, and distinctively combining medico-legal and bioethical insights, this book engages scholars and students from both disciplines, as well as informing clinicians about the scope (and limits) of law at the limits of life.