How is informed consent related to emotions and empathy? An exploratory neuroethical investigation.
ABSTRACT Informed consent is crucial in daily clinical practice and research in medicine and psychiatry. A recent neuroethical investigation explored the psychological factors that are crucial in determining whether or not subjects give consent. While cognitive functions have been shown to play a central role, the impact of empathy and emotions on subjects' decisions in informed consent remains unclear.
To evaluate the impact of empathy and emotions on subjects' decision in informed consent in an exploratory study.
Decisional capacity and informed consent to a subsequent imaging study were evaluated with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Empathy and emotion recognition were measured with the Multifaceted Empathy Test (MET) and the Florida Affect Battery (FAB).
Psychiatric subjects were recruited from a general psychiatric hospital and a forensic state hospital.
A mixed group of 98 healthy men and forensic and non-forensic psychiatric subjects were investigated.
Both empathy (MET) and emotion recognition (FAB) correlated with MacCAT-CR scores. Higher cognitive empathy and good emotion recognition (compared with low empathy and emotion recognition) were associated with increased decisional capacity and higher rates of refusal to give informed consent.
This study shows an empirical relationship between decision-making and informed consent, on the one hand, and emotions and empathy on the other. While this study is exploratory and preliminary, the findings of a relationship between informed consent, emotions and empathy raise important neuroethical questions with regard to an emotional-social concept of informed consent and potential clinical implications for testing informed consent.
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ABSTRACT: Only competent persons can give informed consent to health care. Current approaches define competence in essentially cognitive terms, thereby ignoring the fact that someone may be cognitively competent yet lack the capacity to give a valid consent. I outline a more robust theory of competence that includes not only cognitive but also emotional and valuational parameters. I then distinguish competence from capacity, and indicate the role this distinction can usefully play in the extended and continuing care setting. I also show how this distinction is consistent with several recent Canadian legal decisions, and outline its usefulness in interpreting and applying relevant provincial statutes.Canadian journal on aging = La revue canadienne du vieillissement 02/2005; 24(3):295-304. · 0.92 Impact Factor
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ABSTRACT: A central ethical issue in schizophrenia research is whether participants are able to provide informed consent, particularly for protocols entailing medication washouts or placebo treatments. Few data show how patients with schizophrenia and psychiatrists assess such scientific designs regarding potential harm, willingness to participate, and the relative influence of clinicians, family members, and financial incentives upon participation decisions. In this preliminary study, structured interviews were conducted with schizophrenia patients (N=59), and parallel surveys were completed by attending and resident psychiatrists (N=70). Four hypothetical research protocols were rated. Patients were asked about their own views; psychiatrists provided both their personal views and predictions of patient views. Patients and psychiatrists both perceived substantially different levels of harm across the four protocols, identifying significantly greater harm for medication washouts or placebo treatments. Participants were less willing to enroll in protocols perceived as more harmful. Schizophrenia patients found enrollment decisions relatively easy. Patients and psychiatrists indicated that doctor recommendations, monetary incentives, and, to a lesser extent, family preferences had a mild influence on participation decisions. Given hypothetical protocols with variable design elements, schizophrenia patients and psychiatrists made meaningful and discerning harm assessments and participation decisions. These findings suggest that schizophrenia patients may have strengths in the research consent process that may not be fully recognized. The impact of outside influences upon research enrollment decisions remains uncertain. While psychiatrists were often accurate in predicting patient responses, data suggest the importance of clarifying views of individual patients regarding specific protocols.American Journal of Psychiatry 05/2002; 159(4):573-84. · 14.72 Impact Factor
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ABSTRACT: Uncertainty regarding the degree to which persons with schizophrenia may lack decision-making capacity, and what the predictors of capacity may be led us to examine the relationship between psychopathology, neurocognitive functioning, and decision-making capacity in a large sample of persons with schizophrenia at entry into a clinical trial. In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial, a clinical trial sponsored by the National Institute of Mental Health designed to compare the effectiveness of antipsychotic drugs, subjects were administered the MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) and had to demonstrate adequate decision-making capacity before randomization. The MacCAT-CR, the Positive and Negative Syndrome Scale (PANSS), and an extensive neurocognitive battery were completed for 1447 study participants. The neurocognitive composite score and all 5 neurocognitive subscores (verbal memory, vigilance, processing speed, reasoning, and working memory) were positive correlates of the MacCAT-CR understanding, appreciation, and reasoning scales at baseline. Higher levels of negative symptoms, but not positive symptoms, were inversely correlated with these three MacCAT-CR scales. Linear regression models of all three MacCAT-CR scales identified working memory as a predictor; negative symptoms made a small contribution to the understanding and appreciation scores. Negative symptoms and aspects of neurocognitive functioning were correlated with decision-making capacity in this large sample of moderately ill subjects with schizophrenia. In multiple regression models predicting performance on the MacCAT-CR scales, working memory was the only consistent predictor of the components of decision-making capacity. Individuals with schizophrenia who have prominent cognitive dysfunction, especially memory impairment, may warrant particular attention when participating in research.Schizophrenia Research 01/2006; 80(1):1-8. · 4.59 Impact Factor
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What is neuroethics? Empirical and theoretical neuroethics
The recent progress in neuroscience has led to ethical
questions concerning the emergence of a novel field,
neuroethics. Neuroethics can broadly and preliminarily
tific observations and ethical concepts. Roskies  dis-
tinguished between ethics of neuroscience and neuro-
science of ethics. The ethics of neuroscience deal with
ethical problems in neuroscience arising from new forms
of ethics investigates the neural mechanisms that
may possibly underlie ethical concepts and practices
like informed consent, moral judgment, free will, and
No sharp distinction exists between the neuroscience of
ethics and the ethics of neuroscience. Consider the
example of informed consent: How valid is the informed
consent of patients whose cognitive and emotional
capacities are altered or deteriorated by the nature of
their disorder, as, for instance, in dementia or schizo-
phrenia? This is an issue in the domain of ethics of
neuroscience. It has also triggered empirical investi-
gations of those cognitive and neural functions that are
implicated in giving a valid informed consent that falls
more into the domain of neuroscience of ethics (see  as
well as [3??]).
Another such example where neuroscience of ethics and
ethics and neuroscience converge is the recent discussion
about moral judgment. What is a moral judgment and
how does it affect our ethical decisions in the current
neuroscience? The question about the nature of moral
judgment has triggered many neuroscientific investi-
gations of the neural mechanisms underlying moral judg-
ment (see ) that touches upon the neuroscience of
ethics. However, the focus on the impact of moral judg-
ment on our ethical decisions in neuroscience may rather
be considered a question for the ethics of neuroscience.
The discussion of moral judgment thus provides one
possible node point where both neuroscience of ethics
and ethics of neuroscience intersect and converge.
Although a clear-cut distinction between neuroscience of
ethics and ethics of neuroscience seems to remain
unclear, they share their focus on empirical issues; be
they predominantly neuroscientific, as in the neuro-
science of ethics, or rather practical or ethical, as in the
ethics of neuroscience. One may consequently subsume
both ethics of neuroscience and neuroscience of ethics
under the umbrella what may be called empirical neu-
roethics. The first aim of my paper is to highlight some
recent development in empirical neuroethics, thereby
focusing on informed consent and moral judgment.
Empirical neuroethics focuses on the empirical, that is,
psychological and neural conditions that may underlie
ethical concepts like informed consent, free will, and
Canada Research Chair for Mind, Brain and
Neuroethics, Michael Smith Chair for Neuroscience
and Mental Health, Institute of Mental Health
Research, University of Ottawa, Ottawa, Ontario,
Correspondence to Georg Northoff, Institute of Mental
Health Research University of Ottawa, 1145 Carling
Avenue, Ottawa, ON K1Z 7K4, Canada
Tel: +1 613 722 6521; fax: +1 613 798 2982;
Current Opinion in Psychiatry 2009, 22:000–000
Purpose of review
Neuroethics is a recently emerging field that deals with predominantly empirical
and practical issues of ethics in neuroscience. In contrast, theoretical and
methodological considerations have rather been neglected and thus what may be
called theoretical neuroethics.
The review focuses on informed consent and moral judgment as examples of empirical
neuroethics and norm–fact circularity and method-based neuroethics as issues
of a theoretical neuroethics.
It is argued that we need to consider theoretical and methodological issues in order
to develop neuroethics as a distinct discipline, which as such can be distinguished
from both philosophy/ethics and neuroscience.
informed consent, method-based neuroethics, moral judgment, norm–fact circularity
Curr Opin Psychiatry 22:000–000
? 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins
0951-7367 ? 2009 Wolters Kluwer Health | Lippincott Williams & WilkinsDOI:10.1097/YCO.0b013e32832e088b
CE: Namrta; YCO/200430; Total nos of Pages: 5;
Informed consent and emotions
Informed consent is crucial in clinical scientific studies of
healthy individuals and psychiatric patients. This has led
to an extensive research of the factors and functions
that is, whether they accept, refuse, or remain ambivalent
about study participation (see [2,5–13]). Giving informed
consent requires the capacity to make a decision, that is,
decision making [7,8,12–20]. Decision making is a com-
plex process that involves both cognitive and affective
functions, as pointed out by recent neuroscientific
Cognitive functions in decision making concern atten-
tion, working memory, executive functions, and others
(see [7,8,13–20,23]). More specifically, the capacity to
make a decision in informed consent, the so-called deci-
sional capacity, involves cognitive functions like under-
standing, appreciation, and reasoning. These cognitive
functions and, therefore, decisional capacity have
recently been systematically investigated with the
MacArthur Competence Assessment Tool for Clinical
Research (MacCAT-CR) [5,11]. The MacCAT-CR
focuses predominantly on cognitive functions like under-
that are supposedly implicated in the decisional capacity
for informed consent.
In addition to cognitive functions, decision making in
general and decisional capacity in informed consent in
particular involve empathy and emotions [2,6,9,10,21,
22,24]. Empathy describes the ability to share another
person’s cognitive and emotional inner life (see [25,26,
27?,28,29??,30,31]). Empathic sharing between the con-
senting individual and the investigator may be crucial in
determining decisional capacity and ultimately the con-
sent itself. This is possible only when the consenting
person is able to recognize the investigator’s emotions,
thus requiring emotion recognition . In contrast to
cognitive functions, the impact of empathy and emotion
recognition on decisional capacity and the consent pro-
cess has yet to be investigated empirically.
The involvement of specific cognitive and affective
functions in informed consent may also provide some
clues about its possible underlying neural mechanisms.
Cognitive functions like working memory and attention
arewell knowntobeassociated withneuralactivityinthe
lateral prefrontal cortex, whereas emotional functions
rather involve medial cortical and subcortical regions
[33,34]. If so, the balance between, for instance, medial
and lateral prefrontal cortical functions may be crucial in
constituting the kind of decision making that is crucial in
informed consent. Interestingly, recent imaging studies
demonstrated reciprocal modulation between neural
activity in medial and lateral prefrontal cortex during
affective and cognitive functions . This suggests that
a valid informed consent may be necessarily (though not
sufficiently) dependent on a specific balance between
affective and cognitive functions and thus between
medial and lateral prefrontal cortex. If the medial–lateral
prefrontal cortical neural activity is altered and unba-
lanced, as, for instance, in depression and schizophrenia
(see [35,36??,37]), the constitution of decision making
implicated in informed consent may be affected. This in
turn may diminish the validity of the consent. Such
scenario remains highly speculative though at this point
because no imaging study during the decision making of
informed consent has yet been conducted.
We make moral judgments daily like whether we should
help the person in front us to get up to his feet even if it
means that we would then come too late to work, entail-
ing possible rebuff by the boss. These kinds of situations
present us with a moral dilemma whether we should act
in the interest of others or rather according to our own
goals and interests. Various imaging studies [4,38,39,40?]
presented sentences where persons described moral
dilemma situations where they had to choose between
self-interest and moral decisions, that is, decisions that
were in favor of other persons rather than their own.
These imaging studies revealed the regions that are
particularly active during moral action and judgment.
Various studies (see [4,38,39,40?]) demonstrated the
involvement of the medial prefrontal cortex (MPFC)
and the ventral striatum in moral judgment.
This, however, raises several problems. The above-men-
tioned regions, the MPFC and the ventral striatum, are
not only involved in moral judgment but also in various
other processes ranging from emotion, mentalizing with
inference of other’s mental states, learning of reward
contingencies (reward representation), and thinking
about one’s own mental states resulting in self-awareness
(see  for an overview). This raises not only the
question about the anatomical specificity of these regions
for moral judgment but also about the psychological
components implicated in moral judgment.
Does moral judgment implicate various psychological
functions as diverse as learning, reward, mental state
attribution, theory of mind, and so on? How can we
characterize moral judgment in both psychological and
neural terms? The above-mentioned studies clearly
indicate that emotions and empathy are central psycho-
logical processes in moral judgment (see also ). What
does this imply in ethical regard? Does this mean that
people with deficits in emotions and empathy show
reduced moral judgment? Psychopaths show indeed
severe deficits in their own emotions and the sharing
and understanding of other’s emotions, empathy that also
History and philosophy
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seems to go along with deficits in medial prefrontal
cortical activation. Does this mean that they are unable
to make appropriate moral judgments? In the case of
psychopaths, this is certainly true at a behavioral level, as
they do indeed often commit crimes, thereby remaining
unaffected by both own and others’ emotions. One would
consequently hypothesize that psychopaths who com-
mitted crimes may show severe deficits in medial pre-
frontal cortical activity during moral judgment. This
remains to be tested though in future empirical studies.
In contrast to the empirical issues, theoretical issues
have largely been neglected in current neuroethics.
How does the kind of ethical concept, as presupposed
in neuroethics, impact both practical issues of its
application in neuroscience and study designs for the
investigation of its neural correlates? And how do the
empirical findings in both ethics of neuroscience and
neuroscience of ethics impact the definition of the
ethical concept in question? This raises also a more
methodological rather than a conceptual issue. How
can we make the translation between ethical concepts
and neuroscientific findings? We do need predefined
rules and valid methodological strategies for linking
ethical concepts and neuroscientific findings. These
conceptual and methodological issues may be subsumed
under the umbrella of theoretical neuroethics. The
second aim is to provide a brief discussion of conceptual
and methodological issues that fall into the domain of
Empirical neuroethics deals with the empirical and
practical aspects of the linkage between neuroscientific
focuses on the methodological and conceptual aspects of
such linkage that allow to link ethical concepts and
neuroscientific facts and thus descriptive and normative
various issues in empirical neuroethics, the discussion of
methodological and conceptual issues and thus theor-
etical neuroethics has remained rather sparse so far.
Owing to the vital importance of these issues for the
future mapping of neuroethics as a distinct and separate
discipline in its own right, I want to devote the second
part of this review to a brief account of theoretical
Methodological confusions between norms and facts
Are moral judgments ‘located’ in the above-mentioned
regions? Is moral judgment nothing but the neural
activity in these regions? This is no longer an empirical
question but one that touches upon conceptual and
methodological issues that fall into the domain of what
I call theoretical neuroethics.
and informed consent must be hybrids, conceptual
hybrids as I call them. A conceptual hybrid denotes a
single concept that contains or implies two or more
different types of concepts, as for instance normative
and descriptive concepts. Neuroethical concepts may
be characterized as conceptual hybrid, as they are neither
purely normative concepts, as for instance concepts from
philosophical ethics, nor purely descriptive, as concepts
in neuroscience. The hybrid nature of neuroethical con-
cepts thus consists in the linkage between normative and
descriptive dimensions, that is, between norms and facts.
One may go even one step further and argue that this
linkage between norms and facts defines neuroethical
concepts as neuroethical. If there is no such norm–fact
linkage, neuroethical concepts would degenerate either
into ethical and thus purely normative concepts or neu-
roscientific concepts as seemingly purely descriptive.
To identify moral judgment with activity in specific brain
regions is thus to commit two confusions. First, one
confuses the necessary conditions, that is, the neural
mechanisms, and what they condition, that is, the moral
judgment as the result. This also implies that one may
neglect the difference between necessary and sufficient
conditions and to regard the neural facts not only as
necessary but also as sufficient condition.
Second, one also confuses descriptive and normative
components of moral judgment. The neural observations
describe facts, the descriptive component, whereas the
moral judgment also implicates a normative component
that goes beyond the descriptive component by referring
to normative dimensions. If one now infers what kind of
brain state is morally correct from the empirical findings
about moral judgment, one confuses descriptive and
normative components and thus facts and norms. This
is problematic though, as one cannot infer the latter, that
is, norms, from the former, that is, facts, which would
mean to neglect their principal difference.
Linkage between norms and facts in neuroethical
The question is now how we can link the two different
dimensions, norms and facts, within the neuroethical
concepts. We have different choices. One may disregard
the normative level and reduce it to the factual one;
ethical norms are then unilaterally replaced by neural
facts, that is, unilateral replacement. This, however, is to
neglectthe principaldifference between norms and facts.
Alternatively, one may accept the norm–fact distinction
and consider norms and facts in a parallel or bilateral way,
resulting in what may be called bilateral parallelism.
and bilateral parallelism, do not do justice to the close
Empirical and theoretical neuroethics Northoff 3
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intertwining of ethical concepts and neuroscientific
observations in the current neuroethical debate. Unilat-
eral replacement of norms in favor of facts falls short of
considering the idiosyncratic nature of the normative
component when compared to the descriptive one. As
pointed out in the second confusion, we cannot infer
norms from facts. However, bilateral parallelism falls
short of taking into account the close interdependence
between normative and descriptive components and
thus between norms and facts. The current neuroethical
debate in general and the above-described examples
of moral judgment and informed consent in particular
point out that changes inone,as for instancethedescrip-
tive component, may entail changes in the other, the
What we need is a methodological strategy to link norms
and facts, that is, ethical concepts and neuroscientific
findings, in a much closer and tighter way without falling
into either unilateral replacement or bilateral parallelism.
We may need to devise systematic methodological strat-
account for their principal difference as well as for their
One such methodological strategy may be to go back and
forth, that is, to circulate or oscillate between ethical
concepts and neuroscientific findings and thus between
norms and facts; I call this ‘norm–fact circularity’. How
can we briefly define such norm–fact circularity’?
The usual starting point of empirical neuroethics is an
ethical concept that is linked to neuroscientific obser-
concept, as neuroscience of ethics, or to reveal its
relevance in neuroscientific research, as in ethics of
neuroscience. What, however, is often neglected is
how this first encounter of ethical concepts with neuros-
cientific observations bears upon the ethical concept
itself. What is implied for the concept of informed con-
sent if informed consent is driven empirically by
emotions and empathy rather than cognitive functions?
What does the fact of emotion/empathy imply for the
norms inherent in informed consent? Do we have to
conceptualize the linkage between norms and facts in
informed consent (and moral judgment) in a different
way if emotions/empathy are predominant rather than
We may thus make conceptual modifications in neu-
roethical concepts depending on the neuroscientific find-
ings. This then makes the initial ethical concept a truly
neuroethical concept in a literal rather than merely
figurative sense. The circularity between ethical con-
cepts and neuroscientific findings goes, however, one
step further. The revised and modified neuroethical
concepts may make different empirical approaches and
study designs in subsequent neuroscientific investi-
gations necessary in order to raise further empirical sup-
port. There is such circularity or a loop between ethical
concepts and neuroscientific findings and thus between
norms and facts – I call this ‘norm–fact circularity’.
describes a methodological strategy to account for the
close interdependence between norms and facts without
neglecting their principal differences. As such, it aims to
describe how normative and descriptive dimensions
in neuroethical concepts can be linked to each other in
a systematic way that goes beyond mere intuitive con-
nection as in bilateral parallelism or unilateral replace-
ment. What is needed in the future is the development of
a systematic method that details the different steps
norm–fact circularity by giving exact methodological
prescriptions and measures of validity and reliability.
One may now argue that such ‘systematic norm–
fact circularity’ is a merely theoretical playground
methodology. If neuroethics wants to establish itself as a
separate discipline that is different from its neighboring
disciplines like philosophy, ethics, and neuroscience, it
must develop a special methodology.
Only the development of a specific methodology (or even
several methodological strategies) will allow neuroethics
to establish itself as a discipline with its own rights as
different from philosophy/ethics and neuroscience. As
such, it needs to be based more on a (or seven several)
specific methodological strategy(ies) rather than a certain
result, as for instance in unilateral replacement with the
consequently speak of a method-based neuroethics as
distinguished from result-based neuroethics.
I here gave a brief review of the distinct aspects or
dimensions being prevalent in current neuroethics.
These included empirical aspects that focus on the
practical and empirical issues arising form the encounter
between ethical concepts like moral judgment and
informed consent and neuroscientific findings as in
emotions and empathy. Such neuroethical encounter
presupposes the principal possibilityoflinking normative
and descriptive dimensions and thus norms and facts.
The second part of the review, therefore, focused on
some often neglected theoretical and methodological
issues on how facts and norms can be linked in an
interdependent way without neglecting their principal
difference. This makes the elaboration of systematic
History and philosophy
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methodological strategies as specific neuroethical necess-
ary, which may then provide the ground for the future
development of a truly method-based neuroethics.
References and recommended reading
Papers of particular interest, published within the annual period of review, have
been highlighted as:
Additional references related to this topic can also be found in the Current
World Literature section in this issue (pp. 000–000).
of special interest
of outstanding interest
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Empirical and theoretical neuroethics Northoff5
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QUERIES: to be answered by AUTHOR/EDITOR
<AQ1> Please check whether the intended
meaning of the sentence is retained after
making the edits.
<AQ2> Please update Ref. .
<AQ3> Please provide the complete
bibliographic details in Ref. .