The Concept of Informed Consent and its Concrete Application in
International Bioethics
Florian Braune
Introduction
The increasing number of international cooperations in health care and health research
require a common ethical basis. Normative documents like declarations or guidelines
have to rely on bioethical key concepts that can serve as a cross-cultural basis.
The concept of Informed Consent is generally accepted in international declarations.
Some documents referring to international ethical codes including the concept of
Informed Consent are the Nuremberg Code, the Declaration of Helsinki (in particular
the version Edinburgh) and the 1981 International Standards on Biological Medical
Research Involving Human Subject issued by CIOMS. Based on the international
documents cited above, several guidelines and declaration were passed on a national
level.
Informed Consent stands for a key concept of bioethical practice, formulating a
condition for medical intervention, for therapy and research. With the help of this
concept, dignity and respect towards the affected person is to be guaranteed. Informed
Consent is based on the concept of individual autonomy grounded in Western
Philosophy. However, whilst in western society respect for persons and selfdetermination is seen in close relationship to the principle of autonomy, this concept is
regarded as inadequate and insufficient in other cultures. So Informed Consent should
not forcingly be understood in terms of an “Individual Informed Consent” related to
the autonomy of the involved person. It can also correspond to a “Community
Consent” that is based to a lesser extent on autonomy.
Especially Confucian ethics, which in large parts of (South-) East Asia defines values and
norms, stands in opposition to this western based conception. But at the same time
globalisation and modernization ask for an answer concerning these different conceptions: On
one hand countries like China are confronted with these questions and have to deal with
economic as well as political challenges influencing the country in a premodern and modern
way simultaneously. On the other hand, countries like the United States, Canada and Great
Britain are grasped by flows of migration resulting in culture mosaics. Therefore the plural
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societies of these countries are often characterized by a variety of moral principles. Therefore
a strict adherence to the western grounded definition of Informed Consent in all countries of
the world may lead to a break-down or breaking off in communication. This consequence
would neither correspond to the different interpretations of Informed Consent nor serve the
patient well-being. Besides, it is not helpful to understand conceptions as opposed to each
other but rather as additions and refinements each in itself important from a particular points
of view. In particular the position of the affected person/patient has to be examined. The
person is either wished conceived as autonomous or as part of a social context as this is the
case in China. Questions like what is a person, what are a person`s rights, and what constitutes
ethical behaviour towards persons, are closely linked to these considerations, and have
enormous effects on the person him-/herself and on the person´s social background. Because
of that, establishing Informed Consent in cross-cultural bioethics means risk and chances at
the same time. Taking Informed Consent as an example may help to clarify varying ways of
handling and accepting different moral values. This approach of taking different moral values
into account needs to be qualified in the light of the given concrete social and cultural context,
in order to become sufficiently meaningful and instructive in practice. These concrete
interpretations can be influenced by considerations emphasising either the individual
orientation – to be understood as a predominantly individual decision-making process
(Individual Informed Consent), or the social orientation – as a social process (Community
Consent), as guiding the act of giving consent. Bioethics in different countries and cultures
might come to different conclusions with regard to that. It has been found that those
differences can be distinguished along the lines of European or Northern American and
Chinese bioethics. However, our project aims to analyse these differences in a way that avoids
an inadequate polarization between East and West. A deeper understanding of far eastern
medical and bioethical knowledge will not only be an enrichment but will also help to
improve the interaction of western-oriented healthcare professionals and - for example Chinese patients. The main concern is to understand the complex interdependence of the
individual and society. Therefore our primary concern will be to analyse Western and Chinese
bioethics literature dealing with Informed Consent. We have to look for inherent theoretical
foundations and implemented assumptions. It is important to identify the underlying
philosophical ideas which influence the prevailing interpretation of Informed Consent. We
will develop an analysing tool. With that a detailed examination on Chinese normative
documents concerning Informed Consent on a national level should follow. This will provide
us with a general idea of how the concept of Informed Consent is realized and how solutions
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regarding tensions between the individual and society are found. In a further step, our project
will analyse implications for the use of the concept of Informed Consent in normative
documents issued by international organizations, such as WHO and UNESCO. We hope that
interviews with Chinese bioethicists representing the discourse currently under way will allow
us to draw a more precise picture and to understand the inherent values, experiences and
contextual conditions.
The Importance of Informed Consent
Postmodern societies are characterized by a high degree of individualism. This
individualism is expressed in the way people plan their lifes. The right for selfdetermination is claimed emphatically. These developments are also mirrored by
questions raised in the field of medical ethics.
Medical ethics is founded on commonly acknowledged ethical principles: These are
the principles of respect for autonomy, non-maleficence, beneficence and justice. This
principle-oriented conception refrains from ethical theories. In this way identification
and structurization of ethical problems are facilitated, thus consensus is easier to be
achieved. The four principles approach to biomedical ethics (4PBE) has been
increasingly developed as a bioethical method since the 1970s. Despite its wide
acceptance and popularity, it has been challenged from a cross-cultural perspective.
Medical ethics focuses on the patient who is to be respected. The most prominent
principle of medical ethics is the principle of autonomy. It comes from the traditions of
Kant and liberal political philosophy. The liberty of the individual is often seen as a
key part of the principle of autonomy. Informed Consent is the tool to realize
autonomy in medical practice. We frequently see this philosophy represented by the
use of “rights” language. Rights come in two different forms: negative rights and
positive rights1. Autonomy is primarily related to negative rights – a right to be free
from the interference of others to act on one´s own will.
Hippocratic beneficence incorporates some elements of Informed Consent, but only
when the clinican believes Informed Consent will benefit the patient. This is called the
therapeutic privilege – that is to say physicians withhold information only if they feel
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it was in the best interest of the patient. That makes sense in an ethic based on
beneficence, but it is not fully compatible with an ethic of patient autonomy. So we are
currently observing a continuing evolution of the principle of autonomy accompanied
by a shift from the more paternalistic Hippocratic basis for consent and its related
doctrine of therapeutic privilege to one grounded in respect for patient autonomy.
According to Robert Veatch we can differentiate three standards of disclosure for
consent to be adequately informed. Certainly, it is impossible to fulfill the meaning of
Informed Consent in an overall sense. The patient cannot be told everything The
question is rather how much information must be transferred for a consent to be
adequately informed. The professional standard is related to Hippocratic tradition and
– as mentioned above – not necessarily serves patient autonomy. The reasonable
person standard demands to disclose what a reasonable patient would want to be told
or would consider being significant. But there is a problem with persons who may not
be “reasonable”. The subjective standard is based on the life plan and interests of the
individual patient and comes closer to the principle of autonomy thus ensuring selfdetermination.
The conception of Informed Consent is based on the five components disclosure,
comprehension, voluntariness, competence and consent/refusal. Informed Consent
includes being informed and giving consent. Therefore the physician has to offer
information, and has to secure that the patient has the ability to understand actively the
informations provided. This includes making sure that the patient is not handicapped
by lack of medical knowledge or poor literacy. The subject should also be explicitely
informed of the right to refuse or withdraw consent. Free consent in the strict sense is
the key of giving consent.
Research on Informed Consent focus on theoretical as well as applied matters: What is
a person, what are a person´s rights, what constitutes ethical behaviour towards
persons? Who is competent to give Informed Consent, how is that to be determined,
what constitutes sufficient information, how is that to be determined?
Underlying the discussion of autonomy is the basic assumption in western medicine
that good healtcare involves choices by informed individuals. This decision-making
1
A positive right implies more. It is a right not only to act autonomously but also to have access to the means
necessary to carry out one´s actions.
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model bases on abstract principles – devoid of the social context (e.g., the family of
the patient). Abstract principles call for an ideal patient. The reality, even in the
western hemisphere, is quite a lot more complex: the question is if a patient in any
circumstances really wishes to make individual decisions, values autonomy as the only
basic principle and wants to be disclosed all relevant informations regarding his state
of health.
Obstacles regarding Informed Consent
Unless incompetent, we expect the patient to take individual responsibility for consent.
And if the patient is incompetent, we`ll have to determine which individual will act as
the patient´s proxy. This is maybe problematic for persons, or their proxies, from
cultures with a more collective sense of identity and decisionmaking, limiting the
meaningfulness of Informed Consent in a pluralistic society, and in the international
community.
Informed Consent is situated in a particular historical and socio-cultural context which
transmits certain world views and value systems about persons, illness, and doctorpatient relationships. It is socially established through the institutions of medicine, law,
public policy, and through health care delivery systems.
Much of conventional Western bioethical analysis is based on such dichotomies like
autonomy versus paternalism and duties versus rights. “Either/or” distinctions contrast
sharply with the conception of moral order in Chinese culture, which treats apparent
opposites such as the individual and the group as complementary rather than mutually
exclusive.
The concept of autonomy best highlights the contrast between Western and Chinese
cultures. In the West, the principle of autonomy implies that every person has the right
to self-determination. In traditional Chinese culture, greater social and moral meaning
rests in the interdependence of family and community, which overrides selfdetermination. The interests and rights of the patient are subordinated to those of his
family. Within Chinese culture the person is viewed as a “relational self” – a self for
whom social relationships, rather than rationality and individualism, provide the basis
for moral judgement. According to Chinese tradition it is not enough just to obtain
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consent from the patient alone. It is quite necessary to obtain consent also from
representatives of the patient´s family. Family, the basic political economic and
cultural unit in society, is a deeply rooted concept in Chinese tradition. Neglecting the
opinion of family representatives will often have severe impact on the communication
between the physician and the patient and his family. Consequently, many Chinese
may accept the right of family members to receive and disclose information, to make
decisions and to organize patient care. Therefore interaction between western-guided
healthcare professionals and Chinese patients may be affected by differences in values
and in the perception of nature and meaning of illness. If not acknowledged, these
differences in perspective can lead to a complete breakdown in communication.
As we have seen, for patients of some cultural backgrounds, autonomy may not be the
primary principle by which Informed Decisions are framed. In their view factors
overriding exist. To name but a few, there are the principles of filial duty2 and of
protecting the elderly. They are closely related to the principle of beneficence.
Differences between cultures are based on the western perception of autonomy as a
cultural value. The health care professional imperative to ensure autonomous,
informed decision making cames into conflict with a Chinese family´s moral
imperative – filial duty, that is, protecting the patient. Essential element of protection
is to keep the patient not informed about the disease and its prognosis (nondisclosure).
Nondisclosure as protection due to filial obligation is considered a cultural value in
China thus conflicting inevitably with the western interpretation of Informed Consent
emphasizing telling the truth.
Providing improved quality of life for the patient seems to be a common goal of
western-oriented professionals and family members, but how that is to be achieved is
unclear. In worst case scenarios disclosure clashes with nondisclosure and danger of a
communication breakdown increases.
Nondisclosure as protection is seen as appropriate by people close to a specific cultural
background like China but also Latin America in cases when speaking openly of death
is regarded as disrespectful as well as portent of bad luck, when privacy is violated
because of a part of the body that maybe is affected. The disease is acknowledged; its
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potential terminal aspect not. To speak about it means to remove hope, one of the basic
premises to heal an ailment. Protectiveness does not mean to deny an illness. It is
understood as comforting the patient in a really difficult situation. All societies seem to
recognize “the need for hope”, but they differ in understanding the conditions of hope.
In Western terms hope appears to be upheld through autonomy and active participation
in treatment choices. In China hope is maintained through the family´s absorption of
the impact of the illness and through the family´s control of medical information.
Patients faced by a progressive disease show a decreasing willingness to make
decisions and instead increasingly rely on family members in terms of benevolence.
This can also been seen as an autonomous act: the patient has implicitly decided not to
decide. This is an alternative interpretation of the principle of autonomy and shows
that the gap between different and rival principles sometimes depends on the
perspective.
Some limits of Informed Consent
To respect autonomy, thus respecting self-determination, can be understood as
demonstrating genuine respect for human integrity. This seems to be a western-based
approach. Therefore it is to ask wether the individualism inherent in Informed Consent
is respectful to all people or cultures? As we have seen, formalistic requirements of
Informed Consent may be inconsistent with certain cultural or ethnic belief systems.
As a result we have to acknowledge that there are several limits of Informed Consent:
1. We cannot give Informed Consent when we are very young or very ill (especially
when receiving emergency treatment), mentally impaired, demented, unconscious or
confused. Proxy consent has to be given which – even in western societies – usually is
family consent.
2. Applying Western bioethics concepts across different cultural and ethnic groups
may cause major difficulties: Conformance with cultural expectations may contradict
2
The principle of filial duty comprises for example beginning-of-life, death-and-dying and Informed Consent
issues. To show filial piety is to have offspring or to insist in taking all measures to extend a parent´s life because
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Informed Consent requirements of disclosure and autonomous patient decision
making. Respect for that compels to obtain consent in ways that are consistent with the
patient’s own values regarding the particularities of his language, custom, and culture.
A disclosure requirement, which is truthful information about diagnosis and prognosis,
may stand against the accentuation of the importance of positive thinking.
3. Formal specifications of Informed Consent (fixed disclosure requirements, isolated
individual decision making, signed consent forms) may advance individual autonomy
and human dignity for many patients in Western cultures – but the same formalism
leads to alienating and dehumanizing of those who view caring and healing not as a
bilateral contractual relationship with a physician.
4. A fourth limitation of Informed Consent is that physicians or individuals use
information (family history information, genetic information) about third parties that is
disclosed without their consent. Prior consent to disclosure of such information from
relatives would often be impractical or impossible. This is another modification
proving Informed Consent to be a mere relative term than an absolute standard.
5. A fifth limitation of Informed Consent procedures is that they have limited value for
public health policies. Public policies ignore individual choices. We cannot adjust
water purity levels or food safety requirements relying only on individual choice, or
seek Informed Consent for health and safety legislation or quarantine restrictions.
These limitations are illustrated by the public health measures against the SARS virus.
Public health policies can be undermined if their implementation depends on
individual Informed Consent.
6. A sixth limitation emerges when people with adequate competence to consent are
under duress or constrait (prisoners, soldiers), and so are less able to freely determine
their will. This has been traditionally seen as problematic in recruiting subjects for
research; this is no less problematic in obtaining Informed Consent in medical
treatment. In the case of research projects undue influence and pressure from society
it can only be expressed to a living parent.
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may limit Informed Consent. For example in countries like China the spirit of
collectivism and devotion to the country is encouraged amoung citizens. Thus people
may not consider to refuse consent if requested to participate in such projects.
Evidently Informed Consent cannot be relevant to all medical decisions. In medical
ethics Informed Consent is commonly viewed as the key to respecting patient
autonomy. If Informed Consent is ethically important, this cannot be only because it
secures some form of individual autonomy. Contemporary accounts of autonomy have
lost touch with their Kantian origins, in which the links between autonomy and respect
for persons are well argued; most of them reduce autonomy to some form of individual
independence, and show little concern about its ethical importance.3 The ethical
importance of Informed Consent in and beyond medical practice is more elementary. It
provides reasonable assurance that a patient has not been deceived or coerced.4
Thus the question arises, whether Informed Consent is only valid if it corresponds to
the principle of autonomy. This principle can undoubtedly help to avoid that the
interests of patients are disregarded. Nevertheless this can also be fulfilled by other
principles. They could function as complementary elements to bind Informed Consent
as an abstract conception to the respective social cultural background and to legitimate
it. In a way this is a reinterpretation of Informed Consent. Taking into account certain
socio-cultural factors and the limits of Informed Consent cited above, there are
reasons, in case of doubt, to adopt a "beneficence-oriented", rather than an "autonomyoriented" approach in obtaining Informed Consent. The aim should be to avoid
Informed Consent as a battle ground where one must force his or her view on the other
and to create the possibility of a true dialogue.
Reproductive Medicine
Focussing just on beginning-of-life issues we still have to deal with a vast field of
topics regarding reproductive medicine and Informed Consent. New reproductive
3
4
O´Neill O. Autonomy and trust in bioethics. Cambridge: Cambridge University Press 2002.
O´Neill O. Some limits of Informed Consent. J Med Ethics 2003;29:4-7.
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techniques and technologies have always triggered fears of unnatural, harmful
outcomes, social disruption, and destruction of families. For example sex selection is
often envisaged as reinforcing sexism and women´s subordination.
Topics concerning our attention are, to name but a few, abortion, cloning, embryo as
well as fetal research, personhood, population control, reproductive technologies and
sex selection. We will emphazise technologies like artifical insemination, in vitro
fertilization, egg donation and surrogate motherhood but also dealing the highly
controversial debate whether homosexuals should have access to reproductive
technology to procreate children and have a family. Reproductive cloning has to be
considered, too, but even if this topic draws great attention at the moment it is more of
academic concern than a proven reproductive technology.
As we have seen, one approach to a cross-cultural understanding of Informed Consent
is to acknowledge that the principle of autonomy is not questioned itself but rather
should be seen in a broader view balanced by other principles.
Focussing on the importance and implications of Informed Consent, and its underlying
reference to different principles, we will carefully analyse the meaning of this concept
in Chinese normative documents on a national as well as an international level. This
will help to draw a more precise picture of Informed Consent and its concrete
application. Our analysis of bioethical literature is under way and we will soon start
with critical examination of documents from China concerning reproductive medicine
and Informed Consent.
Normative Documents
Obtaining normative documents regarding beginning-of-life issues and Informed
Consent is maybe one problem. But the more basic question beyond is, what can we
expect from them? According to Ole Doering, China´s move towards biotechnology
has been accompanied by the introduction of a modern bioethical framework. So the
Chinese government issued a declaration in 1998 expressly banning reproductive
cloning. Likewise, China´s human-genome projects are governed by strict rules on
sample collection and Informed Consent. But even with such laws in place,
enforcement and monitoring will need improvement. The question therefore is which
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meaning can be drawn from any practical regulations concerning medical ethics? What
do laws, guidelines, and declarations may tell us about their role in real live dealing
with these documents? Do documents issued by officals that seem to adopt
institutional and law reforms by international standards still reflect culture related
values?
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