1. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman
Medical Ethics In Debate
Casual Consent to Treatment:
A Neglected Issue in our Health
Care System
While internationally the medical community has effected a drift from the traditional concept
of simple consent to the more sophisticated notion of informed consent, consent still
continues to be a largely neglected component of our health care system. There is lack
of recognition of the significance of consent to treatment and hence the consent process is
taken as a casual formality both by our doctors as well as patients. Most of the time the
doctors are forced by local cultural factors and social customs to compromise on the
principles of consent taking. This compels them to take added responsibility and a great
professional risk. There is a dire need to rectify this trend because an informed consent not
only ensures the patient’s autonomy, self-determination and informed decision-making
but is also a reaffirmation of the doctor’s ethical and legal responsibilities towards his
patient.
This article highlights the various conceptual and methodological processes involved in the
consent with identification of the deficiency areas in our own system.
KEY WORDS : Consent to treatment, Informed consent.
Muhammad Saaiq*
Khaleeq-Uz-Zaman**
*Postgraduate Resident,
Department of Surgery,
PIMS, Islamabad.
**Professor and Head,
Department of Neurosurgery,
PIMS, Islamabad.
Address of Correspondence:
Dr. Muhammad Saaiq
Medical Officer,
Department of Surgery, PIMS,
Islamabad, Pakistan.
E-mail
muhammadsaaiq5@gmail.com
Introduction
In the last few decades the traditional paternalistic
model of patient care has been replaced by one that
emphasizes patient autonomy, empowerment and full
disclosure of facts. The entire health care delivery is
being redesigned from the patient’s perspective.1
It is
generally agreed worldwide that patient’s consent is
imperative for any medical intervention unless he is
incapable of consenting or the doctor is legally required
to intervene without the patient’s wishes.2
Even if it is a
legal requirement it is ethically more appropriate to
obtain the patient’s consent.3
The various aspects of
medical management for which consent is considered
mandatory include clinical examinations, investigations,
therapeutic interventions and participation in clinical
research etc.4,5
Whereas internationally there is growing recognition of
the significance of consent both for the doctor as well as
the patient, our doctor community still continues to be
largely informal about this very key component of
health care system.
What Constitutes a Consent?
Generally speaking consent is a mutual agreement,
compliance or understanding between the patient and
his care provider whether a person or institution.
Traditionally consent has been described as either
implied or expressed. Implied consent is the one which
is neither expressed verbally nor in writing and is
provided by the demeanour of the patient. In most of our
clinical or hospital practice it is the valid form of consent
for routine clinical assessment and treatment. e.g. a
patient visiting a clinic for the management of common
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2. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman
cold, sore throat etc. In such cases the implied consent
would be sufficient for routine clinical examination,
however more complex examination such as that of
private parts or female breast would require an explicit
consent. Expressed consent refers to the one which is
expressed either verbally or in writing. The expression
should be done in the presence of a third party
unrelated to the patient so that this evidence remains
unbiased in the event of any allegation against the
doctor . 4-6
In view of the ever-increasing new diagnostic and
therapeutic interventions and sophisticated research
protocols, the traditional concept of consent has much
changed. Now it is an era of informed consent which
adequately satisfies both ethical as well as legal aspects
of the standard medical practice of the contemporary
era. 7-9
What are the essentials of an
informed consent?
Historically there has been a move from simple to
informed consent and the basic philosophy behind this
drift is to ensure patient’s autonomy and right of self-
determination in making informed decisions about his
health. 10,11
Meaningful and fair consent essentially demands that
the patient be given sufficient and understandable
information to make a valid choice of his treatment. The
consent form is not equivalent to consent.12
The
important attributes of informed consent are information
13
, trust 14
and lack of coercion 15
. The consent
process often starts at the time of admission with implicit
rules of communication and participation being
conveyed to the patient. The signing of consent form
just prior to surgery while on the ward tends to be a re-
affirmation of the same.
Modern law emphasizes patient’s consent to treatment
not only through liability for unauthorized touching ( i.e.
criminal assault and/ or civil battery) but also through
liability for negligence. 16
New dimensions to the
traditional informed consent are being sought and there
is reconsideration of even legislative provisions
regarding public education programmes towards
consent related specific issues such as disclosure ,
advance directives, substitute decision, emerging
treatments and advocacy. 17
The generally agreed elements to be disclosed for
eliciting informed consent from a legally competent
patient include the diagnosis, the patient’s prognosis if
untreated, alternative treatment options , the success
rate of each option, the risks and benefits of the
anticipated procedure and the patient’s right to exercise
veto power over a doctor’s decision. 16,18
How much risk-information to deliver
in the consent process?
Over the last two decades particularly there has been an
explosive expansion of the understanding of how people
perceive and code risks and then use this information in
decision making. 19-21
There is growing evidence that the patients often
employ simplifying heuristics in judgment and decision
making. These heuristics may lead to bias in how
people interpret information. However much of our
understanding of risk perception is based on laboratory
studies and it is less clear whether risk perception in the
real world exhibits the same pattern and biases. 19
Legally, informed consent for therapy is a risk-
management tool that functions essentially as a release
of liability. If the patient is informed of all the expected or
potential side-effects or toxicities of a treatment, he
cannot sue the doctor or hospital because those side
effects occur. The moral doctrine of informed consent is
derived from a respect for the patient's autonomy as
well as the patient's vulnerability. The physician's goal is
not to minimize liability but to help the patient make the
best decision. These two goals are not necessarily
incompatible but they often lead to different attitudes
towards informed consent and different decisions about
what information needs to be shared with patients. If the
goal is risk-management then informed consent forms
should be encyclopaedic providing the "whole truth" to
the patient. This would however not meet the moral
goals of shared decision-making because few patients
could make sense of such data. This may elicit even
counterintuitive and probably counter-productive
response. 9
Even in the developed countries patients don’t realize
the purpose and significance of information and consent
form. In a country like the United States, less than 31%
of the people have any college education. In this context
expressing and understanding risk is a problem equally
faced by doctors and patients across the world. 22-24
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3. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman
Consent taking in developing
countries like ours!
We in our set up are faced with yet more complicated
issues. The stingy botherations are: What kind of
information to deliver ? How much risk information to
communicate? Whom to tell and Whom not to tell?
When and how to communicate? etc. Since our society
is suffering from a social divide, we in our clinical
practice encounter two extreme varieties of people. i.e.
the deprived and poor ones and the affluent and
influential ones . The former strata , owing to their
uneducated and ignorant behaviour prompt a
‘communication block’ on part of the dealing doctor
while the latter group owing to their narcissistic
behaviour cause an ‘empathy block’. As a result,
effective communication is impaired at the very outset of
doctor-patient interface.
Not infrequently we encounter problems when we are
about to break bad news to our patients. For instance a
lady with breast cancer would be all set for surgery but
the sons would insist on not disclosing any information
to their mother about the diagnosis as well as the plan
for surgery.
In Neurosurgical practice we encounter yet more
strange situations. For instance a patient with sciatica
would seek our advice and when he is advised surgery,
he would go away saying that he has heard of the risk
of paraplegia and life long disability associated with
spinal surgery. Similarly a patient with acoustic neuroma
would be ready to undergo surgery but would disappear
if the risk of facial palsy is communicated to him. These
circumstances force us not to tell the patient all the likely
risks involved in the anticipated procedure, however
who can guarantee the ‘cure without any risk of
complications’ . Still our patients would search for
someone who can offer cure with no chance of risks
whatsoever and at times end up with the so called
100% healers.
Who is competent to consent to
treatment?
Anyone who can give a legally valid consent must be
competent. There exists a fine balance between
patient’s autonomy and self-determination on one hand
and protection of the incompetent patient from potential
harm on the other hand. Competence refers to the state
in which a patient’s decision making capacities are
sufficiently intact for their decisions to be honoured. 25
This capacity to make decisions is required for anyone
to give a valid informed consent however informed
consent requires more than this capacity, for example,
trust and lack of coercion. More importantly there must
be an understanding of what is being consented to .
14,15,26
Generally the current recommendation is that in non-
emergency situations, individuals who are competent to
give informed consent to treatment should be extended
the right to refuse it as well. 27
Who are incompetent to consent?
Incompetence refers to a status of the individual as
defined by the functional deficits ( due to mental illness,
mental retardation or other mental condition) judged to
be sufficiently great that the person currently can’t meet
the demand of a specific decision making situation
weighed in light of its potential consequences. 25
Patient’s understanding of the information about
treatment is the main determinant of his capacity to
give informed consent. Incapacity is generally
considered in terms of understanding and
communication. 28-30
In England the law emphasizes a
patient’s understanding of the information about the
proposed treatment, potential risks and benefits of
treatment and the consequences of not taking the
treatment. 3
Thus any person would be considered
unable to take a decision on mental treatment in
question if he is unable to understand or retain the
information relevant to the decision, unable to make a
decision based on the information or unable to
communicate a decision. 3
Mental disorders associated
lack of insight would incapacitate the patient to consent
for treatment .
Most of the criteria for competence in current use
emphasize cognitive rather than affective dimension of
capacity to consent. Clinical experience indicates that
affective disorders may impair competence in a
detectable and identifiable way. In particular patients
with major affective disorders can retain the cognitive
capacity to understand the risks and benefits of a
medication yet fail to appreciate its benefits. 31
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4. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman
How should a doctor approach an
incompetent patient?
In cases where the patient is unable to give an informed
consent to any treatment such as when the patient is
unconscious or mentally incapable, the doctor’s duty to
preserve life remains paramount. In non-emergency
situations court approval is required for procedures such
as sterilization, abortion, organ donation or experimental
studies. 32
A patient's incapacity to give informed consent to one
medical intervention should not be assumed to imply
incapacity to give consent to all other interventions.
Legally as well as ethically if a patient is incapable of
giving consent to one intervention it does not
necessarily imply incapacity in general . For example a
patient suffering from schizophrenia may be capable of
giving informed consent to the treatment of his diabetes
but not to the treatment for his schizophrenia or vice
versa. Thus each proposed intervention would require
an independent assessment
of the patient’ s particular
capacity to give informed consent for that specific
intervention. 25
A challenging situation arises when a clinician is
required to assess a mentally ill patient’s capacity to
give informed consent to a clinical examination. The law
of the land in the form of mental health act for instance
would solve such issues by ordering or requiring the
doctor to examine the patient even without his consent.
The recent trend of encouraging patients with learning
disabilities to actively participate in decision making
about their psychological and medical treatment raises
even more complex questions regarding their ability to
consent.
How to take children’s consent to
treatment?
Children’s consent to treatment is one of the most
important issues surrounding the complex area of
consent to treatment. Conceptual and methodological
issues continue to be debated in this grey area and the
approach to the problem varies from country to country.
33-37
In general a child or young adolescent whose
competence is in doubt will be found rational if he
accepts the proposal to treatment but may be found
incompetent if he disagrees to a medially indicated
treatment. 38
Refusals of children or their parents to medically
indicated treatment result in serious legal and ethical
dilemmas putting the doctor in an embarrassing
situation. Such situations demand careful and sensitive
clinical and ethico-legal intervention and close
cooperation among professionals particularly doctors
and social workers.39
Professionals have to decide
whichever legal route is best for a given child.
In the UK , since the introduction of children act 1989
several cases have been brought on the issue of a child
or young adolescent refusing to consent to a medically
indicated treatment or assessment. 40-42
In the US,
parents usually must consent to medical procedures
involving minor children, however parental consent is
not required in areas such as emergency situations,
medical care in pregnancy, treatment of sexually
transmitted diseases , treatment of substance abuse
and experimental procedures. Moreover parents can’t
withhold medical treatment when a child’s life is
threatened by an illness or emergency. 18
We at our national level don’t have clear guidelines
regarding the knotty issue of children’s consent to
treatment and are blindly following what the Westerns
are practicing. We need to enact essential legislation to
avoid inconveniences which such issues pose to
doctors from time to time.
What is the ‘presumed consent’ to
organ procurement from cadavers?
Generally a person is considered to have a legitimate
and primary proprietary in his or her living or dead body
and thus has first right to control what happens to his or
her body before and after death. 43
The concept of presumed consent has been popular in
the transplant circles since 1968. 44
It has been given
the status of law in Singapore in 1987 , stating that all
majors are presumed to consent to organ donation if
they don’t explicitly object to it . Muslim community of
Singapore is generally considered objector unless they
opt for it. For minors and mentally incapacitated people,
consent is sought from next of kin. 45
This policy of presumed consent for organ
procurement is certainly an attempt to allow for
fulfillment of the needs of informed consent, however it
is a highly complex issue requiring further work
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5. Casual Consent to Treatment: A Neglected Issue in our Health Care System Muhammad Saaiq and Khaleeq-Uz-Zaman
particularly in our setup by close coordination among
medical and legal professionals on one hand and
religious scholars and public leaders on the other hand.
How to tackle the consent issue in
medical education, training and
research in our setup?
We have an interesting anecdote to share with our
readers. It is rather a sort of personal experience
which someone may enjoy as a joke but it really
carries a great meaning in its depth. One of our final
year MBBS clinical batches happened to examine an
elderly male who presented with features of bladder
outflow obstruction. Following his digital rectal
examination by two students when a third one came
forward , the patient stood up and said “I know
you are all students but my anal canal is not your
‘madrassa’ “ This explicit display of the patient’s
feelings is a real reflection of what exactly is happening
in most of our teaching institutions whether
undergraduate or postgraduate. Another equally
important but ignored area is the medical research
conducted on cognitively impaired human subjects.
There is a dire need to evolve standardized approaches
to such issues, which should not only safeguard the
ethicolegal aspects from the patient’s perspective but
also ensure proper training of the medical trainees. This
need is all the greater owing to the fact that we are
faced with ignorance, lack of awareness and lack of
appropriate legal and professional guidelines
appropriate to our own indigenous population and local
circumstances.
.Conclusion
Informed consent is an indispensable component of
contemporary medical and surgical practice. It not only
ensures the patient’s autonomy, self-determination and
informed decision-making but is also a reaffirmation
of the doctor’s ethical and legal responsibilities
towards his patient. In our set up the consent is taken
for granted in the patients’ management. It is high time
that this should be taken seriously. There is an urgent
need for a properly designed study to look into the
problems relating to the consent process and come up
with clear guidelines that could be safely practiced by
doctors in our community.
21) Edwards A, Elwyn G. Understanding risk and lessons for clinical risk
communication about treatment preferences Qual Saf Health Care
2001; 10 (90001) : i9 - 13.
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