Consent Guidelines 15012013
Consent Guidelines 15012013
Consent Guidelines 15012013
1.
Definition
In general terms, CONSENT is the voluntary acquiescence by a person to the proposal of another; the
act or result of reaching an accord; a concurrence of minds; actual willingness that an act or an
infringement of an interest shall occur.
Consent is an act of reason and deliberation. A person who possesses and exercises sufficient mental
capacity to make an intelligent decision demonstrates consent by performing an act recommended
by another. Consent assumes a physical power to act and a reflective, determined, and
unencumbered exertion of these powers1.
Consent refers to the provision of approval or assent, particularly and especially after thoughtful
consideration.
2.
3.
Every patient as an individual has a choice whether or not to undergo a proposed procedure,
surgery, treatment or examination.
A medical practitioner is obliged to disclose information to the patient and to warn the patient of
material risks before taking consent is. Failure to obtain a patients consent or disclose material risks
may be interpreted as a failure of the standard of care resulting in a disciplinary inquiry by the
Medical Council or may even be construed as a breach of duty of care and legal action instituted.
While a patient might consent to a procedure after being informed in broad terms of the nature of
the procedure, this consent will not amount to an exercise of choice unless it is made on the basis of
relevant information and advice.
The medical practitioner must inform the patient, in a manner that the patient can understand,
about the condition, investigation options, treatment options, benefits, all material risks, possible
adverse effects or complications, the residual effects, if any, and the likely result if treatment is not
undertaken, to enable the patient to make his own decision whether to undergo the proposed
procedure, surgery, treatment or examination.
4.
Explanatory Notes/Documents
It is recommended that practitioners provide additional information on risks and adverse effects of
any procedure in a written explanatory document which the patient (or next-of-kin or legal
guardian) can read, request further explanation where necessary, understand and append a
signature to that effect.
These Explanatory Notes will be considered an annexure to the main consent form signed by the
patient or next-of-kin or legal guardian.
Where such explanatory notes or document are not available or not in standard use, the practitioner
may note down the risks and adverse effects, as explained to the patient (or next of kin or legal
guardian) in the patients case notes and duly signed/initialled by him, with the date.
5.
There are several exceptions to the rule that the consent of a patient must be obtained before
commencing any procedure, surgery, treatment or examination, and they include the following:
A medical emergency is defined as an injury or illness that is acute and poses an immediate risk to a
person's life or long term health. Consent is not required in emergencies where immediate
treatment is necessary to save an adult person's life or to prevent serious injury to an adult person's
immediate and long term health where the person is unable to consent, subject to there being no
unequivocal written direction by the patient to the contrary, or where there is no relative or any
legal guardian available or contactable during the critical period to give consent.
In such circumstances, a consensus of the primary surgeon (who is managing the patient) and
another registered practitioner is obtained and the surgeon signs a statement stating that the delay
is likely to endanger the life of the patient. The registered medical practitioner must co-sign the
consent form.
Specific arrangements apply for the obtaining of consent from a third party such as a parent or
guardian of a child patient (see infra, Part 6 et seq.).
Consent of the patient may not be required for any treatment that may be ordered by a court of law,
for example, an order for the specific treatment of a minor, or a patient on life-support.
6.
The Laws of Malaysia Act 21: Age of Maturity Act 1971 states under Age of majority: The minority
of all males and females shall cease and determine within Malaysia at the age of eighteen years and
every such male and female attaining that age shall be of the age of majority
Generally, whether a young person is sufficiently mature to provide a valid consent to medical
treatment depends not only on his or her age but also on whether he or she has sufficient maturity
and intelligence to understand the nature and implications of the proposed procedure, surgery,
treatment or examination. This must be decided on a case-by-case basis, and whatever decisions
made must be in the best interest of the patient.
It is important to note that for the purposes of the Regulations, a patient who is unmarried and
below 18 years of age does not have the capacity to give valid consent to any medical procedure or
surgery.
If a minor presents with an adult other than a parent, the attending medical practitioner should
attempt to ascertain the adult's relationship to the child and whether the adult is the child's
guardian. Where the adult does not appear to be the child's guardian, but bears some relationship to
the child, and confirms that the parent/guardian is aware that he/she is accompanying the child, it is
reasonable to assume that the parent or guardian has delegated responsibility to that person, unless
there is any indication to the contrary (i.e. a previous objection by the parent to that person
exercising any authority in relation to the child).
Where the patient is an infant as defined under the Guardianship of Infants Act 1961, it would be
prudent for the medical practitioner to consult or obtain the consent of the infants legal guardian.
Under the Guardianship of Infants Act 1961, the guardian of the person of an infant shall have the
custody of the infant, and shall be responsible for his support, health and education2.
The Law Reform (Marriage & Divorce) Act 1976 makes it clear that each parent has full responsibility
for each of his/her children who is under 18 years of age. Parental responsibility is not affected by
changes to relationships (i.e. if the parents separate). Each parent has the responsibility for his/her
child's welfare, unless there is an agreement or a Court has made an order to the contrary3.
This means that the consent of either parent to his/her child's medical treatment is usually
sufficient. There are two circumstances where the consent of either parent may not be sufficient:
i.
ii.
Where no formal court orders have been made, and one parent consents and the other
refuses. The best way of handling this situation is by counselling the parents and trying to
reach agreement on what is in the child's best interests.
Where a Court of law has made an order to the contrary.
In recognising the evolving capacity of the child, the United Nations Convention on the Rights of the
Child (commonly abbreviated as the CRC, CROC, or UNCRC) as a human rights treaty setting out the
civil, political, economic, social, health and cultural rights of children, defines a child as any human
being under the age of eighteen, unless the age of majority is attained earlier under a state's own
domestic legislation4.
7.
Impairments to reasoning and judgment which may make it impossible for someone to give
informed or valid consent include such factors as basic intellectual or emotional immaturity, high
levels of stress such as Post Traumatic Stress Disorder (PTSD) or as severe mental retardation, severe
mental illness, intoxication, severe sleep deprivation, Alzheimer's disease, or being in a coma.
In such circumstances, and in an emergency to save life, the procedure as outlined for emergency
treatment or management should be followed.
When there is a relative, next-of-kin or legal guardian is available, the consent may be obtained from
such a person if an elective or non-emergency operation is necessary from a medical practitioners
considered opinion.
Under the Mental Health Act 2001, consent is generally not required for conventional treatment
apart from surgery, electroconvulsive therapy or clinical trials for patients with mental disorder as
defined by the said Act5.
In instances where consent is required it must first be obtained from:
i.
ii.
iii.
8.
Types of Consent
In all instances or episodes of taking consent, whenever possible conducted in privacy, it must be
ensured that the patient (or next-of-kin or legal guardian) is fully aware of the objective and process
of giving consent, be comfortable and composed.
a. Implied consent is a form of consent which is not expressly granted by a person, but rather
inferred from a person's actions and the facts and circumstances of a particular situation
(or, in some cases, by a person's silence or inaction). This may become an issue if there is
any dissent or disagreement arising from the patients interpretation of the practitioners
actions or the outcome thereof.
b. Expressed consent may be in oral, nonverbal or written form and is clearly and
unmistakably stated. Issues may arise when the consent is through oral communication, as
stated under implied consent.
c. Informed consent can be said to have been given based upon a clear appreciation and
understanding of the facts, implications, and future consequences of an action. In order to
give informed consent, the person concerned must have adequate reasoning capacity and
be in possession of all relevant facts at the time consent is given. This term was first used in
a 1957 medical malpractice case by Paul G. Gebhard in the USA6,7.
Informed consent is a medico legal requirement or procedure to ensure that a patient
knows all of the risks and costs involved in a treatment. The elements of informed consents
include informing the patient of the nature of the proposed procedure, surgery, treatment
or examination, possible alternative treatments, and the potential risks and benefits of the
treatment.
d. Valid consent
Valid consent can be defined as the voluntary agreement by an individual to a proposed
procedure, given after appropriate and reliable information about the procedure, including
the potential risks and benefits, has been conveyed to the individual.
It is generally accepted that consent to be valid should be informed; the requirements
for obtaining valid consent are:
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
e. Verbal consent is given by using verbal communication, and may be open to debate and as
far as possible, should be avoided.
f.
9.
Written Consent
The Private Healthcare Facilities and Services (Private Hospitals and Other Private Healthcare
Facilities) Regulations 2006 states in Part VIII Consent under section 47 (3) Consent obtained or
caused to be obtained under this regulation shall be in writing.8
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Without prejudice to the above, which relates to practice in private healthcare facilities and services,
written consent when not taken in a standard consent form, should nevertheless be recorded in the
patients case notes/record that the patient had been informed and had consented to a particular
stated procedure like setting up an IV line or giving rectal enema. This is to safeguard against any
unexpected outcome.
c.
d.
The doctor and the patient must have met or know each other in the context of doctorpatient professional relationship.
The doctor who is planning to operate or do an invasive procedure on a patient must
establish personal contact with the patient, in other words the two must meet before the
intended procedure.
The doctor must explain to the patient the nature of the procedure and its objective, and
alternative procedures.
The doctor must explain possible complications, which may delay or affect the result of the
procedure, as well as influence the duration of stay in the ward.
These pre-requisites are best satisfied when the person who is planning to perform the procedure
personally and directly takes the consent from the patient. This would establish and uphold the
tenets of good medical practice and pave the way for an accepted standard and quality of
professional care.
confirm the nature of the information given to the patient by the other practitioner in the course of
taking the consent.
In a department with many practitioners of varying competence, skill and experience, the ultimate
and direct responsibility rests upon the Head of Department for having allowed a junior practitioner
(including trainees, medical officers and housemen as part of their training) to take consent and
perform a specific procedure as described above, or for having delegated a specialist to make such
decisions on his behalf.
It is not enough for the Head of that department to assume or to claim that a particular practitioner
has the competence, skill and experience to perform a procedure, surgery, treatment or
examination independently and without supervised assistance unless the Head of Department
himself is so aware and convinced, and has reason to believe it to be so.
The medical practitioner should assist the patient to understand the material provided and, if
required, explain to the patient any information that he or she finds unclear or does not understand.
The medical practitioner must afford the patient the opportunity to read the material and raise any
specific issues of concern either at the time the information is given to the patient or subsequently.
The medical practitioner must ensure that any pre-prepared material given to the patient is current,
accurate and relevant to the patient.
If such pre-prepared information material does not disclose all material risks either in general
terms or otherwise, the medical practitioner must provide supplementary information on such
material risks as are not disclosed, verbally. The likelier the risk, the more specific the details
should be.
An inadequate or inaccurate information sheet may have significant negative implications in
subsequent litigation. It may give rise to an inference that the patient was not properly informed or
ill-informed. In most cases in determining what "material risks" should be disclosed, an information
sheet cannot be a substitute for a full and frank discussion with the patient.
Any additional information provided should be specifically noted on the information sheet or in the
medical practitioners case notes.
[Explanatory notes and documents prepared by the practitioner in Section 4 do not come under this
category].
examination as the circumstances or the disease condition may have changed during that
period or the patient may have forgotten the details of the consent.
It sometimes is the practice of convenience in many healthcare facilities that consent is
taken when the patient is being seen in the clinic by the practitioner, and while scheduling
the intervention, which may be in a weeks time or later. In such instances, when the
patient is seen on admission at the time before the surgery, it is best to remind him/her
about the proposed procedure, surgery, treatment or examination and salient points in the
consent form previously signed by the patient. Nothing should be taken for granted.
b.
c.
d.
Consent on admission
Based on the principles that consent must be specific for a procedure, blanket consent
on admission of a patient, either as an out-patient or in-patient, is not allowed. The reason
that this will cover all treatments, including those which may be perceived to be minor, like
giving injections or per vaginal examination, and which may be considered implied, is not
acceptable. Similarly, consent for release of information and details on diagnosis of
diseases and/or management, to employers or third party payers (Managed Care
Organizations or insurance firms) has to be specific and contemporaneous, and not
blanket at time of commencement of employment. Similarly, too, consent for the release
of results and/or reports on pre-employment medical examination to the prospective
employer has to be obtained from the applicant.
e.
f.
Consent for keeping (for teaching purposes) organs or tissues removed at surgery
Patients may request for specimens removed at surgery (limbs, spleen, gall bladder, etc.)
to be ritually disposed and this should be complied with. In instances where such a request
is not made, the surgeon may seek the consent of the patient or next-of-kin to retain the
specimens for medical education or research purposes, but without having to reveal the
identity of the patient. Under section 2 of the Human Tissues Act 1974, where the
deceased during his lifetime has, either in writing or verbally in the presence of two or
more witnesses during his last illness, expressed a request that his body or a specified
tissue in his body be used after his death for therapeutic purposes, or for purposes of
medical education or research, the person lawfully in possession of his body after his death
may authorize the use of the deceaseds body or removal of the organs, unless he has
reason to believe that the request was withdrawn10.
g.
h.
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However, this does not apply where the patients directive contains instructions for illegal activities,
such as euthanasia or the termination of pregnancy.
Should there be an Advance Care Directive, the medical practitioner should consider whether it is
sufficiently clear and specific to apply to the clinical circumstances which have arisen. The medical
practitioner should also consider the currency of the directive, whether it can be said to be made in
contemplation of the current circumstances (for example, whether the directive was made before or
after the diagnosis of the current illness). Whether there is any reason to doubt the patient's
competence at the time that the directive was made, or whether there was any undue pressure on
the patient to make the directive, are factors that should be considered.
In an emergency, the medical practitioner can treat the patient in accordance with his or her
professional judgment of the patient's best interests, until legal advice can be obtained on the
validity or ambit of any Advance Care Directive that may have been given by the patient. Where
there are concerns about the validity or ambit of an Advance Care Directive in a non-emergency
situation, the medical practitioner should consult the patients spouse or next of kin and the medical
practitioner should also consider the need to seek legal advice and to discuss the issue with his or
her colleagues, or other clinicians involved in the patients care. Such discussions should be
documented in the patient's medical case notes.
References:
1.
2.
3.
4.
5.
6.
7.
Eric Pace, the New York Times, on P.G. Gebhard, 26 Aug 1997.
8.
9.
The Malaysian Medical Council Ethical Guideline on Audio & Visual Recordings.
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Notes:
a. The initial draft was prepared by the MMC Committee chaired by Datuk Dr. Mahmud Mohd
Nor, with Mr. Darryl S.C. Goon, Dr. Eeson Sinthamoney, Dato Dr. Abu Hassan Asaari, Dr. (Mr.)
Zulkiflee Osman, Dr. (Mr.) Zainal Ariffin Azizi, Dr. Lim Wee Leong, Dr. David Quek Kwang Leng,
Mdm. Narkunavathy Sundareson, Mr. Donald Joseph Franklin, Mr. Mohamad Fazin Bin
Mahmud, Dr. Rosnah Binti Yahya and Dr. Nor Akma Binti Yusuf as members and submitted to
the Council on 9 November 2010.
b. In view of various comments about the initial report by members of the Council, Dato Dr. Abdul
Hamid Abdul Kadir, Chairman of the MMC Ethics Committee was appointed to review the
report.
c. The sentiments expressed by those present at a meeting convened to discuss the major issues
in consent taking, held on 10 January 2012, have also been taken into consideration in the
preparation of this draft, as well as at meetings of the MMC in March 2012 and few times at
subsequent Council meetings.
d. Amendments to the draft suggested by some members of the Malaysian Medical Council (Dato
Dr Megat Burhainudin bin Megat Abdul Rahman, Professor TA Lim, Professor Dr Zainul Rashid
Mohd Razi and Dr Milton Lum), at various times, were considered at a meeting on 7 December
2012, at which were present Dato Dr Megat Burhainudin bin Megat Abdul Rahman, Professor
TA Lim and Dr Milton Lum.
e. This draft on Consent in Medical Practice covers in great detail one section in the Code of
Professional Conduct. Aspects of Consent are also covered in MMC Guidelines on
Confidentiality, Good Medical Practice, Release of Medical Records and Reports, Assisted
Reproduction, Organ Transplantation, Clinical Trials and Biomedical Research, Audio and Visual
Recordings in Medical Practice.
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