UNDERSTANDING INFORMED CONSENT
One of the first principles of
medical law is that a competent adult patient must give consent to medical
treatment. Simply touching a patient without their consent, however
benevolently, is prima facie unlawful[1].
For consent to be valid, it must be given voluntarily by someone who has the
capacity to act and whom understands what the treatment involves.
One of the central issues of
informed consent to medical treatment is working out exactly how much
information patients need to be properly or adequately informed. Not informing
a patient in broad terms about the treatment they are about to receive could
constitute assault and make you criminally liable. Not providing adequate
informed consent might also expose you to an action for damages based on
clinical negligence. The move away from the Bolam Test, which advocated that the
standard set by reasonable medical opinion was the basis on which to test
clinical negligence versus that of the reasonable patient test which assesses
clinical negligence on the patients’ need to know, has placed a greater burden
on health professionals to understand a patient’s needs and to act accordingly.
In the past medical professionals
were under no duty at all to provide patients with information about their
prognosis, or advantages and disadvantages of different treatments. The
assumption was that a doctor would exercise her customary care and skill on
deciding on the best course of action for a patient. The classic Hippocratic
Oath assumes that treatment decisions are for the doctor alone “I swear by
Apollo and Aesculapius that I will follow that system of regimen which
according to my ability and judgment I consider for the benefit of my patients”
Until relatively recently, it
would not have occurred to medical professionals that patients might be well
placed to make their own choices about their medical care. It was thought that
informing patients about a poor prognosis, possible side effects, or
availability of alternative treatments would be likely to cause distress and
confusion and might jeopardise the patient’s recovery.
It is trite that the doctor
patient relationship involves a major imbalance of power, some of which stems
from social norms. A patient expects to be disadvantaged because of their lack
of knowledge, their lack of training and because we desperately want to believe
our treating professional is all knowing and all powerful and therefor will make
the correct diagnosis and provide a complete cure[2].
Emily Jackson argues that while
it is true that there is significant information imbalance in the doctor
patient relationship, it is important to also remember that medical
professionals are not always all-knowing and all-powerful. In addition to the
problem of false positives and false negatives and the inevitability of human
error, medical knowledge itself is often uncertain and tentative. Telling
patients, the truth might force doctors to explain what they do not know and
what is uncertain[3]. That
does not excuse us from telling patients the truth to empower them to make
their own decisions.
CONFIDENTIALITY
Unlike patient autonomy, which is
a relatively recent preoccupation of medical law and ethics, a doctor’s duty to
respect her patients’ confidentiality has its origins in the first codes of
medical ethics[4]
and reserves unqualified protection in the modern version of the Hippocratic
Oath “I will respect the secrets which are confined in me, even after the
patient has died”.
Both deontological (duty-based)
and teleological (consequentialist) reasoning can be used to justify the
existence of a duty of confidence between patients and doctors. Deontological
argument would be to emphasize the patient’s right to privacy and her interest
in controlling access to what will be often sensitive and personal information.
The consequential argument for respecting patient confidentiality is that high
quality care depends upon a patient being honest with their doctors.
There are two reasons why it is
important for doctors to respect their patient’s confidentiality. Firstly,
information about a patient’s health is private, and she should have the right
to control who has access to it. Secondly, without a guarantee of
confidentiality, a patient might withhold information that is necessary to
diagnose and treat her appropriately.
PROTECTION OF PERSONAL INFORMATION
Data protection is another important
consideration and the Protection of Personal Information Act (POPIA)[5]
has specific and stringent guidelines on protecting patient information and
disclosure thereof to third parties.
Without express consent no
information on a patient can be shared, bar specifically allowed for by law.
Both the National Health Act (NHA)[6]
and the Health Professions Council’s (HPCSA) Ethical Rules of Conduct: Informed
Consent[7]
stipulates when and how patient information may be distributed without consent
by law. The legal duty of confidentiality is not absolute. The reality of
modern medical treatment is that patient information will be shared among a
team of health care professionals and is provided for in the NHA and the HPCSA
Guidelines.
Rule 13 of the Ethical Rules of
the HPCSA states that a practitioner may divulge information regarding a
patient only if this is done:
·
In terms of a Statutory provision,
·
at the instruction of a court,
·
in the public interest,
·
with the express consent of the patient,
·
with the written consent of a parent or guardian
of a minor under the age of 12 years,
·
in the case of a deceased patient with the
written consent of the next of kin or the executor of the deceased’s
estate.
Disclosures in the public
interest would include but not be limited to situations where the patient or
other persons would be prone to harm because of risk related contact.
Patients have a right to expect
that information about them will be held in confidence by healthcare
practitioners. Confidentiality is central to trust between practitioners and
patients. Without assurances about confidentiality, patients may be reluctant to
give practitioners the information they need to provide good care.
Guideline 4 of the HPCSA deals
with retaining confidentiality. Where healthcare practitioners are asked to
provide information about patients, they should seek the consent of patients to
disclosure of information wherever possible, whether the patients can be identified
from the disclosure or not.
Comprehensive information must be
made available to patients about the potential for a breach of confidentiality
with ICD10 coding. Anonymise data where unidentifiable data will serve the
purpose must be utilised. Keep disclosures to the minimum necessary. Healthcare
practitioners must always be prepared to justify their decisions in accordance
with these guidelines.
Healthcare practitioners should
make sure that patients are aware that personal information about them will be
shared within the healthcare team - and patients must be told the reasons for
this. It is particularly important to check that patients understand what will
be disclosed if it is necessary to share personal information with anyone
employed by another organisation or agency providing health or social care.
Practitioners cannot treat patients safely, nor provide continuity of care,
without having relevant information about the patient's condition and medical
history.
In some circumstances where
patients have consented to treatment, express consent (orally or in writing) is
not usually needed before relevant personal information is shared to enable the
treatment to be provided. For example, express consent is not needed before a
general practitioner discloses relevant personal information to a medical
secretary so that she can type a referral letter. In such circumstances, when
the practitioner informs the patient that he or she is referring the patient to
somebody else, the patient is assumed to have given implied consent to such
disclosure being made to the secretary.
The healthcare practitioner must
make sure that any recipient to whom personal information about patients is
disclosed, understands that it is given to them in confidence, which they must
respect. Anyone receiving personal information to provide care is bound by the
legal duty of confidentiality - whether they have contractual or professional
obligations to protect confidentiality.
Circumstances may arise where a
patient cannot be informed about the sharing of information, for example
because of a medical emergency. In these cases, the healthcare practitioner
should disclose the relevant information promptly to those providing the
patients' care and explain the situation to the patient after the emergency has
passed.
The Constitution of the Republic
of South Africa[8]
Chapter 2 The Bill of Rights, which is the highest law in the land, protects a
person’s Right to Human Dignity[9]
and the Right to Privacy[10]
and by extention the need for privacy and consent to medical procedures. The
provisions of the Bill of Rights are codified in several statutes.
BIOETHICAL CONSIDERATIONS
Medical ethics has a long history
unlike bioethics which is a more recent phenomenon. In the past conscientious
medical professionals were trained to act paternalistically towards patients,
to treat patients according to the medical professional’s judgment and not what
would be best for the patient with little regard for each patient’s perspective
or preference[11].
Problems arise due to intimate and central aspects of a patient’s life, such as
disability, sexuality, psychological well-being, life style, self-image and
bodily integrity, to name but a few. It is not within the medical professional’s
scope to make choices that rest within a patient’s value system[12].
Medical paternalism is being
challenged the world over as patient autonomy is on the rise, rejecting the
medical professional’s superior medical knowledge and increasingly insisting on
their own rights[13]. The culmination of this was the case of
Montgomery v Lanarkshire Health Board[14]
in which the following was stated
“it has become increasingly clear that the paradigm of the
doctor-patient relationship implicit in the speeches in that case has ceased to
reflect the reality and complexity of the way in which healthcare services are
provided, or the way in which the providers and recipients of such services
view their relationship. One development which is particularly significant in
the present context is that patients are now widely regarded as persons holding
rights, rather than as the passive recipients of the care of the medical
profession. They are also widely treated as consumers exercising choices: a
viewpoint which has underpinned some of the developments in the provision of
healthcare services.”[15]
“The social and legal developments which we have mentioned point away
from a model of the relationship between the doctor and the patient based upon
medical paternalism. They also point away from a model based upon a view of the
patient as being entirely dependent on information provided by the doctor. What
they point towards is an approach to the law which, instead of treating
patients as placing themselves in the hands of their doctors (and then being
prone to sue their doctors in the event of a disappointing outcome), treats
them so far as possible as adults who are capable of understanding that medical
treatment is uncertain of success and may involve risks, accepting
responsibility for the taking of risks affecting their own lives, and living
with the consequences of their choices”.[16]
The HPCSA Guidelines reiterate
that patients have a right to information about the healthcare services
available to them, presented in a way that is easy to follow and use.
The National Health Act provides
that healthcare providers, this includes healthcare practitioners, must inform
patients of the following:
·
The patient’s health status except in
circumstances where there is substantial evidence that the disclosure of the
patient’s health status would be contrary to the best interests of the
patients;
·
The range of diagnostic procedures and treatment
options generally available to the patients;
·
The benefits, risks costs and consequences
generally associated with each option; and
·
The patient’s right to refuse health services
and explain the implications, risks and obligations of such refusal.
Patients also have a right to
information about any condition or disease from which they are suffering. Such
information should be presented in a manner easy to follow and use, and should
include information about the diagnosis, prognosis, treatment options, outcomes
of treatment, common and serious side-effects of treatment, the likely time
frames of treatment, and the expected costs, where relevant.
Healthcare practitioners should
always give patients basic information about the treatment they propose to provide
but should respect the wishes of any patient who asks not to be given detailed
information. The latter requests place a considerable onus upon health care
providers because, without such information, patients cannot make proper
choices as partners in the health care process.
Information about patients is
requested for a wide variety of purposes including education, research,
monitoring and epidemiology, public health surveillance, clinical audit,
administration and planning, insurance and employment. Healthcare practitioners
have a duty to protect the privacy of patients and respect their autonomy.
Seeking consent of patients to
disclosure is part of good communication between healthcare practitioners and
patients and is an essential part of respect for the autonomy and privacy of
patients.
The following principles should
be applied:
·
Healthcare practitioners must obtain express
consent where patients may be personally affected by the disclosure, for
example when disclosing personal information to a patient's employer or to a
medical scheme for ICD-10 coding.
·
When seeking express consent, health care
practitioners must make sure that patients are given enough information on
which to base their decision, the reasons for the disclosure and the likely consequences
of the disclosure.
·
Healthcare practitioners should also explain how
much information will be disclosed and to whom it will be given.
·
If the patient withholds consent the healthcare
practitioner should first attempt to persuade the patient to consent.
·
If the patient continues to refuse consent, or
consent cannot be obtained, the consequences of disclosure and non-disclosure
should be explained to the patient. Disclosures may be made only where they can
be justified in the public interest.
Obtaining consent where the
disclosure is made for research, educational, training, efficient
administration of health services or clinical audit purposes has its own set of
rules to consider. If identifiable data is to be used this can only be done
with informed consent of the patient. The following guidelines are given;
·
Use of identifiable patient data is permitted
for purposes of the efficient administration of
health services and for clinical audit, with the proviso that only information
relevant to the purpose of disclosure is revealed, and disclosure is only made
to personnel with a direct interest in that information.
·
Where de-identified information can serve any of
the above purposes, it is incumbent on the healthcare provider to de-identify
these data as soon as possible before making use of the data.
·
Where healthcare practitioners have control of
personal information about patients, they must not allow anyone access to that
information for study, research or medical audit unless the person obtaining
access has been properly trained and authorised by a health establishment, a
healthcare provider or comparable body and is subject to a duty of confidentiality
in their employment or because of their registration with a statutory
regulatory body.
Disclosures in the public
interest:
·
In cases where healthcare practitioners have
considered all the available means of obtaining consent, but are satisfied that
it is not practicable to do so, or that patients are not competent to give
consent, or exceptionally, in cases where patients withhold consent, personal
information may be disclosed in the public interest where the benefits to an
individual or to society of the disclosure outweigh the public and the
patient's interest in keeping the information confidential, (e.g. endangered
third parties such as the spouse or partner of a patient who is HIV positive,
who after counselling refuses to disclosure his or her status to such spouse or
partner; or reporting a notifiable disease).
·
In all such cases the healthcare practitioner
must weigh the possible harm (both to the patient, and the overall trust
between practitioners and patients) against the benefits that are likely to
arise from the release of information.
·
Examples of circumstances to protect the patient
or other persons from death or serious harm, include, but are not limited to:
o
Access to prophylactic treatment for a person
who has had contact with an infectious disease, or
o
An employee with a health condition which may
render him or her unable to work safely posing a danger to co-workers or
clients
o
A driver of a vehicle who requires medication to
control an illness that might impair his or her driving ability.
Professional organisations and
Government regulatory bodies that monitor the public health or the safety of
medicines or devices, as well as registries of notifiable conditions, rely on
information from patients' records for their effectiveness in safeguarding
public health. For example, the effectiveness of the system of notifiable
conditions depends on information provided by clinicians.
Healthcare practitioners must
co-operate by providing relevant information wherever possible. The
notification of some communicable diseases is required by law and in other
cases healthcare practitioners should provide information in anonymised form
when that would be sufficient.
Where personal information is
needed, healthcare practitioners should seek express consent before disclosing
information, whenever that is practicable. For example, where patients are
receiving treatment there will usually be an opportunity for a health care
practitioner to discuss disclosure of information with them.
Personal information may
sometimes be sought about patients with whom healthcare practitioners are not
in regular contact. Practitioners should therefore make sure that patients are
given information about the possible value of their data in protecting public
health in the longer-term, at the initial consultation or at another suitable
occasion when they attend a health establishment. It should be clear that they
may object to disclosures at any point. The healthcare practitioner must record
any objections so that patient’s wishes can be respected. In such cases, the
practitioner may pass on anonymised information if asked to do so.
Where patients have not expressed
an objection, healthcare practitioners should assess the likely benefit of the
disclosure to the public and commitment to confidentiality of the organisation
requesting the information. If there is little or no evident public benefit,
they should not disclose information without the express consent of the
patient.
Where it is not practicable to
seek the consent of patients for disclosure of personal information for these
purposes, or where patients are not competent to give consent, health care
practitioners must consider whether the disclosures would be justified in the
public interest, by weighing the benefits to public health of the disclosure
against the possible detriment to the patient.
The automatic transfer of
personal information to a registry, whether by electronic or other means,
before informing the patient that information will be passed on, is
unacceptable, save in the most exceptional circumstances. These would be where
a court has already decided that there is such an overwhelming public interest
in the disclosure of information to a registry that rights of patients to
confidentiality are overridden; or where healthcare practitioners are willing
and able to justify the disclosure, potentially before a court or to the HPCSA,
on the same grounds.
Healthcare practitioners must
obtain express consent from patients before publishing personal information
about them in media to which the public has access, for example in journals or
text books, whether the practitioners believe the patients can be identified or
not. Express consent must, therefore, be sought to the publication of, for
example case-histories about, or photographs of patients. Where health care
practitioners wish to publish information about a patient who has died, they
should consider the guidelines in this booklet before deciding whether to do
so.
Situations arise where healthcare
practitioners have contractual obligations to third parties, such as companies
or organisations, as well as obligations to patients. Such situations occur, for
example when practitioners:
·
Provide occupational health services or medical
care for employees of a company or organisation;
·
Are employed by an organisation such as an
insurance company;
·
Work for an agency assessing claims for
benefits;
·
Provide medical care to patients and are
subsequently asked to provide medical reports or information for third parties
about them;
·
Work as district medical officers or forensic
pathologists;
·
Work in the armed forces;
·
or Work in correctional services.
If healthcare practitioners are
asked to write a report about or examine a patient, or to disclose information
about a patient from existing records for a third party to whom the
practitioners have contractual obligations, they must:
·
Be satisfied that the patient has been told at
the earliest opportunity about the purpose of the examination or disclosure;
·
the extent of the information to be disclosed;
·
and the fact that relevant information cannot be
concealed or withheld.
·
Healthcare practitioners should show the form to
the patient before they complete it to ensure that the patient understands the
scope of the information requested;
·
Obtain, or have seen, written consent to the
disclosure from the patient or a person properly authorised to act on the
patient's behalf.
·
Disclose only information relevant to the
request for disclosure.
·
Include only information that they can
substantiate, and ensure that it is presented in an unbiased manner;
Patients may wish to see reports
written about them before they are disclosed, in all circumstances healthcare
practitioners should check whether patients wish to see their reports - unless
patients have clearly and specifically stated that they do not wish to do so.
Disclosure of personal
information without consent may be justified where failure to do so may expose
the patient or others to risk or death or serious harm. Where third parties are
exposed to a risk so serious that it outweighs the patient's right to
confidentiality, healthcare practitioners should seek consent to disclosure
where practicable. If it is not practicable, they should disclose information
promptly to an appropriate person or authority. They should generally inform
the patient before disclosing the information. Such circumstances may be:
·
A person who is placing co-workers at risk because
of illness or some other medical condition. If healthcare practitioners are in
doubt about whether such disclosure is justified, they should consult an
experienced colleague or seek advice from a professional organisation. The
safety of persons must come first always;
·
A patient who continues to drive, against
medical advice, when unfit to do so: In such circumstances healthcare
practitioners should consider disclosing the relevant information to the
patient’s next-of-kin or the traffic authorities or police. Where such a
patient is employed as a professional driver the employer should be informed.
·
A disclosure that may assist in the prevention
or detection of a serious crime: In this context, serious crimes, means crimes
that will put someone at risk of death or serious harm, and will usually be
crimes against the person, such as abuse of children.
·
Healthcare practitioners may be required to
disclose information to satisfy a specific statutory requirement, such as
notification of a notifiable disease or suspected child or elder abuse.
·
Healthcare practitioners must also disclose
information if ordered to do so by a judge or presiding officer of a court.
They should object to the judge or the presiding officer if attempts are made
to compel them to disclose what appear to them to be irrelevant matters, for
example matters relating to relatives or partners of the patient, who are not
parties to the proceedings.
Healthcare practitioners should
not disclose personal information to a third party such as a lawyer, police
officer or officer of a court without the patient's express consent, except in
the circumstances described above.
Healthcare practitioners may
disclose personal information in response to an official request from a
statutory regulatory body for any of the healthcare professions, where that
body determines that this is necessary in the interests of justice and for the
safety of other patients. Wherever practicable they should discuss this with
the patient. There may be exceptional cases where, even though the patient
objects, disclosure is justified.
In all cases, should healthcare practitioners
decide to disclose confidential information they must be prepared to explain
and justify their decisions.
THE NATIONAL HEALTH ACT
The National Health Act requires
that healthcare providers (which includes health care practitioners) and health
care establishments are responsible for personal information about their
patients and must make sure that such information is effectively protected
against improper disclosure always. For example, this means that employees such
as clerks and receptionists must also be trained to respect the confidentiality
of patients when dealing with personal information.
Many improper disclosures are
unintentional. Healthcare practitioners should not discuss information about
patients where they can be overheard or leave patients' records where they are
vulnerable to disclosure, either on paper or electronically, where they can be
seen by other patients, unauthorised healthcare personnel or the public.
Healthcare practitioners should endeavour to ensure that their consultations
with patients are private.
PATIENTS WHO LACK CAPACITY
Various aspects require
consideration in instances where a patient lacks capacity to act. The Mental
Health Care Act[18]
makes provision for Respect, Human Dignity and Privacy for mental health care
patients[19]. Every mental health user must be provided
with care, treatment and rehabilitation services that improve the mental
capacity of the user to develop to full potential and to facilitate his or her
integration into community life[20].
Treatment must intrude as little as possible and must be in line with his or
her mental health status[21]
Consent to care, treatment and
rehabilitation services and admission to health establishments[22]
is dealt with in Section (9) (1) A health care provider may provide care,
treatment and rehabilitation services to or admit a mental health care user
only if the user has consented to the care, treatment and rehabilitation
services or to admission; authorised by a court order or a Review Board; or due
to a mental illness in which the delay in providing care, treatment and
rehabilitation services or admission may result in the- (I) death or
irreversible harm to the health of the user; (ii) user inflicting serious harm to
himself or others; or (iii) user causing
serious damage to or loss of property.
Disclosure of information is
dealt with by section 13 (1) A person or health establishment may not disclose
any information which a mental health care user is entitled to keep
confidential in terms of any other law. (2) Despite subsection (1); the head of
the national department, a head of provincial department or the head of a health
establishment concerned may disclose such information if failure to do so would
seriously prejudice the health of the mental health care user or of other
people. (3) A mental health care provider may temporarily deny mental health
care users access to information contained in their health records if
disclosure of that information is likely to; seriously prejudice the user; or cause
the user to conduct himself or herself in a manner that may seriously prejudice
him or her or the health of other people.
Problems may arise if healthcare
practitioners consider that a patient is incapable of giving consent to
treatment or disclosure because of immaturity, illness or mental incapacity[23].
If such patients ask them not to disclose information to a third party, the
healthcare practitioners should try to persuade them to allow an appropriate
person to be involved in the consultation.
If patients refuse to give
consent and healthcare practitioners are convinced that it is essential and in
the patient’s medical interests, they may disclose relevant information to an
appropriate person or authority. In such cases the healthcare practitioner must
tell the patient before disclosing any information and seek the consent of the
person legally designated to give such consent in terms of the National Health
Act.
The National Health Act provides
that if no person has been mandated or legally appointed to give consent, then
in the following order of precedence, a spouse or partner, parent, grandparent,
adult child or adult brother or sister may give consent.
Rule 57 of the Supreme Court
Rules sets out the procedure to be followed if a person does not have the
capacity to act. The court is requested to address three aspects in its
enquiry: (i) to declare the patient of unsound mind and incapable of managing
his/her affairs; (ii) to appoint a curator ad litem; (iii) to appoint a curator
bonis or curator personae or both. It is not essential that a person be
declared mentally ill in terms of the Mental Health Care Act before a curator
can be appointed to his estate.
A person that does not have the ability
to make decisions over his own person, such as medical procedures and
treatment, needs the assistance of a curator ad personae. The definition of a
curator personae is the curator “over the person” of the patient and means the
control over the patient's personal welfare. In the case of the application for
curator personae the request is that the patient be declared unable to see to
his personal needs. Only property of the patient is really the concern of the
Master of the High Court due to his dealing with "estates" which are
proprietary and not personal rights. A curator persona is appointed with far
less formality. He/she is in practice responsible for all decisions where money
is not involved.
The definition of “INCAPACITY” for
legal purposes is function-based (i.e. ability to make specific decision at a
specific point in time) and accommodates fluctuant and temporary incapacity in
terms of cognitive functioning based on clinical evaluation. It is not
equivalent to inability to communicate and does not regard illiteracy as
inability to communicate or make decisions. It includes the safeguarding of
interference in lives of eccentric persons. It is not based on a finding by a
specific person or the court but by supporting clinical evidence of at least two
medical professionals one of which should be an alienist (not having treated
patient).
Best interests of the person are
defined with reference to the least restrictive option, necessary only about
individual circumstances and needs and an adult must be encouraged to
participate. The person’s cultural environment, values and beliefs must be
respected as far as is reasonable and practicable and past and present wishes
and feelings need to be considered. Consideration must be given to the views of
persons with an interest in the welfare of the adult or the proposed
intervention.
[1]
Medical Law: Text, Cases and Materials page 166
[2]
Michael Jones – Informed Consent and Other Fairy Stories 1999 7 Medical Law
Review 103-34, 129
[3]
Medical Law: Text, Cases and Materials page 167
[4]
The Hippocratic Oath – “whatever things I see or hear concerning the life of
men, in my attendance on the sick or even apart therefrom, which ought not to
be noised abroad, I will keep silence thereon, counting such things to be as
sacred secrets”
[5] No
4 of 2013
[6] No
61 of 2003
[7]
Booklet 4
[8]
Act 108 of 1998
[9]
Section 11
[10]
Section 14
[11]
Susan Sherwin – A Relational Approach to Autonomy in Healthcare
[12]
Susan Sherwin supra
[13]
Medical Law – Text Cases and Materials page 4
[14] [2015]
UKSC 11 On appeal from: [2013] CSIH 3; [2010] CSIH 104
[15]
Para 75 page 24 supra
[16]
Para 81 page 26 supra
[17] http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/Booklet%205.pdf
[18]
Act 17 of 2002
[19]
Chapter III (8) (1)
[20]
(8) (2) supra
[21]
(8) (3) supra
[22]
Section 9 of Act 17 of 2002 supra
[23] http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/Booklet%205.pdf
