Document 18
Sponsor: Clinical Governance Board
Name: Informed Consent
ORGANISATIONAL
POLICY:
INFORMED CONSENT
AUTHORITATIVE SOURCE:
Code of Health and Disability Services Consumers Rights. (The Code)
Health and Disability Sector Standards
Standards for Health and Disability Services
Care of Children Act 2004
The Health Information Privacy Code 2020
Privacy Act 2020
AUTHOR:
Chief Medical Officer
PURPOSE:
To ensure that legal, ethical, and professional obligations relating to informed consent are achieved.
Facilitate the provision of good patient care
SCOPE:
The Code states that every person has the right to effective communication, to be fully informed and
to give informed consent. Every provider of health and disability services has a duty to enable people
to exercise their rights.
DEFINITIONS:
Informed Consent:
Is an interactive process between a health professional and person where the person gains an
understanding of what is involved in receiving a proposed procedure or treatment. Consent must be
voluntary and there should be no pressure on the person to give their consent. Should the person
require an interpreter please refer to the Interpreters Policy and Tikanga Best Practice Policy.
Informed consent is revalidated at every procedure or treatment instance.
Written Consent:
Informed consent that is acknowledged, through a pro forma document or other instrument, signed
by both the person or the person’s legal representative and the health professional. If no form exists
or is able to be used, the details should be recorded in the person’s clinical record. Written consent
for a procedure remains valid unless circumstances change (e.g. clinical condition, patient
competence, clinician availability, procedural technique, personal circumstances).
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 1 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
Verbal Consent:
If verbal consent is given, it should be documented in the health record. Although informed consent
for a health care procedure may be given verbally, it should be given in writing in the following
circumstances:
If it assists the informed consent process.
If the patient or the clinician requests a written consent.
Medical Emergency:
An acute situation, which is likely to result in death, or permanent injury or prolonged and avoidable
pain and suffering, unless interrupted with prompt, corrective treatment.
Provider:
Providers are widely defined in the Health and Disability Commissioner Act. They include anyone
providing or claiming to provide any sort of health or disability service whether public or private.
POLICY STATEMENTS:
1. Every provider involved in the provision of a health or disability service has a duty to ensure
patients/consumers are given the appropriate information to enable them to make an informed
choice.
2. Informed consent meets dual obligations – to obtain valid consent and warn of material risks.
The standard for informed consent is that every person has the right to information that a
reasonable consumer, in that consumer’s circumstances, needs to make an informed choice or
give informed consent.
3. The key elements of informed consent are:
3.1. Open and honest communication between the parties.
3.2. Provision of all necessary information to the person.
3.3. The competent person’s freely given consent.
3.4. The person performing the procedure shall obtain consent. It is expected that all
members of the health team will work together to support the consent process.
3.5. Sufficient information will be provided to the person to enable the person to make an
informed decision. The person is entitled to request a written summary of the relevant
information. This information will include:
An explanation of his or her condition including the results of any relevant tests
and investigations
an explanation of the options available, including an assessment of expected risks,
side effects, benefits and if applicable costs of each option
the name, status and qualifications of the person who will perform the procedure
any other relevant information requested by the person or volunteered by the
health professional
advice that the person has the right to refuse consent
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 2 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
advice the person has the right to consider fully the information given and seek
further opinion
Notification of any proposed participation in teaching or research and that it has
received ethical approval.
Consequences of not accepting treatment
Implications of existing advance directives
Issues related to body parts – (refer to Tikanga Best Practice Guidelines)
Recovery and recuperation
3.6. The person may withdraw or decline consent at any time - the procedure will not be
carried out.
3.7. A person may waive the right to discuss details of treatment/procedures. This should be
documented in the clinical record. The person should be given the opportunity to
change his/her mind.
4. Consent of Children
4.1. A health professional must assess a child’s competency to decide whether he/she is
able to give consent. This assessment should include if the child is able to understand
the nature, purpose and possible consequences of the proposed investigation or
treatment as well as the consequences of non-treatment. There is no age for consent
under the Care of Children Act 2004.
4.2. Consent to any medical, surgical, or dental treatment or procedure (including a blood
transfusion) to be carried out on a child may be given—
(a) By a guardian of the child; or
(b) if there is no guardian in New Zealand or no guardian of that kind can be found
with reasonable diligence or is capable of giving consent, by a person in New
Zealand who has been acting in the place of a parent; or
(c) If there is no person in New Zealand who has been so acting, or if no person of that
kind can be found with reasonable diligence or is capable of giving consent, by a
District Court Judge or the chief executive.
Children over the age of 16 are considered legal adults.
4.3. Consent to abortion—
Consent by a female child (of whatever age) has the same effect as if she were of full age:
(a) Consent to the carrying out of any medical or surgical procedure for the purpose of
terminating pregnancy by a person professionally qualified to carry it out; and
(b) Refusal to consent to the carrying out on her of any procedure of that kind.
Children over the age of 16 are considered legal adults.
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 3 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
5. When is informed consent required?
5.1. Written consent must be obtained when:
Written informed consent is legislatively required if:
the patient is to participate in any teaching or research or
the procedure is experimental or
the patient will be under general anaesthetic or
there is a significant risk of adverse effects on the patient
Written consent is also legislatively required if the patient is admitted under the Mental
Health (Compulsory Assessment and Treatment) Act 1992:
(S.59) in order to receive treatment after the first month of a compulsory
treatment order (unless treatment is approved by the psychiatrist appointed by the
Review Tribunal); or
(S.60) when electro-convulsive treatment is ordered (unless treatment is approved
by the psychiatrist appointed by the Review Tribunal); or
(S.61) when “brain surgery” is proposed
Health New Zealand – Te Whatu Ora Tairāwhiti also requires written consent in the
following situations:
Where either the patient or Health New Zealand, Te Whatu Ora Tairāwhiti requests
it
Where consent is given by the patient’s legal representative
Where a medical or nursing or midwifery student is to undertake an examination
or a procedure whilst the patient is under general anaesthetic or sedation
Where clinical video, audio or photographic recordings (including digital
photographs) are taken. Please note this consent is not for the treatment but to
allow the photographs or video to be taken.
Where it is planned to retain any body parts that are removed or obtained in the
course of a health care procedure (refer to the Health New Zealand – Te Whatu
Ora Tairāwhiti policy “Return of Human Tissue”)
Where transfusion of blood or blood products is required
Where the patient does not want to be resuscitated – refer to Shared Goals of Care
and Resuscitation Decisions policy
Where a medication is prescribed that is not yet approved/ registered for use in
NZ, or the medication is being used for a purpose other than which it is registered.
5.2. Where written consent is not required, it is advisable that the health professional
documents in the clinical record that consent has been obtained.
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 4 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
5.3. Other circumstances requiring consent:
Consent is required in situations beyond those set out above at 5.1 where treatment
is proposed. Examples include:
Every health care service (treatment or procedure)
Where a student, staff member or external personnel wish to observe procedures
in theatre
Where a patient’s information will be used for cases studies, peer review or
exemplars
Where a teacher wished to involve the patient in a teaching or clinical
demonstration session
Note: Consent is not required where information is used for teaching purposes and is not
identifiable to the patient
6. Confirmation of consent
6.1. There are no limits placed on the length of time over which consent for treatment or a
procedure remains valid. However, a patient may change their mind and withdraw their
consent at any time. Immediately prior to the procedure confirmation of consent is
required to be documented on the consent form.
6.2. The need to obtain new consent arises when there is a change to some relevant
circumstance e.g. new information about complications of the proposed treatment; a
significant change in the patient’s condition, new or different treatment is proposed or
where consent has been withdrawn.
7. Competence
7.1. All people are to be presumed competent. It is the Clinician’s responsibility to ascertain
whether the patient is competent to give informed consent. Medication, intellectual
disability, mental illness, inebriation, or physical injuries may affect the informed
consent process. Where a person has diminished competence the person retains the
right to make informed choices and give informed consent to the extent of his/her level
of competence. This principle is applied to children.
7.2. Competence requires that the person is able to:
a) Understand in broad terms the nature of the treatment
b) Retain the information and weigh up the information to reach a decision
7.3. Where a person is not competent to make an informed choice and give informed
consent, and no person entitled to consent on behalf of the person is available to give
consent, the provider may provide services where:
a) It is in the best interests of the person; and
b) Reasonable steps have been taken to ascertain the views of the person; and
c) Either, -
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 5 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
i. If the person's views have been ascertained, and having regard to those
views, the provider believes, on reasonable grounds, that the provision of
the services is consistent with the informed choice the person would make if
he or she were competent; or
ii. If the person's views have not been ascertained, the provider takes into
account the views of other suitable persons who are interested in the
welfare of the person and available to advise the provider.
7.4. Where a consumer is deemed not competent to consent and has a welfare guardian
and/or person with enduring Power Of Attorney this authority needs to be supplied and
a copy put into the patients notes.
Those individuals entitled to Consent on behalf of the consumer include:
A parent or legal guardian
Welfare guardian, or person with enduring power of attorney
8. Consent and the removal of body parts/Human tissue
8.1. Every person has the right to make a decision about the return or disposal of any body
parts removed or obtained in the course of a health care procedure.
8.2. Any body parts or bodily substances removed or obtained in the course of a health care
procedure may be stored, preserved, or utilised only with the informed consent of the
person.
8.3. With the exception of coronial post mortem, written consent is required for post-
mortem examination.
9. Emergency Procedures
9.1. In a medical emergency or medically urgent situation, the primary need is to treat the
person and informed consent may not be possible. In such cases the principles are the
same as for the non-competent person.
10. Teaching and Research
10.1. An accredited ethics committee must approve all research before people are invited to
participate and give consent. Written consent is required for research. There is a need
to renew consent if there is any change or amendment to the research after consent
has been obtained.
10.2. Consent must be obtained for the involvement of trainees in the care of people. This
includes providing information about the extent of the involvement of the trainee and
the trainee’s experience.
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 6 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
11. Procedures without Consent:
11.1. There are legally defined circumstances where people may, or must, be treated without
obtaining their informed consent. These are people:
Receiving treatment under the Mental Health (Compulsory Assessment and
Treatment) Act 1992. (Note: an attempt should still be made to obtain the person’s
consent.)
Who are mentally disordered, where consent has been given by the High Court
under the Jucidial Review Procedure Act 2016
Whom a judge has ordered be detained and treated as alcoholics or drug addicts
under the Substance Addiction (Compulsory Assessment and Treatment) Act 2017.
who have an infectious disease posing a public health risk, and a medical
examination order has been made by a District Court on the application of the
Medical Officer of Health (Health Act 1956, S.92ZH)
Whom a blood specimen is required by police or a doctor under the Land Transport
(Road Safety and Other Matters) Amendment Act 2011 in cases of suspected drunk
driving (note the doctor need not suspect the person of being the driver but simply
involved in a motor vehicle accident).
Where a Court-appointed welfare guardian or an authorised attorney makes
decisions on a person’s behalf pursuant to the Protection of Personal and Property
Rights Act 1988. Note that the welfare guardian cannot refuse standard medical
treatment or procedure. They cannot consent to electro-convulsive treatment, the
person taking part in any medical experiment unless it is for the purpose of saving
their life or preventing serious damage to their health, nor to any surgery or
treatment designed to destroy any part of the brain, or brain function for the
purpose of changing the person’s behaviour.
Who are children where a Family Court judge requires a medical examination
(Children, Young Persons and their Families Act 1989)
Where a High Court judge orders a blood sample be taken pursuant to the Criminal
Investigations (Bodily Samples) Act 1995.
Treated under the Armed Forces Discipline Act 1971 where the person’s treatment
is considered necessary to protect the health of other members of the Armed
Forces.
Treated under the Crimes Act 1961, which authorises the use of "such force as may
be necessary" to prevent suicide or any offence likely to cause immediate and
serious injury. This allows restraint without consent under these circumstances.
RELATED STANDARDS AND PROCEDURES: The Code of Health and Disability Services Consumer’s Rights – i.e.
RIGHT 1 - Right to be treated with respect
RIGHT 2 - Right to freedom from discrimination, coercion, harassment and exploitation
RIGHT 3 - Right to dignity and independence
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 7 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Sponsor: Clinical Governance Board
Name: Informed Consent
RIGHT 4 - Right to services of an appropriate standard
RIGHT 5 - Right to effective communication
RIGHT 6 - Right to be fully informed
RIGHT 7 - Right to make an informed choice and give informed consent
RIGHT 8 - Right to support
RIGHT 9 - Rights in respect of teaching or research
RIGHT 10 - Right to complaint
Health Information Privacy Policy
REFERENCES: Medical Council of New Zealand; Information, Choice of Treatment and Informed Consent. March,
2011
; www.mcnz.org.nz
Health and Disability Commissioner; Informed Consent in the Code of Health and Disability Services
Consumer’s Righ
ts Providing appropriate information and clear communication vital to obtaining
informed consent from consumers — Health & Disability Commissioner (hdc.org.nz)
Code of Health and Disability Services Consumers' Rights — Health & Disability Commissioner
(hdc.org.nz)
Health and Disability Commissioner; The Informed Consent Process and the Application of the Code
to Children; August 1998
Care of children Act 2004 Part 2, Sections 36-38
__________________________________________
Authorised By: Chair – Clinical Governance Board
Date of Approval: April 2024
Next Review Date: April 2026
Author: Chief Medical Officer
Date of first approval: November 1998
Authorised by: Chief Medical Officer
Date last review completed: April 2024
Version #6
Page: 8 of 8
The electronic version is the up-to-date version. Te Whatu Ora Tairāwhiti will
not take any responsibility for an outdated paper copy being
used.
Document Outline
