DGD12-044
Standard Operating Procedure
Consent and Treatment
Purpose
This standard operating procedure (SOP) outlines the process for Health Directorate staff to
follow to gain valid informed consent from consumers prior to all clinical activities,
treatments or procedures, with the exception of medical treatment given in an emergency
to save the consumer’s life or prevent serious harm.
Scope
This SOP provides all Health Directorate staff with information and support to assist in
meeting legal obligations to gain valid informed consent. It is to be read in association with
the Health Directorate Consent and Treatment Policy and associated SOPs:
 Consent and Treatment: Children or Young People SOP
 Consent and Treatment: Capacity and Substitute Decision Makers SOP.
Procedure
1. Treatment in an emergency
1.1 Where urgent medical treatment is required to save a consumer’s life or prevent serious
harm and the consumer is not able to provide consent to the required treatment at the
time through a lack of capacity, (e.g. because the consumer is unconscious) medical
treatment can be given, provided that:
 The treatment is a necessity
 There is no written:
o Health directive, or
o Not For Cardiopulmonary Resuscitation Order (NFCPR) by the consumer to
the contrary, and
 Consent cannot be sought from a substitute decision maker due to urgency of the
treatment.
Note: Unless consumers are unconscious or otherwise severely incapacitated, they are
potentially still able to understand the treatment process and may still be able to give
consent, depending on the nature of the emergency.
1.2 The circumstances that comprise the emergency and the consumer’s lack of capacity to
consent must be documented in the clinical record.
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Review Date
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1.3 In accordance with their duty of care, when health professionals identify serious or
potentially life-threatening clinical issues for consumers in the community setting they
MUST telephone for an ambulance to convey the consumer to hospital. The consumer must
be informed that:
 An ambulance will be called, and
 Their right to refuse treatment and/or transport by the ambulance service. Refer
to Section 8 - Refusal of clinical treatment and withdrawal of consent for further
information.
The health professional will inform the consumer’s General Practitioner and Treating
Medical Officer of the request for ambulance transport.
1.4 When a consumer arrives in the operating theatre without consent
If a consumer arrives in the operating theatre holding bay without valid or documented
consent, the operating team must first determine whether the consumer requires
emergency treatment. If emergency treatment is necessary and must be provided
without delay, the consumer is deemed by law to have consented to the treatment, e.g.
to save the life of the consumer.
All other cases of consumers arriving in the operating theatre holding bay without valid
or documented consent (where it is not an emergency):
 Must not proceed to the operating theatre or treatment area, and
 Must be reported to a relevant Clinical Nurse Manager, Medical or Surgical
Director and other relevant health service administrators.
Surgery must be postponed or cancelled until valid informed consent is obtained. A
standard consent form must be used. Each case must also be:
 Documented in the consumer’s clinical record
 Reported as a clinical incident on the RiskMan incident management system, and
 Investigated in accordance with the Health Directorate RiskMan Incident
Reporting Policy.
2. Written consent
Written consent is where the consumer signs a document (e.g. a consent form
completed on admission as an inpatient or on entering a program) to confirm their
agreement to a clinical activity, treatment or procedure. Written consent is advisable for:
 Any healthcare which carries significant risks to the patient, and
 Where a consumer doesn’t have the capacity to consent and a substitute decision
maker provides consent.
Students and interns may not be delegated to gain consent for treatment or procedures
that require written consent.
Where a document relating to consent is not signed by the consumer, staff should
assume that the consent has not been given (see also ‘Consumers with communication
and/or cognitive difficulties’ below).
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2.1 In the Health Directorate, written consent must be obtained for:
 Invasive or non-invasive treatments or procedures where there are significant
risks or complications, e.g. surgery.
 Electroconvulsive therapy
 Unapproved therapeutic goods accessed via the Special Access Scheme
 Oral health procedures on children and young people under the age of 18 years
 Immunisations on children and young people under the age of 18 years
 Male and female sterilisation
 Medications with high risk complications or new or unusual medications, and
 Participation in clinical trials of a particular medicine, treatment or procedure and
medical research.
Written consent should also be considered for treatments or procedures that require
general, intravenous sedation, or regional anaesthesia.
Areas need to make their own assessments whether, in addition to those listed in Item
2.1, written consent is needed for specific clinical activities, treatments or procedures
performed in their area and ensure their staff are aware of requirements.
Furthermore, health professionals may choose to obtain written consent whenever they
consider it important to document consent in this way.
2.2 Responsibility for obtaining written consent
Where written consent is required the health professional responsible for the clinical
activity, treatment or procedure is responsible for ensuring valid informed consent is
obtained from the consumer, either by gaining consent themselves or delegating this
responsibility.
If a health professional delegates the task of gaining consent, they remain responsible for
ensuring:
 The health professional delegated the task:
o Is able to do so within their scope of practice, and
o Understands and is capable of informing the consumer of all relevant
information including the risks and benefits, and
 The consent documentation is properly completed.
When the treating health professional is not the health professional who obtained
consent the treating health professional must ensure consent has been gained before
proceeding with any treatment or procedure.
2.3 Documenting written consent
Health Directorate staff must use a form endorsed for use by the Health Directorate,
signed by the consumer and incorporated into the clinical record to document written
consent. Information about the process used to gain consent must be recorded as
required, either on the consent form or in the clinical record and as a minimum include:
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The consumer’s core identifiers (full name, date of birth and Health Directorate
medical record number if available). To avoid transcription errors, a Health
Directorate approved patient identification label must be used to document core
identifiers where possible. Labels from facilities outside of the Health Directorate
must not be used.
How any communication barriers were addressed
Any substitute decision maker used if the consumer doesn’t have the capacity to
consent, (Refer to: Health Directorate Consent: Capacity and Substitute Decision
Maker SOP for information on how to assess consumer capacity to consent)
The presence of a Health Directive or revocation
Space to record the relevant risks, benefits and alternatives
Any tools used to support decision-making, e.g. information sheets
The consumer’s specific wishes or any concerns they may have regarding the
proposed clinical activity, treatment or procedure
Who will perform the treatment or procedure
Date and time when the consent was given, and
The full name, title and signature of the health professional obtaining the
consent.
Abbreviations are not to be used on consent documents due to the potential for
misinterpretation or misunderstanding.
3. Verbal consent
Verbal consent is where the consumer orally states their agreement to a clinical activity,
treatment or procedure but does not sign a document.
‘Non-verbal’ consent refers to situations where a consumer cannot or does not give
signed written consent or consent by spoken word.
3.1 Procedures requiring verbal consent
Verbal consent is considered adequate for treatments or procedures such as:
 Blood or blood products
 Suture of minor lacerations
 Insertion of chest drains, and
 Local anaesthetic (e.g. for a consumer needing suturing).
3.2 Responsibility for obtaining verbal consent
If verbal consent is adequate for the treatment or procedure it is the responsibility of the
health professional performing the treatment or procedure to ensure valid informed
consent is obtained and documented in the clinical record.
Students and Allied Health Assistants
Verbal consent must be sought from the consumer for any clinical activity, treatment or
procedure to be undertaken by a student health professional or Allied Health Assistant
(AHA). The supervisor of the student is responsible for ensuring valid informed consent is
obtained and recorded in the clinical record.
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3.3 Documenting verbal consent
Information about the process of obtaining consent must be documented in the clinical
record and should include as a minimum the points listed in Item 2.3. However, the
consumer does not need to sign a document, e.g. a consent form.
4. Implied consent
Implied consent is another type of consent where the consumer indicates their
agreement through their actions or by cooperating with the health professional’s
instructions. For example when a consumer:
 Extends their arm to provide a routine blood sample for testing
 Takes and swallows medication that is provided, or
 Attends an appointment for the purpose of receiving information or advice
regarding management of their condition.
Implied consent is adequate for routine non-invasive procedures and is not required to
be documented in the clinical record.
5. Obtaining single consent for multiple procedures or treatment programs
Where a planned program of treatment involves a number of stages or treatments, a
single consent process, written or verbal as appropriate, may be followed. In this
situation, the health professional is to outline the elements of the program, including the
consequences of withdrawal at a future date and the right of the consumer to do so, and
document it in the clinical record.
If any aspects of the treatment program change, additional written or verbal consent is
required.
6. Communication and consent
Consumers must be able to understand the information likely to influence their decision
about whether to consent to health care or not.
The amount of information or time required to gain informed consent will vary according
to the consumer and their individual needs.
The National Health and Medical Research Council (NHMRC) Guidelines for Medical
Practitioners on Providing Information to Patients 2004 and Communicating with
Patients: Advice for Medical Practitioners provide valuable resources for staff. The
guidelines are available at www.nhrmc.gov.au.
6.1 Culturally and linguistically diverse consumers
Staff should be aware of the consumer’s cultural and linguistic background so that
information can be provided in a form and manner that is understood. Ways to achieve
this may include:
 Being aware of different culture’s ways of engaging in the health system
 Contacting the Aboriginal and Torres Strait Islander Liaison Service for advice and
support as required
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Use of an interpreter if English is not the consumer’s first language. Every
attempt should be made to obtain an accredited interpreter before using family
or friends to interpret. Interpreters must sign the relevant request or consent
form to identify that they have acted as an interpreter for the consumer during
the consent process (verbal or written), and
Using non-verbal tools, e.g. use of communication boards, to facilitate the
consumer’s understanding.
6.2 Consumers with communication and or/cognitive difficulties
Consumers who rely on non-verbal means of communication must be given every
opportunity to express their consent decision.
The standard consent documentation may be used to acknowledge written consent by
writing ‘Consumer unable to sign’ in the space for the signature, and signed by the health
professional and a witness.
When a consumer cannot communicate with staff using verbal or non-verbal means, for
health professionals to be sure valid informed consent can be gained, the substitute
decision making process should be followed. The reasons why the consumer cannot
provide consent must be documented in the clinical record. Refer to: Health Directorate
Consent to Treatment: Capacity and Substitute Decision Maker SOP.
6.3 Key points to communicate
When obtaining consent it is necessary to communicate the following key points:
The consumer’s rights, for example:
 Consumers have the right to refuse treatment, and withdraw their consent at any
time.
The diagnosis or condition to be treated, for example:
 The nature and seriousness of the consumer’s condition.
Specifics of the treatment, for example:
 What the proposed treatment or procedure involves, and
 Who will perform the treatment or procedure.
Possible risks and benefits, for example:
 The expected benefits (including the possibility the benefit may not be achieved)
 Anticipated recovery implications
 Common side effects and related risks
 Any significant long term physical, emotional, mental, social, sexual or other
expected effects, and
 The time and cost involved including any out‐of‐pocket expenses, if appropriate.
Uncertainty, for example:
 The degree of uncertainty of the diagnosis and any therapeutic outcomes, and
 Whether the treatment or procedure is conventional or experimental.
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Alternative courses of action, for example:
 Other options for diagnosis and treatment, and
 The likely outcome of not having the proposed treatment or procedure, or of not
having any treatment or procedure at all.
Financial information including:
 The cost of the treatment or procedure,
 and any out of pocket expenses the consumer will incur.
In order to make an informed decision, consumers must be given sufficient time to
consider and understand the information and the implications of their decision.
Consumers shouldn’t feel rushed into any decision and should be given the opportunity
to contact staff when they feel they have arrived at an appropriate decision.
6.4 Pre-prepared information
Where available, health professionals may provide appropriate written or audiovisual
information resource materials to supplement their discussion of the benefits and risks
of a proposed treatment or procedure. Any information resources developed for use
must be appropriately endorsed to ensure accuracy and relevance to consumer needs.
Appropriate processes should be maintained to ensure resources are continually
reviewed and updated to ensure currency.
Consumers need to be provided with the opportunity to ask questions after they have
looked at any information resource materials provided.
6.5 Responding to, and documenting the consumer’s concerns
Where necessary health professionals need to clarify information and respond to
consumer concerns. Where a consumer raises concerns about adverse outcomes, a
record of the discussions held and the decision reached should be fully documented in
the clinical record.
7. When a consumer refuses information
Health professionals have a legal duty to disclose information to the consumer. However,
common law recognises that information need not be given where doing so would be
damaging to a consumer’s physical or mental health.
Information regarding a treatment or procedure may not be provided in circumstances
when:
 A consumer expressly asks not to be given information, e.g. doesn’t want to see
graphic pictures or hear explicit detail. Consumers have the right to say they
don’t want to receive information, or
 A health professional judges, and is able to justify, that disclosure may harm the
consumer.
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Any decision to withhold information, whether at the consumer’s request or the health
practitioner’s judgement must be carefully considered and the reasons clearly
documented in the clinical record.
8. Refusal of clinical treatment and withdrawal of consent
8.1 A consumer can refuse all or part of any care and may withdraw previously given consent
at any time, even when this decision differs from health professional recommendations
and where the decision to decline care may result in decline in their health or their
death. In this situation the health professional must discuss the implications of not
receiving the recommended care with the consumer to ensure the consumer has all the
relevant information to make a considered decision.
 Refusal may be written, verbal or by any form of communication possible
 This decision must be documented in the clinical record by the treating health
professional and confirmed in writing by a second health professional
 If there is any concern about the capacity of the consumer to give valid consent
Refer to: Health Directorate Consent to Treatment: Capacity and Substitute
Decision Maker SOP.
8.2 With consideration of the consumer’s wishes the plan of recommended care should be
revised and consumer consent obtained.
8.3 Where the consumer continues to refuse recommended care the issue must be
reported and escalated through line management. With advice from clinical and legal
experts as necessary, the Health Directorate Executive will provide direction to the
relevant health professionals and treating teams regarding any further actions to be
taken.
Consumers should be encouraged to develop an Advance Care Plan to document their
wishes about future health care. Refer to SOP: Consent and Treatment: Capacity and
Substitute Decision Maker for further information.
8.4 The consumer’s General Practitioner and Treating Medical Officer must be kept informed
at all times.
Evaluation
Outcome Measures
 Consumers provide valid informed consent wherever it is required.
 All forms used to document written consent are endorsed for use by the Health
Directorate and comply with this policy and associated SOPs.
Method
 Documentation of consent audits overseen by the Governance Health Service
Standard Group.
Related Legislation, Policies and Standards
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Legislation
Age of Majority Act 1974
Children and Young People Act 2008
Civil Law (Wrongs) Act 2002
Guardianship and Management of Property Act 1991
Health Practitioner Regulation National Law (ACT) Act 2010
Health Records (Privacy and Access) Act 1997
Health Regulation (Maternal Health Information) Act 1998
Medical Treatment (Health Directions) Act 2006
Medicare Australia Act 2005
Mental Health (Treatment and Care) Act 1994
Powers of Attorney Act 2006
Public Advocate Act 2005
Road Transport (Alcohol and Drugs) Act 1977
Transplantation and Anatomy Act 1978 (2.2, 2.3, 2.5)
Policy
Clinical Record Management Policy
Clinical Record Documentation SOP
Release or Sharing of Clinical Records or Personal Health Information SOP
Consent and Treatment Policy
Consent and Treatment: Children or Young People SOP
Consent and Treatment: Capacity and Substitute Decision Makers SOP
Guidelines for Assessment of Decision Making Capacity by ACRS Psychologists SOP
Consumer and Carer Participation Framework
Consumer Feedback Standards: Listening and Learning
Patient Identification: Correct Patient, Correct Site, Correct Procedure Policy
Patient Identification: Correct Patient, Correct Site, Correct Procedure SOP
Standards
ACHS EQuIP 5:
1.1 Consumers/patients are provided with high quality care throughout the care delivery
process.
1.1.3 Consumers/patients are informed of the consent process, and they understand and
provide consent for their health care.
1.6 The governing body is committed to consumer participation.
1.6.2 Consumers/patients are informed of their rights and responsibilities.
3.1.5 Documented corporate and clinical policies and procedures assist the organisation to
provide quality, safe health care.
National Safety and Quality Health Service (NSQHS) Standards:
Governance for Safety and Quality in Health Service Organisations
Partnering with Consumers
Patient Identification and Procedure Matching
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Definition of Terms
Capacity
The term capacity is used in this document to mean a person is capable of:
 Understanding the nature and effect of decisions about consent and
communicating the understanding verbally or non-verbally
 Freely and voluntarily making decisions about consent
 Communicating the decisions verbally or non-verbally, and
 Retaining the information, their decision and their consent.
The type of assessment required to determine someone’s capacity will vary depending on
the type of decision being made.
Clinical Activity
Clinical activities improve, maintain or assess the health of a person in a clinical situation and
may include invasive and non-invasive procedures (including those performed in settings
other than the operating room). Some examples are:
• Invasive - taking a specimen of blood
- giving medication via an intravenous, intramuscular or subcutaneous route
- inserting intravenous access, or
- performing a surgical procedure, including a procedure performed in
medical imaging.
• Non-invasive - interventions such as evaluating, advising, planning
(E.g. dietary education, physiotherapy assessment, crisis intervention,
bereavement counselling, a procedure in medical imaging) and giving
medication.
Common law (Also known as case law)
Law developed by judges through decisions of courts/tribunals rather than through
legislation.
Consumer
In this document the term ‘consumer’ refers to patients, consumers and clients under the
care of the Health Directorate.
Health Directive – ACT
A Health Directive contains instructions that consent to, or refuse, specified medical
treatment or treatment which may occur in the future. Health Directives become effective in
situations where the consumer doesn’t have the capacity to make health care decisions for
themselves. A Health directive is legally binding and must be followed. It doesn’t apply
where the consumer has or regains capacity to consent. (Medical Treatment (Health
Directions) Act 2006)
Health Professional
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There are two Acts which define ‘health professionals’: the Medical Treatment (Health
Directions) Act 2006 (ACT) and the Health Practitioner Regulation National Law (ACT) Act
2010. For the purpose of this document a ‘health professional’ includes all doctors, dentists,
nurses and allied health professionals engaged the Health Directorate to care for consumers.
Informed consent
A person gives consent based upon an appreciation and understanding of the facts and
implications of an action. The person must be given the relevant information and have the
capacity to understand it.
Valid consent is based on the fundamental legal principle that the law protects the integrity
and autonomy of the person. Consent for a procedure or treatment is valid if:
 The consumer has the capacity to give consent
 Full information on risks, benefits and alternatives has been provided and
understood, with understanding demonstrated
 The consent is given freely, and
 The consent is specific to the procedure.
Substitute Decision Maker
Where it has been identified that an adult consumer does not have the decision-making
capacity to provide consent to treatment or procedures themselves the following substitute
decision makers can provide consent:
 Health Attorney
 The Attorney, under an Enduring Power of Attorney
 Guardian, if approved
 Public Advocate of the ACT if appointed guardian, and the
 Chief Psychiatrist or Community Care Coordinator (where there are issues relating to
mental health or mental dysfunction and the consumer is under a Mental Health
Order).
Treatment
Medical or surgical management of a consumer (including any medical or surgical procedure,
operation, examination and any prophylactic, palliative or rehabilitative care) normally
carried out by, or under the supervision of a Health Professional.
Treating medical officer
Medical officer who is delegated responsibility for all or part of the care of a consumer. The
treating medical officer may be a junior medical officer or senior medical officer and may not
be the admitting senior medical officer.
Treating Team
The treating team includes all service providers (located within, or external to the ACT) who
provide a service for the ACT Government Health Directorate involved in diagnosis, care or
treatment for the purpose of improving or maintaining the consumer’s health for a
particular episode of care (Health Records (Privacy and Access) Act 1997).
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References
Guidelines for Health Care Professionals Including Medical Practitioners and Dentists. (1999)
Office of the Public Advocate of the ACT Australian Capital Territory Government
Informed Consent for Health Care Treatment. (1999). Office of the Public Advocate of the
ACT. Australian Capital Territory Government
Guide to Informed Decision-making in Healthcare. (2011) Queensland Health. Queensland
Government
Guidelines for Medical Practitioners on Providing Information to Patients. (2004) National
Health and Medical Research Council (NHMRC) (www. nhmrc.gov.au)
Associated SOPs
Consent and Treatment: Children or Young People SOP
Consent and Treatment: Capacity and Substitute Decision Makers SOP
Disclaimer: This document has been developed by Health Directorate, specifically for its own use. Use of this
document and any reliance on the information contained therein by any third party is at his or her own risk and
Health Directorate assumes no responsibility whatsoever.
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