Consent can be a tricky topic, especially with changing patient expectations, but essentially needs to address three elements. Here’s a guide for GPs.
As a colleague noted recently: “Consent in 2019 - it’s a different concept to when I trained.”
A changing environment seems to be raising levels of concern in the medical profession about whether they are getting the consent process right.
An ageing population; changing family and social dynamics; increased time pressures; changing patient expectations and access to information all add to practitioners’ concerns.
A scan of the media illustrates the complexity of the issue. Stories cover issues ranging from claims a surgeon failed to obtain consent for surgery, young women concerned they were not informed of the potential for birth defects from prescription medication and women who say they were not advised of the risk of prolapse or episiotomy during vaginal birth to issues around informed consent for transgender individuals, concerns about consent to sharing of health information and complaints relating to out-of-pocket costs of treatment.
What is informed consent?
Australian law and medical practice recognises that individuals have the right to make informed decisions about their medical treatment. Legally, a practitioner who touches a patient or performs a procedure or treatment on them without their permission may have committed an assault. If the patient gives permission but has not been given sufficient information about the procedure and associated risks, they may bring a claim of medical negligence against the practitioner.
The duty to disclose information to patients is part of the overall duty of a medical practitioner to exercise reasonable skill and care. Failure to disclose information or to obtain proper consent can also give rise to a professional conduct complaint.
There are exceptions in the case of emergency (discussed later). Specific considerations also apply to children and patients who have lost the capacity to make decisions on their own behalf. Patients also need to be informed and give their consent to costs (financial consent) and disclosure of personal information.
Importantly, consent is not just about getting a signature on a form, rather it is about a process of shared decision-making. As another colleague recently put it: “The thing we need to understand about informed consent is that it’s about the conversation, not the form. It’s not about a tick list to ensure you’ve disclosed every conceivable risk, it’s about understanding the patient and what is materially relevant to her or him and working through that with the patient.”
Studies of complaints and claims in Australia and overseas have consistently found that it is now relatively rare for a patient to claim that they have not consented to a procedure at all. However, an Australian study published in 2011 found that in almost 80% of cases where consent was raised, the patient claimed that a complication of treatment had not been mentioned or fully understood. While the study found most consent complaints involved surgery (92%), cosmetic procedures (16%) and medication (8%) are also problem areas.
An effective consent process needs to address three elements:
- Capacity — who can give informed consent?
- Disclosure — what information do patients need?
- Voluntariness — are they giving consent freely?
These concepts will be examined in the following scenarios.
Children and consent
A new patient, Anna, visits her GP alone. She tells the GP she is 16 and wants to have a mole on her chest removed. Anna says she has begun to do some photographic modelling, and she’s been told the mole has to go. She doesn’t want the GP to tell her parents because they don’t approve. When the GP asks Anna about how best to contact her, she asks to be contacted by email.
Having decision-making capacity means that a patient can:
- understand the facts involved;
- understand the main choices;
- weigh up the consequences of the choices;
- understand how the consequences affect them; and
- communicate their decision.
Whether or not a patient has capacity to consent to a particular treatment is a question for the medical practitioner to decide in each case. In the case of adults, the starting point is that adults are generally presumed to have capacity unless there is a reason to be concerned about their ability to make a decision.
If the patient is a child or young person, as in the case of Anna, she may be able to give consent herself and may not need the consent of a parent or guardian, provided she has achieved a sufficient level of understanding and maturity to enable her to understand fully what is proposed.
This is known as Gillick competence or the mature minor doctrine. In South Australia, a person aged 16 or over can make decisions about their medical treatment as validly as an adult. In all other states and territories, the relevant age is 18.
Importantly, the question of capacity relates to the specific decision in the specific circumstances — so the practitioner may decide that Anna has capacity in relation to some decisions but not others. One of the challenges can be assessing that a child understands the long-term implications of a procedure or treatment.
In general, the riskier the procedure, the higher the standard should be to ensure that the child fully understands the nature of the procedure.
There are certain types of medical procedures to which a child cannot consent and require court authorisation (often known as special medical procedures or special medical treatment, such as treatment that leads to permanent infertility). If you are unsure about whether a procedure needs court authorisation, contact us on 1800 128 268.
In this case, the GP needs to be satisfied of Anna’s capacity. In doing so, they should consider her age and her insight into the nature of the treatment and its possible side effects, as well as her intelligence and general attitude, personality and health.
If the GP decides Anna has capacity, they do not need authority from her parents.
Cosmetic treatments have some specific requirements. In Queensland, cosmetic procedures may not be performed on children unless they are reasonably believed to be in the child’s best interests.
The Medical Board’s guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures also set out additional steps for patient assessment and informed consent for cosmetic procedures. These include either a seven-day or three-month cooling-off period for patients under 18 plus evaluation requirements, depending on whether the treatment is major or minor.
Disclosure of information
If the GP determines that Anna has capacity, they need to discuss the procedure with her and provide her with information about the procedure and its associated benefits and risks.
While a physical examination may be clinically necessary, the reasons for this may not be obvious to the patient. Where an examination is required, medical practitioners need to ensure that the patient understands the nature of the examination and why it is necessary, and that they have an opportunity to ask questions or refuse the examination.
For any intimate examination (such as an examination that includes the breasts), consider involving a third-party observer with the consent of the patient.
While legally consent may be expressed or inferred from the patient’s conduct, the more significant the decision or treatment, the more important it is to get written consent. Be careful not to assume consent from a patient’s silence or compliance. This is particularly the case where patients may be vulnerable or where there are cultural or communication issues. It is much better to check than to risk misunderstanding and possibly a legal action or complaint.
How much information?
Another frequently asked question is how far a practitioner has to go in informing a patient of the risks of a treatment or procedure.
Practitioners are not expected to disclose every conceivable risk or side effect of a treatment. However, the law in Australia is clear that a practitioner must inform the patient of risks to which:
- a reasonable person in the patient’s position would be likely to attach significance, or
- the practitioner is or should be aware that the particular patient would be likely to attach significance.
A key aspect of the consent conversation therefore is asking the patient about what is important to them and anything they are particularly worried about.
Medical practitioners will generally tell patients about the most common risks to help them decide whether to go ahead with a treatment or procedure. However, the likelihood of a risk occurring is not the sole determining factor in whether to inform a patient of a risk or not.
In general terms, a known risk should be disclosed when an adverse outcome is a common event even though the detriment is slight, or an outcome is severe even though its occurrence is rare.
Patients need to be aware of the potential for complications in any procedure. When quoting complication rates, practitioners need to be clear on whether the data they are presenting relies on their own experience or whether they are referencing the literature.
The law is not entirely clear about whether warnings should be given in percentage terms. Courts have commented that using words such as rare, uncommon, likely, probable and very possible are imprecise and elastic. It can be difficult to be satisfied that the patient has understood these issues in the way the practitioner intended. The cases suggest that the more serious the risk, the more important it is to explain it in percentage terms. However, there are differing views about the effectiveness of providing percentages as a way of explaining the likelihood of a risk.
If quoting percentages, especially where the numbers are small, it is probably helpful to express the numbers as a fraction of 100, for example, 10% equates to 10 people in 100.
It is important for the GP to have a discussion with Anna about the risks and benefits of having the mole removed by a specialist surgeon, compared with having the mole removed by the GP. Issues such as the potential for scarring on the chest of a young person would need to be raised here. The GP’s experience with the procedure compared with that of the specialist will be relevant to this discussion.
The doctor who performs the procedure has the duty to advise the patient about the risks and benefits. This duty can be delegated to someone else, such as a practice nurse, but the ultimate responsibility for providing the information rests with the doctor performing the procedure.
The GP also needs to advise Anna about the costs of any treatments they will be providing, as well as the costs of any treatments for which she is referred.
As Anna has told the GP she doesn’t want her parents involved, the cost of procedure may well be a significant consideration for her. Practitioners can generally provide information about billing policy and long consultations on a website and in the waiting room.
If referring patients to a specialist for treatment, the GP doesn’t need to know the exact costs involved but does need to advise that there may be out-of-pocket costs. Provide the contact details for the specialist so patients can check any costs involved.
In the case of cosmetic treatments, patients need to be given detailed written information about costs, including:
- total cost;
- details of deposits required and payment dates;
- refund of deposits;
- payments for follow-up care;
- possible further costs for revision surgery or additional treatment; and
- advising the patient that most cosmetic procedures are not covered by Medicare.
It is critical that practitioners document their discussion with the patient. The contemporaneous notes in the patient file should capture the discussion, including:
- an outline of the clinical decision-making process based on the patient’s history and presentation;
- the nature of the treatment and proposed approach, as well as any questions the patient asked and the practitioner’s responses;
- documentation of risks discussed; and
- any information sheets, diagrams or illustrations provided to the patient.
It is advisable to discuss with the child or young person the benefits of informing their parents about their condition and proposed treatment. However, having determined the young person is Gillick competent, practitioners cannot discuss the treatment with the young person’s parents or anyone else without their consent.
Contacting younger patients can raise practical issues if they are living at home, so be careful not to inadvertently breach their privacy when communicating with them. It is safest to ask about the best way to contact them and whether it is okay to leave a message or send correspondence to the home address.
The Privacy Act does not prescribe how a healthcare organisation should communicate health information to patients or third parties. Any method of communication may be used as long as the organisation takes reasonable steps to protect the information transmitted and the privacy of the patient.
Based on advice provided by the Office of the Australian Information Commissioner and the RACGP, there are several steps that practices can take to manage email communication.
Practices should consider the type of information to be sent, the sensitivity of the information and the patient’s circumstances. Policies and procedures should cover issues such as ensuring staff know what they can and cannot send by email, advising patients about the risks associated with unencrypted email and obtaining and documenting their consent, using password-protected attachments where appropriate, checking email addresses and retaining copies of emails in patients’ clinical files.
Mrs Dawson, 75, is a relatively new patient who recently moved to be near her daughter. She is suffering from congestive cardiac failure and COPD, and recent pathology has revealed an iron-deficiency anaemia. The GP wants to refer her for further investigations, including a colonoscopy. Mrs Dawson seems a little confused when she comes to the practice on this occasion.
An adult is presumed to have decision-making capacity unless there is evidence to the contrary. In the case of Mrs Dawson, who is not well known to the practice, her treating GP may have questions about her capacity.
Importantly, practitioners need to consider a patient’s capacity to make a particular decision at the time the decision needs to be made. Individuals may lack capacity to make a decision in one instance, but that does not mean they lack capacity to make any decisions at all, or that they will not be able to make that decision in the future.
It can be helpful to ask a patient in a similar situation some direct questions such as:
- What is your understanding of your condition?
- What is your understanding of what will happen if nothing is done?
- What issues are most important to you in deciding about your treatment?
- What are you thinking about as you consider your decision?
Where the treatment is non-urgent, as in this case, and the GP is still unsure about a patient’s capacity to consent, it may be appropriate to suggest the patient return with a family member who could assist them. Alternatively, it may be appropriate to seek an opinion from a psychiatrist or geriatrician. If the GP decides a patient does not have capacity to make the decision under consideration, it will be necessary to obtain consent from the correct substitute decision-maker. The requirements vary from state to state, but in general there is a hierarchy of substitute decision makers who should be consulted.
Practitioners may fear disclosing too much information because of a concern that a list of potential risks may be overwhelming and may deter the patient from treatment. However, informed consent requires that patients can decide between all treatment options, including watching and waiting, or managing without surgical interventions.
To reiterate, the consent process is not just about getting a signature on a form, it is about the conversation between the practitioner and the patient.
As discussed above, the practitioner needs to inform patients (or their substitute decision-maker if they lack capacity to make decisions about further tests) about any risks to which a reasonable person in their position would be likely to attach significance; or that the practitioner is — or should be — aware of that the patient would likely consider significant. One of the best ways of finding out whether the patient is likely to attach significance to a risk is to ask them what is important to them.
After discussing the options with the patient, practitioners need to confirm that the patient has understood what has been explained. Just asking if they understand is unlikely to be sufficient. Some ways practitioners can reassure themselves about the patient’s understanding include:
- asking open-ended questions such as, ‘What do you understand as …?’;
- offering reading material or more resources about the procedure;
- suggesting they take some time to think about options and plan a second appointment;
- suggesting a support person attends the next appointment;
- encouraging the patient to ask questions; and
- suggesting a second opinion if appropriate, particularly for complex procedures or where the patient is clearly undecided.
At first Mrs Dawson seems to agree with the GP’s suggestion that she be referred for further tests, but she says she needs some time to think about it and talk to her daughter. A week later, she returns with her daughter and says she doesn’t think she will bother having the colonoscopy after all.
She seems to be deferring to her daughter, who appears concerned about the time involved, potential expense and discomfort. In this scenario, the GP may be concerned that the patient is not making her decision voluntarily and free from influence.
The requirement of voluntariness does not imply that the practitioner, or a patient’s family member, cannot try to persuade them. But if the practitioner determines that the patient does have capacity, they need to be free to make their own decision without undue influence or pressure. The practitioner might try to speak with the patient alone to understand their concerns and work out what they want to do.
Confirming and documenting consent
It is critical that practitioners document their discussions with patients. The practitioner’s contemporaneous notes in the patient file should capture the discussion, including:
- an outline of the clinical decision-making process based on the patient’s history and presentation;
- the nature of the treatment and proposed approach, as well as any questions asked by the patient and the practitioner’s responses;
- documentation of risks discussed; and
- any information sheets, diagrams or illustrations provided to the patient.
The practice receives a call from the father of a patient. He explains that his 11-year-old son Chris has been involved in an accident at a school camp and the insurer needs a copy of Chris’s medical records. Chris’s mother normally brings him to the practice and Chris has mentioned in the past that his parents are divorced, but there is no record of any Family Court order.
Parents have the right to access their child’s medical records until the child is competent to make their own health care decisions. Divorced or separated parents do not lose this entitlement so either parent can access the record, unless there is a Family Court order preventing them from having access.
A patient, or a parent acting on their behalf if the patient is a child and does not have capacity, can request copies of the records to be sent to a third party such as an insurer. Before providing any records, make sure the consent:
- is in writing and signed by the patient (or the parent in this case);
- clearly indicates to whom the records should be released and which records are covered; and
- is current (as a guide, authorities more than 12 months old should be queried).
Always check the request carefully and make sure to avoid sending records not covered by the request. Insurers may ask for all the records but the consent may only cover certain records.
If the records contain sensitive information, such as mental health issues, check that the patient is aware that these may be included and confirm that they can be released. If specialists’ letters are included in the records to be released, these are still part of the patient’s medical record and should be produced. There is no need to obtain specific consent from the specialist, even if the letters include a note stating that they should not be supplied to third parties without the specialists’ consent.
As a courtesy, the practice can advise the other parent that a request was made to provide a child’s records.
If there is an emergency and a person cannot provide consent, practitioners may perform life-saving procedures to avoid a serious and imminent threat to the patient’s life or health.
In Australia, this exception is relatively narrowly interpreted. It does not apply, for example, when it would be merely inconvenient to wait for the person to be able to provide informed consent.
Emergency situations involving a serious threat to the life, health or safety of an individual, or to public safety, may also justify disclosure of personal information.
Ensuring that patients are provided with sufficient information to give informed consent may seem complex and does cause concern for practitioners. It may be helpful for the practitioner and patient to consider:
- What is the patient’s understanding of their illness or condition?
- What result are they looking for from this treatment?
- What is important to the patient and what are they willing to manage or compromise on?
- How would they manage a common outcome after treatment?
Practitioners need to be aware of issues such as capacity, but at its core, the consent discussion is about having the conversation with the patient. By ensuring they understand patients’ needs, concerns and priorities, practitioners are better placed to give patients the information they need and together come to a shared decision about their treatment.
The NHMRC’s General guidelines for medical practitioners on providing information to patients, 2004
Australian Commission on Quality and Safety in Health Care. Helping patients make informed decisions: communicating risks and benefits
The RACGP’s Standards for General Practices 5th edition, 2017
You’ve got mail — but should you reply?
New South Wales Government Attorney General’s Department of NSW Capacity Toolkit, 2008
The Victoria Department of Health and Human Services Guide to the Medical Treatment Planning and Decisions Act for health practitioners, 2016
References are available on request.
A version of this How To Treat article was originally published on AusDoc.PLUS on 1 March 2019.