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A question of consent

Valid consent is an integral part of quality care and is the source of frequent enquiries from MPS members in the Caribbean. Gareth Gillespie presents a recent case and provides some core guidance

A significant proportion of clinical negligence claims are settled simply because valid consent was not obtained or documented. In theory, where harm has befallen the patient and consent was not obtained, this could also give rise to claims for assault or battery and, in extreme cases, criminal charges, but fortunately in practice this is exceptionally rare. For consent to be valid:

The patient must be competent

  • Mental capacity is decision-specific. Assessment of a person’s capacity should be based on his/her ability to understand, retain and weigh in the balance the information relevant to a particular decision. The person must also be able to communicate their decision. A patient who is unable to make a decision about a complex proposal is not necessarily incapable of making any decisions at all, and may be perfectly able to consent where the issues are simpler. The starting point in the case of adults is always to presume that the patient has capacity until it is shown otherwise.

The patient must have sufficient information to make a choice 

  • Without adequate information, patients are unable to make decisions about their treatment. The information provided should, for example, include: an explanation of the investigation, diagnosis or treatment; an explanation of the probabilities of success, or the risk of failure; or harm associated with options for treatment. The patient should be given time to ask questions.

The patient must be able to give their consent freely 

  • Pressuring patients into consenting to treatment can invalidate the consent. To ensure that consent is freely given, patients should, where possible, be given time to consider their options before deciding to proceed with a proposed treatment. Be aware, too, that patients’ friends and relatives may also try to exert their influence and that this can be subtle but nevertheless powerful.

In all circumstances, any discussions about consent must be fully documented in the patient record.

Verbal or written consent?

There are very few occasions where the law specifically requires written consent – for example, in relation to the storage and use of gametes and embryos in fertility treatment. But in the main, a verbal consent is just as valid as written consent. Consent is a process – it results from open dialogue, not from getting a signature on a form. However, it is imperative to document any information about discussions regarding consent.

The official guidance

Not all countries across the Caribbean region provide specific guidance on consent, but the two sets of guidelines below give a flavour of the standards that doctors should seek to uphold: The Medical Council of Jamaica’s A Guide to Ethical Practice in Jamaica says doctors should aim: “To treat every patient politely and considerately, respecting them and their dignity, being patient in listening to them and respecting their views; “To give patients information in a way they can understand; “To respect the rights of patients to be fully involved in decisions regarding their health care, actively involving them in discussions, and to seek consent for procedures only after adequately informing the patient.”

The Medical Council of Guyana’s Code of Conduct and Standards of Practice states, in paragraph 9:

“(1) Every patient has a right to receive all relevant information about his condition and proposed treatment.  

(2) The medical intervention in respect of a person shall not be undertaken without his full, free and informed consent if he has the capacity to do so. 
  
(3) Every medical practitioner has a responsibility to – 
   (a) fully disclose to the patient or his attendant the extent of any risk involved and be satisfied that the patient understands such risk; 
   (b)provide information about possible alternative interventions, which may be available and appropriate; 
   (c) inform the patient as to whether the proposed treatment or procedure is regarded as an experimental one or not; 
   (d) ensure that consent has not been given under duress. 
   
(4) If the patient is unconscious or of unsound mind, or is a minor child or otherwise unable to give valid consent, the attending medical practitioner has a responsibility to obtain the consent of an appropriate relative or guardian but urgent treatment should not be withheld in such cases if there is an immediate threat to the patients’ life or health.”

Case study

MPS was contacted recently by an orthopaedic surgeon in Trinidad. The surgeon had been asked by his employer to use a newly-developed consent form template, and approached MPS for advice on a number of matters surrounding the taking of written consent.

MPS advice

Any procedure undertaken by a clinician on his patient requires the patient’s consent. Failure to obtain consent would mean that the clinician is at risk of a claim in negligence, battery or even criminal assault.

In order to obtain that consent it is necessary to provide the patient with the required information to enable the patient to understand what the procedure consists of, why it is necessary and its risks and benefits. In describing the risks, it is important to cover those that are commonly likely to occur and to discuss any serious risks that a patient may wish to know about.

In discussing risks, you should bear in mind what an average patient may need to know, but also what the specific patient in front of you may wish to know

In discussing risks, you should bear in mind what an average patient may need to know, but also what the specific patient in front of you may wish to know. For example, for a procedure that may very rarely render a patient hoarse, even temporarily, this particular risk may have less significance for an office worker than it would for a teacher or even more, for an opera singer.

The amount of information that needs to be imparted may also depend on the degree of risk a particular procedure carries. For example, carrying out a phlebotomy procedure may only require a relatively brief explanation and consent can be implied by the fact that the patient presents their arm for the tourniquet to be tied around it and allows a needle to be inserted into the vein.

In obtaining consent, while all the above should be borne in mind, it is essential to ensure that the information imparted to the patient and any special questions they may have discussed with you is properly recorded. This is to ensure that should there be any dispute in the future as to what was discussed and indeed whether consent was even obtained, this can be clearly identified by reference to the record of the consent. The fuller that record, the less risk of dispute. Where that information is recorded is not absolutely key, although clearly a full reference in the medical records is helpful.

Ensure that the information imparted to the patient and any special questions they may have discussed with you is properly recorded

Consent forms, essentially, are only evidence that the issues of consent have been discussed. However, depending on how detailed they are and how well completed, they may not list all the risks and benefits that may have come up for discussion. Therefore you may need to consider a separate record of the discussions in the medical notes, in addition to signing any consent form.

There is no standard consent form. As stated above, a consent form is merely evidence that consent has been obtained from a patient for a particular procedure. Therefore, a form does constitute a legal document that would show evidence of informed consent. However, how informed a consent it is depends on the information the clinician has imparted to the patient and whether he has ensured that the patient has understood that information and whether the amount of information imparted is sufficiently comprehensive.