Consent I Notes

Introduction

Learning Objectives: how much information must be provided to patients before they can consent to medical treatment, and what recourse might patients have if they are not provided with enough?

Learning Goals:

what are the ethical justifications for informing patients about their medical treatment

how does the law protect patient’s interests in medical disclosure

describe the alternatives to the law of tort in protecting patient consent

Central Issues:

if a patient has capacity, treatment should not take place without her consent. The difficult question is working out how much information patients need in order to be properly informed.

a failure to inform the patient in broad terms about the medical treatment she is about to receive could lead to an action in battery.

a patient who claims to have been inadequately informed might bring a claim in negligence, in that the failure to warn her about a particular risk was a breach of the doctor’s duty of care to inform about material risks.

information is material if a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor should reasonably be aware that the particular patient would be likely to attach significance to it.

causation raises particular difficulties in ‘informed consent’ cases because the patient has to prove that if she had been told about the risk which has now materialised, she would have refused treatment.

professional guidance appears to impose more onerous duties of information disclosure upon doctors than tort law, but because a ‘reasonable doctor’ will follow professional guidelines, these more stringent standards might be directly incorporated into the doctor’s duty of care.

Why inform patients?

In the past, the Hippocratic oath assumed the treatment decisions are for doctors alone. As a result of growing importance re patient autonomy, giving patients more information redressed the imbalance of knowledge between doctor and patient.

Of course, this is not to say that doctors are all-knowing, meaning that telling patients the truth sometimes involves explaining to them what is not known and uncertain. This is particularly the case re alternative treatment options, as there is very rarely a ‘best solution’ in medicine. Few treatments have no risks or side effects, it may be necessary to weigh the advantages and disadvantages of different treatment options, as well as the possibility of doing nothing. In this regard, although doctors can diagnose problems and explain/carry out procedures, the patient is the only one who has the expertise to judge the suitability of a particular treatment, and its side-effects of their life.

The Hippocratic model has been replaced by the partnership model of decision making, where both the patient and doctor have specialist knowledge which must be shared in order to ensure that the patient makes the best possible choice for themselves.

What is informed consent?

For a patient to be capable giving informed consent, they must be competent, must understand the information disclosed to them and appreciate its significance, and must give consent freely. What is focused on in this set of notes is the information which must be disclosed to the patient, and how to facilitate their understanding of it. In particular, one of the major concerns is what doctors choose to disclose to patients - because doctors approach their jobs with a certain value framework, they may be inclined to reveal or withhold certain information based on an assumption of shared values held by the patient. However, this is dangerous, and as we will see, the law now regulates to some extent the bare minimum which must be disclosed to a patient - this bare minimum standard covers the four critical elements of disclosure: (1) the nature of the procedure; (2) the proposed risks; (3) alternatives; and (4) the benefits of the procedure.

Of course, like all general rules, there are exceptions to where informed consent is not necessary. For example, where consent is waived, in cases of emergency, or therapeutic privilege. All these exceptions must be allowed within reason so as to prevent abuse (e.g. duress in signing waiver forms, or doctor’s exercising paternalistic judgement re therapeutic privilege).

Challenges faced by informed consent

The most basic and persistent challenge is the balancing act between overly demanding criteria of consent, and under demanding criteria for consent i.e. how much consent is necessary to protect the rights which we think are protected by consent? This manifests itself in the legal decisions over the years, which have changed positions (as will be seen below). It also manifests itself in discussions around the quality of consent - how much explaining should a doctor have to do, and how far should the doctor go to ensuring that the patient is genuinely informed?

Another more recent challenge is that the concept of informed consent is too narrow to account for modern medical advances, especially in the field of biomedical ethics. Negligence may be a good model for understanding what has gone wrong in some cases, but this rationale provides an inadequate framework for determining what we ought to be doing in soliciting consent in institutions for research, and what degree of consent is sufficient. Arguably, the law’s focus now is on what is illegal, as opposed to growing concerns in recent medical advances re what is unethical.

This precipitates the further question of whether a distinction between treatment and research should be drawn so sharply in terms of consent. Perhaps today patients are overprotected in research and under protected in treatment.

Ethical basis for patient information

There are both deontological and consequentialist justifications for the twin elements of informed consent: (a) to seek the patient’s consent prior treatment; and (b) to ensure the patient has sufficient information. The deontological justification...

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