Limitation of Consent to Treatment: template form + Guidance Notes (with downloads)

NOTE: the illness termed “myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome” or “ME/CFS” by England’s National Institute for Health and Care Excellence (NICE) is the subject of many different names and case definitions.

In this blog post, I refer to the NICE guideline so the term “ME/CFS” has to be used, rather than ME (myalgic encephalomyelitis). ME is the complex, multi-systemic neuroimmune disease with which I have lived since 1981. See About for more information about ME and about my work. I am a barrister.

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I was recently asked by a UK ME advocate, Eleanor Rosen, if I could help with drafting a Limitation of Consent form. This form would create a document which ME (or “ME/CFS”) patients could prepare in advance and take with them to medical appointments which they anticipate might be challenging.

Consent

According to the British NHS website, consent must be “voluntary” and “informed”, and the person giving it must have “capacity”. For more information, follow that link to the NHS site.

The starting-point would be that consent is generally implicit in the mere act of being present at a medical appointment. However, that would not necessarily extend to a situation where the appointment is imposed on a patient by a health or social care professional.

Equally, it is arguable whether or not consent to an appointment automatically extends to consent to treatment. Historically, some patients with ME or “ME/CFS” have experienced problems because they have been prescribed so-called “treatments” which have turned out to be harmful.

Informed consent [this section added 1 July 2022]

There is an ever-increasing body of case law on “informed consent”, most of which is too esoteric to be relevant in using this form. Informed consent takes place on a routine basis in all healthcare settings, usually without further incident.

Issues around consent generally only arise when a patient has experienced serious harm as a direct result of healthcare provision and subsequently takes legal action against the provider and/or connected third party.

Purpose of the form

Despite being first documented nearly a hundred years ago, ME has remained an illness which frequently causes severe tensions between patients and healthcare professionals. The purpose of the proposed Limitation of Consent form is to a) act as a memory aid during the appointment for the patient (or parent/guardian/carer) and b) provide written support for withdrawal of consent if they become concerned about the direction the appointment is taking.

The updated NICE guideline from 2021 makes it clear that ME is a “fluctuating medical condition” (para 1.6.4) and specifies types of treatment which are not recommended for ME patients. It is clear from the guideline that ME (without co-morbidities) is not a psychiatric, psychosocial, medically unexplained or functional neurological disorder. Nevertheless, patients are too frequently steered towards, or forced into, those directions, often with disastrous results.

Legal and evidential validity

A Limitation of Consent document, whilst it has no legal force, provides a statement that can be produced and shown to the healthcare professional who is conducting the appointment, if the patient feels that they are being treated in an inappropriate manner. The document explains that, from this point onwards, consent for treatment is being withdrawn.

This document cannot provide legal protection or any other guarantee. Nevertheless, the hope is that patients may feel reassured that, if difficulties arise during an appointment with a healthcare professional, they have a written document prepared which indicates their withdrawal of consent to treatment. It may also provide useful evidence at a later date if there is any dispute about if/when consent to treatment was withdrawn.

Before an appointment

It is advisable to make efforts to find out in advance of an appointment what approach any particular clinic/healthcare practitioner takes with this illness. Where patients already know or strongly suspect that the approach may be unhelpful, then the better option is to seek more appropriate treatment elsewhere (if such exists).

This form is designed for situations where patients are uncertain, or simply anxious, about an imminent appointment. It is intended for use as a fallback, rather than as a pre-emptive strike. Submission of the form in advance of an appointment could run the risk of setting up a hostile reaction so any such move should be approached with caution.

Applicability

The form is primarily for use by patients in England. However, theoretically, it could be used in any country which recognises the NICE guideline NG206 for “ME/CFS”.

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The Limitation of Consent to Treatment form and accompanying Guidance Notes

Eleanor provided me with an initial outline and we have produced two pdf documents (see below for simple text versions). The Guidance Notes must be read before using the form.  

TO VIEW or DOWNLOAD THE DOCUMENTS click on links below:

1. Limitation of Consent MECFS form
2. Limitation of Consent Guidance Notes

For information purposes, the unformatted text of each document is below 

LIMITATION OF CONSENT TO TREATMENT FOR PATIENT WITH ME/CFS
NB: please read Guidance Notes before using this form
Complete this form before your appointment and keep a copy.
Take this form with you so you can show it to your doctor if
you become concerned about the direction of the appointment.
Patient’s name _________________________________
Address _______________________________________
Date of birth ___________________________________
PATIENT STATEMENT: I was diagnosed with the illness
ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)
as defined in the NICE guideline NG206 of 29 October 2021.
[Complete where possible] This diagnosis of ME/CFS was made
on _________ at _________________ by_________________
I consent to be seen and treated only by healthcare
professionals who are familiar with the above NICE guideline
and who understand that ME/CFS:
a) is “a fluctuating medical condition” [para 1.6.4]
b) is not appropriate for treatment with graded exercise
therapy [para 1.11.14]
c) is not appropriate for treatment with cognitive behavioural
therapy other than as a purely supportive treatment [para
1.12.28]
d) must not be treated with the Lightning Process or other
similar therapies [para 1.12.27]
e) is an illness where the most severely affected patients “may
not be able to swallow and may need to be tube fed” [page 8]
I do not consent to be seen or treated by any healthcare
professional who treats ME/CFS primarily as a psychiatric,
psychosocial, medically unexplained, functional neurological or
other similar disorder.
If I am referred to, or seen by, any such professional, then my
consent to treatment is withdrawn immediately.
Name___________________________ [patient/parent/guardian/carer]
Signature & date__________________________________

LIMITATION OF CONSENT FORM – GUIDANCE NOTES
Important: please read before using form
1. Defining consent
The British NHS website gives a useful overview of consent to
medical treatment. The full version can be found at this link.
These extracts provide a summary of the considerations and
requirements for informed consent to be given by/on behalf of
a patient:
• Consent to treatment means a person must give
permission before they receive any type of medical
treatment, test or examination.
• This must be done on the basis of an explanation by a
clinician.
• Consent from a patient is needed regardless of the
procedure, whether it’s a physical examination, organ
donation or something else.
• The principle of consent is an important part of medical
ethics and international human rights law……
• For consent to be valid, it must be voluntary and
informed, and the person consenting must have the
capacity to make the decision. [my emphasis]
2. Legal force of the Limitation of Consent form
The Limitation of Consent form is an informal document, not a
legal one. It can neither compel anyone to take a particular
course of action nor can it prevent a particular course of action.
Remember that this form will contain private and confidential
medical information.
3. Purpose of the form
The purpose of this document is to assist ME/CFS patients by:
• Providing a written memory aid which can be prepared in
advance of medical appointments by a patient,
parent/guardian (of a child under 16) or carer.
• Providing written support for patients who need to explain
that they do not consent to be treated by certain types of
healthcare professionals.
This document cannot give any guarantee or protection beyond
that purpose.
NB. This document will not assist if there is a genuinely held
belief by the healthcare professional that there is a psychiatric
issue, whether primary or co-morbid, however misguided that
may be.
In those circumstances, the only option is to remind the
professional that the patient is entitled to a second opinion
from their preferred ME/CFS medical specialist.
4. Significance of the most recent NICE guideline NG206
A healthcare professional who believes that a psychiatric,
psychosocial, functional neurological or medically unexplained
approach is the correct way of treating an ME/CFS patient, is
likely to be unfamiliar with the most recent NICE guideline.
In those circumstances, it should be pointed out that this
healthcare professional may not be an appropriate person to be
dealing with an ME/CFS patient at this point.
This may be particularly important in cases relating to a child,
a very severely affected patient and/or a patient who urgently
requires tube feeding [see page 8 of the NICE guideline].
5. Evidential value of the form
This document’s evidential value is limited as it simply confirms
what the patient is saying at the time of the appointment.
It is possible that this document could be used as evidence in
proceedings at a later stage if there is a dispute about if/when
consent was withdrawn. However, this will depend on the
circumstances of each individual case.
6. Recording an appointment
Recording an appointment with the clear consent of all other
attendees would be useful. Evidence acquired by secret
recording is not normally admissible and therefore is not
advisable.
7. Lasting power of attorney for patients who are
severely affected
Adult patients who are very severely affected by illness and
unable to communicate with healthcare professionals may be
deemed to lack capacity.
Patients who may be in this situation should consider setting up
a lasting power of attorney [see gov.uk website]. This enables
a relative or carer to speak for them and make decisions on
their behalf.