Embed Size (px)
Citation preview
ConsentED HOROWICZ
Ed is a 21 year old Olympic gold medal winner (and part-time underwear model). He has ruptured his ACL and surgery is offered as treatment.The surgeon Ms Hehir, explains to Ed that the surgery can only proceed with his consent.What does this mean?
SESSION OBJECTIVES To review the bioethical principles that
underpin consent as a requirement in healthcare, within our society.
To understand the requirement of consent. To gain an understanding of the legal issues
around consent. To gain an understanding of the consent
process.
AUTONOMY The most significant and fundamental bioethical
principle in relation to consent Everyone has the right to self determination for the
decisions they make, especially in respect of their own body.
What about healthcare professionals knowing best?
Paternalism To not allow a person to exercise autonomy was an
accepted part of medical practice in society, through medical paternalism.
Paternalism is where the choices of an individual are overridden by another person in authority, in order to benefit or avoid harm to that individual.
It is now considered by medicine as the most fundamental patient right.
There are circumstances when a patient is not deemed competent to make an autonomous choice.
Beneficence & Non-maleficenceBeneficence- The principle of a positive
obligation to do good for our patients. To be honest and act with integrity.To provide all of the information.To understand that we are concerned
with what is good for that patient and not what is good for the healthcare professional/ organisation.
To accept the decision!
Non-maleficence- To do no harm! The oldest ethical principle in healthcare.
To not be dishonest. To not withhold information. To not coerce a patient’s into undergoing a treatment.
Coercion cannot allow a decision to be considered autonomous.
Carrying out treatment without the patient’s knowledge would be considered harmful.
Justice
Justice- That every person is entitled to the same rights to be able to consent or refuse treatment.
The duty to provide information is regulated and equitable.
Is this always the case? Consider emergencies or those who lack
capacity- We will come back to this later in the course!
Consent
Consent is a precondition of autonomous decision making!
“A patient who is sufficiently mature and intellectually competent to understand what is entailed in treatment is entitled to make up his or her own mind as to whether to accept or reject proposed medical treatment. This right is part and parcel of his or her autonomy, of sovereignty over one’s own body.”
(Brazier, 1987, at p172)
TAKE HOME MESSAGE PLEA
Consent is a process!!!
NOT A FORM!!!!
Acting Without Consent
Any healthcare professional who intentionally or recklessly undertakes any form of medical investigation or treatment without consent is acting unlawfully.
Such action could result in both or either a criminal or civil action.
Consent also applies to research participation and other relevant data sharing.
Acting Without Consent
Criminal charges could consist of Assault, Actual Bodily Harm or even Grievous Bodily Harm.
The difficulty with criminal prosecution is that often actions are not done through malice and as such criminal charges are rare.
Civil actions are the more common in this area of tort law, usually through Trespass Against the Person (Battery) or Negligence.
Civil actions are inter-part disputes; eg: Doctor V Patient or Nurse V Patient. E.g. Ms B [2002]
What Constitutes Consent? Consent can be either verbal, given through gesture
(e.g. holding an arm out for a blood pressure measurement) or written.
Written consent is not a legal requirement per se but serves as evidence that a person has consented and documented evidence is legally required.. (Exceptions to this include some provisions under the Mental Health Act and the Human Fertilisation and Embryology Act 2008.)
Written consent is best practice for invasive, complex or lengthy treatment and almost entirely mandatory at national and local policy level.
Informed Consent
In healthcare consent is not considered valid unless the patient has made an informed decision, this is known as informed consent.
Informed Consent
Faden and Beauchamp (1986, 274) identify 5 elements to informed consent;
-The relevant information has been given (disclosure)-The relevant information has been understood (comprehension)-The person is uncoerced (voluntariness)-The person is capable of consenting (competence/capacity)-The consent has been given (decision)
Informed Consent The onus is on the healthcare professional to
take into account the person’s ability to understand the information given and present it in an appropriate style.
This may sound obvious but consider the use of jargon, abbreviations and other everyday medical terminology that we use but that importantly patients do not understand!
Informed ConsentDoes informed consent really exist? To be truly informed the patient has to be given
information relating to all aspects of a proposed treatment and this includes alternatives.
There are obstacles to this and the courts have been reluctant to recognise informed consent as a principle ;
Firstly, can a person with no medical knowledge really understand such information and can we truly make sure that they do?
Secondly, the information given is at the discretion of the healthcare professional who can be influenced by their own knowledge, speciality, personal ideology and even financial restrictions.
Ed has been told that the operation is minor and that he will be up and about in no time.
Is this adequate?
What else might he need to know?
Tort of Battery A claimant can bring a claim of Battery against a
healthcare professional if they fail to comply with the consent of a patient or act without that patient’s consent.
Consider; A patient expresses a wish to be cannulated in her right
arm but is instead cannulated in her left arm. Wrong site surgery (also actionable in negligence) A doctor who discovered that his patient’s womb was
ruptured whilst performing minor gynaecological surgery performed a sterilisation without her consent. Devi v West Midlands AHA [1980]
Ms B [2002].
Consent as Negligence How can consent be negligent? Inadequate Information Inaccurate Information Failure to discuss alternative treatments Failure to recognise that the patient does not
understand the information
How Much Information Is Enough?
There is no legal framework that states exactly what facts and specific information should be given.
The starting point was in Chatterton v Green [1981]. The court held that consent was valid if the patient had been told in broad terms about the nature of the procedure.
Traditionally and predominantly the law operated a “professional standard” approach, i.e. the standard to which it is the practice for the profession to offer. This approach was very medically paternalistic- Doctor knows best!
Professional Standard Approach The Bolam test:Bolam v Friern Hospital Management Committee [1957] “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.”In other words a doctor of the same training can avoid liability if another doctor stands up in court and states that the actions of the defendant were reasonable.
-Modified in Bolitho v City and Hackney HA [1997]Where there is more than one opinion, the court is entitled to take a logical analysis in deciding the most appropriate.
What Was Insufficient?
For a patient to be successful in a claim of negligence or battery as a result of lack of information, they have to demonstrate that they were not given such information.
In Chester v Afshar [2002] the Court of Appeal held that the phrase;
“ I’ve done hundreds of these and I haven’t crippled anyone yet” fell way beyond the legal and professional standards.
However Until Now!Montgomery v Lanarkshire HB
In March 2015 the UK Supreme Court held that in cases of negligence in relation to consent, the Bolam test was no longer the correct approach. Doctors or other consenting healthcare practitioners must take , as their Lordships stated ;
‘reasonable care to ensure that the patient is aware of any material risk involved in any recommended treatment, and of any reasonable alternative or variant treatments’.
The Law and Consent Now,How to Legally Obtain Consent.
Does the patient know about the material risks of the treatment proposed?
-What sort of risks would a reasonable person in the patient’s circumstances want to know?-What sorts of risks would this particular patient want to know? Does the patient know about reasonable alternatives? Has reasonable care been taken to ensure that the patient knows
all this? Do any exceptions to my duty to disclose apply? (Necessity,
likelihood of causing harm and the patient not wanting to know. Documentation of the consent process properly as evidence.
Consent and the Human Rights Act 1998
In 1998 the UK incorporated the European Convention of Human Rights and Fundamental Freedoms (ECHR) into domestic legislation.
The decision in Montgomery appears to promote, in conjunction with GMC guidance and existing law, the following rights;
Article 2: The right to life Article 3: the right not to be subjected to inhuman or
degrading treatment Article 8: The right to private and family life Article 9: The right to freedom of thought and religion
Consent Guidance for Professionals Both the DoH and the GMC have issued
professional guidelines prior to this. There are two key documents that provide this. Department of Health – ‘Reference Guide to
Consent for Examination or Treatment’. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/138296/dh_103653__1_.pdf
General Medical Council – ‘Consent: patients and doctors making decisions together’. Importantly Montgomery is in support of these!
www.gmc-uk.org/guidance/ethical_guidance.asp
Ed comes into the anaesthetic room for his surgery.
You check with him the procedure and that he has signed his consent form, which he has.
Happy? Ed then says “ This op is only minor isn’t it?
I have a modelling job the day after tomorrow so I will be fine by then won’t I?
Still happy?
References
Beauchamp.T and Childress.J, 2009. Principles of Biomedical Ethics, 6th Edition, Oxford: Oxford University Press.
Brazier.M. and Cave.E, 2011. Medicine, Patients and the Law. 5th Edition, London: LexisNexis / Penguin.
Faden, R. and Beauchamp, T. 1986 A History and Theory of Informed Consent Oxford: Oxford University Press
Fletcher.N, Holt.J, Brazier.M and Harris.J, 1995, Ethics, Law and Nursing. Manchester: Manchester University Press.
Harris.J. (Ed), 2001. Bioethics. Oxford: Oxford University Press. Herring.J, 2012. Medical Law and Ethics. 5th Edition, Oxford: Oxford University
Press. Mason.J and Laurie.G, 2013. Law and Medical Ethics. 12th Edition Oxford: Oxford
University Press. Pattinson.S, 2011. Medical Law and Ethics. 3rd Edition, London: Sweet and Maxwell.
