Informed consent in medicine is essential. In March 2015, the Supreme Court handed down its judgment in Montgomery v Lanarkshire Health Board, which raised the legal standard for what informed consent actually means. The case has shaken the medical profession. Dr Daniel Sokol, barrister and ethicist, discusses its significance to patients and their relatives.
On 19th August 1947, 20 Nazi doctors and 3 medical administrators heard their fate at the International Military Tribunal in Nuremberg, Germany. They had been charged with murder, torture and ‘other atrocities committed in the name of medical science.’ They had frozen people to death in tanks of ice water. They had deprived people of oxygen to simulate high altitudes until they died. They infected subjects with cholera, smallpox and other diseases. They inflicted, and infected, battle wounds and left them untreated. None of the subjects, of course, had given consent. Seven of the defendants received the death penalty and 9 long prison sentences.
Out of these trials emerged the Nuremberg Doctors’ Code of 1947. The first principle states that ‘the voluntary consent of the human subject is absolutely essential.’ The purpose of consent, therefore, is to protect against the use of force, duress, constraint and coercion.
The purpose of consent, therefore, is to protect against the use of force, duress, constraint and coercion.
It allows people to make autonomous decisions based on their own values and beliefs.
From these sinister episodes in medical research, the notion of consent has become increasingly embedded into regular clinical practice. The old-fashioned paternalism of doctors made way for a greater emphasis on patient autonomy. Today, in the UK and many other parts of the world, doctors must ask permission before performing tests and procedures on patients, with a few limited exceptions.
The case of Montgomery has raised the legal standard for informed consent in medicine. The facts are tragic and simple.
Nadine Montgomery was a petite, diabetic woman who gave birth to a severely disabled son. The obstetrician had not told her of the 9-10% of shoulder dystocia (when the baby’s shoulders cannot pass through the pelvis) in diabetic women. The obstetrician considered the risk of serious injury to be too small to disclose and was concerned that Ms Montgomery would, if told, have opted for a caesarean section, which carried its own risks.
During the birth, the baby’s head failed to descend and the obstetrician used forceps. It took 12 minutes to deliver the baby. During that time, the umbilical cord was blocked and the baby’s brain was starved of oxygen. It was born with cerebral palsy. With a caesarean section, the baby would probably have been healthy.
The Supreme Court held that the obstetrician should have told Ms Montgomery of the risk of shoulder dystocia and discussed the option of a caesarean section. The Court held that doctors must take ‘reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.’
So doctors must tell patients about reasonable alternatives.
They must also tell them about material risks, which are risks that a reasonable person would want to know or that this particular patient would want to know
. They must also tell them about material risks, which are risks that a reasonable person would want to know or that this particular patient would want to know.
The particular patient
Doctors should get to know their patients and tailor the information they give to the individual patient. As time is a limited resource in the modern NHS, we should, as patients, be pro-active (if we are well enough) and ask doctors about options: “are there any other choices apart from keyhole surgery for my hernia?” We should tell them about the sort of things that matter to us or concerns us (“I want to get back to work as quickly as possible” or “I need to keep my sense of smell as I work as a sommelier” or “I don’t want to risk damaging my vocal cords as I’m a teacher”). Whilst a good doctor would elicit that information, not all doctors are good communicators, especially when holding a long ‘to do’ list on a busy shift. We can assist them by volunteering that information.
The Supreme Court stressed the importance of avoiding ‘bombarding the patient with technical information which she cannot reasonably be expected to grasp’.
In a past visit to the dentist, the fast-talking dentist explained the procedure as I reclined in his chair, blinded by the overhead lights. He kept using a word that was alien to me. I eventually interrupted him to find out what it meant. A ‘composite’ is, quite simply, a filling. His jargon risked undermining the quality of the consent.
If anything is unclear, patients or their relatives should ask for an explanation in plain English (“sorry, can I just stop you there? What exactly do you mean by a hysterectomy?”). They can ask for a leaflet or more information in writing. Even if thrust under their nose, patients should refrain from signing the consent form unless satisfied that they understand the procedure and the reasonable alternatives. And, once signed, the consent can always be retracted, up until the very last moment.
If patients feel pressured or have second thoughts about the operation, they should ask for more time without fear or embarrassment, even when wheeled into theatre. They can also ask for a second opinion.
Patients as partners
Although Montgomery placed the onus of obtaining informed consent on doctors, it also endorsed the idea of a partnership between doctors and patients. It is not an equal partnership: patients are ill, often frightened, in an unfamiliar environment and usually less medically knowledgeable than their medical partners, but as patients and relatives we should, whenever possible, play an active part in helping doctors understand what we need to give consent. This two-way dialogue should reduce misunderstandings and enhance patient autonomy.