What Hippocrates didn’t tell us

Jade Loughran
by Jade Loughran, Specialty Advisor and Medical Writer
September 2019

As we look forward to the imminent launch of Concentric’s digital consent platform, and with it a gentle evolution in the way patients and clinicians make decisions in healthcare, we took a little time to look backwards. What is the origin of ‘informed consent’? When did it become a routine part of medical practice? What we found was unexpected…

First stop, the not too distant past for many of us. On the first day of medical school we were each presented with a copy of the General Medical Council’s Good Medical Practice. Most dutifully read one or two of the component booklets, and committed to memory the four cornerstones of medical ethics. Upon these all of our medical practice, in theory at least, would hang.

Beneficence. Non-maleficence. Autonomy. Justice.

The principle of autonomy is particularly relevant when considering informed consent. That a patient, equipped with information about their condition, the treatment offered, its risks, benefits, and alternative options, including doing nothing, arrives at a decision about what is best for them, without duress or pressure from the Doctor, or from anyone else.

No surprises so far.

What Hippocrates Didn’t Tell Us

Three of the basic principles, beneficence, non-maleficence, and justice, have strong origins in the writings of Hippocrates. Autonomy, strikingly, does not. In fact, the four principles as we know them today were not published in medical ethics literature until Beauchamp and Childress in 1985. 2355 years after Hippocrates’ death.

While the writings of many early physicians mentioned elements that would be considered part of the consent process, namely information giving, this was not in the context of autonomy. The emphasis was on giving information to enable co-operation with a plan made by the physician. A true paternalistic model.

Informed consent has evolved through the ages of medical practice, from paternalism to practice more closely resembling patient-centred decisions. The drivers of change have been varied, as we’ll see in considering a number of historic cases.

Physician-centred Care

In the 18th and 19th centuries it was the physician who was at the centre of any patient’s care. They made their assessment of the patient and decided upon a course of action, without much discussion or justification.

While this appears shocking by modern day standards, it was the norm and done with the firm belief that such practice was in the patient’s best interests. In an age before antiseptics and antibiotics, many illnesses rapidly became life threatening, and as Thomas Percival wrote in 1803, it was believed that the patient should be “guarded against whatever would be detrimental to him,” including it would seem, knowing the truth about their diagnosis. Diagnoses and details would rarely be disclosed or discussed.

However, there were changes afoot. Some physicians had begun to advocate giving information to their patients. Benjamin Rush and John Gregory, innovators in the field at the time, were physicians who wanted their patients to be more informed. A first step, but crucially in terms of modern consent standards, the purpose of this information was to afford patients some understanding, improving their cooperation with the physician’s decision.

Battery and Coercion

As early as the early 20th century we see public consent cases demonstrating a real shift in thinking.

One such case was Schoendorff vs the society of NY Hospital, in 1914. The patient had consented to an examination under anaesthesia, but not to an operation, which the surgeon decided to proceed with. In the legal report it is documented that ‘every human being of adult years in sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits a battery’. This was the first time such a stance, reflecting a description of autonomy not too dissimilar to that which we hold today, was described.

But the shift in thinking, and in practice, was not straightforward from that point.

During the Second World War and the huge turmoil in Europe, Doctors used prisoners held in Nazi camps to conduct experiments, both of a medical research nature and to further military developments. The subjects, including many children, did not volunteer, were not asked permission, and did not give consent.

The details of these ‘experiments’ are appalling. And performed by those within our profession. There are hundreds of examples, but consider Dr Signund Rascher’s approach to informed consent as he placed a healthy 37 year old in a low-pressure chamber. Sat with a colleague, he watched as man suffer a horrific end to his life, suffocating from a lack of oxygen, carefully documenting his changes in behaviour over the 30 minutes until he died.

The horrors revealed at the end of the war led to the detailing of rules regarding the conduction of research studies, initially in the Nuremberg code of 1947, and followed by the Declaration of Helsinki in 1964. It was in 1964, well within living memory, that it was declared adequately that an individual had the right to make an informed decision about participating in research, and crucially, without coercion.

Patient Power and Professional Resistance

In 1957 a landmark case (Salgo vs Leland Stanford Jr University board of trustees) saw a further step change in medical law’s approach to consent. From physician-centred, to information for cooperation, to assent, Salgo introduced a new concept: the patient’s understanding of risk. Here we see mention of the requirement of a Doctor to disclose the risks of a treatment as ‘an extension of the duty to disclose the treatments’ nature.’ Soon after, in 1960, we see the emergence of negligence being used in consent cases where the discussion of risk was deemed insufficient.

Natanson vs Kline, around this time, is a good example of the move from physician-centred to patient-centred decisions. The ruling described that a man should be able to ‘prohibit the performance of life-saving surgery or other treatment’. This is the first real mention of a patient being able to withhold consent for a procedure deemed necessary by their Doctor.

1957 was an important year in the field of informed consent. In parallel, the famous Bolam vs Friern case was playing out. This case shaped the requirements of what would be discussed with patients for the next 60 years. It was a question of negligence, in a case where a patient suffered injury after not being given a muscle relaxant for the performance of electroconvulsive therapy.

In the Bolam case it was ruled that because the Doctor ‘acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’, he was not guilty of negligence. The Bolam principle, as it became known, has been applied to many situations since, to determine what actions, including the provision of information, a reasonable body of Doctors might take.

So by the early 1970s a much more familiar version of informed consent had emerged. In 1972, Canterbury vs Spence discussed a more ‘patient-orientated’ approach to the information that was provided. However, this was not always popular with the medical profession. There was a feeling that the demands of informed consent would be difficult to fulfil, and that providing patients with full information about the risks of a procedure would lead to patients refusing to undergo surgery that would be deemed necessary by the medical community.

This requirement, despite resistance, was affirmed by the 1995 World Health Organisation declaration on patients’ rights, stating that patients have the right to be fully informed about their health status, and that information must be provided to enable a patient the right of self-determination. So there we have it. Informed consent. The story was thought to have finished.

Shifting Expectations

But in 2015, the status quo changed again. In the landmark Montgomery vs Lanarkshire case, a diabetic lady of small stature, Nadine Montgomery, underwent a vaginal delivery which resulted in shoulder dystocia and hypoxic injury to her baby, leading to cerebral palsy. The patient sued for negligence, stating that if she had known her personal increased risk of these complications she would have opted for a caesarean section. The key point this case demonstrated is a move in what information should be discussed. It is a move away from the Bolam principle, whereby the information discussed is what the Doctor deems reasonable, towards discussing the risks and benefits that the individual patient would deem important. Again, as in the 1970s, there is resistance from the medical profession, that this is difficult to navigate and risky for clinicians. The GMC, and I suspect each of us in our heart of hearts, are clear that what is expected, and what we would want as patients, would be to be in receipt of all information that may be important to us.

So what does the history of consent tell us about informed consent in 2019 and beyond? If it tells us one thing, it’s that medical practice has always evolved, and will continue to evolve. What will be the element of our practice that seems right and proper now, that will be shocking to generations to come?

As we continue on informed consent’s story through the 21st century, let’s consider ourselves as expert facilitators, sharing information with our patients that is relevant and understandable, and guiding each individual through the options. Let’s make our consultations a conversation, where questions are asked freely, and time is an opportunity.

To find out about how Concentric Health can support your daily practice, delivering a better informed consent experience for both you and your patients, get in touch today at hello@concentric.health

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