All the people in England today being given the Pfizer BioNTech covid vaccine are necessary guinea pigs. They are guinea pigs because they are participating in the early post marketing surveillance of a vaccine that, at this stage, we know very little about. We will come to just how little we know soon enough, but for now we should note that they are necessary guinea pigs, because, given that an effective vaccine against covid–19 is a common good, the only way we are ever going to know more about the vaccine is by giving it to lots of people. That, bluntly, is how it has to be. But this context, of participating in a mass trial, means that informed consent, always of paramount importance, is, in this particular context, of dominant importance. The distinction here between paramount and dominant, which both mean supreme, is that paramount merely describes a position, whereas dominant adds an element of dominion: that which is dominant is not only above all else, it also rules over all else.
Which brings us to the rule of law over informed consent. All doctors are familiar with the Bolam test, the long-standing legal test for medical negligence. The test is disarmingly simple — and, some might say, equally disarming to a patient alleging negligence — if a doctor can produce a body of responsible medical opinion — it doesn’t have to be many doctors, just a small number will do — that would have acted as the doctor said to be negligent did, then the doctor has not been negligent. It is a low bar, but on the face of it, it is fair enough — if other responsible contemporary doctors would have done the same thing, then that is fair enough. But it has one huge great gaping hole. It relies solely on medical opinion — the doctors know best — and takes no account at all of the patient. The patient is merely the passive recipient, and has no say on what is or is not reasonable in his or her particular case.
Bolam (Bolam v Friern Hospital Management Committee ) was chiefly about a procedure, and the harms it caused, but it was also about consent, though the consent part has been largely eclipsed by the procedural part. Bolam was a voluntary mental patient who consented to electro-convulsive therapy (ECT). It was common but not exclusive practice in those days to give ECT without anaesthetics, muscle relaxants or restraint, and the patient had a full blown convulsion, which could cause serious injuries. This happened to Bolam, who suffered fractures of both hips. He subsequently sued for negligence, on the grounds that he was not given muscle relaxants, not restrained, and that, had he been warned of the risks, he would not have consented to the treatment. Directed by the judge that a medical man “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”, the jury returned a verdict in favour of the defendant: the doctors knew best, and, inter alia, it was for the doctor to decide how much to tell, or not tell, the patient.
Bolam, and in particular the question of who decides how much to tell, or not tell, the patient, was reaffirmed in Sidaway v Bethlem Royal Hospital Governors . The patient claimed that she would not have consented to a neurosurgical operation, had she been warned about the risks, which subsequently came to pass. The point at issue here was not the competence of the surgeon, which was not in doubt, but whether, by withholding information, the surgeon had impaired the patient’s ability to give fully informed consent. The case was muddied by the fact the surgeon had since died, so that his account could not be heard, and there was a glimmer of dissent from one of the lords hearing the case, but at the end of the day, the judges unanimously dismissed the appeal. Four of the five judges relied almost exclusively on Bolam: if a responsible body of medical opinion was of the view that the best interests of the patient were not best served by providing her with an alarming catalogue of rare and catastrophic complications, then so be it, and therefore a surgeon acting in such a way could not be said to be negligent.
By 2015, however, the tide had finally turned. Bolam got the boot. Ms Montgomery, a short (small pelvis) diabetic (big baby) nulliparous (no previous births, so more of an unknown) highly intelligent (not medical, but her mother and sister were) woman nearing delivery, was nudged towards vaginal delivery by a caesarean averse obstetrician who chose not mention a rare but serious risk of vaginal delivery (obstruction, and subsequent cerebral palsy for the child), believing if she did, it would cause the patient to want a caesarean section. The labour went ahead, the outcome was calamitous, and the bady was born with cerebral palsy. Ms Montgomery subsequently sued, claiming that had she known of the risks, she would indeed have resisted vaginal delivery, and asked for a section. The issue at stake here was not the appalling conduct of the labour itself, but was the patient sufficiently informed to make the right decision for her over how her baby was delivered? More generally, the question here is who controls the final decision: the doctor, by manipulating the flow of information, in what they believe to be the patient’s best interests, or the patient, in full possession of all the relevant information.
Recall that the Bolam/Sidaway principle is doctor knows best: it is for the doctor to decide, in the patient’s best interests, how much information to give, and how much to withhold. The Supreme Court judges hearing Montgomery’s final appeal came to a different conclusion. After a comprehensive review of the law (the judgment runs to 38 pages), the key finding comes in paragraph 87 (emphasis added):
“An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to 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. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.” Montgomery v Lanarkshire Health Board 
How does this affect gaining informed consent to administer the Pfizer BioNTech vaccine? In the past, under Bolam and Sidaway, the doctor or indeed any other suitably trained person obtaining consent had considerable largesse to decide how much information to reveal. If a responsible body of medical opinion had it that there was no point in frightening the person contemplating being vaccinated with a raft of unknowns and uncertainties, then so be it. Today, Montgomery has turned that on its head. Instead of it being for the doctor to decide on a doctor knows best basis, the doctor now has to ensure that the patient is aware of any risk that a reasonable person is likely to consider significant. This is a fundamental shift: the frame of reference has moved from what the doctor thinks is best, to what a reasonable person is likely to consider significant. The locus of control has shifted from the doctor to the reasonable person, and with that, it is no longer the case that doctor knows best.
Dr No takes the view that the fact we know very little about the vaccine means that having the vaccine entails a significant risk, of unknown unknowns. Under Montgomery, it is no longer good enough for us to say that we believe it to be in the patient’s, and, more controversially still, in the population’s, best interests to have the vaccine, and therefore there is no need to bother with all that complicated unknown unknowns nonsense. Instead, we have a duty to ensure that the patient is aware of any risks that a reasonable person is likely to consider significant.
All we really know about the Pfizer vaccine, chiefly from ad hoc press releases, an MHRA ‘agency knows best’ announcement and an ‘Information for healthcare professionals’ leaflet, is that, based on a small number (less than 200 cases), the vaccine appears to be effective in preventing PCR confirmed symptomatic covid–19, and that, based on around 22,000 recipients, mild to moderate but self-limiting adverse reactions are common. On the other hand, the list of what we do not know is considerable and significant. We do not know: how long immunity will last; whether the vaccine reduces transmission; whether the vaccine protects especially the more vulnerable against serious and fatal covid; what, if any long term serious adverse reactions will occur, or what the long term effects of injecting mRNA are. Nor do we know — and this is of particular significance given that many of the first recipients will be women of child bearing age — anything about the effects of the vaccine on pregnancy and the foetus.
When asked what kept him awake at night, Harold Macmillan the prime minister famously replied, ‘Events, dear boy, events.’ Donald Rumsfeld’s famous ‘unknown unknowns.’ All of these unknowns are by definition risks. None of them is necessarily a reason not to have the vaccine, and perhaps more to the point, we, as a society, need these necessary guinea pigs to have the vaccine, to discover more about these risks. But, in this new Montgomery world, it is not for doctors to decide whether a person should have a vaccine, or to attempt to nudge the patient into consenting by holding back information on risk. Instead, the job of doctors is to tell the person contemplating the vaccine of these unknowns, these risks, and then let the person, not the doctor, decide.