Regulation

Cross-Post: Self-experimentation with vaccines

By Jonathan Pugh, Dominic Wilkinson and Julian Savulescu.

This is a crosspost from the Journal of Medical Ethics Blog.

This is an output of the UKRI Pandemic Ethics Accelerator project.

 

A group of citizen scientists has launched a non-profit, non-commercial organisation named ‘RaDVaC’, which aims to rapidly develop, produce, and self-administer an intranasally delivered COVID-19 vaccine. As an open source project, a white paper detailing RaDVaC’s vaccine rationale, design, materials, protocols, and testing is freely available online. This information can be used by others to manufacture and self-administer their own vaccines, using commercially available materials and equipment.

Self-experimentation in science is not new; indeed, the initial development of some vaccines depended on self-experimentation. Historically, self-experimentation has led to valuable discoveries. Barry Marshall famously shared the Nobel Prize in 2005 for his work on the role of the bacterium Helicobacter pylori, and its role in gastritis –this research involved a self-experiment in 1984 that involved Marshall drinking a prepared mixture containing the bacteria, causing him to develop acute gastritis. This research, which shocked his colleagues at the time, eventually led to a fundamental change in the understanding of gastric ulcers, and they are now routinely treated with antibiotics. Today, self-experimentation is having something of a renaissance in the so-called bio-hacking community. But is self-experimentation to develop and test vaccinations ethical in the present pandemic? In this post we outline two arguments that might be invoked to defend such self-experimentation, and suggest that they are each subject to significant limitations. Continue reading

Are Immunity Passports a Human Rights Issue?

Written by Julian Savulescu

A shorter version of this post appears in The Telegraph

Imagine you are about to board a plane (remember that…) Authorities have reason to believe you are carrying a loaded gun. They are entitled to detain you. But they are obliged to investigate whether you have a gun. And if you are not carrying a gun, they are obliged to free you and allow you to board your plane. To continue to detain you without just cause would be false imprisonment.

Having COVID is like carrying a loaded gun that can accidentally go off at any time. The main ground for restricting people’s liberty is if they risk harming other people. This is the justification for quarantine, isolation, lockdown and other coercive measures in the pandemic. But if they are not a risk to other people, they should be free.

The ‘loaded gun’ analogy fails to acknowledge that most who are infected are significantly less harmed than gunshot victims: most recover swiftly and fully. However, in a pandemic, there is a second reason to restrict liberty: to decrease the number who fall ill and “save the NHS”. A person becoming ill not only threatens to harm others who become infected, but also increases the strain on the NHS themselves.

While research on immunity and transmission is ongoing, typically, immunity (natural or via a vaccine) both protects the individual from getting ill and reduces transmission to others. The Federal Drug Administration in the US has admitted as much. A recent study by Public Health England showed natural infection confers similar immunity vaccination (the SIREN study). There are also reasons to believe natural immunity might reduce transmission (by specific antibodies in the airways, called IgA).

An immunity passport would record a past infection (or presence of antibodies) or vaccination. It could be a bracelet, an app on the phone, or a certificate. An immunity passport would constitute evidence that a person was no longer a threat to herself or others. Because people have a human right of freedom of movement, they should be released from current lockdown if they are known not to be threats. There is no ethical basis to imprison people who are not a threat.

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The Libertarian Argument Is the Best Argument Against Immunity Passports. But is it good enough?

Written by Julian Savulescu and Alberto Giubilini

The government has reportedly flirted with the introduction of vaccination passports that would afford greater freedoms to people who have been vaccinated for COVID-19. However, the UK’s Minister for the Cabinet Office, Michael Gove, recently announced that vaccination passports are not currently under consideration in the UK. However, the issue may linger and businesses may introduce such requirements.

One of us (JS) defended immunity passports in the context of affording people with natural immunity greater freedom during lockdown, if immunity significantly reduces the risk of infecting others.

Vaccination passports–after vaccines have been made available–can be seen as a mild form of ‘mandatory vaccination’.  Proof of vaccination could be a requirement to, for example, access certain places (e.g. restaurants, hospitals, public transport, etc, depending on how restrictive we want the mandate to be) or engaging in certain social activities (e.g. mixing with people from different households) or enable health care or other care workers to not self-isolate if in contact with a person with COVID (there were 35 000 NHS workers in isolation at the peak of the pandemic because of contact). It is worth noting that this kind of measure has already been in place globally for a long time in a more selective way, e.g. in the US where, in most states, children cannot be enrolled in schools unless they are up to date with certain vaccinations. These are also a form of “vaccination passports”, which simply do not use that term. Yellow Fever Vaccination Certificates are required to travel to certain parts of the world where Yellow Fever is endemic.

The ethical ground for restriction of liberty is a person represents a threat of harm to others. That is, the grounds for lockdown, quarantine, isolation or mandating vaccination is to reduce the risk one person poses to another. However, if a person is no longer a threat to others, the justification for coercion evaporates. If either natural immunity or a vaccine prevents virus transmission to others (and this remains to be determined), the grounds for restricting liberty disappear. This is one argument for an immunity or vaccination passport – it proves you are not a threat to others.

Moreover, if we thought there were sufficient grounds for the drastic and long lasting restrictions of individual liberties entailed by lockdowns and isolation requirements, it is at least legitimate to ask whether there are also sufficient grounds for vaccination passports, given that the individual cost imposed – getting vaccinated – is likely to be much smaller than the cost entailed by those other measures (unless the risks of vaccines are significant).

However, the more effective a vaccine is, the greater the opportunity for individuals to protect themselves. A Libertarian could then argue that the risk of harming others is nullified. If you want to protect yourself, you can vaccinate yourself. If this is true, then a vaccine doesn’t need to give us herd immunity. We can take individual responsibility.

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Mandatory Morality: When Should Moral Enhancement Be Mandatory?

By Julian Savulescu

Together with Tom Douglas and Ingmar Persson, I launched the field of moral bioenhancement. I have often been asked ‘When should moral bioenhancement be mandatory?’ I have often been told that it won’t be effective if it is not mandatory.

I have defended the possibility that it could be mandatory. In that paper with Ingmar Persson, I discussed the conditions under which mandatory moral bioenhancement that removed “the freedom to fall” might be justified: a grave threat to humanity (existential threat) with a very circumscribed limitation of freedom (namely the freedom to kill large numbers of innocent people), but with freedom retained in all other spheres. That is, large benefit for a small cost.

Elsewhere I have described this as an “easy rescue”, and have argued that some level of coercion can be used to enforce a duty of easy rescue in both individual and collective action problems. Continue reading

Pandemic Ethics: Testing times: An ethical framework and practical recommendations for COVID-19 testing for NHS workers

Dr Alberto Giubilini, Senior Research Fellow at the Oxford Uehiro  Centre for Practical Ethics and Wellcome Centre for Ethics and Humanities was part of an independent rapid-response project to develop an ethical framework for COVID-19 swab testing for NHS workers. Following a stakeholder consultation, the expert group have published a report identifying ethical considerations and providing practical guidance and recommendations to identify good practice and support improvement.

The report is available online. 

We’re All Vitalists Now

By Charles Foster

It has been a terrible few months for moral philosophers – and for utilitarians in particular. Their relevance to public discourse has never been greater, but never have their analyses been so humiliatingly sidelined by policy makers across the world. The world’s governments are all, it seems, ruled by a rather crude vitalism. Livelihoods and freedoms give way easily to a statistically small risk of individual death.

That might or might not be the morally right result. I’m not considering here the appropriateness of any government measures, and simply note that whatever one says about the UK Government’s response, it has been supremely successful in generating fear. Presumably that was its intention. The fear in the eyes above the masks is mainly an atavistic terror of personal extinction – a fear unmitigated by rational risk assessment. There is also a genuine fear for others (and the crisis has shown humans at their most splendidly altruistic and communitarian as well). But we really don’t have much ballast.

The fear is likely to endure long after the virus itself has receded. Even if we eventually pluck up the courage to hug our friends or go to the theatre, the fear has shown us what we’re really like, and the unflattering picture will be hard to forget.

I wonder what this new view of ourselves will mean for some of the big debates in ethics and law? The obvious examples are euthanasia and assisted suicide. Continue reading

Pandemic Ethics: Extreme Altruism in a Pandemic

Written by Julian Savulescu and Dominic Wilkinson

Cross-posted with the Journal of Medical Ethics blog

Altruism is one person sacrificing or risking his or her own interests for another’s interests. Humans, like other animals, have a tendency towards altruism. This is usually directed to members of their own group. An example is donating a kidney to a family member. This is quite risky – it involves immediate risk of death from anaesthesia or post-operative complications, and long term risk of kidney failure.

But sometimes people are altruistic towards strangers.

Altruism often involves fairly small personal sacrifices. (For example, most people donate to charity, but in countries like the UK, it is typically only a tiny proportion of their income) Where someone can cause great benefit to another person at little or no personal cost, there is an ethical obligation for them to do so. This is the Duty of Easy Rescue. A whole movement has arisen called Effective Altruism which aims to ensure that altruistic acts do as much good as possible.

Altruism can also be extreme. Some people give up their entire livelihood to work overseas for aid agencies or charities. During a pandemic, health workers may take on significant personal risk to provide front-line medical care. In times of war, people may choose to literally give their life for others of their nation.

We can define extreme altruism as an act taken for the benefit of another that involves making large life-altering or life-threatening sacrifices or personal risks.

Society’s approach to extreme altruism is inconsistent. At times of obvious societal need, it encourages it (for example, clapping on the doorstep for ‘key workers’ is in order to offer our appreciation for their altruistic assumption of great risk) or even requires it by conscription of military personnel. At times of perceived lesser need, it is discouraged or even banned. For example, in normal times people are only allowed to take part in research, even if they do so with full knowledge and for no payment, if the risk of the research is minimal, and not if the risks are similar to everyday life. In some jurisdictions, altruistic kidney donations to strangers are banned.

It is not clear why extreme altruism should be limited to national emergency. If someone is competent, knows all the relevant facts, and is thinking clearly and choosing autonomously, they should be able to sacrifice their interests or even life for others. If someone is permitted to participate in highly risky personal activities for purely personal benefit (e.g. climbing Mount Everest, base jumping, or boxing) they ought to be permitted to at least take equivalent risks for the benefit of someone else (e.g. participating in research). Just as a rational, clear thinking person who is competent should be able to sacrifice their own life through suicide for any reason, they should be able to do this for the benefit of others.

We have argued at various points for extreme altruism in medicine. In one sense, there is a constant national emergency: we are all aging and slowly dying. There is a war against aging and death: we are fighting it with medicine. And people should be able sacrifice their interests or lives in this war. 

Extreme altruism extended to COVID-19

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Guest Post: Pandemic Ethics. Social Justice Demands Mass Surveillance: Social Distancing, Contact Tracing and COVID-19

Written by: Bryce Goodman

The spread of COVID-19 presents a number of ethical dilemmas. Should ventilators only be used to treat those who are most likely to recover from infection? How should violators of quarantine be punished? What is the right balance between protecting individual privacy and reducing the virus’ spread?

Most of the mitigation strategies pursued today (including in the US and UK) rely primarily on lock-downs or “social distancing” and not enough on contact tracing — the use of location data to identify who an infected individual may have come into contact with and infected. This balance prioritizes individual privacy above public health. But contact tracing will not only protect our overall welfare. It can also help address the disproportionately negative impact social distancing is having on our least well off.
Contact tracing “can achieve epidemic control if used by enough people,” says a recent paper published in Science. “By targeting recommendations to only those at risk, epidemics could be contained without need for mass quarantines (‘lock-downs’) that are harmful to society.” Once someone has tested positive for a virus, we can use that person’s location history to deduce whom they may have “contacted” and infected. For example, we might find that 20 people were in close proximity and 15 have now tested positive for the virus. Contact tracing would allow us to identify and test the other 5 before they spread the virus further.
The success of contact tracing will largely depend on the accuracy and ubiquity of a widespread testing program. Evidence thus far suggests that countries with extensive testing and contact tracing are able to avoid or relax social distancing restrictions in favor of more targeted quarantines.

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The Perfect Protocol? Ethics Guidelines in a Pandemic

Written by Joshua Parker and Ben Davies

One question occupying politicians and healthcare workers in the middle of this global pandemic is whether there will be enough ventilators when COVID-19 reaches its peak. As cases in the UK continue to increase, so too will demand for ventilators; Italy has reported overwhelming demand for the equipment and the need to ration access, and the UK will likely face similar dilemmas. Indeed, one UK consultant has predicted a scenario of having 8 patients for every one ventilator. Aside from anything else, this would be truly awful for the healthcare professionals having to make such decisions and live with the consequences.

Ethics is an inescapable part of medical practice, and healthcare professionals face numerous ethical decisions throughout their careers. But ethics is challenging, often involving great uncertainty and ambiguity. Medics often lack the time to sort through the morass that is ethics.  Many therefore prefer heuristics, toolboxes and a handful of principles to simplify, speed up and streamline their ethics.

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Pandemic Ethics: Covid-19 Shows Just How Much of Ethics Depends on (Good) Data

Written by Hazem Zohny

In times of crises, the archetypal ethicist sits in the proverbial armchair and hums and haws, testing out intuitions about an action or policy against a jumble of moral theories. Covid-19 shows why the archetypal ethicist is as useless as antibiotics are for viral infections.

This is because virtually all the difficult ethical questions this pandemic raises boil down to having access to the relevant data, rather than the relevant intuitions or theories.

Consider these questions, all sourced from recent blogs in this Pandemic Ethics Series:

But also: Should isolation have started earlier? How draconian is too draconian? Should we aim for herd immunity? What criteria should determine who gets the ventilator if they start to run out? Etc. Etc.

These all seem like meaty moral questions – and they are. But their meatiness does not really stem from the values or principles they call into question. Instead, it is the uncertainty of the empirical data surrounding all aspects of the pandemic that should incite all the humming and hawing.

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