Research Ethics

Is a Publication Boycott of Chinese Science a Justifiable Response to Human Rights Violations Perpetrated by Chinese Doctors and Scientists?

By Doug McConnell

Recently the editor-in-chief of the Annals of Human Genetics, Prof David Curtis, resigned from his position, in part, because the journal’s publisher, Wiley, refused to publish a letter he co-authored with Thomas Schulze, Yves Moreau, and Thomas Wenzel. In that letter, they argue in favour of a boycott on Chinese medical and scientific publications as a response to the serious human rights violations happening in China. Several other leading journals, the Lancet, the BMJ and JAMA have also refused to publish the letter claiming that a boycott against China would be unfair and counterproductive.

This raises two separate ethical issues: 1. Should journals refuse to publish a letter arguing in favour of a boycott on Chinese medical and scientific publications? 2. Should journals actually establish a boycott on Chinese medical and scientific publications? Continue reading

‘Waiver or Understanding? A Dilemma for Autonomists about Informed Consent’

by Roger Crisp

At a recent New St Cross Ethics seminar, Gopal Sreenivasan, Crown University Distinguished Professor in Ethics at Duke University and currently visitor at Corpus Christi College and the Oxford Uehiro Centre, gave a fascinating lecture on whether valid informed consent requires that the consenter have understood the relevant information about what they are being asked to consent to. Gopal argued that it doesn’t. Continue reading

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

Press Release: UK Approves COVID-19 Challenge Studies

Responses to the UK COVID-19 Challenge Studies: 

“In a pandemic, time is lives.  So far, over a million people have died.

“There is a moral imperative to develop to a safe and effective vaccine – and to do so as quickly as possible.  Challenge studies are one way of accelerating vaccine research.  They are ethical if the risks are fully disclosed and they are reasonable.  The chance of someone aged 20-30 dying of COVID-19 is about the same as the annual risk of dying in a car accident.  That is a reasonable risk to take, especially to save hundreds of thousands of lives.  It is surprising challenge studies were not done sooner.  Given the stakes, it is unethical not to do challenge studies.”

Prof Julian Savulescu, Uehiro Chair in Practical Ethics, and Director of the Oxford Uehiro Centre for Practical Ethics, and Co-Director of the Wellcome Centre for Ethics and Humanities, University of Oxford

“Human challenge studies are an important and powerful research tool to help accelerate our understanding of infectious diseases and vaccine development.  They have been used for many years for a range of different infections.

“The announcement of the UK Human Challenge Program is a vital step forward for the UK and the world in our shared objective of bringing the COVID-19 pandemic to an end.  With cases climbing across Europe, and more than 1.2 million deaths worldwide, there is an urgent ethical imperative to explore and establish COVID-19 challenge trials.

“All research needs ethical safeguards.  Challenge trials need to be carefully designed to ensure that those who take part are fully informed of the risks, and that the risks to volunteers are minimised.  Not everyone could take part in a challenge trial (only young, healthy volunteers are likely to be able to take part).  Not everyone would choose to take part.  But there are hundreds of young people in the UK and elsewhere who have already signed up to take part in COVID challenge studies.  They deserve our admiration, our support and our thanks.”

Prof Dominic Wilkinson, Professor of Medical Ethics, Oxford Uehiro Centre for Practical Ethics, University of Oxford

Further Research

Read more about the ethics of challenge studies:

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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

Continue reading

Pandemic Ethics: Is it right to cut corners in the search for a coronavirus cure?

By Julian Savulescu

Cross-posted from The Guardian

The race is on to find a treatment for coronavirus. This race is split between two approaches: the trialling of pre-existing drugs used for similar diseases, and the hunt for a vaccine. In both instances, important ethical decisions must be made. Is it OK to reassign a treatment that comes with side-effects? And with thousands dying from coronavirus every day, is it acceptable to cut corners in the search for a vaccine?

Read more: https://www.theguardian.com/commentisfree/2020/mar/25/search-coronavirus-cure-vaccine-pandemic

The Doctor-Knows-Best NHS Foundation Trust: a Business Proposal for the Health Secretary

By Charles Foster

Informed consent, in practice, is a bad joke. It’s a notion created by lawyers, and like many such notions it bears little relationship to the concerns that real humans have when they’re left to themselves, but it creates many artificial, lucrative, and expensive concerns.

Of course there are a few clinical situations where it is important that the patient reflects deeply and independently on the risks and benefits of the possible options, and there are a few people (I hope never to meet them: they would be icily un-Falstaffian) whose sole ethical lodestone is their own neatly and indelibly drafted life-plan. But those situations and those people are fortunately rare. Continue reading

Puberty-Blocking Drugs: The Difficulties of Conducting Ethical Research

The ethics of research trials for young people with gender dysphoria are complicated.
Billion Photos/Shutterstock

Dominic Wilkinson, University of Oxford and Julian Savulescu, University of Oxford

A recent Newsnight programme reported that a major UK puberty-blocking trial is under investigation. Doctors at a London clinic provided drugs to block the development of puberty in young adolescents with gender dysphoria, a condition where the person experiences discomfort or distress because of a mismatch between their biological sex and gender identity.

The trial began in 2011. A year after starting the drugs, the young people were apparently more likely to report thoughts of wanting to harm themselves. The worry is that perhaps the treatment they received was causing them to have these thoughts of self-harm and suicide.

One of the criticisms of the study, put forward on Newsnight, is the design. The study involved giving the drugs to a group of adolescents and monitoring the effects. However, there was no control group, that is, adolescents who did not receive the drugs. This makes it hard to be sure whether the rates of self-harming thoughts are related to the drugs, would have happened anyway, or perhaps were lower than they would have been without treatment. Continue reading

Four Lessons from the Covert Separation and Study of Triplets

Written by Julian Savulescu

Today, the Journal of the American Medical Association published an article entitled “Three Identical Strangers and The Twinning Reaction— Clarifying History and Lessons for Today From Peter Neubauer’s Twins Study” written by Leon Hoffman and Lois Oppenheim.  It provides background to a documentary, Three Identical Strangers, which gained a lot of attention earlier in the year into “the lives of Edward Galland, David Kellman, and Robert Shafran, triplet brothers who stumbled upon each other in their college years and enjoyed a brief period of celebrity before emotionally confronting the implications of their separation.” One triplet ultimately committed suicide.

The triplets were part of a covert research study by child psychiatrist Peter Neubauer who followed them up for many years to study gene-environment interactions in triplets separated at birth. The article alleges that Neuberger was wrongly blamed by the triplets and film makers for their separation at birth. The authors argue it was “Viola Bernard, then a prominent child psychiatrist from Columbia University and consultant to a now-defunct adoption agency” who was responsible for their separation because she “believed that children born of the same pregnancy and placed for adoption would fare better if they were raised by separate families.” The authors review some evidence from the child development literature at the time that supported the idea that twins or triplets would fare better if adopted, experiencing less sibling rivalry and having greater access to parental resources.

Importantly they argue that Bernard and Neubauer acted independently of each other. Moreover, the secrecy was required by laws at the time. “It was illegal at the time of the study to provide information about biological families to adoptive parents, a practice that did not begin to be modified until the late 1970s and 1980s.”

Hoffman and Oppenheim conclude:

“So the study was ethically defensible by the standards of its time—principles of informed consent and the development of institutional review boards lay in the future.10 However, these documentaries demonstrate how unsatisfactory that defense is to the study’s families who live with its legacy.

The films’ message for today’s child specialists and researchers is thus something other than their surface themes of outrage and restitution. They rather provide an unusually dramatic example of the potential for harm from human participant research, even if only observational.”

I would like to draw four other lessons from this episode.

Continue reading

Medical Nihilism: When A Dose Of Scepticism Can Be Healthy

In his 2018 book, the philosopher of science, Jacob Stegenga defends the view “that we should have little confidence in the effectiveness of medical interventions.” (Stegenga 2018) On the face of it, he acknowledges, this position seems unreasonable: most of us can think of myriad ways in which modern medicine has improved – perhaps saved – our own lives and the lives of those close to us. The asthma attack I had as a baby, effectively treated at the time and subsequently managed through the use of seemingly magical medications which relax the muscles around the airways, opening them up and allowing air to pass freely again. Or the schoolfriend whose ruptured appendix could have resulted in a fatal infection, but for emergency surgery and the administration of antibiotics. Or the countless lives made less painful by the availability of cheap and safe painkillers. 

Medical sceptics tend to get a bad rep – anti-vaxxers who risk the lives of children by regurgitating debunked myths about the links between vaccines and autism, leading to dips in herd immunity and disease outbreaks; credulous folk who believe in the mystical powers of homeopathy and eschew conventional therapies in favour of potions that contain little more than water. This is not the sort of company one wishes to associate with. Continue reading

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