Research Ethics

Editing the germline – a time for reason, not emotion

Gyngell, Douglas, Savulescu

There are rumours in the scientific community that the first studies involving the genetic modification of a human embryo are about to be published.[1] If true this would be the first case of an experiment in which genes in germ cells (sperm and egg cells) have been intentionally modified.  This has caused some concerns in the scientific community due to the fact that these modification are potentially heritable.  A commentary in Nature, (written by four leading scientists and one philosopher) published an appeal that we “Don’t edit the human germ line”.  Science meanwhile published a commentary which outlines “A prudent path forward for genomic engineering and germline gene modification”. The fact that two of the world’s most prestigious journals are publishing commentaries on human genetic modification shows just how powerful gene editing techniques have become. The rapid speed with which these technologies have developed has taken the scientific community, and everyone else, by surprise. Just three years after the DNA cutting nuclease Cas-9 was first used to modify DNA, scientists have been able to make heritable modifications to yeast, plants, mice, rats, pigs and even primates. It has been claimed that experiments conducted in China, currently under review, have used these same technologies to modify the DNA of human embryos.[2] Continue reading

A Dutch university prohibits a PhD student from thanking God in his acknowledgments

A Dutch university (Wageningen University) prohibited a PhD student from thanking God in his thesis acknowledgments. The student, Jerke de Vries, wrote, “My Father God, thank You, it’s the most wonderful thing to be loved and honoured by You.” The university refused to grant him his thesis unless he deleted this reference to God. The university argues that science should be independent from politics or religion (political statements are also banned). The student refused to delete God from his acknowledgments and instead tore the whole page of acknowledgments out altogether.
Is the university right to state that science should be independent from politics and religion, or is this a case of discrimination against religious persons? The university has refused to clarify their decision. Continue reading

Philosophy and animal experimentation: Animal ethics workshop with Christine Korsgaard.

By Dominic Wilkinson @Neonatalethics

 

On the 3rd December, as part of the Uehiro lecture series, the Centre for Practical Ethics held a workshop on Animal Ethics at the Oxford Martin School.*

The workshop included first a short summary of her Uehiro lectures by Professor Christine Korsgaard, and then a series of responses by invited guest speakers from the University of Oxford and elsewhere including Professor Jeff McMahan, Professor Cecile Fabre, Dr Mark Sheehan, Professor Valentin Muresan, Dr Emilian Mihailov, Dr Caroline Bergmann and Dr James Yeates. Continue reading

One Success in Research Ethics

Research ethics committees often behave unethically*. One example is their failure to understand the ethical basis for obtaining consent and the appropriate limitations. There is a simple rule – “get consent”. I discuss this in greater detail in Bioethics: Why Philosophy Is Essential to Progress, JME 40th Anniversary Issue.

But ethics is more complicated than this. It involves the weighing of different ethical reasons. Sometimes, those reasons can speak overall in favour of not obtaining consent in the way prescribed by various ethical guidelines. Deliberation is required. It is import to also consider the value of good research.

I was Chair of the Department of Human Services Victoria Ethics Committee between 1998-2002, I tried to improve various aspects of research review. You often don’t know if anything you do has any beneficial effect. But recently, Pam Snow came up to me after a lecture. I couldn’t remember her but she kindly told me her story. Here it is. I am relating it as a case study in how “deliberative” research ethics review can actually do some good. I asked her to put her thoughts in writing to show how ethicists can work with researchers to find a way to bring about a good outcome.

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“Please randomize me – but don’t tell my family that you did”

Last week various newspapers (see here and here) reported on a planned research study of adrenaline for patients suffering a cardiac arrest outside hospital. The PARAMEDIC 2 trial (full protocol here) involves ambulance officers randomly giving patients either the traditional resuscitation drug adrenaline, or a salt-water solution (placebo). The trial has been strongly criticized by Ruth and Lindsay Stirton, writing in the Journal of Medical Ethics.

There are two main controversial elements to the trial design. The first involves the lack of consent for involvement in the trial, the second involves the researchers’ plan not to inform families of patients who died that their loved one had been in a research trial.

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What has Facebook (with some psychologists) done?

In my academic and musty corner of the universe, there has been a lot of talk in the past few days about this publication in the prestigious Proceedings of the National Academy of Sciences. Researchers tweaked a Facebook algorithm such that Facebook users would see a higher proportion of posts with negative or positive emotional content in their feed. They wanted to know whether a user seeing a different proportion would influence the emotional content content of that user’s posts in a positive or negative direction. The news: it did (a little bit).

People are less interested in that, however, and more interested in whether the researchers acted unethically. The BBC has a short round-up of some tweets here, and among other things the Guardian quotes Labour MP Jim Sheridan calling for an investigation here. Slate tagged its story on the issue with the headline ‘Facebook’s Unethical Experiment’ – a headline that shifts blame away from researchers and entirely to Facebook. There are many more news stories on this out by now: you get the picture. Continue reading

When the poison is the antidote: risky disaster research

A recent report by Lipsitch and Galvani warns that some virus experiments risk unleashing global pandemic. In particular, there are the controversial “gain of function” experiments seeking to test how likely bird flu is to go from a form that cannot be transmitted between humans to a form that can – by trying to create such a form. But one can also consider geoengineering experiments: while current experiments are very small-scale and might at most have local effects, any serious attempt to test climate engineering will have to influence the climate measurably, worldwide. When is it acceptable to do research that threatens to cause the disaster it seeks to limit?

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Medical ethics are ridiculous

In a blistering letter in the current issue of the British Medical Journal, Miran Epstein identifies some of the factors we should consider in assessing the claims of so-called ‘evidence-based medicine’.[1] Nobody rationally disagrees with the suggestion that medicine should have an evidence base, and everybody should agree that in order for medicine to be based on reliable evidence, it should be free of the following ‘polluters’:

  •  financial conflicts of interest
  •  inadequately rigorous selection criteria, outcome measures and criteria of statistical significance
  • the practice of testing products against placebo or no treatment (rather than current treatment), and then shouting ‘Eureka!’
  • recruiting subjects using financial incentives that introduce outcome bias
  • marketing campaigns masquerading as research

Closing down comments

Popular Science  has decided they will no longer permit comments on their new articles.  If you are a ‘vexing commenter’, a ‘shrill boorish specimen’, rather than a ‘delightful, thought-provoking commenter’, it now turns out you were never welcome. Of course, they have a perfect right to close their comments: it is their website. Their reasons for doing so, however, show a distressing lack of respect for the value of free speech and free opinion.

It is true that some people are shrill, boorish and vexing, but some people are merely called that because they are saying things others do not wish to hear. Climate skeptics are frequently dismissed in these terms. Very good, you might say. But so were abolitionists, feminists and gay rights activists. This is that well known irregular verb, I am forthright, you are argumentative, he is boorish, she is shrill, we are reality based truth speakers, ye (you all) are clamorous and they are vexatious liars.

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Ethics and the Limits of the Randomized Controlled Trial: Time to Enhance Access to Novel Therapies in Lethal Diseases?

Parts of this blog are drawn from ‘Improving access to medicines: empowering patients in the quest to improve treatment for rare lethal diseases’, a forthcoming paper  in the Journal of Medical Ethics

Jenn McNary witnesses the miracles that modern medicine can produce every day when she sees her son Max, once increasingly reliant on a wheelchair due to his Duchenne muscular dystrophy, now able to walk, run and jump, the progression of his deadly disease apparently halted due to his enrolment in a clinical trial of a new drug, Eteplirsen.

Tragically, she also witnesses the suffering of her son Austin, who has the same genetic condition, denied the drug as his disease progresses and left no longer able to leave his wheelchair unaided. Like most with Duchenne muscular dystrophy, he is expected to die in his early twenties.

Eteplirsen works by rewriting some of the genetic code that is linked to the disease. If Max’s improvement is repeated in other patients in the trial who are receiving the drug and not the placebo, it is likely that in a few years this treatment will be revolutionizing the prognosis for Duchenne sufferers and offering hope to many of the 1 in 3600 boys who are affected by the disease.

In the meantime, patients like Austin are denied treatment, on the grounds that the drugs have not been tested- in order to protect him from unknown side effects and complications, and to test its efficacy scientifically. Yet the alternative for Austin is continuing degenerative disease, and in a few years, death.

Les Halpin, founder of Access to Medicine, and himself a motor neuron disease sufferer has argued that for those with life threatening and rare illnesses, current drug approval procedures do not work. He argues in our forthcoming paper that “for such individuals, the “risk-return ratio” is different compared to patients with more benign conditions and drug regulations should be adapted to allow such people the opportunity to try out new combinations of drugs”. He has argued for greater use of new media to track patient progress, and cites the use of the website ‘Patients Like Me’ by MND patients to track their progress on lithium treatment.

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