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.
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.
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
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?
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.
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.
Follow Rebecca on Twitter
Scientific discoveries about how our behaviour is causally influenced often prompt the question of whether we have free will (for a general discussion, see here). This month, for example, the psychologist and criminologist Adrian Raine has been promoting his new book, The Anatomy of Violence, in which he argues that there are neuroscientific explanations of the behaviour of violent criminals. He argues that these explanations might be taken into account during sentencing, since they show that such criminals cannot control their violent behaviour to the same extent that (relatively) non-violent people can, and therefore that these criminals have reduced moral responsibility for their crimes. Our criminal justice system, along with our conceptions of praise and blame, and moral responsibility more generally, all presuppose that we have free will. If science can reveal it to be an illusion, some of the most fundamental features of our society are undermined.
The questions of exactly what free will is, and whether and how it can accommodate scientific discoveries about the causes of our behaviour, are primarily theoretical philosophical questions. Questions of theoretical philosophy—for example, those relating to metaphysics, epistemology, and philosophy of mind and language—are rarely viewed as highly relevant to people’s day-to-day lives (unlike questions of practical philosophy, such as those relating to ethics and morality). However, it turns out that the beliefs that people hold about free will are relevant. In the last five years, empirical evidence has linked reduced belief in free will with an increased willingness to cheat,1 increased aggression and reduced helpfulness,2 and reduced job performance.3 Even the way that the brain prepares for action differs depending on whether or not one believes in free will.4 If the results of these studies apply at a societal level, we should be very concerned about promoting the view that we do not have free will. But what can we do about it? Continue reading
Podcast of Uehiro Seminar given by Gwen Adshead
‘The Bad Seed’ was a popular 1954 novel in which a well brought up young girl begins to manifest behaviour characteristic of a criminal psychopath. As the plot develops, the girl’s mother discovers that her own mother was a serial killer who was executed when she was herself a girl.
In this Uehiro Seminar, Gwen Adshead Forensic Psychotherapist at Bluebird House & Broadmoor Hospital explores this idea of the ‘bad seed’ using research into those who exhibit ‘callous and unemotional’ traits when children. In contrast to the theme of the novel, Dr Adshead points out that the causes of behaviour even for individuals who exhibit violent behaviour consistently both as children and adults are mediated by factors other than genetic predisposition. For example, there is a relationship between childhood physical abuse and neglect and delinquency and violence in later life. Dr Adshead argues that a more constructive approach to addressing violence in society might be to explore causes such as parenting rather than focusing disproportionate attention on the children. The lecture and discussion that follows raise fundamental issues to do with our attitude to genetic and other predictors of subsequent violence in adult life, the question of how resources should be allocated to address such problems, and how blame fits within this research framework.
You can listen to the podcast of the seminar here
Paul Troop and Sabrina Stewart
As Ben Goldacre reveals, the status quo in drug testing is nothing less than a scandal. Pharmaceutical companies are suppressing and blocking information, perfectly legally, that is causing adults and children to die. Reforming the system wouldn’t be too hard – a registry for all drug trials, before they begin, should be enough to get rid of most of the problems of suppressed publications. And compelling all pharmaceutical companies to put their trial results in the public domain would help tremendously.
All of us are present, past and future users of medicines. Getting rid of ineffective and dangerous drugs should be the great moral crusade of our time: this is far more important in terms of death and suffering, than the relatively few people who suffer from terrorism, violent crime, or even road accidents.
Imagine a political party that pledged to reform the drug testing system and do absolutely nothing else during their term in parliament. This would be a party it would be morally imperative to vote into office. Nothing else on offer in politics comes anywhere near.