Research Ethics

The reproducibility problem and the status of bioethics

There is a long overdue crisis of confidence in the biological and medical sciences. It would be nice – though perhaps rather ambitious – to think that it could transmute into a culture of humility.

A recent comment in Nature observes that: ‘An unpublished 2015 survey by the American Society for Cell Biology found that more than two-thirds of respondents had on at least one occasion been unable to reproduce published results. Biomedical researchers from drug companies have reported that one-quarter or fewer of high-profile papers are reproducible.’

Reproducibility of results is one of the girders underpinning conventional science. The Nature article acknowledges this: it is accompanied by a cartoon showing the crumbling edifice of ‘Robust Science.’

As the unwarranted confidence of scientists teeters and falls, what will – and what should – happen to bioethics?

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Why are unethical neonatal trials still taking place in developing countries?

By Dominic Wilkinson, @Neonatalethics

Earlier this year, the Lancet published a trial (the ‘ACT’ trial) involving 100,000 babies at risk of being born prematurely in developing countries. Half of the mothers in the ACT trial did not receive a simple cheap medicine that has been previously shown in multiple trials and meta-analysis to reduce the risk of death for premature babies. From the ACT trial results, it appears that 89 additional babies died as a result of their mothers taking part in the trial.

Surely this is an egregious example of unethical research? It appears to be in breach of the World Medical Association Declaration of Helsinki standards. Why did ethics committees allow the research? Why did a major journal like the Lancet publish it? Why aren’t bioethicists and activist and advocacy groups like Public Citizen jumping up and down in outrage?

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Pinker Bioethics: What Should We Learn?

Julian Savulescu 
Twitter @juliansavulescu

Steven Pinker has recently written an op-ed questioning the contribution of bioethics to the safe and efficient regulation of research. This has been widely misinterpreted and criticised, though Alice Dreger has written a recent accurate blog in support of Pinker. Pinker provocatively said that bioethics should get out of the way of research. This has been interpreted to mean that we should give up ethics review of research. Nobody, not me, and not Steven Pinker, thinks we should abandon ethical review of research. He actually says, ” Of course, individuals must be protected from identifiable harm, but we already have ample safeguards for the safety and informed consent of patients and research subjects.” Pinker is objecting to the unnecessary, unproductive obstruction that much bioethics represents to good research and regulation.

I largely agree with him and have said as much myself over the years. I recently wrote a piece for the anniversary issue of the JME arguing as much. I applaud him for trying to generate some self-reflection in the field.

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Guest Post: The Moral Imperative for Bioethics

By Daniel K. Sokol
Daniel Sokol, PhD, is a bioethicist and lawyer at 12 King’s Bench Walk, London. He has sat on several ethics committees, including the UK’s Ministry of Defence’s Research Ethics Committee.

In a recent Opinion piece in the Boston Globe, Professor Steven Pinker made the surprising suggestion that the primary moral goal of today’s bioethics should be to “get out of the way”. “A truly ethical bioethics”, he argued, “should not bog down research in red tape, moratoria or threats of prosecution”.

This bold assertion no doubt echoes the thoughts of many scientists whose research requires the approval of an ethics review committee before springing to life. As a PhD student many years ago, I experienced first hand the frustrations of the tedious review process. I spent hours drafting the protocol, revisions and responding to the Committee’s questions, time I would have preferred to spend conducting research. While a popular sentiment, getting out of the way is not the goal of bioethics.

The goal of bioethics is to allow potentially beneficial research while ensuring that the risk of harm to participants and others is proportionate, reduced to the lowest practicable level, and within morally acceptable limits. The risk of harm can never be eliminated, but it can usually be reduced with minimal effort or cost. It may be as simple as testing a new piece of equipment one more time in a laboratory before attaching it to a human for testing.

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A Code of Conduct for Peer Reviewers in the Humanities and Social Sciences

1. The fact that you disagree with the author’s conclusion is not a reason for advising against publication. Quite the contrary, in fact. You have been selected as a peer reviewer because of your eminence, which means (let’s face it), your conservatism. Accordingly if you think the conclusion is wrong, it is far more likely to generate interest and debate than if you agree with it.

2. A very long review will simply indicate to the editors that you’ve got too much time on your hands. And if you have, that probably indicates that you’re not publishing enough yourself. Accordingly excessive length indicates that you’re not appropriately qualified. Continue reading

The moral imperative to research editing embryos: The need to modify Nature and Science

Chris Gyngell and Julian Savulescu

Human genetic modification has officially progressed from science fiction to science.  In a world first, scientists have used the gene editing technique CRISPR to modify human embryos. While the study itself marks an important milestone, the reason it is truly extraordinary is the scientific community’s reaction to it. In refusing to publish this study on ethical grounds, the world’s two leading science journals Nature and Science, appear to be demonstrating a lack of clear and consistent thinking on ethical issues. Continue reading

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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