Should bioethics "get out of the way of research"?

04 August 2015

Portrait of Professor Julian Savulescu

by Professor Julian Savulescu
Uehiro Chair in Practical Ethics

Professor Julian Savulescu has held the Uehiro Chair in Practical Ethics at the University of Oxford since 2002. He has degrees in medicine, neuroscience and bioethics. He directs the Oxford Uehiro Centre for Practical Ethics within the Faculty of Ph...


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.

Two of the cases which are held up as showing the need for bioethics are those of gene therapy death victim Jesse Gelsinger and asthma study death victim Ellen Roache.

That is exactly right – they show the need for good bioethics. However it was bad and sloppy bioethics that failed to prevent their deaths. I have previously argued that it was a mistake to enrol patients with the mild form of the disease Gelsinger was suffering from, rather than babies with the lethal form of disease. It is either because ethics committees do not understand the concept of expected risk or because they prioritise getting consent (their obsession in my experience) over reduction in expected harm

Ellen Roache died because the researchers did not do a systematic review of the literature. I argued with Iain Chalmers and Jennifer Blunt about 5 years before that systematic review of the literature was necessary to prevent harm, that researchers were continuing to repeat placebo controlled studies and harming patients. This was an opportunity for bioethics and ethics committees to do prevent harm and do some good – they failed.

These are just two examples of how the ethics review system fails. Following these deaths, I wrote an Editorial in the JME: Two deaths and two lessons: Is it time to review the structure and function of research ethics committees?

But as I wrote recently, it fails in another way – by obstructing good research. As Sokol acknowledges, huge amounts of bureaucracy and red tape delay research and raise it costs.

I have recently written on the moral imperative to conduct gene editing research. This is yet another example of where bad bioethics threaten to retard important research.

Imagine there is a disease killing 100,000 people per year. For every year a cure is delayed, 100,000 people die. Time in medical research is money, but it is also human life. The massive delays which unnecessary and inefficient ethics review causes costs lives – we just cannot see whose lives. To be sure there are many promising lines of research that have not resulted in lifesaving cures so far, such as stem cell research. But enormous progress has been made in medical research overall, with the saving of millions of lives. While one of line research may lead to a dead end, overall it contributes to knowledge that together does save lives, as Pinker says, millions of lives. Delaying participants in this race literally has life and death consequences.

Has bioethics done more good than harm? Or more accurately, does the harm it has prevented outweigh the harm it has failed to prevent? It is not at all obvious what the answer is in relation to research.

There is one thing I would qualify about Pinker’s critique: we don’t have “ample safeguards for the safety and informed consent of patients and research subjects” because bioethics is frequently focussed on the wrong targets. I recently said in a heavily edited letter to Nature that we have ethics review processes to protect people in any future gene editing research. In principle, that is correct. But as the Gelsinger gene therapy death shows, these processes need to be improved.

The moral imperative for bioethics is to get out of the way when it should get out of the way (even stronger, it has a duty to facilitate and support ethical and beneficial research); but it is also imperative to stand up when it should stand up. The problem is, we often don’t know when. What we need is less obstruction of good and ethical research, as Pinker correctly observes, and more vigilance at picking up unethical research. This requires competent, professional and trained bioethicists and improvement of ethics review processes.

This opinion piece reflects the views of the author, and does not necessarily reflect the position of the Oxford Martin School or the University of Oxford. Any errors or omissions are those of the author.