1. The best is the enemy of the good – any basically good idea must be pursued ab absurdam

2. Once there is a body of people responsible for executing a basically good idea, they will keep themselves in a job even at the expense of actually undermining the job they are supposed to be doing (see also the Resuscitation Council – raison d’etre = to create simple protocols so that everyone knows what to do in an emergency. Actual operating procedure = make continuous clinically irrelevant changes with the protocols till no one knows what to do)

What I don’t like is doctors taking their pet theory on how a therapy might work and trying it out on a guinea pig patient, and then writing it up as a ‘case report’. This is sheer misrepresentation – they need to be honest and admit when they are experimenting.

I’m horrified by the implication in the thread that we could abandon using ethics committees. Looking at some of the badly designed and ethically suspect research that still gets submitted to journals, plenty of institutions could do with tightening up their processes, not loosening them.

People seem to think it is easy to work out what research is ethical and what isn’t. Where harm might be caused, and where it won’t be. It isn’t that simple. Researchers will often be too deep into the project to be aware of the risks (unable to see the wood for the trees, as noted above). Take the example of a ‘simple questionnaire’. If this questionnaire happens to include questions about childhood sexual abuse, is it still simple?

There are many other initiatives NRES has underway which are designed to facilitate and promote ethical research and cut down the bureaucracy for researchers, yet also protect the safety, dignity and wellbeing of research participants. The recently launched Integrated Research Application System (IRAS) is a good example of this. Rather than having to complete a number of separate application forms for the various review bodies, researchers can now enter their information once – in IRAS (www.myresearchproject.org.uk)

If you would like to find out more about other initiatives NRES has underway, we would be more than happy to update you fully.
Jane Thompson
Communications Lead
National Research Ethics Service

“Ethical review boards can and do prevent harm coming to patients”.

Sure there are examples of this happening – but can you prove that that statement is true in the overall (net) case?

Do they do more good than harm?

Who speaks for the people who would have benefited from the outcome of trials which did not go ahead? Or the people who were harmed because the trial was delayed by the bureaucratic process?

Your social science exchange with Wonko interests me. And the pragmatic points earlier.

Once you have “human institutions” involved in the process, beyond the basic objective empiricism of the research itself, human values involved in their psychology and decision-making come into play.

Like Wonko, I’d have suspected from earlier encounters that you might not have been sympathetic to this view.

My agenda in pointing it out is that it is quite simply better to recognise this value-laden issue and ensure such “human nature” is taken into account transparently, and independently of the science itself, rather than somehow denying it and allowing it to distort the picture science ends up with.

Ian

A REC is required to return an opinion within 60 days of receipt of the application. Their SOPs stipulate six (not 21) copies of a protocol, though many waive this.

Where a REC requires (not demands) changes, it will be where a researcher has overlooked some salient point relating to the welfare of their study participants or indeed the law of the land. REC committees also offer researchers a great deal of informal advice from a huge range of professional skill sets – for free

The recent launch of IRAS has eliminated a great deal of duplicate form-filling and constant efforts are underway to further streamline the process.

No one likes to be told what to do, Ben, but grow up over this issue.

I’m not saying the trials themselves should be standardised….as a good trial has internal consistancy anyway.

It was the gross inefficiency of the multi approvals boards i was getting at.

So of course I have an objection to your stroke study. Although you, as the designer of the study, may be indifferent about the treatment options, the many clinicians who will be asked to implement your study (involving every new stroke patient in the UK for a week) may not be. Some of those clinicians will therefore be treating their patients in ways that, in their view, are not best for their patients. They will be doing so for research and not clinical reasons, and with a population in which the ability to provide informed consent may be not just impaired but difficult even to determine, on a case-by-case basis. If this kind of study
doesn’t require review, then why review anything?

And I’m much less optimistic about how much can be accomplished in a few years of massive clinical studies, although if there really were exactly two universal stroke treatments about which all clinicians were perfectly indifferent, I guess I would concede the point.

An interesting piece, but i wonder if some of the overzealous application of ethical review isn’t as a result of medical snafus of the past (aided by some just slightly sensationalist reporting…). Dare i mention Alder Hey ? I have been involved in applications to ethical review boards to access human tissue for research. And it’s long winded, sometimes arbitrary, and a pain. However, the public have a right to some protection from well meaning medics (or scientists, including me!), who may not see the wood for the trees (and who may have cream cheese for brains). Yes, there will be cock-ups and some crazy rules, but would it be reasonable to scrap the system and say anything goes ?

www.badscience.net/?p=487

It costs £500m to bring a drug to market. Much of that is spent on randomised trials. We have made these trials so spectacularly complicated and expensive that they are beyond the reach of governments, academia, and even small companies: only huge international pharmaceutical corporations can afford to run drugs trials now, and so corporations are in complete control of the information. This is bad, as the problems with Vioxx, SSRI’s, and other drugs have shown.

We could whinge about that: or, while they’re all on holiday in Provence with their au pairs, we could castrate the ethics committees, on the grounds – ironically – that they do more harm than good. Imagine there are two drugs called Sixofone and Halfadozen. Nobody knows which one is better for treating Sickitis. The drug companies periodically do trials, but funnily their own drug always seems to come out the best.

In our clinic, the doctor sees 200 patients in a month with Sickitis. If she gives Sixofone or Halfadozen to her patients entirely at random, on a whim, as a reflection of her own indecisiveness, then the regulation is the same as for any prescription: give reasonable verbal information about risks and benefits, thus obtaining informed consent, and so on.

But let’s say the same doctor, in a spirit of enquiry, recognises that there is massive clinical uncertainty – nobody knows which of these drugs is better after all – and she wants to test her hunches, rather than simply act on them: then she’s in trouble.
She could run a speculative little trial, giving 100 patients Sixofone, and compare them with the others on Halfadozen; but she’d be struck off, unless she went through so much red tape that the idea becomes entirely unmanageable. After passing through the endless obstructive and bureaucratic hoops of the ethics committees, from each and every patient she would need to obtain elaborate written consent, and give huge amounts of information.

Remember, nobody knows which is best, and if she wanted to hand over the same drugs, entirely at whim, outside of her “trial”, there’d be no problem. This is a huge double standard, and it costs us knowledge.

If we ever had a scientist in charge of health, instead of tinkering with payments to big pharma, they would do one simple thing: move hell and high water to collect and collate the best and cheapest evidence on healthcare. First you would give huge amounts of money to the Cochrane Collaboration, which collects and collates data independently on all healthcare interventions (and is quietly one of the most subversive organisations ever to be created, because it blows the lid on false commercial claims). Doctors waste money by irrational prescribing decisions, so give them clean, clear, accessible information, and that will stop.

But more than that, we are in a unique position to generate data: we have inherited an extraordinary information resource, in this vast monolith of the NHS. Nobody knows what the best treatment for stroke is, but if we randomised every single new stroke patient in the UK, over one week, into a rough trial, we’d have our answers in a couple of years.

If you have an ethical objection to that, it better be more important than finding out what is best for stroke victims, because the entire health service is like the clinic I described above. Where there is uncertainty, the patients, and their data, are unique national assets: if we can find a way to use them, systematically, efficiently, ethically, as a resource for research and information, then it wouldn’t matter about Big Pharma’s power any more. But as long as knowledge is expensive, multinational corporations will perpetuate their stranglehold on it, and we will be beholden unto them. It’s just an idea for your cornflakes.

The end winners in this have to be Big Pharma, who can afford the costs of complying with whatever obstacles an ethics committee chooses to throw in front of them.

tinyurl.com/22bjx5

And
www.bmj.com/cgi/content/full/328/7432/121

> APA members, trained, clinical professionals on their register, who have signed up to their codes of practise, now participate in these activities.

I’m not necessarily condoning their actions (anyone interested in my own inconclusive opinion on the above film can read it here), but I’m not sure how the ethical codes of conduct come into it. Doctors, who have taken the Hippocratic Oath, have been known to join the armed forces in times of war and shoot enemy soldiers dead. There are plenty of valid reasons to condemn them for doing so — opposing the war in question, for instance, or opposing their unit’s tactics — but I don’t think the fact that they’re doing something to enemy soldiers that they wouldn’t be allowed to do to their patients is one of them. The context matters.

There is still a requirement for inpedendent ehtical approval for each centre in most cases. Where the trials are multinational, this is probably understandable. For national trials this can be inefficient and frustrating. In the UK it is compounded by the fact that there are effectively 4 autonomous health services, and that by the fact that Scotland has a different legal system.

I’m fairly sure that having just one to cover the whole country would be a much more economical way to do these things.

As well as reducing the number of people working on them it would also mean that they could better track all the research being undertaken in each area.

For example 2 different researchers in seperate locations looking into the same thing could be put in touch with each other with a view to sharing data or methodology.

Benefits could include things like each study getting twice the sample size.

Also the amout of work for the researchers would be cut down as there would only be one process to follow even for multi-centre studies.

and as an added benefit it might save a couple of small forests worth of paper.