Sunday, 18 December 2011

NHS research ethics procedures: a modern-day Circumlocution Office

In Little Dorritt, Charles Dickens rails against the stifling effects of bureaucracy:
No public business of any kind could possibly be done at any time without the acquiescence of the Circumlocution Office.… the Circumlocution Office was down upon any ill-advised public servant who was going to do it, or who appeared to be by any surprising accident in remote danger of doing it, with a minute, and a memorandum, and a letter of instructions that extinguished him.
 Substitute “NHS research ethics procedures” for Circumlocution Office, and “researcher” for public servant, and you have a perfect description of a contemporary problem.

December 2010
My programme grant has been running now for over a year, and it’s time to gird up my loins to tackle NHS ethics. I’ve had plenty of other research to keep me busy, but I’m aware that I’ve been putting off this task after earlier aversive experiences. “Come on,” I tell myself, “you deal with unpleasant and bureaucratic tasks regularly - reviewing grants, responding to reviewer comments, completing your tax return. You really just have to treat this in the same way.”
It starts well enough. I track down a website for the Integrated Research Application System IIRAS). I start to have misgivings when it tells me that it’ll take approximately an hour to work through its e-learning training module. To my mind, any web-based form that requires training in its use needs redesigning. But I bite the bullet and work through the training. Not too bad, I think. I can handle this. I start to complete the form. I’m particularly happy to find little buttons associated with each question that explain what they want you to say. A definite improvement, as in the earlier versions you spent a lot of time trying to work out what the questions were getting at. It also cleverly adapts so that it excludes questions that aren’t relevant to your application. This turns out to be a two-edged sword, as I discover some weeks later. But at present I am progressing and in a cheerful mood.
The process is interrupted by need to travel from Australia to UK, Christmas, snow, massive revision to do to address reviewer comments on a paper, etc.

January 2011
Input more information, design information sheets, consent forms, etc, etc. Still feeling buoyant. The form is virtually complete, except for some information from collaborators and bits that need to be completed by Oxford R&D. I realise we want an information video for kids who can’t read, but it’ll need to be approved, but we don’t want to go to all the trouble and expense of making it before getting approval. Discuss with helpful person from Oxford R&D, who suggests I write a script for approval. I also book in the film crew, shortlist and interview candidates for research assistant posts on the project, send draft to all collaborators for approval, and ask geneticist collaborator for help with some details. Am finding that progress is slower and slower, because navigating the form is so difficult: it displays one page at a time and does not scroll. You can specify a question to go to, but it’s not easy to remember which questions correspond to which numbered item, and so you end up repeatedly printing out the whole form and shuffling through a mountain of paper to find the relevant question. Keeping things consistent is a big headache.

February 2011
Two weeks’ holiday, then enter final details that were sent to me by collaborators and send the whole lot off to R&D.
The dynamic form starts to reveal its diabolic properties when I enter a new collaborator from Cardiff, only to find that the form now pops up with a new question, along the lines of “How will you meet the requirements of the Welsh Language Act 1993?”. I won’t. We’re studying language, and all our tests are in English, so only English speakers will be recruited. Explain that, and hope it works out.
But now it gets seriously worse. I’ve entered lots of clinical colleagues as “NHS Sites”, but it turns out they aren’t sites. They are Patient Identification Centres. I have to delete them all from the form. Well, I think, at least that makes life simpler. But it doesn’t. Because now they aren’t sites any more, new questions pop up. Who will do the patient recruitment, and how will we pay for it? This one is a Catch 22. Previously our research assistants have been supervised by a consultant to go through records to find relevant cases. Some places required that you get honorary NHS status, and that could necessitate fulfilling other requirements. I actually had to get vaccinated for tetanus as part of getting an NHS contract some years ago. They said it was in case I got bitten by a child, something that has not happened to me in 35 years of researching. But I digress.  Now, it seems, even a fully vaccinated, child-proofed, police-checked researcher is not allowed to go through medical records to identify cases unless patients have given prior consent. Which, of course, they won’t have, since they don’t know about the study.
“Help!” I say to my lovely clinical colleagues. “What do we do now?”. Well, they have a suggestion. If I can register with something called CLRN, then they can help with patient recruitment. I’m given contact details for a research nurse affiliated with CLRN who soothes my brow and encourages me to go the CLRN route. I have to fill in something called a NIHR CSP Application Form which apparently goes to a body called the “portfolio adoption team” who can decide whether to adopt me and my project. All of these forms want a project start date and duration. I did have early April as notional start date, but that’s beginning to look optimistic.
Late February: comments back from R&D. Have been through application with a fine toothcomb and picked up various things they anticipate won’t be liked by the ethics committee. Impressed with the thoroughness and promptness of the response, and found the people at R&D very helpful over the phone, but my goodness, there is a lot to cope with here:
First, it seems I am still in a muddle about the definition of NHS sites, so have filled in bits wrongly that need to be entered elsewhere. Am also confused about the distinction between an “outcome” and an “outcome measure”.
Then there is the question of whether I need “Site specific forms”. The word “site” is starting to cause autonomic reactions in me. Here’s what I’m told: “Please supply an NHS SSI form for each research site; Please note for Patient Identification Centres (PICs)  R&D approval is required but you do not need an SSI form for these provided no research activity takes place on that site – taking consent to take part in the project is a research activity, giving out information on the study/advertising the study is not considered a research activity.”
I also baulk at the suggestion that I should add to the information sheet: “The University has arrangements in place to provide for harm arising from participation in the study for which the University is the Research Sponsor. NHS indemnity operates in respect of the clinical treatment with which you are provided.”  Since I don’t understand what this means, I doubt my participants will, and the participants aren’t receiving any clinical treatment. Out of curiosity, I paste these two sentences into a readability index website. It gives the passage a Flesch-Kincaid Grade Level of 22, with readability score of 4 (on a scale of 0 to 100, where 100 is easy). I try to keep my information sheets at maximum 8th grade level, so reword the bits I do understand and delete the bits that seem irrelevant or incomprehensible.
I reluctantly went along with the idea that I should devise an “Assent form” for children. This is like a kiddie consent form, but with easier language, to be signed by both child and researcher. They seem to be a blanket requirement these days, regardless of the level of risk posed by research procedures. I dislike the Assent form because I am not sure what purpose it serves, other than to make children nervous about what they are getting themselves into. It has no legal status, and we can’t gather psychological test data from unco-operative children. Others share my view that this requirement is incoherent and wrong. But I want to do this study, so feel I have no choice. I had a look on the web and NHS guidance sites to look at suggested wordings, and did not like them, so did a modified and simplified version I hoped would be approved. It would be interesting to do some research on Assent forms to see how they are perceived by children.

March 2011
Hooray! By the start of March, I’m ready to submit my forms. Since  IRAS is all electronic, I had assumed I would do it with a button press, but that would be too simple. Multiple copies must be sent by snail mail within a specific time frame. There has been serious research on the environmental impact of this. But first there is the question of booking an appointment with an ethics committee. There’s a whole centre devoted to this task, and they have standard questions that they ask you about the nature of the research. I was doing well with these until we got to the question about children. Yes, I was going to do research with children. Ah, well then I couldn’t go to any old ethics committee, I had to go to one with a paediatrician. And, unfortunately, there weren’t any slots on committees in Oxfordshire with paediatricians. But, said the helpful girl on the phone, I could try calling the Oxfordshire people directly and they might be able to book me in. At 12.05 I call the number I’ve been given, only to get an automated message saying the office is only open from 10 to 12. Since the following morning I’m busy (I am trying to do my regular job through all this), despair starts to set in. But I break out of a meeting to call them the next morning. The phone rings. And rings. Back to my meeting. Break out again, repeat experience. Eventually I get through. Person at end of phone takes me through the same list of questions about type of research, and finds a convenient slot with an Oxfordshire committee, which I can make if I move an appointment. Move the appointment. Get called back to say that committee can’t unfortunately take me, because they don’t do proposals with children. Am offered another slot on a day when I have arranged to examine a PhD in London. Next one in Oxford is a month later, well after the proposed start date for the research. Best they can do is to offer me a slot with a Berkshire committee, who do have a paediatrician and are just one hour’s drive away, and which is later than the original slot, but sooner than the Oxford one. I decide to go for it. I then receive a remarkable document with a lot of multicoloured writing, which gives me a booking confirmation number, and a lot of instructions.

This triggers a frantic process because you then have seven days to get all the material delivered to the ethics committee. This may not seem difficult, except that all the information sheets and consent forms need to have little header put on them with the booking number and date, and they also want copies of things like a CV, copies of test forms and suchlike, and worse still, there have to be signatures not just from me but also from R&D, who are in a hospital a couple of miles away up a hill. Unfortunately coincides with a period when my PA is absent, and so I rush around like a demented cockroach getting this all together. I’d not budgeted much time for this bit, as I’d assumed submission would involve pressing a button on my computer and uploading some attachments and my diary was full. Somehow I had to find a couple of hours for fiddling with forms, a trip up the hill for a signature the next day, and a journey to the post office to ensure it would all get delivered on time.
I also needed to get the documents to CLRN. This could be done by email, but that soon bounced back. Once more the critical distinction between sites and centres eluded me, and I was told that I had to submit corrected documents because:
 “In Part C, if the only research site is the University of Oxford and the other organisations listed are Participant Identification Centres (PICs), there should be listed under the heading Participant Identification Centre(PIC)Collaborator/Contact immediately below the University of Oxford entry, and not separately.”
So back to the form again to alter this bit. At last it is accepted. But this now triggers new emails, including one from London saying:
“We have been notified that you may be participating in the above study. If the Chief Investigator or Study Coordinator confirms this, Central and East London CLRN will be supporting you locally through the NIHR CSP process and we look forward to working with you on this project.
If this is confirmed, please email all relevant documents to me when you submit your SSI Form through IRAS. The documents you need to submit are listed on the Checklist tab within your SSI Form in IRAS…..etc etc”
The SSI form was one I thought I didn’t have to complete, so I phoned the number given on the email, who said they couldn’t comment and I should ask Oxford, so I asked Oxford, who agreed I didn’t need to do anything.
Meanwhile, there’s yet another form that has popped up that wants to know what training in ethics the researchers have had. Since I haven’t had formal training, I’m told I can either go on a half-day course, or take an on-line course in five modules, each lasting around 45 minutes. I try the online course, but find most of the material is not relevant to me. It starts with pictures of concentration camp victims to emphasise why people need to be protected from reseachers, then goes on to give information focussed on clinical trials. I’m not doing a clinical trial. The quizzes at the end of each module don’t seem designed to check whether you have mastered the subtleties of ethical reasoning, so much as whether you know your way around the bureaucratic maze that is involved in ethical approval, and in particular whether you understand all the acronyms.

April 2011
The six weeks from early March to mid April were joyfully free from communications with ethics people, and normal life resumed. My new staff took up their posts and we made a start on filming for an information DVD for the project, and decided that we would delay the editing stage until after the Berkshire meeting. The day of the committee meeting dawned sunny and bright and I drove off to Berkshire, where I had a perfectly reasonable chat with the ethics committee about the project for about 15 minutes. The Paediatrician was absent. I explained I wanted to assemble the information video, but was told I had to wait until I received a letter documenting changes they’d want me to make. When this arrived, about a week later, they wanted some minor rewording of one sentence. This would be trivial for a written information sheet, but entailed some refilming and careful editing. In addition, the committee raised a point that had not been discussed when I met with them, namely that they were concerned at a statement we had made saying we would give feedback to parents about their children’s language assessment if we found difficulties that had not previously been detected. This, I was told, was an incentive, and I should “soften” the language. This was seriously baffling, as you either tell someone you’ll give them feedback or you don’t. I could not see how to reword it, and I also felt the concern about incentives was just silly. I sent them a copy of a paper on this topic for good measure.

May 2011
Oh frabjous day! At last I receive a letter giving consent for the study to go ahead. I think my troubles are over, and we swing into action with those parts of the project that don’t involve NHS recruitment. But joy is short-lived. I am only just beginning to understand the multifarious ways in which it is possible to Get Things Wrong when dealing with the Circumlocutions Office. I now start to have communications with the CLRN, who want copies of all documentation (including protocol, consent forms, the information video, etc etc - a total of 15 documents) and then tell me:
“The R&D Signature pages uploaded to the doc store on 27th June 2011 do not marry up with the R&D Form uploaded on 15th March 2011”
Requests for new form-filling also come in from the CCRN Portfolio. I’m getting seriously confused about who all these people are, but complete the form anyway.
And, worst still, in August I get a request from TVCLRN for a copy of  the letter I sent to Berkshire in which I responded to their initial comments. I had written it at a time when my computer was malfunctioning so it’s not with other correspondence. I spend some time looking on other computers for an electronic copy.  It seems that without a copy of this letter, they will not be satisfied. Anyhow, I think this will be simple to sort out, and phone the Berkshire ethics committee to ask if they could please send me a copy of the letter that I had written to them. Amazingly, I’m told that “due to GCP guidelines” the Berkshire ethics committee cannot give me a copy. Stalemate. I can’t actually remember how we dealt with this in the end, as my brain started to succumb to Circumlocution Overload.

The last 6 months
We have a meeting with the clinical geneticists with whom we’re collaborating, and I find that most of them are as confused as I am by the whole process. We discuss the Catch 22 situation whereby we aren’t allowed to help go through files to identify suitable patients because of ethical concerns, which means they have to take time out of their busy schedules to do so. This is where the CLRN is supposed to help, by providing research nurses who can assist, but only if we complete loads more paperwork. And having done this, after months of to-ing and fro-ing with requests for documentation or clarification, one of the CLRN centres has just written this week to say they can’t help us at all because they are a Patient Identification Centre and they need to be a PI, whatever that is. I’m currently trying to unravel what this means, and I think it means that they have to become an NHS Site - which was what I  had originally assumed when I started filling in the forms. But in order for them to do so, there are yet more forms to complete.
Meanwhile, in October, I had a request from the UKCRN saying I needed to upload monthly data on patient recruitment in a specific format, and sending me a 35 page manual explaining how to do this. Fortunately, after several exchanges on email, I was able to establish that we did not need to do this, as the hospitals we were dealing with were Patient Identification Centres rather than Sites. But now we have a PIC that wants to become a Site, who knows what new demands will appear?
And then, this week, a new complication. The geneticists who are referring to our study need to check with a child’s GP that it is appropriate to send them the recruitment materials. But an eagle-eyed administrator spotted that this letter “was not an ethically approved form”. I was surprised at this. This is not a letter to a patient; it is a standard communication between NHS professionals. Nevertheless, my R&D contact confirmed that this letter would need approval, and that I’d have to fill in a form for a “substantial amendment”, which would then need to be approved by all the R&D sites as well as the Berkshire ethics committee.
When I expressed my despair about the process on Twitter, I had some comments from ethicists, one of whom said “If you're doing research on ppl then someone has to look after them, no?” Of course, the answer is “yes”, and in fact the project I’m working on does raise important ethical issues. As another commentator pointed out, the problem is not usually with the ethics procedures, and it is true that the IRAS form is much better  than its predecessor and guides you through issues that you need to think about and offers good advice. But the whole process has got tangled up in bureaucratic legal issues and most of my problems don’t have anything to do with protecting patients and have everything to do with protecting institutions against remote possibilities of litigation.

Concluding thoughts
1. In the summer, I was contacted by a member of the public who was concerned about the way in which a medical project done at Oxford University was being used to promote unproven diagnostic tests and treatment for a serious medical condition. I recommended that my contact should write to the relevant person dealing with ethics in the University. I was sanguine that this would be taken seriously: here was an allegation of serious infringement of ethical standards and all my dealings with our R&D department indicated they were sticklers for correct procedures. A month or so passed; they didn’t reply to the complainant. I was embarrassed by this and so wrote to point out that a serious complaint had gone uninvestigated. After a further delay we both got a bland reply that did not answer the specific questions that had been raised and just reassured us the matter was being investigated. This just confirms my cynicism about the role of our systems in protecting patients. As Thomas Sowell pointed out: You will never understand bureaucracies until you understand that for bureaucrats procedure is everything and outcomes are nothing.” 
2. The current system is deterring people from doing research. The problem is not with the individuals running the system: they’ve mostly been highly professional, helpful and competent, but they are running a modern Circumlocution Office. I’ve interacted with at least 27 people about my proposal, and that’s not counting the Research Ethics Committee members. I’m a few years off retirement and I’ve already decided that I won’t tangle with NHS Ethics again. I’m in the fortunate position that I can do research studies that don’t involve NHS patients, and I want to spend the time remaining to me engaged in the activity I like, rather than chasing pieces of paper so that someone somewhere can file them, or waiting for someone to agree that an innocuous letter from a Consultant to a GP is ethically acceptable.
3. To end on a positive note: I think there is another way. The default assumption seems to be that all researchers are unscrupulous rogues who’ll go off the rails unless continuously monitored. The system should be revamped as a mechanism for training researchers to be aware of ethical issues and helping them deal with difficult issues. For research procedures that are in common use, one can develop standard protocols that document how things should be done to ensure best practice. On this model, a researcher would indicate that their research would follow protocol X and be trusted to do the research in an ethical fashion. The  training would also ensure that researchers would recognise when a study involved ethically complex or controversial aspects that fell outside a protocol, and would be expected to seek advice from the Research Ethics Committee. The training would not revolve around learning acronyms, but would rather challenge people with case studies of ethical dilemmas to ensure that issues such as confidentiality, consent and risk were at the forefront of the researcher’s mind. This is the kind of model we use for people engaged in other activities that could pose risks to others - e.g.,  medical staff, teachers, car-drivers. Life would come to a standstill if every activity they undertook had to be scrutinised and approved. Instead, we train people to perform to a high standard, and then trust them to get on with it. We need to adopt the same approach to researchers if we are not to stifle research activity with human participants.

Further reading
Kielmann T, Tierney A, Porteous R, Huby G, Sheikh A, & Pinnock H (2007). The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study. Journal of the Royal Society of Medicine, 100 (5), 234-8 PMID: 17470931
Knowles, R. L., Bull, C., Wren, C., & Dezateux, C. (2011). Ethics, governance and consent in the UK: implications for research into the longer-term outcomes of congenital heart defects. Archives of Disease in Childhood, 96(1), 14-20.
Robinson, L., Drewery, S., Ellershaw, J., Smith, J., Whittle, S., & Murdoch-Eaton, D. (2007). Research governance: impeding both research and teaching? A survey of impact on undergraduate research opportunities. Medical Education, 41(8), 729-736.
Warlow, C. (2005). Over-regulation of clinical research: a threat to public health. Clinical Medicine, 5(1), 33-38.
Wilkinson, M., & Moore, A. (1997). Inducement in research. Bioethics, 11, 374-389.


  1. Absolutely spot on! I (and everyone I know who has applied) have had virtually the same experience with gaining NHS approvals. I'm lucky in that most of my studies raise no material ethical issues and can go through the recently devised "proportionate review" for ethical approval, which is relatively streamlined. Multi-centre studies with any risks to participants, no matter how minor, are still a nightmare.

    "If you're doing research on ppl then someone has to look after them, no?"

    As you say, the only answer to that tweet is 'yes' but I think that the approval process as it stands is part of a much larger ethical failing when bureaucracy needlessly delays potentially beneficial research - or worse, when the process puts researchers off from applying completely.

    Funnily enough, I was writing a protocol for ethical approval when I found your post. I'm sending this one to my university's ethical committee. Bet you can't guess why...

  2. I wonder how many people have decided not to pursue research involving NHS patients? My guess would be more than 25% of active researchers, hearing others' views. Sad.

    1. I'm in the middle of the ethics process for my MSc thesis project. In September the University advised us NOT to go down the NHS ethics route as it was "just too complex and time consuming". Being a stubborn mare, I decided that it would indeed be worthwhile to use clinical patients rather than boring old healthies! Since my supervisor has only been resident in the UK for three months I've had to go it alone (attending the hearing alone too, but that's another matter). I'm very much looking forward to the approval letter arriving through my letterbox. I can't help thinking that it's wrong to feel that I've nearly 'beaten the system', rather than reflecting on how much I've learned by working my way through the process.

  3. I know of at least one good scientist who left the UK to do her research abroad purely because NHS ethics made it impossible for her to do any work here. It is a big drain on UK science.

  4. We submitted an NHS application for a PhD project last year. What a mistake that was. I simply cannot believe the amount of time that has been wasted and like you, will not be conducting projects needing NHS ethics any time soon.

  5. I am a post-doc who has been tied up in ethics/contract negotiations, also since Jan. 2011. I am STILL trying to get a contract negotiated so I can start my research, and now have only 9 months of funding left to complete a project that was originally planned for two years. I won't bore you with the details, but suffice to say it has been a massive waste of time, and public money.

    A couple of points:
    1. Agreed that the online IRAS form actually appears to be reasonably well implemented, however it's insane that the 'Proceed to Submission' tab on the system just contains some instructions for how to print out the form and send it by post. For God's sake - is this 1995?

    2. Your final suggestion about how the system could be changed is excellent, however I feel that once a bureaucracy is in place it generates a certain amount of inertia and resistance to change. A lot of the work of the circumlocution office appears to be involved with justifying the existence of the circumlocution office!

    3. I think it's important to note the very real effects this system has on the way that public finance is spent (or wasted) and the wider effects on the UK economy. I have been reliably informed that one of the major reasons that (for instance) major pharmaceutical companies have been pulling out of the UK in recent years (e.g. GSK and Pfizer both closing major labs) and heading for the Far East is because the regulatory environment in the UK makes their work much more difficult and expensive to perform here.

  6. Thanks for the piece, and I can identify with the frustration. After my experience with NHS ethics I'm going to do everything possible to avoid going down this route, which will inevitably have implications for the type of children I study.

    In my experience, there are two components of the system, the ethical approval process, which is relatively straightforward, and the research governance process, which is a bureaucratic nightmare, and it is the latter which takes up all the time. Part of the difficulty is that it's a balkanised system with different regulations and organisational structures in different parts of the country. That said, many of the individuals working in the NHS are fantastically helpful, and do their best to guide you through the system.

    I'd like to think that your blog posting will generate a momentum for change, but if the large pharmaceutical companies cannot use their considerable heft to do so, I'm not sure if we minnows stand a chance.

  7. To add to your references:
    Will C. van den Hoonaard, _The Seduction of Ethics: Transforming the Social Sciences_ (Toronto: University of Toronto Press, 2011).

  8. Thank you for a consoling article. I work on a Clinical Psychology doctoral course. Our trainees generally want to undertake a clinical project for their thesis, and I have supervised two going through the IRAS process. Both were hellish, and were unable to start their research in time to allow a decent recruitment period. In one study all the work we put in together was rather wasted because the sample size was not large enough. The patients who did participate may as well not have bothered. The ongoing project may suffer the same way, certainly we don't have time to get the follow up data that was originally planned.

    The problem with bureaucracies like this is that they mushroom and soon a whole industry is created full of people whose jobs it is to run them. These people are experts only in the bureaucracy and they are motivated to adhere to it and encourage more of it. To me it feels sinister and has completely put me off doing patient research unless it was for a very large study. The process is designed to accommodate big pharmaceutical studies and seems appropriate for them, but as David Colquhoun pointed out, its over-application is actually unethical because it is hindering good exploratory research.

  9. Thanks for sharing and for making me feel that I am not the only one in the world who had the same struggles with NHS ethics.

    When I decided to come over to UK to do my PhD I could never imagine I would come across with such system. In my case the NHS approval took me 14 months! - since the first day we tracked down a website for the IRAS. I got in a point that I thought I would have no time to proceed with my studies.

    Glad it is over!! And that I do not have to go through this way again!!

  10. And today, another communication re ethics. Somebody somewhere received a form that DID NOT HAVE A VERSION NUMBER on it.

  11. Charlie Wilson @crewilson20 December 2011 15:18

    In case it makes you feel better (I'm not sure it will), it seems to be even worse in France. And similar procedures apply to research outside of clinical settings. In theory any research testing normal human subjects on normal stuff (I want some people to learn a few sequences for half an hour), now requires a medical doctor as the PI on the project even before you start ethical review...

    Think I might stick to small furry participants. At least they don't have much history of bringing lawsuits...

  12. This sounds spookily familiar, I'm wondering if I actually wrote it?

    No. I know it's not mine as I have also recently had to change sites from an NHS site to a non-NHS site....warning, never, ever, ever do that if it can be avoided. Almost a year and a half later I finally have approval, shame I need to start writing for my next grant now.

    I have decided it must all be part of a secret plan to weed out all those researchers that don't have a true passion to work with patients.......everyone else would quit after the first 6 months and stick to the healthies.

  13. It's the usual gold-plating by UK bureaucracy of unnecessary and unwanted EU directives.

  14. This all sounds very familiar. The same spirit of procedural box ticking has pervaded my every encounter with NHS ethics, particularly the local variety.

    Thomas Sowell's quote particularly resonates as "the system" clearly disregards any logically desirable outcome in favour of endless rounds of forms that all seem to ask the same questions over and over again.

    To cement this view, at a recent committee meeting we had only minor comments on any aspects of study design, but the application was rejected (for resubmission) due to sub-departments having failed to communicate with each other, and us, about what order applications should be filed in.

    Now 4 months in to the ethics process (my second encounter in the last 2 years) and progressively losing the will to continue a career in UK science. I will likely have to move abroad to continue doing the research I love solely because of the incredible bureaucracy surrounding UK science.

    I know several postdocs on 2-year contracts who have spent a full year just dealing with ethical authorisations. This is clearly an incredible waste of taxpayer resources and it is literally career destroying as those people are unable to publish papers before applying for another job.

    Your last paragraph entirely matches my opinion. Educating researchers in ethical principles, perhaps with some random spot checks by a small government body, would offer the same protection to study participants as they presently enjoy, while making the system work for researchers as well.

    The safety record of research in the UK is exemplary, taking part in a research study is probably one of the safest activities known to humankind. Yet, instead of spending 10-12 hours a day doing science, which I find quite enjoyable, I am spending a good chunk of my time filling out forms for months at a time, for studies with virtually no possible risk to anyone (we are currently negotiating whether fruit juice should be treated as an "Investigational Medicinal Product").

    If this doesn't change, one of the UK's most profound strengths will evaporate within less than a decade. Human studies are becoming nigh impossible to initiate with the small resources available to academia. More and more researchers involved in working with people will have to move abroad to remain competitive internationally in terms of publication records.

  15. NHS Ethics (plus the R&D process) has now become counter-productive. I am currently CI and grant holder for a 1 year funded study. I'm recruiting participants via the 3rd sector but also need NHS ethics/R&D for additional recruitment. I've successfully navigated this process several times (ditto my co-applicant) but it's taken my 5 months to get to the R&D phase and I'm still awaiting approval.

    Research governance is laudable but it's killing research in the UK. Several of my friends sit on NHS ethics committees and they inform me that in the last 12-18 months, applications for REC review have dropped off significantly. It's hardly surprising

  16. I'm so glad you have written this article! I have gone through this process three times in the past 8 months. Each time it gets easier but each time a new hurdles appear, which are extremely nebulous to circumnavigate. Everyone says different things and passes you on to someone else. There is no central resrource for information on the process. I think your suggestions are very good but how will these be executed? Should we start a forum for researchers to share tips about their experiences?