Is this the end of part-time clinical research?

Sir, Research by NHS consultants and their juniors has been a tradition of the Health Service since its inception. It has amused the participants and added to the data available. It has been regarded as meritorious both by appointments committees and the merit award system. I now feel that our ability to perform this research is under serious threat from all angles such that it may become impractical. I write as a full-time NHS consultant who has averaged three original papers a year in refereed journals since my first publication in 1985. Once upon a time you only applied for ethical approval if you were intervening in a patient's care, or you had ethical issues that you perceived and wanted a ruling on. Not so now. Now it is considered unethical not to have ethical approval. On one occasion I was told that I had ethical approval provided the study did not start before June. What can you think of that is unethical in May, but not in June? Sadly anyone who has had dealings with ethical committees will have similar stories. The solution to me would be to pass the researcher as ethical, rather than individual projects, and answer ethical queries from ethical researchers. I have never done anything questionably unethical without ethical approval. The ethics committee also comments on the science of projects. While I would agree that it is not ethical to do a bad study, the ethics committee is rarely competent to judge the science. If you as a researcher have evolved the methodology for a study, persuaded other people to help with the study and maybe even found funding for it then that should do. We have in the past had arguments with ethics committees over methodology, but you know it is easier to agree and so you change to their method even though you believe your method to be better. Maybe that is unethical. Why can’t they state that the science is not part of their remit? Apparently there is worse to come from the EEC. I can’t bear to look. Consent is another issue close to the heart of the ethics committee. The new form has five boxes that have to be ticked and signed for consent. What use is consenting to part of a study? You either follow the protocol or you don’t. There are rumours that our ‘pathology meetings’, where we review histology and try to learn from it, may have to be cancelled because consent was only given for diagnostic purposes not for teaching. Perhaps we will have to promise not to learn anything from a consultation as the patient has only consented to diagnosis and treatment! How much potentially useful research tissue ends up in a bucket because of issues of consent? What is the price to the patient of this research not being done? Trust R&D is another layer of bureaucracy added in the last few years. The trust must not be denied their pound of flesh. Trusts seem to have a view that lots of NHS money is being used for studies. I don’t see it from where I am. Overheads gradually escalate, but they will have to be very careful not to kill the golden goose. I would gladly do a study for 30% of the take and no costs. To be fair our R&D do try and be helpful. Not so trust finance. This is yet another layer that has been imposed on us. They take information that we have given them about how many patients may be recruited, to a study that may take place, and how much time we will spend on it and then tell us whether the study is financially viable. If it isn’t and we still want to do it then presumably we gave them the wrong information. Worse, they want us to have a year's salaries for the nurses in advance before we start. Dream on. How would you get started now? The change in structure of commercial studies has also made things difficult. Five years ago we could recruit 25 patients to one study. Now we recruit 25 patients to five studies. That is five times the set-up work, which is unpaid. The reason for this is that the companies are running tighter time-lines and to make sure they finish the study they recruit more centres. If there is any hold up locally in the above then time for recruitment is reduced. Our current record is being set up on the Wednesday and closed down on the Friday! The other major factor is the counties of eastern Europe, where recruitment seems easier. The number of people you need to do a study has also increased. Our record is five: the doctor/recruiter; the organizing nurse; the blinded joint assessor; the unblinded preparer of the infusion and the unblinded doctor to look at the results and make sure it is safe to continue. Of course, if you are good at recruiting then you will also have the pleasure of entertaining a company auditor, occupying you and the nurses for an afternoon with no advantage to you or the research fund. The monitors are also never away now. There was a time when even the SHOs would do a small research study during their 6-month attachment. Not so now with the reduction in hours and attitude. Even the registrars seem unable to research unless it is full time. Part of this is down to the universities. No longer can you just appear with your life's work and ask for it to be examined. Oh no, you need to register, at great expense, and then stick to the timetable. I know of several good theses that have been completed several years after they were started, and I collected the data for my MD one afternoon and one evening a week over a 4-yr period. They often also expect you to do taught modules that in my experience detract from the collection of data. Then there is the new consultant contract: counting hours and being paid for patient contact it seems unlikely that the trust will want you to spend much time researching. I therefore conclude that I couldn’t do the research I have done if I was starting now. So does it matter? It is fair to say that none of my papers have changed the world. They have, however, improved my understanding of a lot of things and may even have influenced one or two other people. If studies are only done by professional paid-for researchers then only one angle will be represented, i.e. the need to publish and get the next grant. Someone with a different, or no, axe to grind could be a useful counterweight in any situation. Some research will not be done or will be delayed. What will be the consequences to patients of the results not being there? The ability to ask questions about relevant clinical problems that present on a daily basis to clinicians is, I believe, the duty and right of an NHS consultant. If it becomes impossible then job satisfaction and job performance will suffer and future advances will be slower or unrecognized. The author has declared no conflicts of interest.