RTFM

One of the various roles I fulfil is sitting on a research ethics committee. For those unfamiliar with the system, all medical research involving human subjects needs to be reviewed and approved by a research ethics committee before it can take place. We make sure that subjects are not put at unnecessary risk and are properly informed about what they are letting themselves in for.

I've just been reviewing the applications for my next committee meeting. It's pretty depressing stuff. The quality of the research proposals is, with a few admirable exceptions, extremely poor. Some examples of the things I've just been looking through:

• One study proudly proclaimed "this is an observational study", despite saying on the next page that the reseach subjects would be randomised to various interventions that were not clinically indicated. They clearly didn't have a clue what "observational study" actually means.
• Another study, which was to be done in children, included an information sheet which needed to be comprehensible to children aged as young as 6 years. The researchers clearly thought that by taking the adult information sheet, putting a picture at the top, printing it in comic sans font, and making some extremely minor edits, it would magically be comprehensible to the average 6-year-old. It won't.
• One application described some exciting and sophisticated statistical methods in the section on the overall description of the study. I was quite looking forward to reading about these methods in more detail in the statistical methods section of the application. Trouble is, the methods described there were completely different to the ones mentioned previously.
• Most of the applications had not had their statistical methods section looked at by a statistician, and it really shows. Analyses are either not described or are simply the wrong analyses for the data.

Now perhaps I'm spoiled, in that most of the research I am involved in for my day job is funded by pharmaceutical companies, who for the most part have the budgets and skilled personnel to make sure clinical research studies are done to a high standard. Academic research doesn't usually have as much money to spend on getting expert advice.

Is that an excuse? I don't think so. A lot of the reseach we see (and most of the applications I describe above and countless similar ones will get approved) are unlikely to discover anything useful. It would be far better if fewer studies of better quality were done, in my opinion. If fewer studies were done, perhaps there would be more budget available for engaging the services of statisticians, training researchers in research methods, and having protocols written by people who understand how to write a protocol.

But there's something else I find deeply worrying here. Many researchers completely fail to fill in the application forms correctly. Researchers have been known to complain that the system for ethics review is too complex. Sorry, but I disagree. There are very clear instructions for completing the ethics application form available with the form. Researchers clearly don't bother to read them. One obvious example is when a part of the form states "Please make sure this is written in language easily understood by a lay person. Do not simply reproduce the protocol." More researchers than not simply copy and paste large chunks of the protocol into that section. Similar examples of complete disregard for perfectly clear instructions are widespread.

Does it matter? Well, clinical research is all about attention to detail. If a researcher can't be bothered to read the instructions on the ethics application form, what does that say about their attitude? Would you want someone like that experimenting on you? I wouldn't want want them experimenting on me.

Applying for ethics approval is not difficult. You just have to read the manual.