If you ever were involved in research on human subjects or animals, you know about the giant hurdle you have to jump. While funding, performing the experiments, evaluating the data and publication might be difficult and time consuming, the greatest barrier to research usually is to get your study past the local ethics board (and in case of a multi-centre trial past all of the ethics boards involved).
The reasons, why these ethics boards were installed are noble and worthwhile -never again should scientist be able to perform unethical experiments on humans as it had happened in the German concentration camps or the Japanese prison camps. Therefore experiments have to be useful, be performed on consenting adults and must not harm the participants. If you want to transgress these boundaries (e.g. experiment on children on patients with dementia) you have to take additional measures (and fill in a lot of additional forms), IF you get permission to perform your experiments at all.
Everybody can see the good intentions, so where is the problem?
First of all, it requires a lot of work to fill in all these forms, print them out (once if you’re lucky, 12 to 20 times if not) bring them to the ethics board on the specified date and reply to all additional requests (“the date in the patient information sheet differs from the one given on the consent form – please correct your forms and send us the corrected versions in 12 copies”). All this work has to be repeated for each study: So if your study involved a harmless procedure (e.g. taking the blood pressure or an MRI scan) in one group of patient, and you want to make a second study in a slightly different disease, you usually have to start all over again. Therefore young researchers often spend several weeks each year just with these forms and the ethics board instead of doing actual research.
Second, the ethics board takes it’s time to evaluate all the applications – a delay of 6 month is not unusual. So if you have a new treatment that might save 100 lives each year (let’s say a new antibiotic), the additional delay from the ethics board might cause 50 unnecessary deaths. Of course these 50 deaths will not appear in any statistic (as usual, the problem is not on the seen, but on the unseen side of the coin). So ask yourself: when did you last hear of a researcher that killed 50 participants (when one volunteer in a gene therapy trial dies, this makes worldwide headlines)? and how many people are we killing each year just to prevent these visible deaths?
In addition, many trials will never be performed, just to avoid these problems. This is the reason, why almost no medication is tried on children or pregnant women. Of course we avoid dead children in a drug trial. But pediatricians are giving medications to children based on anecdotal evidence, which were only tested in adults. And children are often receiving medications that have been in use for decades, instead of newer and possibly better treatments, as the latter were not tried out by desperate pediatricians yet and no anecdotal evidence is available. So ethical limitations on trials might protect many children from researchers, but it will inevitably harm children as well.
While nobody can really calculate the net effect, I have the (non evidence based) feeling, that the net negative effects are greater than the benefits. If you want to read more about it, have a look at Michael Brooks excellent book “free radicals”, where he shows many medical breakthroughs (e.g. cardiac catheters) that involved overstepping the boundaries and working outside the regulatory framework. And many famous studies, like the Milgram experiment would not pass todays ethics committees – or if they do, it is in a watered down format, where the experiment is stopped before the critical phase (“would they still be willing to kill somebody on a simple order?”).
So maybe we should start to discuss again how to prevent unethical research – and how we prevent unethical prevention of research by the ethics committee.