What regulatory systems do not do
Download a pdf of What regulatory systems do not doAlthough regulatory systems for research impose onerous requirements on researchers before studies start, there are many things they conspicuously fail to do, or do not do well.
Many systems do not do enough to ensure that proposed studies are actually needed – for example, they do not require researchers to demonstrate that they have undertaken a thorough review of the existing evidence before embarking on new studies.
Moreover, most of the effort in regulating research is at the start-up stage, with the emphasis on controlling the entry of participants to studies. But there is surprisingly little effort devoted to monitoring studies once they are running, and to ensuring that researchers publish reports promptly at the end of their work (or even at all), stating how their findings have reduced uncertainty.
“If ethicists and others want something to criticise in clinical trials, they should look at scientifically inadequate work, reinvention of wheels, and above all, unjustifiable exclusions and unjust and irrational uses of resources.”
There is a growing realization that testing treatments is everybody’s business. As patients and the public take up the opportunities now being offered to become involved in planning and conducting research, they are likely to have an increasing voice in ensuring that regulatory obstacles are addressed.