How Much Regulation is Desirable in Clinical Practice?

Abstract

Is regulation of clinical research necessary at all? Some regulation probably is necessary and should have three aims. The first is the obvious one of ensuring so far as possible the safety of the volunteers or patients. The second, which is not quite so obvious and does not always receive the same attention, is to maximise the scientific returns from the research, to make sure the hypotheses being tested are the important ones and that the methods used to test them are the best available. The third is the most powerful reason for the first two; since the subjects of research are from the general population and the money for research comes from the taxpayers, it is essential that citizens should be convinced that safety and good standards of scientific work are being observed. That is why regulation takes place.