All medical trials are run in accordance with European legislation and two government bodies must first approve all trials before any clinical procedures may commence. The two government bodies are the MHRA (Medicines and Healthcare Products Regulatory Agency) and a government authorised Research Ethics Committee.
In order to give approval for the medical trial to go ahead the MHRA experts will assess all applications for new medicines to ensure that they been tested to the required standards, and the Research Ethics Committee have specially trained members in research ethics and often have the sort of experience which will be useful in scrutinizing the ethical aspects of a research proposal.
Members of a Research Ethics Committee will often include patients, members of the public, nurses, GPs, hospital doctors, statisticians, pharmacists and academics, as well as people with specific ethical expertise gained through a legal, philosophical or theological background. The patients and members of the public play a key role, not least in helping to ensure that any information seen by the volunteers is clearly written and can be readily understood.
The PAREXEL Clinical Pharmacology Research Unit works fully in accordance with ICH Good Clinical Practice (GCP), which is an international ethical and scientific quality standard for the conduct of trials.