||The Declaration of Helsinki is a statement of the 'Ethical Principles for Medical Research Involving Human Subjects'. Since 1964 it has been refined in several revisions.
Each country chooses its own approach for putting the principles into practice. In the UK we have a system of local research ethics committees (LRECs) and multicentre research ethics committees (MRECs). These committees are made up of clinicians, statisticians, other researchers, lay people and others (e.g. a legally qualified person, a religious leader). They have to approve the protocols for all clinical trials before they can begin (see page 7).
One of the key principles the research ethics committees consider is the issue of informed consent. This is enshrined in the Helsinki agreement which states that, in clinical research:
|the doctor should obtain the patients freely given informed consent, preferably in writing.