Introduction
Patients within a health system, such as the NHS, might interact with health professionals in a number of different ways. The obvious one is that they are patients in receipt of medical treatment. Another regularly occurring context is that of medical research. In this setting, the person participating in the research might either be a patient (and the research is usually into the condition from which the patient suffers) or she might be a healthy volunteer. In any case, where the aim of the exercise is not primarily to improve an individual’s health condition, different rules apply. A borderline case is that of experimental treatment being provided to patients, where the treatment is not proven, but the doctor may feel that it could be of benefit. We outline the different types of treatment and experiments here.
What is research? Research versus experimental treatment
It is more difficult than it initially appears to get a clear definition of what is meant by research. Indeed, the concept of research must be distinguished from experimental and innovative treatments, and indeed from ‘treatment’ in general terms. A simple definition is provided by the General Medical Council, who state that research refers to:
an attempt to derive generalisable new knowledge. Research aims to find out what is best practice by addressing clearly defined questions with systematic and rigorous methods. It includes studies that aim to generate hypotheses as well as those that aim to test them.
The guidance makes it clear that this might involve and cover both research with human participants as well as records-based research, or research using donated human tissue. Moreover, the definition of research also covers clinical trials. This, according to the GMC, encompasses a wide range of investigations and, for example:
they can test medicines or vaccines, treatments, surgical procedures, devices, or health prevention or care. A clinical trial of investigational medicinal products is a particular type of trial that is governed by legislation.