Introduction

1.1 Many research projects undertaken in the NHS take place across numerous sites, sometimes clustered together, but often spread widely throughout the country. It is a requirement that all such multi-centre research has an a med “principalinvestigator”, who has the prime ethical responsibility for the project and its implementation throughout the UK. This is the individual who applies to a Research Ethics Committee (REC) for ethical approval of the protocol, which includes the patient information sheet and the proposed arrangements for taking consent.

1.2 For much multi-centre research, especially where a modification of the standard patient treatment is involved (e.g. therapeutic research, clinical trials), there is a clear role for a “local researcher” at each research site. This person takes local responsibility for the research project, and there is thus a need for local scrutiny of the suitability of this individual and the local research facilities.

1.3 This is in direct contrast to some types of non the rapeutic research, where there is no need for a local individual to be formally part of the research team. In some of these cases there is no need for any direct contact with the patient or research subject. In others, further patient contact needs to be made only by the principal investigator or members of the specialist research team, once patient consent is obtained. This is particularly, but not exclusively, the case for much epidemiological and health services research. [Conversely some projects in these disciplines still retain a distinct need for a named local researcher, just as in the case of ther apeutic research, and therefore each project needs to be considered individually].