The National Institute for Clinical Excellence (NICE) is one of the new government arm's length agencies, and although its history to date is not long, it has been eventful. As an organisation it presents researchers with significant challenges due to its ever-evolving nature. What can be said of its organisational structure and functioning at one moment does not necessarily hold true the next. Consequently we shall here describe NICE first as it was at the time of our data gathering, and then as it is at the time of writing this book.

At the time of our research

The Institute was established as a Special Health Authority and part of the NHS in April 2000, to promote clinical excellence and the effective use of resources in England and Wales. As one of a series of new regulatory bodies, it had arisen in the context of government moves designed to set clear national standards and improve the quality of care in Britain's NHS. Its task was to bring together and review evidence for clinical practice, making recommendations both as to the clinical effectiveness and the cost-effectiveness of particular interventions (DH, 1997). The aim was that healthcare should become more responsive to individual need, more effective in drawing on the best available clinical evidence, and also more economically efficient (DH,1998: para 2.3). Institute assessments should include “impact on quality of life, relief of pain or disability” (NICE, 2000: Annex C: para 10), as well as having regard for the clinical priorities of the NHS.

At the time of this study (2002-04) NICE was engaged in producing guidance in three areas of health:

• • the use of new and existing medicines and treatments within the NHS – technology appraisals;

• • the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales – clinical guidelines;

• • whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use – interventional procedures.

The appraisals programme was supported by three appraisals committees. The guidelines programme was supported by guideline review groups and guideline development groups drawn from seven national collaborating centres. And the interventional procedures programme was also supported by an advisory committee.