Healthy Volunteering and Phase I Clinical Drug Trials in the UK

This chapter introduces the rationale, context, and main themes of the book. It explores what clinical drug trials are and why a sociological analysis of human involvement is important. It provides a context of human involvement in clinical drug trials; this includes a discussion on the history of human involvement and interrogation of the volunteer as a concept. This chapter charts the changes to regulatory frameworks and how they brought about the shift from the use of captive populations to ‘volunteers’ capable of rational consent. It also includes a discussion on the commercial contexts in which clinical drug trials take place today.