INTRODUCTION

The Human Tissue Act [1] gained Royal Assent on 15 November 2004 and its regulations have been in force since September 2006. It is a complex legal document which has been shrouded in controversy and a degree of confusion since its creation. Countless hours have been spent consulting on and finalising the details of the legislation that regulates comprehensively the storage, removal and use of human tissue from both the living and the dead. The principle issue underpinning the Act is one of patient consent.

Human tissue forms the foundation of pathologists' clinical work, research, audit and education. It must be stressed, however, that pathologists are not the only individuals who will have to work within these new laws; anatomists, transplant clinicians, geneticists and even museum curators are among many others who will need to abide by its rulings. Some of the difficulties encountered in the formation of this legislation stem from the diverse nature of the essential activities performed using human tissues. This is contributed to by the fact that the intricacies of much of this work are little known by those outside the respective fields (Fig. 9.1), and therefore there has been the need for considerable consultation.

The depth of emotion surrounding human tissue should not be underestimated.