School of Life Sciences

Working with human tissue

Introduction

The Human Tissue Authority (HTA) was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004 (HT Act). The HT Act covers England, Wales and Northern Ireland and came into force on 1 September 2006. 

The University of Sussex currently holds one licence (number 12119), this licence covers the storage of human tissue for research purposes under the Act. 

The University of Sussex HTA management policy is to ensure compliance with the Human Tissue Act and with the standards and guidance set by the Human Tissue Authority.   The level of quality required is achieved through adoption of a system of procedures that reflect the regulatory standards and guidelines and the documents contained within this webpage form the Quality Management System for the School of Life Sciences

All staff who work with human tissue are involved in achieving compliance to these procedures and are individually responsible for the quality of their work and should result in a continually improving working environment for all.

The Designated Individual retains responsibility for the Quality Management System with routine operation controlled by the individual PI/CI or PD.

The objectives of the Quality Management System are:

a)         To maintain an effective Quality System complying with the Human Tissue Act and the standards and guidance issued by the Human Tissue Authority.

b)        To ensure compliance with relevant statutory and safety requirements.

c)         To achieve and maintain a level of quality which enhances the University's reputation with stakeholders

Code of Practice Life Sciences

Relevant Materials Table 

Organisational Structure

SOPs of Licenced Activities

SOP 1 Flow Chart 

SOP 2 Risk Assessment

SOP 3 Consenting Patients

SOP 4 Consenting Healthy Subjects

SOP 5 Transport of Human Tissue 

SOP 6 Security and Storage

SOP 7 Material Transfer

SOP 7 Appdx A 
SOP 7 Appdx B 
SOP 7 Appdx C 
SOP 7 Appdx D 

SOP 8 Record Keeping

SOP 9 Adverse Events

SOP 9a Adverse Event Blank Report

SOP 10 Equipment Use and Maintainance 

SOP 11 Withdrawal of Consent 

SOP 12 Disposal of Human Tissue 

SOP 13 Audit 

SOP 14 Change Control

SOP 15 Complaints

SOP 16 Stores Document - Receiving & Sending of Human Tissue

SOP 17 GNOM Biopsies - practical procedures

HTA blank risk assessment form

HTA Risk Assessment 01 - Transport of Human Tissue

HTA Risk Assessment 02 - Storage of Human Tissue

HTA Risk Assessment 03 - Incorrect procurement of samples

HTA Risk Assessment 04 - Loss of donor confidentiality

HTA Risk Assessment 05 - Loss of Traceability & Inappropriate Disposal

HTA Risk Assessment 06 - Safety of Personnel

HTA Risk Assessment 07 Unauthorised Access to Tissue Samples