Study Initiation and Management: Collection and storage of tissues

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Introduction

If collecting new tissue samples from patients or healthy volunteers, or using samples that are surplus to clinical requirements, systems should be in place to manage the collection, storage and consent process (see Should Consent be sought?). These need effective communication, in particular with the following parties (where applicable):

  • Medical/healthcare staff, for example, operating theatre staff, to ensure that only consented samples are taken and used for research
  • NHS departments, e.g. Pathology, to ensure that only samples surplus to requirements are used for research
  • Other members of the research team, to ensure that the risk of sample mix-up during coding is minimised, and that samples are processed and stored in accordance with the research protocol

Further guidance on the use of samples that are surplus to clinical requirements, such as diagnostic samples/pathology archives, is available in Section 6 of the 1st resource below.

Guidance on maximising use and the quality management of established collections of tissue is available in Section 5 of the 1st resource below.

If wishing to use established collections of tissue for research (including diagnostic samples/pathology archives), a flowchart has been developed to help with these decisions (Annex 3 in the 1st resource below). Having a documented agreed set of standards to follow with the provider of any tissues is a good way to manage the responsibilities of both parties. For more information on these standards please visit Transfer of Data/Tissues.

If tissues are being stored for research purposes in England, Wales or Northern Ireland, a licence from the Human Tissue Authority may be required. For more information please visit HTA licence.

The HTA may inspect licensed premises. More information on inspections is available in Audit and inspection

It is good practice for all organisations and staff who store tissues to ensure that sufficient records are kept to track the consent provisions and terms of ethical approval associated with any samples, along with relevant clinical information whilst maintaining sample integrity all of which underpin good science. Information on record keeping is available in the Governance and quality systems section of the HTA's Research Standards and guidance (from the 2nd resource).

Import of tissue samples into England, Wales or Northern Ireland
Guidance on the import and export of tissues is available from the HTA's Research Code of practice in the 2nd resource below. A summary of these requirements has been developed by MRC (3rd resource below). In addition to this the MRC has also developed a Standards for transfer of human tissues document to support those involved in drawing up and negotiating tissue transfer agreements (4th resource below).

Where tissues are imported/exported there is likely to be associated data. It is important this accompanying data is processed in accordance with the Data Protection Act 1998.

Resources