Newcastle Biobanks

Governance

Governance

The use of human samples in medical research is highly regulated.

We store all samples held by Newcastle Biobanks under the ethical and legal framework of the Human Tissue Act (2004). Any confidential donor information is stored under the Data Protection Act (1998).

We have a robust quality management system to maintain the integrity of donated samples, protect patient information, and ensure staff safety.

Information on the governance system adopted in Newcastle is provided below.

Human Tissue Act

The Human Tissue Act 2004 regulates the removal, storage, use and disposal of Relevant Material. If a sample contains even a single cell from a human body it is deemed Relevant Material.
 
Consent is a fundamental principal of the Act. To be stored, samples must have consent in place, unless an approved exemption is established.
 

Licencing

Any establishment storing human tissue samples, for research, must have a HTA licence. A copy of the Newcastle University licence (ref. 12534) is provided in the resources section.
 
The HTA licence only grants approval to store the material. Research Ethics Committee approval is required to use the material in a research project.
 
Each licence has a Designated Individual for oversight. Newcastle University's DI is Dr Chris Morris and Newcastle upon Tyne Hospitals' DI is Professor Philip Sloan. For further details of the governance teams, please see our staff pages.
 
All staff working under the Human Tissue Act licence must be trained every three years. Please email to register for our online training and read our blog for updates (below). 
 

Sample Tracking

Under the Human Tissue Act all samples must be appropriately labelled and traceable. This is to ensure the accurate use of the sample, and that we can retrieve the sample if required e.g. if a patient withdraws consent.
 
Newcastle University uses the Achiever Medical System to track all the samples we store. Achiever has a full audit trail, allowing the full history of the sample to be viewed, from receipt to storage, use, and disposal. Information about the sample, for example clinical information on the disease can also be added to enrich the data. For more information please see our Achiever page. 
 
All samples must be traceable at all times so we use Material Transfer Agreements (MTAs) when sending or receiving material from other institutions. For more information on how to organise an MTA see the Newcastle Joint Research Office website and speak to the relevant biobank manager.
 

Temperature Monitoring

 
The HTA states that temperatures must be monitored and recorded, and systems must be in place 24 hours a day to deal with emergencies.
 
Many freezers are connected to the University’s Building Management System (BMS). This has a direct line to security staff, who alert research staff when there are any unexpected changes in temperature. 
 
The main storage facility at the Central Biobank uses a temperature monitoring system which can be viewedremotely. The system uses email and phone alerts to warn of any temperature deviations. For more information see the Central Biobank pages. 
 
 
Blood tubes

Data Protection Act

In the UK, patient/donor information must be stored and handled under the Data Protection Act (1998). This is to ensure that the three following principles are abided by:

  • Purpose - personal data must only be held for a clear purpose 
  • Fairness - personal data must only be processed for legitimate purposes 
  • Transparency - data subjects must be given certain basic information about the personal data held about them

All Newcastle Biobanks have appropriate NHS approval in place to access any patient data required as part of the biobank. All data is stored on secure computers, with restricted access, and all staff must abide by the relevant data protection policy available on our resources page. 

Quality Management

Newcastle University has a Quality Management System to ensure compliance with the Human Tissue Act (2004).

We have documents that all staff working under the Newcastle University research HTA licence must follow:

  • Quality Manual
  • Standard Operating Procedures (SOPs) 
  • Policies

Copies of these documents are available on the Virtual Research Environment (VRE). For access to the VRE please contact the Governance Team

Further details on key aspects of the quality management system are provided below:

Internal audits

We conduct regular internal audits for all groups storing human tissue under our HTA licence. These audits aim to support researchers to identify any gaps in compliance, to implement solutions to meet regulatory standards and to continually improve the way we work.

Audits cover:

Consent 

  • appropriate consent must be in place for all samples held
  • staff taking consent must be trained to provide appropriate information to the donor

Governance/Quality systems

Quality documents are examined to ensure that:

  • all staff are trained
  • procedures are well documented
  • systems are in place to protect the integrity of all samples and data. 
  • samples can quickly and easily be retrieved
  • consent forms are in place

Premises/Facilities/Equipment

Storage environments are assessed to ensure they are:

  • fit for purpose
  • temperature monitored
  • well maintained
  • secure
  • safe environments for staff

Disposal

We assess the way in which groups dispose of samples making sure it is done with respect, in accordance with donor wishes, and that it is documented.

Persons Designated

Each location storing tissues is overseen by a Person Designated (PD).

It is the PD's responsibility to ensure we follow the Human Tissue Act regulations. – for more information about this role, see our governance pages.

To find out about our research tissue collections, including sample details how to access them see our collections page.