Human Tissue Act Documentation

Complete a risk assessment (Word) of the:

• equipment – storage failure or other damage affecting human tissue quality for useful research

• environment – failure of security arrangements

• processes involved in analysis –

  • receiving and/or storing specimens without appropriate consent documentation
  • storing or using human tissue after consent withdrawal
  • loss of human tissue
  • sample mix-up or loss of traceability
  • transport of specimens to and from the establishment.

Please send completed risk assessment form (per project) to JRES and Dr Priya Madhou.

Train yourself and your staff to understand the requirements for HTA compliance, which are as follows.

• Completing the HTA e-learning training module which is available via the Medical Research Council Learning Management System. You will be required to create your own account to gain access to the training. A certificate is generated on completion of the course and assessment.

• Completing and updating the good clinical practice (GCP) training offered through JRES.

• Ensuring that all staff involved in human tissue attend the HTA workshops run at St George’s annually, through staff development.

• Familiarising yourself and staff with the HTA codes of practiceand associated standards.

Useful documents

Code A – Guiding principles and fundamental principle of consent (PDF)

Code E – Research code of practice (PDF)

HTA research sector licensing standards (Word)

HTA licensing standards checklist (Excel) – useful guide for new research

HTA workshop (Powerpoint)

HTA examples (Word)

Ensure that all the policies and procedures relating to the collection and storage of human tissues by St George’s, University of London are understood and implemented by all the members of staff.

See:

• St George’s governance master file for HTA (PDF)

• data protection guidance (PDF)

• public interest disclosure (PDF)

• professional code of conduct (PDF).

Register to use and be familiar with Item Tracker to ensure sample traceability. To register, please email Ash Sameja.

Please read Policy for use of Itemtracker (Word) for further information.

Finally, print out a full set of standard operating procedures for your laboratory.

Standard operating procedures

Ensure that your project/collection is registered and that both JRES and the Human Tissue Act designated individual (DI), Dr Priya Madhou, have a copy of your registration form (Word). Please email one copy to JRES along with your RES approval, and one to the DI.

Pease note that host site approval will not be given if the HTA registration document does not accompany the RES approval.

What is relevant material?

See appendix A from the HTA (PDF), which is a list of what is considered ‘relevant material’.

Do I need to take consent?

Please refer to the following reference documents:

• Licensing and consent requirements (PDF)
• Guidance on consent (NRES) (PDF)
• Research and guidance from the General Medical Council (GMC) (PDF)

What do I do if an individual wishes to withdraw their consent?

Ask them to complete a request to withdraw consent form (Word) and explain what will happen to their material and any data already collected. Arrange for any specific disposal requests, but if there are none explain the procedures set out at St George’s.

What should I do in the event of an adverse event or incident?

Firstly, halt the processes or procedures resulting in the adverse event (AE). Secondly, complete an AE/incident form (Word) and email it to the Human Tissue Act designated individual (DI), Dr Priya Madhou. The DI will advise further, following an investigation.

What do I need to do to send human material to other research institutes?

Please contact St George's Joint Research and Enterprise Services (JRES).