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 Penny Lympany.

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 Ashraf 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 Penny Lympany, 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.

Philip Adds, Reader in Anatomy, Head of Anatomical Sciences

• Dr Paul Carter, Senior Lecturer in Anatomy, Consultant in Obstetrics and Gynaecology

• Dr Carol Shiels, Senior Lecturer in Cell and Molecular Biology, Pathology Museum Manager

• Dr Paul Johns, Senior Lecturer

• Dr Patricia Prado, Lecturer in Anatomical Sciences

• Dr David Sunnucks, Lecturer in Anatomical Sciences

• Ms Georga Longhurst, Lecturer in Anatomical Sciences

• Lydia Carline, Prosector

• Andrew Bucknall, Senior DR Technical Officer

• Michael Archbold, Senior DR Technician

• Jack Waller, DR Technician

• Sharon Decardi-Nelson, Anatomy Administrator