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In order to maintain a complete rolling ‘live audit’ of our tissue holdings, and to optimise the use of tissues and organs which are archived and stored under controlled conditions, St George’s has implemented the following specific strategy. These steps must be completed by the principal investigator (PI) before commencement of the sample collection.

Documentation process

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Step 1. Risk assessment

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.

Step 2. Training

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)

Step 3. Policy and procedure information

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:

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

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

Standard operating procedures
Standard operating procedures
 Document Description
SOP-GEN1 (PDF) Creating and reviewing standard operating procedures
SOP-GEN2 (PDF) Human tissue licence review group
SOP-R1 (PDF) Procurement of relevant material collected from inside St George’s
SOP-R2 (PDF) Procurement of relevant material collected from outside St George’s
SOP-R3 (PDF) Procedure for registering tissue holdings
SOP-R4 (PDF) Procedures when donors requests to withdraw consent to store human tissue
SOP-R5 (PDF) Management and use of freezers
SOP-R6 (PDF) Management of sample and tracking using Item Tracker™
SOP-R7 (PDF) Procedure in event of withdrawal of consent to store human tissue
SOP-R8 (PDF) Disposal by incineration
SOP-R9 (PDF) Disposal of unidentified foetal tissue
SOP-R10 (PDF) External audit
SOP-R11 (PDF) Procedure for reporting adverse event (AE) and complaint
SOP-R12 (PDF) Procedure for taking informed consent
SOP-R13 (PDF) Risk assessments
SOP-R14 (PDF) Cleaning and decontaminating in laboratories
SOP-R15 (PDF) Procedure for dealing with spills
SOP-R16 (PDF) Induction to new staff
SOP-R17 (PDF) Assessing risk to Human Tissue projects
Step 4. Registration

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.

Staff working under HTA licence 12330

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Designated individual

Philip Adds, Reader in Anatomy, Head of Anatomical Sciences

Persons designated
  • 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

Academic staff
  • 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

Support staff
  • Lydia Carline, Prosector

  • Andrew Bucknall, Senior DR Technical Officer

  • Michael Archbold, Senior DR Technician

  • Jack Waller, DR Technician

  • Sharon Decardi-Nelson, Anatomy Administrator

 

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