Anatomical Examination involving Human Specimens
Legislation and regulation
Legislation under the Human Tissue Act 2004 provides a framework for the collection, storage use and disposal of human samples or specimens (which may be body parts, organs, tissue, bodily waste products, including blood, serum, plasma, etc.). The University is licensed and subject to inspection by the Human Tissue Authority (HTA) to store and use human samples or specimens for anatomical examination, in accordance with the legislation.
These pages provide information on using human specimens for anatomical examination, if you are considering using human samples for research, further information can be found on the Research and Impact Services webpages here; Research involving Human Samples (warwick.ac.uk)Link opens in a new window
Regulation by the HTA requires the University to have a Quality Management System (QMS) in place supported by a Quality Manual (QM), Standard Operating Procedure (SOPs)and Risk Assessments (RA) for the effective management of anatomical examination involving human specimens. Responsibility for supervising the activities under the licence and the implementation of the QMS and the SOPs is with the University’s Designated Individual (DI), currently Professor Richard Tunstall, supported by the University’s Research Ethics and Governance Committee.
For more information, see: Legislation and Regulation.
Policies and procedures
It is important that all human samples and specimens are treated with dignity and respect at all times, and in accordance with the original consent of the donor, where appropriate, and that the quality of the samples and specimens is maintained.
All relevant policies and procedures are documented in the Quality Manual and SOPs.
For more information, see: Quality Management System and Standard Operating Procedures (SOPs).
Registration and training
All staff and students undertaking anatomical examination involving the use of human specimens must be able to demonstrate their competency to do so. They must be familiar with relevant documentation and SOPs and undergo training before being confirmed as trained by the DI Anatomy.
Students or learners being educated, trained or researching on organised courses or events overseen by appropriately trained and registered members of staff do not need to undertake the training referred to below, but will be required to complete a Learner Agreement HTA VF3 (undergraduate)Link opens in a new window, or HTA VF5 (Masters and CPD)Link opens in a new window or Learner Refresher Agreement HTA VF 4Link opens in a new window, further details can be obtained from the course lead.
Each individual working under the HTA (Anatomy) licence will need to complete and record the following training tasks:
1. Read: HTA Code of Practice A: Guiding and Fundamental Principles of ConsentLink opens in a new window
2. Read: HTA Code of Practice C: Anatomical ExaminationLink opens in a new window
3. Attend: HTA Training Session 1 ‘Research using Human Samples ; Knowing your ResponsibilitiesLink opens in a new window’. Send Certificate to anatomyhta@warwick.ac.uk
4. Attend: HTA Training Session 2. Delivered by HTA DI Anatomy. Certificate of attendance provided.
5. Send: Certificate to anatomyhta@warwick.ac.uk
6. Review and Complete: Medical Research Council (MRC) e-learning module and assessment.Link opens in a new window
7. Send: Certificate to anatomyhta@warwick.ac.uk
8. Review: ‘HTA DC1 - Document control’ – lists documents relevant to working under the HTA licence.
9. Read and understand: HTA QM 1, HTA SOP 1-13, HTA RA 1-3, HTA VF1-5 (latest versions are stored in the HTA Anatomy Teams site). Record completion of task by inserting the document version number against your name in the training Excel Sheet ‘HTA TL 1’. The latest version is shown in the column heading.
10. Read and be familiar with: HTA VL 1, HTA SR 1, HTA EC 1. Record completion by typing the document version number against your name in the training Excel Sheet ‘HTA TL 1’.
Upon completion of these tasks, the DI Anatomy will review the training log (certificates and HTA TL 1) and provide sign-off. Sign-off gives permission for an individual to work independently under HTA Anatomy licence. Following sign-off, and a period of on-the-job observation, the DI (Anatomy) may give an individual swipe card access to the HTA facility.
Other staff, for example, technical and administrative staff, supporting anatomical examination involving human specimens are also welcome to attend the in-house training session and may find it valuable to complete the MRC e-learning module.
Please contact the DI for further information and advice - anatomyhta@warwick.ac.uk