1- HTA licences held by Newcastle University and NUTH Organisation HTA Sector Licence Designated Individual named on licence Newcastle University Research Professor Andy Hall () Anatomy Dr Debra Patten () Newcastle upon Tyne NHS Foundation Trust Research Professor Phil Sloan () Post Mortem Dr Nigel Cooper () Application Dr Andy Gennery ()
Storage of anatomical specimens Public display of relevant material from deceased persons. a relevant material is to be stored for a number of “scheduled purposes” a scheduled purposes are defined as the activities relating to the removal, storage and use of human organs and other tissue that require consent. A list of scheduled purposes is provided in Table 3 overleaf (taken from HTA Code of Practice 1 – Consent). Table 3 – Consent requirements under the Human Tissue Act for scheduled purposes Roles and responsibilities under a Human Tissue Act licence The HTA prescribe that three key roles are required under The Act. These are: Licence Holder (LH) Designated Individual (DI) Persons Designate (PD) These roles and the associated responsibilities as summarised in Figure 6 and explained in full in the Human Tissue Act Standard Operating Procedure 2 (HTA-SOP-2). Although the PD role imposes no legal responsibility, it is a licence requirement that the Designated Individual has documented evidence of the PD’s acceptance of the PD role. The individuals assigned roles on the Newcastle University research HTA licence are set out in section 6.3. Figure 6 - Roles and responsibilities required under a HTA research licence Licensing exemptions A number of exemptions exist in which a HTA licence is not required to store a relevant material. Exemptions include: If the material is to be rendered acellular (i.e. cells removed, or disrupted) or transported to another establishment within 7 days If the material is to be stored for diagnostic or other purposes
Campus for Ageing and Vitality Edwardson Building Newcastle University Newcastle upon Tyne NE4 5PL United Kingdom Freeman Hospital Respiratory Freeman Road High Heaton Newcastle Upon Tyne NE7 7DN Institute of Genetic Medicine Human Developmental Biology Resource & Cytogenetics Newcastle University International Centre for Life Central Parkway Newcastle upon Tyne NE1 3BZ School of Agriculture, Food and Rural Development, Nutrition Agriculture Building Newcastle University Newcastle upon Tyne NE1 7RU Tel: +44 (0) 191 248 1300 Fax : +44 (0) 191 248 1301 Tel: +44 (0)191 233 6161 (Switchboard) Tel: +44 (0)191 241 8616 Fax: +44 (0)191 241 8666 Tel: +44 (0)191 222 6900 Fax: +44 (0)191 222 6720 Roles and responsibilities under the Newcastle University research sector HTA licence As required by the terms and conditions of the Human Tissue Act licence (see section 5.2.4), Newcastle University has assigned a number of different roles and responsibilities to oversee compliance with the HTA licence (Ref. 12534). These individuals are set-out below, and summarised in Figure 7. For full role For full descriptions, please refer to HTA-SOP-02. The organisational structure adopted under the Newcastle University Research Sector HTA Licence is provided in the HTA Master File and on the Newcastle Joint Research Office (NJRO) website). Licence Holder and Designated Individual The details of the Licence Holder and Designated Individual named on the Newcastle University research sector HTA licence are provided below. Licence Holder: Newcastle University - Professor Chris Day, PVC for Medical Faculty, named for correspondence Medical Sciences Faculty Office, Medical School, Framlington Newcastle upon Tyne, NE2 4HH
Minimum practice: Best practice: Corrective and preventative actions are taken where necessary and improvements in place are made Investigation check-list completed, and adverse event report provided to QA Manager and DI in accordance with HTA-SOP-03 Systems to receive and distribute national and local information (e.g. HTA communications) PD and associated staff register to receive e-newsletters from HTA. Regular internal HTA newsletter with PD distribution to relevant employees Use of email distribution lists GQ8 Risk assessments of the establishments practices and processes are completed regularly and are recorded and monitored appropriately Minimum practice: Best practice: Documented risk assessments for all practices and processes Safety office template used Risk assessments are reviewed when appropriate Staff can access risk assessments and are made aware of local hazards and training PART 3 – PREMISES, FACILITIES AND EQUIPMENT STANDARDS Premises, Facilities and Equipment Standards PFE1 The premises are fit for purpose Minimum practice: Best practice: A risk assessment has been carried out of the premises to ensure that they are appropriate for the purpose Policies are in place to reviewed and maintain the safety of staff, authorised visitors and students Where appropriate, policies are in place to ensure that the premises are of a standard (and maintained to that standard) that ensures the dignity of deceased persons The premises have sufficient space for procedures to be carried out safely and efficiently
APPENDIX D –Copy of the Newcastle University Research HTA Licence Hub Licence Satellite licences APPENDIX E – Document Revision History Section affected Description of changes Reason for change Page 1 Removal of terminology Newcastle Biomedicine Biobank Due to rebranding to remove the NBB brand – due in July 2015. Throughout Removal of the NBB code. All SOPs have been renamed “HTA”. Change of of QA Manager to Quality Assurance and Development Manager (QADM) Rebranding of the NBB. All documents will now be named HTA under the Newcastle University HTA licence. Change in job of QA Manager Page 7 section added as new section 4& transfer of table 2 “HTA licences held in Newcastle” moved from page 12 of previous edition, to this section. The numbering of all subsequent sections has been affected (increased by 1) Not present in previous versions. Table is required up front to summarise the different contact details for other licences. 5.1. What is the HTA section – wording on the background of the HTA added to say “and many other trusts” To clarify that the Redfern report found the retention of human tissue was widespread throughout the NHS and not restricted to the BRI or Alder Hey.
12.3 Section relabelled Document control, with subsections on each element of control 12.3.2 NJRO website – new section 12.3.3. VRE – new section added 12.3.4 HTA Master File – new section added To enhance the layout of this section The NJRO website, VRE and HTA Master File are all new since the last version, and must be included. QPulse has also been removed, and all reference to QPulse must be removed. 12.4 Risk assessments now included in the documents supporting the QMS section Risk assessments fit alongside SOPs and other documents supporting the QMS as opposed to a stand-alone section 12.9 Training in Quality Documents added To be clear that training may be online, or via reading (absent in previous version) Appendix C Appendix C from previous document (Role Descriptions) removed These documents are now held separately in the HTA Master File and removed from this section for future proofing, should any changes occur.