1
Quality Manual
The collection, storage and use of tissue in research
in accordance with Newcastle University’s research
sector Human Tissue Act Licence (No. 12534)
Mhairi Anderson
Quality Assurance Manager
Newcastle Biomedicine Biobank
Issued: 1st March 2014
Edition 2
The Quality Manual has been designed to give researchers advice on obtaining, storing and using
Human Tissue for Research, both under the HTA Licence and for specific projects.
Last printed 09/02/2016 05:16
Page 1 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
Approval
Last printed 09/02/2016 05:16
Page 2 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
Table of Contents
Table of Contents .................................................................................................................................... 3
Table of Figures ....................................................................................................................................... 5
1.
INTRODUCTION ............................................................................................................................... 6
2.
POLICY AND OBJECTIVES ................................................................................................................. 6
3.
STRUCTURE OF THE MANUAL ......................................................................................................... 7
4.
THE HUMAN TISSUE ACT................................................................................................................. 9
4.1.
4.1.1.
Who regulates compliance with the Human Tissue Act? ............................................... 9
4.1.2.
Which materials are covered by The Act? .................................................................... 10
4.2.
5.
6.
What is the Human Tissue Act? .............................................................................................. 9
Licensing ................................................................................................................................ 11
4.2.1.
Which sectors does the Human Tissue Act regulate? ................................................... 11
4.2.2.
What activities are permitted under a Human Tissue Act licence? .............................. 13
4.2.3.
Do I need a Human Tissue Act licence? ........................................................................ 14
4.2.4.
Exemptions.................................................................................................................... 16
4.2.5.
How are licenses assigned to premises? ....................................................................... 18
4.2.6.
How do I apply for a new or adapted Human Tissue Act licence?................................ 19
4.2.7.
Roles and responsibilities under a Human Tissue Act licence ...................................... 21
4.2.8.
What are the implications of not complying with the licence? .................................... 22
THE NEWCASTLE UNIVERSITY RESEARCH SECTOR HTA LICENCE .................................................. 23
5.1.
What is covered by the Newcastle University research sector HTA licence? ....................... 23
5.2.
Premises ................................................................................................................................ 24
5.3.
Roles and responsibilities under the Newcastle University research sector HTA licence .... 25
5.4.
What does this mean for researchers? ................................................................................. 30
OBTAINING TISSUE ........................................................................................................................ 31
6.1.
How do I obtain tissue? ........................................................................................................ 31
6.2.1
OPTION 1 - Obtaining pre-existing tissue from a Biobank ............................................ 32
6.2.2.
OPTION 2 – Collect new tissue ...................................................................................... 36
6.2.3.
OPTION 3 – Purchasing material from a commercial supplier ..................................... 36
6.3.
Consent ................................................................................................................................. 38
6.3.1.
Which activities require consent?................................................................................. 38
6.3.2.
Who can give consent? ................................................................................................. 40
Last printed 09/02/2016 05:16
Page 3 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
7.
6.3.3.
Are there different types of consent?........................................................................... 41
6.3.4.
How is consent taken? .................................................................................................. 41
6.3.5.
Can consent be withdrawn? ......................................................................................... 42
STORAGE ....................................................................................................................................... 44
7.1.
Sample storage requirements............................................................................................... 44
7.2.
Data storage and protection ................................................................................................. 45
7.3.
What are the options available for storage at Newcastle University? ................................. 46
7.4.
Subcontracting storage ......................................................................................................... 48
7.5.
Appropriate storage period .................................................................................................. 48
8.
SAMPLE TRACKING........................................................................................................................ 50
8.1.
Key Principles of sample tracking ......................................................................................... 50
8.2.
Material and data transfer .................................................................................................... 51
9.
SAMPLE DISPOSAL......................................................................................................................... 53
9.1.
Key considerations in sample disposal ................................................................................. 53
9.2.
Disposal options .................................................................................................................... 54
9.3.
Maintaining proper documentation ..................................................................................... 54
9.4.
Preventing unnecessary waste of human tissue ............................................................... 55
10.
THE QUALITY MANAGEMENT SYSTEM (QMS) .......................................................................... 56
10.1.
The Quality Manual ........................................................................................................... 56
10.2.
Document Management ................................................................................................... 56
10.2.1.
Document Management System .................................................................................. 56
10.2.2.
Documentation supporting the QMS.......................................................................... 58
10.2.3.
Risk assessments ........................................................................................................... 60
10.3.
Adverse events .................................................................................................................. 60
10.4.
Complaints ........................................................................................................................ 60
10.5.
Validation and change control .......................................................................................... 61
10.6.
Audit .................................................................................................................................. 61
10.7.
Training ............................................................................................................................. 62
10.8.
Communication with stakeholders ................................................................................... 63
10.9.
Governance ....................................................................................................................... 64
10.9.1.
Management commitments ......................................................................................... 64
10.9.2.
Access and governance committee .............................................................................. 65
10.9.3.
Laypersons .................................................................................................................... 66
Last printed 09/02/2016 05:16
Page 4 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
11.
APPENDICES .............................................................................................................................. 67
11.1.
APPENDIX A - Minimum and best practice standards for the use of human samples for
research conducted by staff employed by Newcastle University ..................................................... 67
11.2.
APPENDIX B – Glossary ..................................................................................................... 77
11.3.
APPENDIX C: Role Descriptions ......................................................................................... 80
11.3.1.
Person Designate (PD) .................................................................................................. 80
11.3.2.
Human Tissue Act Coordinator (HTAC) ......................................................................... 83
11.4.
APPENDIX D– Supplementary list of materials ................................................................. 85
11.5.
APPENDIX E –Copy of the Newcastle University Research HTA Licence .......................... 89
11.6.
APPENDIX F – Document Revision History........................................................................ 94
Table of Figures
Figure 1 - Structure of Quality Manual ................................................................................................ 8
Figure 2- Human Tissue Authority categories of relevant material................................................ 16
Figure 3 - Summary of licensing requirements................................................................................. 17
Figure 4 - Licensing Premises............................................................................................................. 18
Figure 5 - The Human Tissue Authority licensing process .............................................................. 20
Figure 6 - Roles and responsibilities required under a HTA research licence ............................... 21
Figure 7 - Organisational chart - research sector HTA licence at Newcastle University ............... 26
Figure 8 - Newcastle Biomedicine Biobank (NBB) organisational structure ................................. 27
Figure 9 - Obtaining tissue for use in research ................................................................................. 31
Figure 10 - The Integrated Research Application System (IRAS) process ..................................... 35
Figure 11 - Requirements for consent under the Human Tissue Act .............................................. 39
Figure 12 - Qualifying relationships to provide appropriate consent ............................................ 40
Figure 13 - Storage options for relevant materials at Newcastle University ................................. 48
Figure 14 - Sample disposal options .................................................................................................. 54
Last printed 09/02/2016 05:16
Page 5 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
1. INTRODUCTION
The Human Tissue Act (2004) was set up to regulate the removal, storage, use and disposal
of human bodies, organs and tissue for a number of Scheduled Purposes – such as
research, transplantation, and education and training.
The Act, which covers England, Wales and Northern Ireland, came into force on 1
September 2006.
As human tissue is widely used across Newcastle University, the University holds a
Research licence under the Act (Licence no. 12534) –which governs the management of
human tissue across the University. This licence, and its requirements, must be understood
and respected by all employees who work with human tissues.
This Quality Manual has been produced to provide a comprehensive guide for the use of
human tissues to help all those collecting and using human samples at Newcastle
University.
2. POLICY AND OBJECTIVES
Human tissue is considered to be a precious gift. Therefore, in order to demonstrate respect
for this gift, and ensure high quality research, it is paramount that all human samples are
acquired lawfully, with appropriate consent, and are stored, handled, used and disposed of
respectfully, sensitively and responsibly.
As such, the University requires that all researchers working with human samples, from the
living or deceased, strictly abide by the procedures and standards set out in this Quality
Manual. For a summary of minimum and best practice, refer to Appendix A.
The objectives of the Quality Manual are therefore:
a)
To maintain an effective Quality Management System in compliance with the Human
Tissue Act and the standards and guidance issued by the Human Tissue Authority.
b)
To provide a robust, but practical framework for employees to follow to ensure
compliance with licensing obligations of the HTA
c)
To enhance the University’s reputation for the delivery of research of the highest
quality and ethical standards and ensure public confidence in the ethics of scientific
research
d)
To demonstrate the University’s commitment to defining the quality of its products
and services, and ensuring the continuous review and improvement of quality
standards to promote process excellence and good ethical practice.
To achieve this policy, it is imperative that all staff who work with human tissues understand
their responsibilities under the Human Tissue Act, and are accountable for the quality of their
work.
Last printed 09/02/2016 05:16
Page 6 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
This Quality Manual provides researchers with a comprehensive summary of the Human
Tissue Act regulations, providing a clear description of the range of processes that must be
conducted in order to organise, conduct, and document research using human tissue.
Each employee or student working under the University’s Human Tissue Act licence must
therefore abide by this manual. Additional Quality Policies may also exist within each
academic unit detailing how the quality standards set out in this manual are applied in that
environment.
This policy, and appropriate training, will be made available to all employees and students
working with human tissue.
3. STRUCTURE OF THE MANUAL
This manual has been compiled to provide researchers with guidance on the full range of
processes required when working with human tissues, from study start, to sample disposal.
The structure of this manual is described in figure 1.
Advice for researchers on minimum and best practice is provided in Appendix A. A glossary
on all the terms used in this manual is also provided in Appendix B.
Further appendices include role descriptions for Persons Designate and Human Tissue Act
Co-ordinators (Appendix C), a list of supplementary material as provided by the Human
Tissue Authority (Appendix D), and a copy of the University’s research Human Tissue Act
licensing documentation (Appendix E).
Last printed 09/02/2016 05:16
Page 7 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
Part 1
Part 2
Part 3
Part 4
Part 5
The Human
Tissue Act
Newcastle
University’s Research
Sector HTA licence
Obtaining tissue
for use in
research
Sample storage
and tracking
Disposal
- What is the Human
Tissue Act?
-
-
How do I obtain
tissue?
- Who regulates
compliance with the
Human Tissue Act?
-
-
Informing the DI
of relevant
material
- What materials are
covered by the Act?
What is covered
under the University’s
research HTA licence?
Licensed premises
Roles and
responsibilities
What does this mean
for researchers?
-
- Licensing
• Sectors
• Activities
• Do I need a
licence?
• Assigning licences
• Applying for a
licence
• Licensing
premises
• Roles and
responsibilities
• Implications of
on-compliance
-
Consent
-
When is consent
required?
Who can give
consent?
Types of consent
How is consent
taken?
Withdrawal of
consent
•
•
•
•
-
Storage
requirements
Storage options
at Newcastle
University
Storage period
-
Key
considerations
Options
Documentation
Avoiding waste
-
-
-
Figure 1 - Structure of Quality Manual
Last printed 09/02/2016 05:16
Part 6
The Quality
Management
System
Page 8 of 98
The Quality
Manual
Document
Management
Standard
Operating
Procedures
(SOPs)
Validation and
change control
Audit
Training
Communication
Management
commitments
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
4. THE HUMAN TISSUE ACT
4.1.
What is the Human Tissue Act?
The Human Tissue Act 2004 (The Act) is a legal
framework which regulates the removal,
storage, use and disposal of human bodies,
organs and tissues.
The Act, which came in to full effect on the 1st
September 2006 and applies to England, Wales
and Northern Ireland, was enforced as a direct
response to the findings of the Redfern report1
in which the unauthorised removal, retention,
and disposal of human tissue was found at the
Alder Hey Children’s Hospital and Bristol Royal
Infirmary.
With consent as its fundamental underlying
principal, the Act aims to ensure that all human
tissues are now managed in an ethical and
sensitive manner, by providing a consistent
legislative framework for matters relating to
body donation and the removal, storage and
use of human organs and tissue
4.1.1. Who regulates compliance with the Human Tissue Act?
To ensure compliance with the Act, "The Human Tissue Authority” (HTA) was established.
Acting as an independent government watchdog, the HTA has the following objectives:

To ensure that clear standards are in place for the use of
human tissues

To inspire public and professional confidence in medical
research by ensuring that human tissue is used safely
and ethically, and with proper consent

To provide researchers with support and guidance to
ensure best practice.
To achieve these objectives the HTA has created a number of codes of practice. The codes
of practice provide guidance for researchers and lay down expected standards for each of
1
www.official-documents.gov.uk/document/hc1011/hc05/0571/0571_i.pdf redfern report
Last printed 09/02/2016 05:16
Page 9 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
the sectors the HTA regulates. The codes are designed to support professionals by giving
advice and guidance based on real-life experience.
There are now 9 Codes of Practice, as described below: These can be accessed from the
HTA website:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm
Code 1 Code 2 Code 3 Code 4 Code 5 Code 6 Code 7 Code 8 Code 9 -
Consent
Donation of solid organs for transplantation
Post-mortem examination
Anatomical examination
Disposal of human tissue
Donation of allogeneic bone marrow and peripheral blood stem cells for
transplantation
Public display
Import and export of human bodies, body parts and tissue
Research
4.1.2. Which materials are covered by The Act?
Importantly, “human tissue” defined in The Act, is not restricted to human organs.
According to The Act, a human tissue act licence is required for any material which is
deemed to be “Relevant Material” under Section 53 of The Act. A definition of a relevant
material is provided below:
RELEVANT MATERIAL
“Material, other than gametes, which consists of, or includes
human cells”
The fundamental principle underpinning The Act is therefore that if a sample is known to
contain even a single cell that has come from a human body (e.g. blood cells), then the
sample should be classified as relevant material.
However, this does not include:
(a) embryos outside the human body - this is covered by the Human Fertilisation &
Embryology Act 20082)
(b) hair and nail from the body of a living person.
2
www.legislation.gov.uk/ukpga/2008/22/contents
Last printed 09/02/2016 05:16
Page 10 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
Although DNA is not HTA relevant material, the HT Act has now
created a new offence of DNA ‘theft’ – which is the criminal act of
holding human tissue with the intention of analysing its DNA, without
the consent of the person from whom the tissue came from (see
section 6.3). The University has therefore decided that although
DNA is not HTA relevant material, due to public concerns about the
handling of their DNA, it should be treated as if it is wherever
possible.
For a comprehensive list of materials included in the Human Tissue Act, researchers may
refer to the Human Tissue Authority website:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
4.2.
Licensing
4.2.1. Which sectors does the Human Tissue Act regulate?
To reflect the fact that human tissue may be used in a number of different environments, The
Human Tissue Authority licenses and inspects a number of different sectors. These are
summarised in Table 1 below. For full information, refer to the Human Tissue Authority
website: http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation.cfm
Table 1- Sectors licensed and inspected by the Human Tissue Authority
Sector
Activity
Anatomy
For establishments carrying out anatomical examinations or storing
anatomical specimens. For example, where human bodies are used to
teach students and to train surgeons and other healthcare professionals
Human
application
For organisations that use human tissue and cells to treat patients. For
example, stem cells, skin and heart valves, eye banks, maternity units and
organisations that store skin and bone
Post mortem
for establishments carrying out post mortems, storing human bodies or
organs, tissues or cells from a deceased person and/or removing relevant
material from a deceased person other than in the course of a post mortem
Public
Display
Research
For establishments wishing to put human bodies, body parts and
specimens on public display, e.g. as part of an exhibition in a gallery or
museum. This is only applicable if material is taken from the body of a
deceased person who died less than 100 years ago.
for establishments storing human organs, tissues and cells for research
purposes other than for a specific ethically approved research project
Last printed 09/02/2016 05:16
Page 11 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
For all sectors (with the exception of the Application sector) the Human Tissue Authority
offers licences under the Human Tissue Act (2004). For the Human Application sector,
licences are offered under the Human Tissue (Quality and Safety for Human Application)
regulations 2007.
The Human Tissue Authority is also the Competent Authority under the 2012: “Organs
Intended for Transplantation Regulations”. This is a new area of responsibility for the HTA
and has resulted in a programme of assessment and licensing of UK transplant centres. It is
not formally labelled as a new ‘sector’ within the HTA licensing framework but its standalone
nature makes it the sixth category of licensing. A link to the organ donation and
transplantation section of the HTA website is provided below:
http://www.hta.gov.uk/licensingandinspections/sectorspecificinformation/organdonationandtr
ansplantation/organdonationandtransplantationsector.cfm
As Newcastle University operates across a number of these sectors, the University holds a
number of these sector specific licenses. In addition, the Newcastle Upon Tyne NHS Trust
Foundation, which works closely with Newcastle University, also holds a number of other
licences.
However, as this Quality Manual relates specifically to the collection, storage and use of
human tissues in “research”, this manual relates to the University’s Research sector licence
only. This licence, and the activities which can be conducted under its remit, are described
in section 5.
For queries relating to HTA licences held by Newcastle University or Newcastle Upon Tyne
NHS Foundation Trust, please refer to the following contacts listed in Table 2:
Table 2 - HTA licences held by Newcastle University and Newcastle Upon Tyne
NHS Foundation Trust
Organisation
Newcastle
University
Newcastle upon
Tyne NHS
Foundation Trust
HTA Sector
Licence
Designated Individual named on licence
Research
Professor Andy Hall (andy.hall@ncl.ac.uk) – see
section 5
Anatomy
Dr Roger Searle (roger.searle@ncl.ac.uk)
Research
Professor Phil Sloan (Philip.sloan@nuth.nhs.uk)
Post Mortem
Dr Nigel Cooper (nigel.cooper@nuth.nhs.uk)
Human
Application
Dr Andy Gennery (andy.gennery@nuth.nhs.uk)
Last printed 09/02/2016 05:16
Page 12 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
4.2.2. What activities are permitted under a Human Tissue Act licence?
Each Human Tissue Act licence clearly sets out the activities which may be conducted under
that licence. These activities, called ““Licensable activities”, fall into the following
categories:
1.
2.
3.
4.
5.
6.
Carrying out an anatomical examination
Making of a post mortem exam
Removal of relevant material from a deceased person
Storage of a relevant material for a number of scheduled purposes
Storage of anatomical specimens
Public display of relevant material from deceased persons.
Where 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.
Table 3 - “Scheduled Purposes” – Activities requiring consent
For living and deceased person
For deceased persons
Purposes requiring consent are:
Purposes requiring consent include:
1.
Anatomical examination.
8. Clinical audit.
2.
Determining the cause of death.
9. Education or training relating to
human health.
3.
Establishing after a person’s death the
efficacy of any drug or other treatment
administered to him.
10. Performance assessment.
4.
Obtaining scientific or medical
information about a living or deceased
person which may be relevant to any
other person (including a future person).
12. Quality assurance.
5.
Public display.
6.
Research in connection with disorders,
or the functioning, of the human body.
7.
Transplantation.
Last printed 09/02/2016 05:16
11. Public health monitoring.
Page 13 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
4.2.3. Do I need a Human Tissue Act licence?
As a Human Tissue Act licence is only required for material which is determined to be a
“Relevant Material” under the act, to determine if a researcher needs a Human Tissue Act
licence, they must first establish -
Is the material I wish to use classed as a
“Relevant Material”?
(See section 4.1.2)
To help researchers to answer this question, the Human Tissue Authority has divided
potentially relevant material into four categories.
The categories of relevant material are:
1. Specifically identified - This includes material like bodily organs and tissues,
consisting largely or entirely of cells, and clearly identifiable and regarded as such.
This category of relevant material includes human bodies, internal organs and
tissues, skin and bone.
2. Processed material: Where a process has been conducted which results in a
material either retaining its cells, or where the cells have been removed (material is
rendered acellular).
Importantly:
 A HTA licence is only required to store cells.
Therefore, if the cellular component is removed, or
disrupted, a HTA licence is not required to store the
material
 The Human Tissue Authority grants researchers up to
7 days to remove the cellular component of a relevant
material. During this time, the material can be stored
without a HTA licence. However, after 7 days, if the
material has not been processed to remove the cells,
and no further exemption applies (see section X) then
the material must be stored under a HTA licence.
 Where it is believed that the processing has rendered
the material acellular, the HTA may seek assurance
that the processing has been carried out.
 Under this category plastinated tissue and plastinated
body parts (where the cellular structure is retained by
the plastination process) are to be regarded generically
as relevant material; while plasma or serum, for
example, will be regarded as not.
Last printed 09/02/2016 05:16
Page 14 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
3. Bodily waste: Bodily waste is a less well characterised group of material.
Nevertheless the Authority considers that bodily waste is a relevant material as it
may contain human cells. In cases where a researcher believes that material,
intended for a scheduled purpose, is actually acellular the researcher would need to
consult the Authority for advice.
4. Cell deposits and tissues on microscope slides:
In general cell deposits or tissue sections on microscope
slides are considered to constitute relevant material. This is
because such deposits or sections are likely to contain whole
cells or are intended to be representative of whole cells.
These categories are summarised in Figure 2. However, the fundamental principle remains
that if a sample is known to contain even a single cell that has come from a human body,
then the sample should be classified as relevant material.
The Human Tissue Authority has also produced a supplementary list of materials to provide
stakeholders with guidance on whether specific materials fall within the definition of a
relevant material under The Act. A copy of this list is also provided in Appendix D and on the
HTA website:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
Last printed 09/02/2016 05:16
Page 15 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
•
Type 4:
Cell deposits & tissues on
microscope slides
Type 1:
SPECIFICALLY IDENTIFIED
Consist largely or entirely of human cells & easily
distinguished as such
e.g. Human bodies, skin, bone, bodily organs
RELEVANT
MATERIAL
NONRELEVANT
MATERIAL
Licence required unless
exemption applies
(see section 4.2.4)
NO
e.g. plastinated tissue/ body parts which
retain cellular structure
YES
e.g. plasma, serum
Has the material been
rendered acellular?
N.B. This must be conducted
within 7 days
Type 2:
Processed
Material
Licence not required
UNSURE
Consult the Biobank
Quality Assurance
Manager or HTA
Type 3:
Bodily waste
(including excretions &
secretions)
Figure 2- Human Tissue Authority categories of relevant material
If a researcher determines that the material they wish to use is a “relevant material” under
the act, the material must be stored under a Human Tissue Act licence. However, a number
of exemptions in which a licence is not required to store a relevant material are described
below in section 4.2.4.
4.2.4. Exemptions
Importantly, a number of exemptions exist in which a HTA licence is not required to store a
relevant material. Cases where a HTA licence is not required 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
If the material has Research Ethics Committee (REC) approval in place to use it
If the material is greater than 100 years old
If the material has come from a Research Ethics Committee (REC) approved
research tissue bank where there is permission in place to use the material
Licensing requirements, including exemptions, are summarised in section 4.2. If a
researcher is ever in doubt if a Human Tissue Act licence is required, please contact the
Newcastle Biomedicine Biobank Quality Assurance Manager (contact details in section 5.3).
Last printed 09/02/2016 05:16
Page 16 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
I want to work with human tissue –
Do I need a Human Tissue Act Licence?
HTA licence
not required
Is your material classed as a
“Relevant Material”
under the Human Tissue Act?
no
unsure
Consult the HTA or
the NBB QA Manager
yes
yes
Is the tissue stored with the intent of
rendering it acellular within 7 days?
no
See guidance on
obtaining a licence
for
• carrying out a
post mortem
• public display or
• anatomy
What is the primary purpose you store
organs, tissue or cells for?
Diagnostic purposes
(taken from living only)
Is the tissue
storage
incidental to
transportation?
Yes
HTA licence
not required
No
For research purposes
(living or deceased)
Is the material received from an
Research Ethics Committee (REC)
approved tissue bank with
permission to authorise research?
No
Is the
material
more than
100 years
old?
No
Other
purposes
Is storage for a
specific research
project with
Research Ethics
approval?
No
Yes
HTA licence not required
however, if researchers retain
tissue for future, unspecified
research after the expiry of the
approval, a HTA licence will be
required
Yes
Yes
Are you storing
organs, tissue or
cells to distribute
to other
researchers?
No
Yes
Yes
HTA licence
not required
HTA licence
not required
HTA Licence
required
Figure 3 - Summary of licensing requirements
Last printed 09/02/2016 05:16
Are you storing
organs, tissue or
cells for a future
undefined project
or a project
without ethical
approval?
Page 17 of 98
HTA Licence
required
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
4.2.5. How are licenses assigned to premises?
The HTA licenses premises in three ways
1. Standalone premises,
2. Hub premises
3. Satellite premises.
Standalone premises are where an HTA licence covers a single premise only.
Where licensable activities are at different locations, such as a university carrying out
research on human tissues and/or cells on two different campuses (like Newcastle
University), one location (e.g. the main campus) can become the hub premises and the
second location (e.g. the International Centre for Life) can become a satellite of the hub.
Hub and satellite arrangement may be a useful licensing solution for large or complex
establishments, where the same type of activity is carried out under a single governance
system across multiple locations
This is summarised in Figure 4.
“Satellite
Site”
“Satellite
Site”
“Hub Site”
Main
licence
“Satellite
Site”
“Satellite
Site”
Figure 4 - Licensing Premises
Satellite premises must be under the same governance as the hub premises, including
supervision by the Designated Individual (DI). The DI is responsible for ensuring that suitable
practices are carried out at any licensed premises under their governance, and for ensuring
compliance with the HTA’s licensing conditions and standards. Management of a hub and
satellite premises requires the DI to put robust systems in place to ensure that the same
governance systems are implemented across all licensed premises.
The HTA expects the DI to make regular visits to any and all satellite premises to verify that
the governance systems are working in practice. Additionally, the HTA requires the DI to
Last printed 09/02/2016 05:16
Page 18 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
nominate, and inform the HTA, of appropriate individuals named “Person Designate” based
at each of the satellite premises to oversee the activities taking place under the licence. For
further information refer to section 4.2.7. To see the licensing of Newcastle University
premises, refer to section 5.
4.2.6. How do I apply for a new or adapted Human Tissue Act licence?
The process to apply for a new or adapted Human Tissue Act licence is provided in Figure 4.
As Newcastle University already holds a research and anatomy Human Tissue Act licence,
any requests to update these licences or to apply for a new licence must be made to the
Quality Assurance Manager or associated Designated Individual. Applications will be
reviewed by the Licence Holder in discussion with the Access and Governance committee.
For contact details, see section 5.3.
Where changes are deemed necessary, it is the Licence Holder who is responsible for
applying to the Human Tissue Authority to adapt the licence (see section 4.2.3).
For a full list of roles and responsibilities required under a Human Tissue Act licence,
including the Licence Holder, refer to section 4.2.3.
The licensing process is summarised in Figure 5.
Last printed 09/02/2016 05:16
Page 19 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
TO REQUEST A NEW HUMAN TISSUE ACT LICENCE
Proposed Licence Holder to submit a Research Compliance Report Application (CRA)
-Access CRA via HTA website & submit at least 3 months before required commencement date of work
HTA log the application on the licencing data base and send the applicant an invoice
Licence Holder (LH) must pay fees within 28 days of application (Designated Individual (DI) to ensure payment)
DI/LH have 10 days
to provide
requested material
Notification of intention to
make a representation
within 28 days to:
1. Director of Regulation
2. Head of Regulation
3. Regulation Manager
Phase I – Desk Review
Suitability of DI, LH, Premises and practices
assessed against codes of practice
Additional information sought where required
Denied
Licencing decision
Approved
DI & LH
wish to
appeal
DI & LH happy to continue
LH/DI to respond within 28 days
-
Substantive licence issued
To be displayed in licenced premises, including at satellite sites
Accepted
NEED TO ADAPT THE EXISTING LICENCE?
1 month later
Denied
Yes New licence required
Draft licence issued to DI & LH including any additional conditions
Contact the DI and NBB QA Manager
Is the change required a major change?
e.g. new sector licence/
new activity required
Licence holder sends a request to the HTA to
edit the existing licence e.g. add satellite site
No
Figure 5 - The Human Tissue Authority licensing process
Last printed 09/02/2016 05:16
Page 20 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
4.2.7. Roles and responsibilities under a Human Tissue Act licence
The HTA prescribe that three key roles are required under The Act. These are:
1. Licence Holder (LH)
2. Designated Individual (DI)
3. Persons Designate (PD)
These roles and the associated responsibilities as summarised in Figure 6 and explained in
full in Newcastle Biomedicine Biobank Standard Operating Procedure number 2 (NBB-SOP2). 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 these roles on the Newcastle University research HTA licence are
set out in section 5.3.
LICENCE HOLDER (LH)
LICENCE HOLDER
(LH)
• A corporate body, or named person, responsible for applying for
the Licence
• May apply to change the licence & substitute the DI
DESIGNATED INDIVIDUAL (DI)
DESIGNATED INDIVIDUAL
(DI)
• Named on the licence as the person under whose supervision
the licensed activity is authorised to be carried on
• In a position to ensure that activities are conducted properly,
by people who are suitable to carry out those activities, and
that all the necessary requirements are complied with
• Has primary (legal) responsibility under Section 18 of the
Human Tissue Act to secure:
o that suitable practices are used in undertaking the
licensed activity
o that other persons working under the licence are
suitable
o that the conditions of the licence are complied with
PERSON DESIGNATE (PD)
PERSON
DESIGNATE
(PD)
PERSON
DESIGNATE
(PD)
PERSON
DESIGNATE
(PD)
• A person to whom the Licence applies, and who is named
on the licence.
• The PD assists the DI in supervising the licensable activities
within their groups.
• May be located within a central hub, or at a satellite site,
covered by the same licence
• Multiple PDs may exist under the same licence
Figure 6 - Roles and responsibilities required under a HTA research licence
Last printed 09/02/2016 05:16
Page 21 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
4.2.8. What are the implications of not complying with the licence?
It is a licence requirement that no person shall conduct a licensed activity other than under
the authority of the licence granted. The offences recognised under The Human Tissue Act
are summarised as follows
Offences under The Human Tissue Act:
1. Removal, storage or use of human tissue for Scheduled Purposes (see section
4.2.2) without appropriate consent
2. Storage or use of human tissue donated for a Scheduled Purpose but used for
another purpose
3. Trafficking of human tissue for transplantation purposes
4. Carrying out licensable activities without holding a licence from the HTA
5. “DNA theft” i.e. having human tissue, including hair, nail and gametes with the
intention of its DNA being analysed without the consent of the person from whom
the tissue came from, or of those close to them if they have died. The exemptions
to this include medical diagnosis and treatment, criminal investigations
A person who contravenes this is seen to have committed an
offence unless he/she reasonably believes:


That what he/she does is not an activity to which the
licensed activities applies
That he/she acts under the authority of a licence.
Institutions which fail to comply with The Act face a number of enforceable penalties which
range from a fine, to up to three years’, imprisonment - or both. As the responsibility for
ensuring compliance rests with the Designated Individual, it is the DI who faces prosecution.
Non-conformance with the Act also has number of other significant implications for
researchers:





May invalidate any research conducted using the tissue
Risks the reputation of Newcastle University as a centre for excellence in
translational research
Risks the University’s reputation as an ethical research establishment
May result in a loss of public confidence in the ethics of medical research, limiting the
provision of future samples
Ultimately, removal of the University’s licence would remove the ability to store
human tissue for use in research, with significant consequences on the future of
research at Newcastle University
It is therefore of fundamental importance that all researchers work together with the DI,
PDs and Quality Assurance Manager to ensure high quality, ethical research across the
University.
Last printed 09/02/2016 05:16
Page 22 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
5. THE NEWCASTLE UNIVERSITY RESEARCH SECTOR HTA LICENCE
Newcastle University holds a Research sector Human Tissue
Act licence (No. 12534) which licenses the storage of human
organs, tissues and cells for research purposes other than for
a specific ethically approved research project.
i.e. the licence covers human tissue samples held in storage for future, yet unspecified,
research purposes.
Copies of the University’s licence can be found in Appendix E.
5.1.
What is covered by the Newcastle University research sector HTA
licence?
On the Newcastle University research HTA licence (ref. 12534) it can be seen that the
“licensable activity” covered is:
“Storage of a relevant material for a number of scheduled purposes”
(Licensable activity 4, listed in section 4.2.2).
The licence does not cover any of the other licensable activities named in section 4.2.2, for
example public display or anatomical examination. Should a researcher wish to conduct
these activities, a separate or adapted licence would be required.
The licence lists a number of “scheduled purposes” (activities which require consent) for
which a material can be stored for. These are:










Determining the cause of death
Establishing after a person’s death the efficacy of any drug or other treatment
administered to him
Obtaining scientific or medical information about a living or deceased person which
may be relevant to any other person (including a future person)
Public display
Research in connection with disorders, or the functioning of the human body
Clinical audit
Education or training related to human health
Performance Assessment
Public Health monitoring
Quality Assurance
Last printed 09/02/2016 05:16
Page 23 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
It should therefore be noted that:

This licence is for the “Storage” of relevant material for research, and does not
license the research itself.

For researchers to use the tissue stored at Newcastle University, NHS Research
Ethics Committee (REC) approval is required. For information on how to request
REC approval, see section 6.2.3.

Material may be stored for a range of purposes, such as, public display or
determining the cause of death (“scheduled purposes”).

However, this licence only covers the storage for these purposes. Should an
individual want to actually perform these activities, the appropriate licence would be
required (e.g. public display, or post mortem – see section 4.2.1).
For any researcher who wishes to store a tissue for a purpose not listed on the licence,
please contact the DI or Quality Assurance Manager for advice (see section 5.3 for contact
details). In this case it may be possible to:



Determine if the activity is covered by another sector licence held at the University
Apply to vary the existing licence – see section 4.2.6
Apply for a new Human Tissue Act licence – see section 4.2.6
5.2.
Premises
At Newcastle University, The Medical School, including the Paul O’Gorman building and the
Sir James Spence building is considered to be the “hub” with 4 satellite sites. Each of these
premises must display a copy of its associated HTA licence. The addresses of each of
these sites are provided below:

Licensed premises (Hub site):
Newcastle University
Named individual for correspondence: Chris Day
Newcastle University
The Medical School
Framlington Place
Newcastle Upon Tyne, NE2 4H
Tel: +44 (0) 191 222 6000 (switchboard)
Last printed 09/02/2016 05:16
Page 24 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014

Satellite Premises:
Institute for Ageing
and Health
Brain Tissue
Resource
Freeman Hospital
Respiratory
Institute of Genetic
Medicine
School of Agriculture,
Food and Rural
Development,
Nutrition
Edwardson Building
Newcastle
University
Campus for Ageing
and Vitality
Newcastle upon
Tyne
NE4 5PL
United Kingdom
Freeman Road
High Heaton
Newcastle Upon
Tyne
NE7 7DN
Human
Developmental
Biology Resource &
Cytogenetics
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)
Newcastle University
International Centre
for Life
Central Parkway
Newcastle upon Tyne
NE1 3BZ
Tel:
+44 (0)191 241 8616
Tel:
+44 (0)191 222 6900
Fax:
+44 (0)191 241 8666
Fax:
+44 (0)191 222 6720
5.3.
Roles and responsibilities under the Newcastle University
research sector HTA licence
As required by the Human Tissue Act, Newcastle University (see section 4.2.7) Newcastle
University has assigned a Licence Holder (LH) and Designated Individual (DI) to oversee the
licence.
As the University is spread over a wide campus, the DI has gained the support of a number
of Persons Designate (PDs) to oversee compliance with the Act in their local area. All PDs
have confirmed their acceptance of this role by signing a PD role description (see Appendix
B). This document has been scanned and stored electronically.
In addition, to support compliance, Newcastle University has implemented two additional
roles:

Quality Assurance Manager – to conduct internal inspections, training and develop
and maintain the quality management system.

Human Tissue Act Coordinator - Assigned at the discretion of the PD to support
the PD to ensure compliance in their local environment. This is not a requirement of
the HTA and bears no legal responsibilities; however it plays a vital support function.
A role description for a HTAC is provided in Appendix C.
An organogram is provided in Figure 7.
Last printed 09/02/2016 05:16
Page 25 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
LICENCE HOLDER
(LH)
Newcastle University
Named individual: Professor Chris Day
DESIGNATED INDIVIDUAL
(DI)
Professor Andy Hall
QUALITY ASSURANCE
MANAGER (QAM)
Mhairi Anderson
PERSON
DESIGNATE
(PD)
PERSON
DESIGNATE
(PD)
PERSON
DESIGNATE
(PD)
Human Tissue Act
Coordinator (HTAC) –
Voluntary role introduced by
Newcastle University
Figure 7 - Organisational chart - research sector HTA licence at Newcastle
University
The organisational structure of the Newcastle Biomedicine Biobank is provided in Figure 8,
setting out the tissue collections stored under the Newcastle University research sector HTA
licence.
Contact details for the key personnel under the University’s research sector HTA licence are
provided in Table 4. It should be noted that due to staff changes, these details are subject to
change. Should a Person Designate wish to be removed from the HTA licence, they should
contact the Quality Assurance Manager or Designated Individual. A new PD should then be
appointed, where required.
The most up to date list of Person’s designate named on the Newcastle University research
sector HTA licence can be found on the Newcastle Joint Research Office website on the
human tissue pages:
http://www.newcastlejro.org.uk/research-governance/research-involving-human-tissue3/newcastle-biomedicine-biobank/
In addition to these formal roles, it is the responsibility of all staff operating under the
University’s HTA licence to know their responsibilities under the Act, to treat donated
material with dignity and respect, and to protect the privacy of donors and maintain data
confidentiality.
Last printed 09/02/2016 05:16
Page 26 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
NEWCASTLE BIOMEDICINE BIOBANK
Licence Holder: Newcastle University
Designated Individual: Professor Andy Hall
HUB LICENCE – TISSUE COLLECTIONS
Dermatology
collection
PD: Carole
Todd
Uteroplacental
collection
PD: Mrs B Innes
Musculoskeletal
collection
PD: Tim
Williamson
Central Bank
collections
PD: Dr Amy Peasland
Paul O’Gorman
building
collection
PD: Dr Zoe
Davison
Mitochondrial
Disease
collection
PD: Debra Jones
Academic
Haematology
collection
PD: Prof. Anne
Dickinson
SATELITE LICENCES – TISSUE COLLECTIONS
Centre for Ageing and
Vitality (CAV)
Freeman Hospital
Centre for Life
PD: Dr Chris Morris
PD: Dr Chris Ward
PD: Prof. Susan
Lindsay
School of Agriculture,
Food and Rural
Development
PD: Wendy Bal
Figure 8 - Newcastle Biomedicine Biobank (NBB) organisational structure
Last printed 09/02/2016 05:16
Page 27 of 98
Dental
collection
PD: Dr Wendy
Dirks
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
Table 4- Names and contact details of key personnel on the Newcastle University
research sector HTA licence
Role
Name
Licence Holder (LH) Newcastle University
Professor Chris Day
for correspondence
Contact Details
Newcastle University
The Medical School, Framlington Place,
Newcastle Upon Tyne, NE2 4HH
Tel: +44 (0) 191 222 7003
Email: Chris.day@ncl.ac.uk
Designated
Individual (DI)
Professor Andy Hall
Northern Institute for Cancer Research
(NICR)
Paul O'Gorman Building, Medical School
Framlington Place,
Newcastle upon Tyne, NE2 4HH
Tel: +44 (0) 191 246 4411
Fax: +44 (0) 191 246 4301
Email:andy.hall@ncl.ac.uk
Quality Assurance
Manager and
Person Designate
Mhairi Anderson
Joint Research Office, Level 6, Leazes Wing,
Royal Victoria Infirmary,
Newcastle Upon Tyne, NE1 4PL,
Tel: +44 (0) 191 282 5501,
Fax: +44 (0) 191 282 4524
Email: mhairi.anderson@newcastle.ac.uk
Person Designate
Central Biobank
Dr Amy Peasland
Person Designate
Paul O’Gorman
Building
Dr Zoe Davison
Person Designate
Human Nutrition
Mrs Wendy Bal
Last printed 09/02/2016 05:16
Newcastle Biomedicine Biobank
4th Floor Leech Building
Medical School
Framlington Place
Newcastle upon Tyne, NE2 4HH
Email: amy.peasland@ncl.ac.uk
Telephone: +44 (0) 191 282 4285
Northern Institute for Cancer Research
Paul O'Gorman Building, Medical School
Newcastle University, Framlington Place
Newcastle upon Tyne, NE2 4HH
+44 (0) 191 246 4442
Email: zoe.davison@ncl.ac.uk
Human Nutrition Research Centre
School of Agriculture, Food and Rural
Development
University of Newcastle
Agriculture Building, King's Road
Newcastle upon Tyne, NE1 7RU
Tel: +44 (0) 191 222 6619
Email: wendy.bal@ncl.ac.uk
Page 28 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
Role
Name
Person Designate
Centre for Life
Professor Susan
Lindsay
Person Designate
Centre for Ageing
and Vitality
Dr Chris Morris
Person Designate
Freeman Hospital
Dr Chris Ward
Person Designate
Musculoskeletal
collection
Tim Williamson
Person Designate
Uteroplacental
collection
Barbara Innes
Person Designate
Dental school
Dr Wendy Dirks
Person Designate
Mitochondrial
Disease collection
Mrs Debra Jones
Last printed 09/02/2016 05:16
Contact Details
Institute of Human Genetics
Newcastle University,
International Centre for Life , Central Parkway
Newcastle upon Tyne, NE1 3BZ
+44 (0) 191 241 8656
Email: susan.lindsay@ncl.ac.uk
Medical Toxicology Centre,
Wolfson Unit of Clinical Pharmacology,
Claremont Place,
Newcastle Upon Tyne, NE2 4AA
+44 (0) 191 222 5827
Email: c.m.morris@ncl.ac.uk
Institute of Cellular Medicine (Respiratory)
and ICaMB Room Cookson 1.072, Floor1 ,
Cookson Building Medical School
Newcastle University
Newcastle upon Tyne, NE2 4HH
0191 222 8460
Email: chris.ward@ncl.ac.uk
Laboratory Technician
Institute of Cellular Medicine,
4th Floor, William Leech Building
Medical School Framlington Place, Newcastle
University, Newcastle upon Tyne NE2 4HH
Email: timothy.williamson@ncl.ac.uk
Institute of Cellular Medicine
3rd Floor, William Leech Building
The Medical School
Framlington Place, Newcastle University,
Newcastle upon Tyne, NE2 4HH
+44 (0) 191 222 7160
Email: barbara.innes@ncl.ac.uk
School of Dental Sciences and Institute of
Cellular Medicine, Framlington Place,
Newcastle University,
Newcastle Upon Tyne, NE2 4BW
+44 (0) 191 222 8193
Email: wendy.dirks@ncl.ac.uk
Institute for Ageing and Health
Mitochondrial Research Group
4th Floor Catherine Cookson Building
The Medical School, Framlington Place,
Newcastle upon Tyne, NE2 4HH
+44 (0) 191 222 5137
Email: debra.jones@ncl.ac.uk
Page 29 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
Role
Name
Contact Details
Person Designate
Academic
Haematology
Professor Anne
Dickinson
Haematological Sciences
Institute of Cellular Medicine
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4HH
+44 (0) 191 208 6794
Email: anne.dickinson@ncl.ac.uk
5.4.
What does this mean for researchers?
All researchers storing human tissue under the University’s research Human Tissue Act
licence have a responsibility to know and abide by the Human Tissue Act regulations.
Researchers should be aware of cases in which material has to be stored under the licence,
must disclose this material to the Person Designate or Designated Individual, and must store
the material appropriately in a suitable designated storage location.
In accordance with the terms and conditions of the University’s research HTA licence, the
Designated Individual (DI) must be aware of all relevant material stored at the University.
This includes all relevant material stored for research ethics committee approved research
where a Human Tissue Act licence is not required for the storage of the material. Therefore,
regardless of the method of obtaining tissue, all researchers storing relevant material at the
University have a responsibility to disclose this material to the DI.
Guidance on how researchers can obtain, store, track and dispose of material is contained in
sections 6 to 9. Information on the Quality Management System adopted at the Newcastle
Biomedicine Biobank is provided in Section 10.
Last printed 09/02/2016 05:16
Page 30 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
6. OBTAINING TISSUE
A number of different options are available for researchers to obtain tissue, either for
immediate use in a research project, or for storage for future, yet unspecified research.
These methods are summarised in section 6.1. Regardless of the method of obtaining
tissue, all researchers have a responsibility to ensure that all human tissue is obtained
ethically, and the researcher must be satisfied that appropriate consent is in place for the
samples that have been obtained. The consent requirements under the Human Tissue Act
are therefore set out in section 6.3.
6.1.
How do I obtain tissue?
There are three main options available for researchers for obtaining tissues:
1. Obtaining pre-existing tissue from a biobank
2. Collect new tissue
3. Purchase material from a commercial supplier
These options are summarised in Figure 9 below, and described in full in sections 6.2.1, to
6.2.3.
Denied
no
Tissue
(Relevant
material)
required
Is tissue
available/
eligible from a
pre-existing
Biobank?
yes
OPTION 1:
Discuss
access with
tissue
custodian
yes
Is appropriate
consent in
place to
conduct the
research?
yes
Custodial review by
tissue collections
Access &
Governance
Committee
Complete application
form with supporting
evidence for use and
submit to tissue
custodian
no
no
OPTION 3:
Purchase material from
a commercial supplier
OPTION 2:
Arrange new tissue
collection
Applicant applies for
Research Ethics
Committee (REC)
approval to use the
tissue through IRAS
Approval
denied
Approved
no
Apply for research ethics committee approval
to collect new tissue through IRAS or…
yes
apply to collect new tissue as part of a REC
approved research tissue bank
Approval
granted
Ensure appropriate
consent is in place
Is the tissue stored
as part of an REC
approved research
tissue bank AND the
project within the
scope of the bank?
Tissue released for
use using an MTA
for external
organisations
Approval granted
Collect
Tissue
Biobank
Human tissue act licence
not required during REC
approval duration
Approval
granted
REC approval expires
Has sample been
destroyed/used up?
yes
Email DI to confirm that no
sample is remaining
no
Approval
denied
Apply for extension
of REC approval
yes
no
Do you wish to extend
the REC approval?
Residual tissue must be
transferred to a biobank.
Apply to the DI , or set up a
new REC approved biobank
Figure 9 - Obtaining tissue for use in research
Last printed 09/02/2016 05:16
Page 31 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
6.2.1
OPTION 1 - Obtaining pre-existing tissue from a Biobank
A “Biobank” is a collection of human tissues, cells
and blood that can be used for medical research, or
for other purposes. It can contain many different
types of biological samples (e.g. tissue samples,
DNA and blood) and information (e.g. health
records, diet and lifestyle information, and family
history of disease, gender, age, and ethnicity)
The samples held in biobanks enable researchers to generate data sets large enough to
ensure statistical significance, thus aiding data comparability and strengthening scientific
data.
Researchers may apply to access human tissue stored in biobanks to use in their research.
There are many biobanks located at Newcastle University (see section 5.3) throughout the
United Kingdom and internationally.
If a material is available, to use material stored as part of a biobank researchers must:


Submit an access request to the tissue bank custodian for review, and,
Obtain Research Ethics Committee (REC) approval to use the material – where
appropriate.
Step 1: Submit an access request to the tissue custodian

Once it has been identified that a tissue of interest is stored in a biobank, a
researcher must contact the tissue custodian to discuss access.

A formal application to access samples must then be submitted by the researcher
specifying the proposed use of the sample. Tissue collections should have a formal
access policy with clear steps to be followed.

Access requests will be reviewed by an Access Committee based on scientific merit,
sample availability and consent in place, other research proposals and the ethics of
the proposed research. Often laypersons are asked to sit on access committees to
review the use of human tissue in research from a public perspective and enhance
public engagement. Details on the membership & terms of reference of this
committee are provided in section 10.9.2

The researcher will be informed of the outcome of the application and inform the
applicant if they need to obtain ethical approval to use the samples (step 2). The
provision of tissue may incur some handling costs.
Last printed 09/02/2016 05:16
Page 32 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
As the Human Tissue Act licenses only the storage of material in biobank, to use the
material stored in biobanks, researchers must apply for Research Ethics Committee
approval to use the material. However, some tissue collections may already have ethical
approval in place to use the samples in research. These banks are called “Research Tissue
Banks”.
What is a Research Tissue Bank?

Research Tissue Banks (RTBs) are tissue collections that have prospectively gained
generic Research Ethics Committee (REC) approval for a broad range of future
research to be carried out by the establishment responsible for the bank and/or by
other researchers to whom tissue is released by the bank within the conditions of the
ethical approval.

As a condition of approval, research tissue banks must create access policies which
document the procedures for processing applications to use the bank, the conditions
of access and any governance requirements. Researchers must then apply to use
the bank, and requests are reviewed by an access committee in line with the banks
access policy.

A significant advantage of gaining REC approval as a research tissue bank is that
this negates the need for researchers to obtain separate REC approval for every item
of research they wish to conduct using tissue - providing that the research to be
conducted falls within the scope of the ethical approval that has been granted.

Applications for tissue banks to become research tissue banks is not a legal
requirement, however, ethical approval for an RTB may have benefits by facilitating
programmes of research without a need for individual project-based ethical approval.

Such approval may be given for a period of up to five years and may be renewed
What does this mean for researchers?


If the required tissue is stored as part of a Research Tissue Bank and the proposed
research falls within the scope of the ethical approval that has been granted,
provided the Access Committee approve the request, the researcher can use the
tissue without the need to seek any further REC approval.
However, the custodian reserves the right to audit the recipient’s use of samples if
this is considered necessary, and regular progress reports on the research project
must be provided to the tissue custodian as part of an annual submission to the REC
that approved the tissue bank. This may include study progress, sample quality,
findings and publications.
Last printed 09/02/2016 05:16
Page 33 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014


Researchers may also be requested to acknowledge the biobank as the source of
samples used in their research
If the tissue is not stored as part of a research tissue bank and ethics is not in place
to use the material, researchers must obtain REC approval to use the material (step
2).
For any queries relating to the availability of human tissue at the Newcastle Biomedicine
Biobank, please refer to the Newcastle Biomedicine Biobank website (www.ncl.ac.uk/nbb) or
contact us using the following contact details:
Newcastle Biomedicine Biobank
Faculty of Medical Sciences, 4th Floor Leech Building
Newcastle upon Tyne
NE2 4HH
Telephone enquiries: +00 44 191 282 4285
General email enquiries: biobank@ncl.ac.uk
Pricing and Central Banking Enquiries: amy.peasland@ncl.ac.uk
Step 2: Obtain Research Ethics Committee (REC) approval to use the material – where
appropriate.
Researchers can apply to use human material using the Integrated Research Application
System (IRAS) accessed by https://www.myresearchproject.org.uk/.
The application
process is summarised in Figure 10.
For full information refer to the NRES website: http://www.nres.nhs.uk/applications/. For
any advice/support in completing this process, please refer to the Newcastle Joint Research
Office Website: www.newcastlejro.org.uk/contact us.
NOTE:
Possession of current or pending ethical approval for a specific research project negates the
need for a Human Tissue Act licence to store the material for the duration of the ethical
approval.
However, on expiry of the ethical approval, a Human Tissue Act licence is required to govern
the storage of any residual material. The researcher then has the following options:



Apply to extend the REC approval and continue the project
Transfer of the material to HTA licensed premises (for designated storage locations
at Newcastle University, refer to Figure 8)
Dispose of the tissue (see section 9).
Last printed 09/02/2016 05:16
Page 34 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
Complete on-line IRAS APPLICATION FORM from the IRAS website
https://myresearchproject.org.uk/Signin.aspx
Applications for new Research tissue banks should be flagged to ensure the correct REC is involved
Complete the APPLICANTS CHECK LIST to ensure that all paperwork required to support the application is sent to the REC
-Include a copy of the Human Tissue Act Licence for applications for a new Research Tissue Bank
•
Decide where to apply and BOOK AN AGENDA SLOT at the next meeting of an appropriate REC. Bookings can be made either:
direct with a local REC in the NHS domain in which the research is to be conducted. Applications for new research tissue banks are allocated
centrally, however these may be reviewed locally.
• or via the Central Allocation System (CAS) depending on the nature of your project
SUBMISSION
•
•
Booking confirmation sent by email, with a unique REC reference number and the closing date for the application.
• Add REC reference number to the online application form, with the name of the NHS REC and submission date.
Submit Parts A and B of the application electronically to the allocated REC within 4 working days of the booking, also sending paper copies of:
• Application form with ink signatures , Applicant's Check List , All relevant supporting documents,
VALIDATION
Validation letter issued within 5 working days, acknowledging submission and confirming validity
SITE-SPECIFIC INFORMATION FORM
For multi-site research, PIs at each site must apply for SSI by completing Part C of the completed application and submit it to the Local REC (LREC)
with area responsibility for that particular site, along with a copy of his/her CV.
Site specific assessor notifies the main REC undertaking the ethical review of any objection to the research on site-specific grounds within 25 days.
ETHICAL REVIEW MEETING BY REC/NOTIFICATION OF DECISION
Notification of decision within 60 days of receiving valid application. Notification of the decision within 10 working days of the review meeting
Final decision
DENIED
Provisional decision –
One request for further written information
60 day clock stops during data collection
APROVAL
No opinion –
referee needs to be consulted
RESEARCH COMMENCE
WITHIN 12 MONTHS OF APPROVAL
Figure 10 - The Integrated Research Application System (IRAS) process
Last printed 09/02/2016 05:16
Page 35 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – March 2014
6.2.2. OPTION 2 – Collect new tissue
Where a new tissue collection is required and NHS patients are involved, researchers must
gain ethical approval to collect the tissue. This can be arranged by either
1. Applying to collect new tissue through the Integrated Research Application System
(IRAS) – see Figure 10.
2. Apply via IRAS to set up a new Research Tissue Bank to build a tissue collection
over time - see Figure 10.
3. Applying to the curators of an established Research Tissue Bank to collect new
tissue under the tissue banks pre-existing ethical approval.
Note that institutions wishing to establish a new research tissue bank (option 2), must
implement documented access policies and procedures, including procedures for processing
applications, the conditions of access and any governance requirements. This process must
be made known to potential applicants.
The QA Manager and/or Designated Individual must be consulted by any group wishing to
establish a new research tissue bank under the Newcastle University research sector HTA
licence and the DI must sign off the REC application on IRAS. To enhance governance,
efforts should be made wherever possible to avoid the unnecessary creation of additional
research tissue banks, where the tissue collection may be feasible under a pre-existing
research tissue bank.
6.2.3. OPTION 3 – Purchasing material from a commercial supplier
Although it is illegal to sell relevant material for transplantation, it is not illegal to sell this
material for research purposes and many commercial suppliers have relevant material
available for purchase. However, researchers wishing to purchase relevant material must be
confident that they have purchased material from a reputable source, and that appropriate
consent is in place for the samples.
Where researchers wish to import human bodies, body parts
or tissue into England, Wales and Northern Ireland, they
should be able to demonstrate that the purposes for which
they wish to import such material cannot be adequately met by
comparable material available from sources within those
countries, or is for a particular purpose which justifies import.
This process will help importers to assure themselves of the
integrity of the material and that, as a minimum, it has been
sourced with appropriate consent. They should be able to
satisfy themselves and document the need for importing in
terms of accessibility, quality, timeliness of supply, risk of
infection, quality of service, cost effectiveness, or scientific or
Last printed 09/02/2016 05:16
Page 36 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
research need. Such documentation should be available for
inspection by the HTA. Furthermore, it is good practice for approval to be obtained from a
research ethics authority or the local equivalent in the source country beforehand. For more
information on importing material, please refer to Code of Practice 8, “Import and export of
human bodies, body parts and tissue” (see Section 4.1.1).
Last printed 09/02/2016 05:16
Page 37 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
6.3.
Consent
Consent is the principle that a person must give their permission
for their tissues to be retained or used. The principle of consent
is an important part of medical ethics and the international
human rights law, and is a fundamental underlying principal of
the human tissue act.
The key principles of consent under the HTA, including cases where consent is not required,
are summarised in sections 6.3.1 to 6.3.5, below. The HTA’s full requirements for consent
are set out in Code of Practice 1; “Consent” (see section 4.1.1) and in the consent standards,
as set out in Appendix A, part 1.
6.3.1. Which activities require consent?
Before deciding whether to proceed with the removal, storage or use of tissue for
scheduled purposes, researchers should consider if the activity requires consent.
Under the terms of the Human Tissue Act (2004), consent must be obtained for the
removal, storage and use of human tissue or organs for certain “scheduled
purposes”. Scheduled purposes (i.e. activities requiring consent) are set out in Table
3 on page 13. However, in broad terms, the Act and the HTA's codes of practice require
that consent is required to:
1. store and use dead bodies
2. remove, store and use relevant material from a dead body
3. store and use relevant material from the living
However, a number of exemptions exist in which consent is not required.
Exemptions?
Tissue from the living may be stored for use and/or used without consent, provided that:


the research is ethically approved
the tissue is anonymised such that the researcher is not in possession, and is
unlikely to come into possession, of information identifying the person from whose
body the material has come.
This does not mean that samples must be permanently and irrevocably unlinked –linking can
be made through a third party where necessary – nor that the persons holding the samples
cannot themselves carry out the research. If members of the clinical team take part in the
research, links may be retained to the relevant clinical or patient records, but they must not
contain information giving direct patient identification.
Last printed 09/02/2016 05:16
Page 38 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
In general, obtaining consent is preferable to developing complex systems for keeping
samples unlinked. It represents best practice and has the added benefit of facilitating the
process of obtaining ethical approval.
Further exemptions where samples may be stored or used without consent include:




“Existing Holdings”: As law cannot be applied retrospectively, it is not a
requirement to have consent in place for samples collected before the
implementation of the Human Tissue Act on 1st September 2006. These samples are
classed as Existing holdings. However, a HTA licence is required to store these
materials.
Tissue for DNA analysis which is anonymised
Tissue from the deceased which has been imported
Tissue taken from the living which is anonymised and has received ethical approval
for research without consent
Consent requirements under the Human Tissue Act (2004) are summarised in Figure 11.
For full information see Code of Practice 3.
Was the tissue retained for research
before 1st September 2006?
yes
no
Consent not required
however to ensure best
practice consent should
always be sought
Tissue is classed as an
“Existing Holding”
yes
Is the tissue to be used for DNA
analysis?
yes
Is the tissue anonymised?
no
yes
Is the tissue from the deceased?
no
Qualifying consent is
required (that from living
person DNA has been
derived from)
yes
Is the tissue imported?
no
Appropriate consent is
required
no
Will the tissue be identifiable to the
researcher?
no
Seek ethical approval
for use without consent
Is the tissue from an adult
lacking mental capacity to
consent?
yes
no
Has ethical approval for research
without consent been granted?
no
yes
Appropriate consent is
required
See clinical trials
regulations 2004 & Mental
Capacity Act 2005
yes
Consent not
required
Figure 11 - Requirements for consent under the Human Tissue Act
While informed consent is not a legal requirement in some cases, it is best practice to
ensure that consent is in place where practical. In addition, the HTA has the power to deem
consent to be in place for relevant material from someone who is untraceable, or who has
Last printed 09/02/2016 05:16
Page 39 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
not responded to requests for consent to use of his/her material, if that material could be
used to provide information relevant to another person.
6.3.2. Who can give consent?
The term “Appropriate Consent” is used by the Human Tissue Act to define who may give
consent. Consent is ideally obtained from the individual themselves, either while they are
living, or after their death, as an expression of their wishes. For children, assent may be
given directly by the child, if it is considered that the child is competent to do so.
However, if the wishes of the deceased are unknown, or if a child is considered not to be
competent to make a decision, a nominated representative will be asked to make decisions
relating to donation, where applicable.
If a nominated representative has not been appointed, then the appropriate consent can be
given by someone in a qualifying relationship.
A summary of qualifying relationships, and the order in which they are ranked, is provide in
Figure 12.
Friend of long standing
Ranked 8th
Sibling
Ranked 3rd
Grandparent/ Grand child
Ranked 4th
Niece/Nephew
Ranked 5th
Spouse/Partner
(including civil/same sex partner)
Ranked 1st

Step parent
Ranked 6th
Half brother/sister
Ranked 7th
Parent or child
Ranked 2nd
Individual consent
 Taken from the living, or,
After death as expression of wishes
Figure 12 - Qualifying relationships to provide appropriate consent
It should be noted however, that a nominated person cannot consent to the use of material
for public display or for anatomical examination. Direct consent is required in these cases.
Last printed 09/02/2016 05:16
Page 40 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
6.3.3. Are there different types of consent?
Donors may be asked to give consent for their tissues to be stored/ used for either project
specific purposes, with exemptions (tiered) or for generic research, as described in Table 5.
Table 5 - Types of consent
Type of consent
Application
Project specific
Where the patient only consents to the use of their tissues in a specific
research project
Where a number of “opt-outs” are available that a donor can select, for
example, where the donor does not wish their samples to be
Tiered
Generic




Used commercially (e.g. Provided to pharmaceutical companies)
Used for DNA analysis
Used in animals
Exported
Where the patient provides broad consent (in terms of duration and
scope) for the tissue to be used in unspecified research
It is recommended to request generic consent, where ever possible to avoid the need to
return to the donor to ask for further consent to use the sample in additional research, and
prevent the unnecessary disposal of samples when a research project ends
It is essential that researchers understand what type of consent has been granted, and do
not use tissues out with the terms of the patients consent. Information on the type of
consent granted by donors, including any specific wishes, and the location of signed consent
forms, should be kept alongside sample information in sample tracking systems, and made
clearly visible to those accessing samples. All patient identifiable data should be kept
confidentially in secure systems, and only accessed by individuals with the authority to do so.
The availability of signed consent forms and security of patient data can be audited at any
time by internal or external auditors (the Human Tissue Authority) to ensure that samples are
being stored and used in accordance with donor wishes and confidentiality maintained.
6.3.4. How is consent taken?
Last printed 09/02/2016 05:16
Page 41 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
The person taking consent does not necessarily have to be the clinician responsible for the
patients care (nurse, doctor), but it does have to be someone suitably trained and aware and
able to communicate any risks or benefits of the associated donation. Records must be
made available to demonstrate up-to-date staff training in taking consent, and competency
assessed and maintained.
In cases where a third party (e.g. another organisation) takes consent and collects samples
on your behalf, a Service Level Agreement (SLA) or other formal agreement should be in
place to ensure that consent is obtained in accordance with the Code of Practice on Consent
(Code 1) and the HT Act Part 1.
Consent does not have to be given in writing (i.e. by
signing a consent form). Although it is easier to
demonstrate that consent is in place if it is written,
non-written consent (taken verbally, or non-verbally
e.g. hand gesture) may be taken provided that an
explanation is put into the notes, and is witnessed to
explain the reason why consent is not written.
To be valid, consent must be:



Voluntary: Consent must be given voluntarily, by an appropriately informed person
who has the capacity to agree to the activity in question
Informed: The person who is giving the consent must have a clear appreciation and
understanding of the facts, implications, and future consequences of an action. To
ensure this, all necessary information must be provided by the person taking consent.
This is classed as “informed consent”
Appropriate: The information provided must be appropriate, and take into
consideration the age and mental capacity of the individual giving consent, and any
potential language difficulties. Interpreters, Braille, or large font may be provided
where appropriate.
All groups should ensure that their consent process (whether taken personally or by a third
party) is documented, for example a Standard Operating Procedure (SOP), including the
procedure for providing information on consent.
6.3.5. Can consent be withdrawn?
When a person gives consent for relevant material to be used for a Scheduled Purpose, that
consent remains valid unless the person withdraws it.
Consent can be withdrawn at any time, however if samples have already been used for a
Scheduled Purpose (e.g. research), withdrawal of consent does not mean all relevant results
Last printed 09/02/2016 05:16
Page 42 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
should be withdrawn from the research project. This should be clearly stated on the consent
form, and communicated to the donor.
In some instances it may not be possible to withdraw consent after sample donation, for
example, where the sample has been used immediately and cannot be returned. In these
instances, this must be clearly stated on the consent form.
All groups should have systems in place to ensure that where consent has been withdrawn,
there are methods to remove samples from use (where appropriate).
Last printed 09/02/2016 05:16
Page 43 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
7.
STORAGE
The HTA does not stipulate exact requirements for the storage of
relevant material; however, the premises must be ‘fit for purpose’.
This means that areas used for storage of human tissue for use in
research must provide an environment that is safe for those working
under the licence and preserves the integrity of the tissue.
Furthermore these conditions must be maintained regardless if a
tissue is to be held only for a short period of time, or if there are only
a few items held under the authority of the licence.
In addition, patient data should be appropriately stored, and confidentiality maintained
The HTA’s general requirements for sample storage and the options available for
researchers wishing to store relevant materials under Newcastle University’s research
licence are provided below. For details of the HTA standards relating to premises, facilities
and equipment (PFE) refer to Appendix A part 3.
7.1.
Sample storage requirements
Human tissue should be stored in line with good practice on:
Security
 Risks such as theft or damage must be considered.
 Lockable storage facilities, alarm systems and indelible identification marking of
human tissue should be used, if appropriate
Maintenance
 Establishment and equipment must well maintained and critical equipment subject to
a program of planned preventative maintenance, validation and repair
 Equipment/surfaces must be clean, with a clear decontamination/cleaning policy,
Monitoring

Critical storage conditions should be monitored and recorded

Establishment must have 24 hour contingency arrangements in place should there
be an emergency situation that renders the premises unsuitable for storage, including
instructions for contacting key personnel out-of hours and assessing the impact of
emergencies should they occur.
Traceability
 Records should detail the location of the materials including information about risk.
Health and safety
 Staff should have sufficient space to work, and access to appropriate protective
clothing, materials and equipment to ensure safe working
 Regular temperature monitoring or control, or ventilation must be considered, where
appropriate. See the safety office website: https://safety.ncl.ac.uk/home.aspx
Last printed 09/02/2016 05:16
Page 44 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014

Environmental controls should be in place to avoid potential contamination
Transportation and handling
 Systems should be in place to protect the quality and integrity of human samples
during transport and deliver to a destination
 Methods should consider the safety of all staff and others who may come into contact
with the tissue during transfer.
7.2.
Data storage and protection
The Human Tissue Act storage requirements also apply to the storage of data. Data relating
to donated samples may be either:
•
Identifiable data – Data which clearly link to a
particularly individual e.g. name, address, date of
birth or NHS number.
•
Coded/link-anonymised data – Data which cannot
directly identify an individual, but can be
reconnected back to the donor, if required, by the
use of a controlled code.
•
Anonymised data – data which cannot be linked
back to the original donor, as all links have been
removed.
Generally researchers use anonymised patient data wherever possible. However,
sometimes it is necessary to access information that can directly or indirectly identify a
specific individual.
In the UK, the use of patient data is tightly controlled within a
complex regulatory and governance framework. All personal
information must be stored, handled and disposed of in
accordance with the Data Protection Act (1998).
The Data Protection Act (gives individuals the right to know
what information is held about them, and provides a framework
to ensure that personal information is handled properly.
Researchers must therefore always ensure that where patient identifiable data is stored,
confidentiality is maintained in compliance with the terms of The Act, including the use of
secure, password protected computer systems with restricted access.
Researchers wishing to store or use patient identifiable information from NHS patients must
apply for permission to do so.
Last printed 09/02/2016 05:16
Page 45 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
Governance of data storage:

Following the 1997 report of the Review of Patient Identifiable Information, chaired by
Dame Fiona Caldicott) large NHS organisations (and non-NHS organisations using
the data) must now nominate an appropriate Caldicott Guardian to act as the
'conscience' of the organisation, and review requests to store or use patient data.

Researchers wishing to store patient identifiable data must therefore apply to the
appropriate Caldicott Guardian, detailing the purpose of using confidential
information and how confidentiality will be maintained.

Access should be on a strict need-to-know basis, and data security protected in
password protected computer systems, with restricted access.

Where patient data is stored by groups working at Newcastle University, evidence
must be made available to prove that approval has been granted to store this
information.
The Caldicott application asks for information on the WHO, WHY AND WHERE of patient
identifiable data.
If you wish to store patient names, initials, date of birth, address, or any other patient
identifiable information, you will be asked




WHO will have access to the data
WHAT data will be stored
WHY it is needed, and
WHERE the data will be stored.
The Caldicott Guardian may contact you to suggest alternatives.
For researchers using tissues and data from the Newcastle upon Tyne Hospitals Trust
patients, the Caldicott Guardian can be contacted at caldicott@nuth.nhs.uk.
Or, for other NHS Trusts, consult the Newcastle Joint Research Office:
http://www.newcastlejro.org.uk/contact/
7.3.
What are the options available for storage at Newcastle University?
Relevant material which requires storage under the Human Tissue Act at Newcastle
University must be stored at one of the designated storage locations listed in Figure 8.
These storage locations are maintained to high quality standards and are regularly audited
to ensure compliance with the regulations. However, the first point of contact should always
be the Central Biobank as the University’s primary storage facility. To request to store
material at one of these locations, researchers should contact the appropriate Person
Last printed 09/02/2016 05:16
Page 46 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
Designate or the Designated Individual (for contact details refer to Table 4). Storage may
incur a fee.
Any researcher wishing to store material elsewhere (for example, in their own laboratory)
should contact the Designated Individual or Quality Assurance Manager for approval.
However, to ensure best governance, Newcastle University aims to reduce the number of
tissue collection held across the establishment, and consolidate collections where possible.
Researchers who wish to set up a tissue collection themselves must therefore provide a
sufficient justification to do so. Any new tissue collections which are established must meet
the requirements of the Human Tissue Act and are susceptible to audit at any time by the
Quality Assurance Manager or the Human Tissue Authority.
Relevant material which has research ethics committee approval in place for its use does not
need to be stored under the Act for the duration of the ethical approval. Therefore, there are
no HTA stipulations as to where this material is stored.
However, on expiry of the ethical approval, a Human Tissue Act licence is required to govern
the storage of any residual material.
The researcher then has the following options:



Apply to extend the REC approval and continue the project
Transfer the material to HTA licensed premises (for designated storage locations at
Newcastle University, refer to Figure 8)
Dispose of the tissue (see section 9).
These options are summarised in Figure 13
Last printed 09/02/2016 05:16
Page 47 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
I wish to store relevant material at
Newcastle University
Do you have current REC approval in
place to use the tissue?
no
Material must be stored under the Human Tissue Act. Where
do you wish to store the relevant material.
yes
End
no
The material can be stored at any
appropriate location at Newcastle
University for the duration of the
REC approval (outwith the scope of
the Human Tissue Act)
Option 1:
As part of the
preapproved tissue
collections shown in
Figure 8
Option 2
In your own laboratory, not
part of one of the preapproved
tissue collections shown in
figure 8
REC approval expires
Contact the appropriate
Person Designate for the
collection
Contact the Quality Assurance
Manager or Designated
Individual for advice
Do you have any remaining residual
material?
Approval
granted
yes
Do you wish to extend the REC
approval for the project?
yes
Apply to extend REC
approval for the project
Approval
denied
no
Do you wish to keep the remaining
residual material?
yes
no
Dispose of the material and inform
the R&D team that the project is
complete & there are no remaining
samples
Figure 13 - Storage options for relevant materials at Newcastle University
7.4.
Subcontracting storage
In some cases it may be preferable to subcontract the storage of relevant material to another
organisation. In this case the suitability of the 3rd party should be assessed before
undertaking a contract (e.g. audit of facility, review of compliance). A formal agreement
should be signed to formally confirm these storage agreements.
7.5.
Appropriate storage period
In order to demonstrate respect for human tissue, and ensure the best use of any donated
material, it is best practice to ensure that any tissue which is available for use in medical
research is made available to the research community and access opportunities promoted.
Last printed 09/02/2016 05:16
Page 48 of 98
Quality Manual for HTA Research Licence (No. 12534) Edition 2.0 – Jan 2014
In addition, the Human Tissue Authority recommends that institutions implement systems
which state the frequency of review of collections and the criteria for disposal/further storage.
These policies should take into account the duty to the donor to make good use of their
samples.
To enhance access to valuable tissue collections for research, details of tissue collections
available for use will be communicated by the Newcastle Biomedicine Biobank website:
www.ncl.ac.uk/nbb.
Last printed 09/02/2016 05:16
Page 49 of 98
8. SAMPLE TRACKING
As traceability is a fundamental principle of the Human Tissue Act, it is essential that records
are maintained which provide an audit trail throughout the lifespan of the sample (i.e. from
collection, transfer, storage, and use, through to disposal).
Sample tracking can be undertaken by many means, but records of how many samples are
in storage at any one time is key for HTA reporting. Each institute working under The Act
must therefore have a secure, clear and documented sample tracking system in place which
includes a clear process for tracking the import and export of samples from/to countries
outside England, Wales and Northern Ireland.
The fundamental principles of sample tracking are set out in Code of Practice 9 (Research)
and in HTA standards on Governance and Quality (see Appendix A, part 2). A summary of
the key principles is provided in section 8.1. Sample transfer agreements are explained in
section 8.2.
8.1.

Key Principles of sample tracking
Each establishment should have a clear labelling system for human tissue and all
human tissue must be assigned a unique code in order to ensure traceability. Ideally
a Laboratory Information Management System (LIMS) should be used.

Record-keeping must include the
o
Location of the human tissue (e.g. fridge/freezer)
o
A description of the tissue & specific donor requests
o
Consent details: Location of signed consent forms,
type of consent (specific, tiered, generic)
o
Sample history – where it was obtained, transfers,
any adverse events relating to the sample, etc.

The researcher must be able to trace all samples and their derivatives back to its
original consent (unless an exemption applies) and retrieve it within a timely manner.
It is best practice to receive a copy of the signed consent record with each sample
however; this must only be accessed by authorised personnel to maintain donor
confidentiality.

An audit trail must be maintained to document the chain of custody, e.g. the names
of the person that the sample has been transferred from/to (see section 8.2).

Once a sample has been issued for processing, there is no longer an HTA
Last printed 09/02/2016 05:16
Page 50 of 98
requirement to further track the sample; however it is good practice to have records
of the processed samples and where they are located.

8.2.
Traceability must be maintained through to sample disposal (see Section 9).
Material and data transfer
In line with the HTA’s policy on traceability, the transfer of
relevant material must be tracked.
If human tissue is
transferred between establishments, consideration must
therefore be given to safety, and minimising the likelihood of
theft, damage or loss during transport.
In addition, data
should be carefully controlled during transfer to protect donor
confidentiality.
Therefore, some form of formal arrangement, should define how the human tissue and any
associated data is protected, any potential contamination risks associated with the material,
and who is responsible for disposal if applicable (Code of Practice 9, section 112).
Two such methods used at the University to track the transfer of relevant material and
associated data are:
1. Material Transfer Agreements (MTAs)
2. Service Level Agreements (SLAs)
These transfer agreements are managed by the following two teams:


Grants and Contract (G&C) Department
o Joint Research Office, Level 6, Royal Victoria Infirmary, Newcastle Upon
Tyne, NE1 4PL (www.newcastlejro.org.uk)
Intellectual Property (IP) & Legal Services Team
o Research & Enterprise Services, Research Beehive, Old Library Building,
Newcastle upon Tyne, NE1 7RU
(http://www.ncl.ac.uk/res/about/office/intellectual/legal.htm)
For incoming material (i.e. material coming into Newcastle University), or outgoing material
(i.e. material going out of the University) researchers should submit the appropriate
questionnaire to allow the transfer to be set-up:


Incoming Material Questionnaire:
o http://forms.ncl.ac.uk/view.php?id=1682
Outgoing Material Questionnaire:
o http://forms.ncl.ac.uk/view.php?id=1698
The transfer of biological samples must comply with safety requirements for sample
transport in line with UN3733 standards. The processes which must be followed to arrange
a material transfer, including safety requirements, are provided in NBB-SOP-07.
Last printed 09/02/2016 05:16
Page 51 of 98
In some instances, the terms of the transfer may be covered by another formal agreement
e.g. a collaboration agreement, or protocol. In these instances researchers must be
confident that the arrangement satisfies the requirements of the HTA regulations. For any
queries, please contact the Grants and Contracts team (www.newcastlejro.org.uk/contact).
Last printed 09/02/2016 05:16
Page 52 of 98
9. SAMPLE DISPOSAL
As the collection and use of Human Tissue is considered to be a precious gift, according to
the underlying principles of The Act, to make the best use of samples, sample destruction
should be avoided unless it is absolutely necessary – for example.



If the integrity of the samples has been irretrievably compromised
If the patient has withdrawn consent for use
If the ethical approval or consent for a study dictates that samples must be destroyed
at the end of a particular study.
However, where sample destruction is required, researchers must be aware of the ethical
consideration, and associated requirements under the Human Tissue Act. Researchers
should therefore consult Code of Practice 5: Disposal of Human Tissue.
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code5disposal.c
fm?faArea1=customwidgets.content_view_1&cit_id=713
The key requirements of disposal are summarised below. For full disposal standards as set
out by the HTA, see Appendix A, part 4. For the Newcastle Biomedicine Biobank disposal
policy, refer to the Newcastle Biomedicine Biobank website (www.ncl.ac.uk/nbb/governance).
9.1.
Key considerations in sample disposal
There are particular sensitivities relating to the use and disposal
of tissue, therefore it is essential for researchers to recognise the
nature of the material being handled, the sensitivity of the feelings
of the donors and the bereaved. This may be particularly
sensitive in cases following pregnancy loss.
What does this mean for researchers?

Where researchers are responsible for collecting human tissue, processes should be
in place to inform individuals, or their relatives, how tissue will be disposed of after
use. Staff should be prepared to discuss the issue of disposal, explaining the options
available and who will be responsible for any associated costs.

Staff should be appropriately trained, and be familiar with the establishment’s
arrangements, including what is available locally, basic legal requirements and the
options available to those wanting to make their own arrangements to dispose of
tissue. Where appropriate, such information should be available in writing for people
to take away with them. They may wish to discuss it with relatives or community
members before making their choice.

Staff should be sensitive to cultural/religious and language differences, whilst being
aware that choices are for the individual or relative to make.
Last printed 09/02/2016 05:16
Page 53 of 98
What does this mean for researchers...?

9.2.
Prior to disposal, donor consent and any decisions made by an Ethics Committee
regarding disposal should be examined to determine the donor wishes.
Disposal options
Depending on whether the tissue is from the deceased or the living, a number of different
disposal options are available, which must be carefully selected. These are summarised in
figure 14.
Is the Tissue from the living?
no
Tissue is from the deceased
yes
For surplus
tissue
For “Existing Holdings”
i.e. samples held prior to
1st September 2006
For pregnancy
loss before 24
weeks gestation
For surplus
tissue
For “Existing Holdings”?
i.e. samples held prior to
1st September 2006
For stillbirths or
neonatal deaths?
Dispose via
incineration
Dispose via incineration
Burial/Cremation
or incineration
(where
appropriate) may
be requested
Dispose via
incineration
Is the material
identifiable?
Cremation or
burial
Dispose via
incineration/
burial
Dispose via
incineration/
burial or
cremation
Figure 14 - Sample disposal options
In general however, the disposal of any tissue should be handled in accordance with any
reasonable wishes expressed by the donor or their relatives, as long as the method of
disposal is legal. Whichever method of sample disposal is utilised, appropriate
documentation of the disposal route must be maintained.
9.3.
Maintaining proper documentation
In accordance with the Human Tissue Act’s requirements for sample tracking (see Section 8)
establishments must ensure that they have systems in place to maintain proper records and
documentation for all tissue they acquire or pass on to others. This includes at minimum:
 The date/time of disposal
 The method of disposal (route used & place)
 Reason for disposal
Last printed 09/02/2016 05:16
Page 54 of 98
This information should be recorded in the tissue tracking database used within each
department, in accordance with local policies/procedures and these records must be made
available to auditors on request to demonstrate sample traceability throughout its full
lifecycle. Decisions regarding the retention period for this documentation will be made at a
department level in line with the establishments documented policy.
9.4.
Preventing unnecessary waste of human tissue
To avoid any unnecessary destruction of human tissue, which may have otherwise been
kept for use in valuable research, generic consent for research should be sought where ever
possible (see section 6.3). The provision of generic consent ensures that tissues can be
retained for further use, hence promoting the most effective use of the tissue. However,
requests for generic consent must be treated on a case-by-case basis, and handled
sensitively by the requestor.
Last printed 09/02/2016 05:16
Page 55 of 98
10. THE QUALITY MANAGEMENT SYSTEM (QMS)
Failure to comply with the HT Act is a criminal offence. Where any
institution is shown to have failed to comply with its responsibilities
under The Act, the institution may face a number of serious
consequences.
To promote high quality standards at Newcastle University, and
ensure compliance with The Act, a Quality Management System
(QMS) has been implemented. This system is described below.
10.1. The Quality Manual
This Quality Manual sets out the key features of the Human Tissue Act, and Newcastle
University’s responsibilities under its remit. The aims of this manual are set out in section 2.
All researchers working under Newcastle University’s Human Tissue Act licence must
therefore abide by the standards set out in this manual. The manual can be accessed
electronically, via the human tissue pages of the Newcastle JRO website
(http://www.newcastlejro.org.uk/research-governance/research-involving-human-tissue3/newcastle-biomedicine-biobank) or through the Q-Pulse document management system.
When printed, this manual expires within 7 days.
10.2. Document Management
10.2.1. Document Management System
All biobanks should establish and maintain a procedure to control all documents that form
part of their QMS, and comply with HTA standards on Governance and Quality (see
Appendix A, part B).
The Newcastle Biomedicine Biobank (NBB) Q-Pulse is the
document management system adopted by the Newcastle
University to act a central repository for all Human Tissue
Act related documents.
As a central access point, Q-Pulse provides a controlled environment to ensure quality
documents are version controlled, and regularly reviewed. As printed versions of quality
documentation expire after 7 days; Q-Pulse provides access to the most up-to-date versions
of documentation. Additional documentation, such as the HTA newsletter and external
communications may be stored in this location for communal access.
Online access to Q-Pulse is through the following link:
http://qpulse.ncl.ac.uk/QPulse5Web/UI/Open/Login.aspx
Last printed 09/02/2016 05:16
Page 56 of 98
A user name and password can be granted by the Quality Assurance Manager.
All quality documents relating to the general management of the Newcastle Biomedicine
Biobank will also be uploaded on the human tissue pages of the Newcastle Joint Research
Office website under the section “Human Tissue Resources and FAQs”:
http://www.newcastlejro.org.uk/research-governance/research-involving-human-tissue-3/
All groups working under the University’s research sector HTA licence should have access
to this website, and read and record training in the quality documents uploaded, where
appropriate.
When a new/edited document has been uploaded, the Quality Manager will contact all
Persons Designate by email to highlight the presence of the new document, and stress the
need for staff to read these documents and record training.
Appropriate document retention periods will be determined on a case by case basis within
groups.
Group specific quality documents (SOPs, policies, training documents etc.) may be stored at
the group’s discretion until the review of the Q-Pulse document management system is
complete. Documents may be in hard copy or electronic and may be digital, photographic or
written, provided that document management complies with the HTA quality standards:



All aspects of the establishments work must be supported by ratified documents,
policies and procedures as part of the overall governance process.
o Policies and procedures should be in place to cover all licensable activities,
and be approved by authorised personnel
o Documents must be legible, easily identifiable and readily available
o Documents must contain a unique identifier, the review date or date of issue,
version number, total number of pages and the name of the authoriser
o Appropriate risk management systems must be in place
o There must be a documented system of quality management and audit
A document control system should be in place covering all quality documents, which
is regularly audited
o Change control should be in place for the implementation of new or revised
operational procedures
There must be a systematic and planned approach to the management of records
o Documented procedures must be in place for the creation, amendment,
retention and destruction of records
o There must be back-up/recovery facility in the event of loss of records
In addition, biobank management at each tissue collection should ensure that a master list is
maintained of all groups documents which are currently authorised for use and their location.
These standards will be assessed by the Quality Assurance Manager during internal audits.
Last printed 09/02/2016 05:16
Page 57 of 98
10.2.2. Documentation supporting the QMS
A number of documents have been created to support the Quality Management System at
the Newcastle Biomedicine Biobank, including Standard Operating Procedures, policies and
risk assessments.
The process adopted for managing Standard Operating Procedures (SOPs) at Newcastle
Biomedicine Biobank (creation, amendment, retention and destruction of records) has been
documented as part of NBB-SOP-01, found on the human tissue pages of the NJRO website.
http://www.newcastlejro.org.uk/research-governance/research-involving-human-tissue3/newcastle-biomedicine-biobank
In addition to this SOP, the Newcastle Biomedicine Biobank has implemented a core set of
SOPs and policies which must be adhered to by al groups working under the University’s
Research HTA licence. The aim of these documents is to implement a consistent set of
standards across the University in relation to key aspects of the Act. A list of these
documents (denoted “NBB-SOP-" or “NBB-POL”) is provided in Table 6
Table 6 - List of NBB SOPs and policies available on the Newcastle Joint Research
Office website
Document
NBB-SOP-1
NBB-SOP-2
NBB-SOP-3
NBB-SOP-4
NBB-SOP-5
NBB-SOP-6
NBB-SOP-7
NBB-POL-2
NBB-POL-3
Title
Document Management – The lifecycle of Standard Operating Procedures
at the Newcastle Biomedicine Biobank (creation, retention, amendment and
removal)
Roles and Responsibilities under the Newcastle University Research
Human Tissue Act Licence (Ref. 12534)
Adverse Event Reporting under the Human Tissue Act at the Newcastle
Biomedicine Biobank
Internal Audit Procedure for Research Groups Covered by the Human
Tissue Act Licence (Ref. 12534)
Induction and training of staff working at the Newcastle Biomedicine
Biobank under the research Human Tissue Act licence (Ref. 12534)
Complaints procedure under the HTA research licence (Ref. 12534)
The Transfer of Human Material into and out of Newcastle University under
the Newcastle University HTA research licence (Ref. 12534)
Disposal of Human Tissue Stored under the Research Human Tissue Act
Licence (Ref. 12534)
Consent of Human Tissue Stored under the Research Human Tissue Act
Licence (Ref. 12534)
Additional documents may be added to this website at any time, including other
SOPs/policies related to the work under the Human Tissue Act. Therefore researchers
should always refer to the website to access the most up-to-date list.
In addition to these core documents, it is recommended that all groups working under the
HTA have records in place which document their local procedures and provide evidence that
activities are being performed in compliance with the requirements of the Quality
Last printed 09/02/2016 05:16
Page 58 of 98
Management System. Each group should therefore have documented policies and
procedures which cover all aspects of activity relating to their biobank, including but not
limited to consent, collection, storage, release and transport of tissue and data, the
management of the biobank and its adherence to applicable quality and regulatory standards.
These topics, and information that should be included, are summarised in Table 7.
A separate SOP is not required for each topic (topics can be combined) however each group
should ensure that they sufficiently document their local procedures such that they are easily
understandable (e.g. by auditors, new starters, other staff).
Table 7 - Recommended topics to be included in local SOPs
Topic
To include
Sample receipt, storage
and tracking
Details on the banks procedure for receiving, logging and
tracing samples to ensure traceability. Any local procedures for
transferring samples should also be described.
Access policy
Tissue collections, in particular research tissue banks, must
have a formal access policy in place to document the procedure
to follow for requesting and reviewing access to samples.
Consent
The procedure for providing information on consent and the
consent process. Where consent is managed by 3rd party,
information should be provided on how evidence of consent is
obtained, and where consent forms are stored. See section 6.3
Training
Department specific methods for identifying training
requirements and recording training
Temperature monitoring
Methods used to ensure sample integrity is maintained. E.G.
Freezer monitoring system used, UPS, emergency rota.
Equipment maintenance &
calibration
Methods and frequency of equipment maintenance and
calibration and where this information is stored.
Cleaning &
decontamination
Methods, frequency and documentation methods.
Contingency (disaster)
planning
Procedures to be followed in the event of equipment/system
failure.
Risk assessment and
safety
Methods for conducting and documenting risk assessments in
the local environment.
Disposal
Disposal methods and recording disposal.
Last printed 09/02/2016 05:16
Page 59 of 98
Note that this list is not exhaustive, and groups may have other SOPs in place to document
local practices. All SOPs must be made readily available to all staff and inspectors (e.g.
through Q-Pulse) and training provided and documented. A series of policies and SOPs
have been written for use by PDs and users under the HTA research licence.
10.2.3. Risk assessments
It is an HTA standard that appropriate risk management systems are in place to protect staff
and samples. Risk assessment of the establishment’s practices and processes must be
completed regularly to ensure they are fit for purpose, and recorded and monitored
appropriately.
Risk assessments templates can be obtained from the Newcastle University Safety Office
website: https://www.safety.ncl.ac.uk/riskassessment.aspx
For any further advice, please contact the QA Manager (see contact details in section 5.3).
10.3. Adverse events
An adverse event is any occurrence which threatens, or has the potential to threaten, the
integrity of samples, and/or associated data, the safety of staff, or undermines good practice.
Adverse events, or near misses, will be managed according to NBB-SOP-3. All corrective
and preventative actions must be managed in a timely manner to maintain the integrity of
samples, protect patient data and ensure staff safety.
10.4. Complaints
Complaints relating to the University’s research sector HTA licence, received either internally
(from University staff) or externally (from other organisations), should be managed in
accordance NBB-SOP-6. Researchers should contact their local Person Designate in the
first instance, or contact the QA Manager. All complaints should be managed promptly, and
escalated where necessary.
Last printed 09/02/2016 05:16
Page 60 of 98
10.5. Validation and change control
For computer systems that support HTA relevant material or
clinical trial material, such as the document control system QPulse, validation may be required dependent on the complexity of
the system being utilised.
In addition, in the case of critical procedures, processes,
equipment (such as freezers), facilities or utilities may need to be
qualified to ensure they are secure and appropriate for use.
In all cases a risk assessment should be completed to ensure
that the level of validation is proportionate to the risk and
establish which elements require validation. Validation may be
conducted as part of the manufacturer installation process, in
which case regular checks may be made to maintain the
validation e.g. through a maintenance contract to provide
calibration of the system.
Changes to systems which have previously been validated, or
hold a validation exemption certificate need to be controlled to
maintain the validated state. These changes must be assessed
to determine what level of re-validation or testing is required to
test the new functionality, or to document the reason why no
further testing is required.
Change control should be managed following discussion with the Quality Assurance
Manager.
10.6. Audit
Official inspections reviewing compliance with the Human Tissue Act are conducted on a
regular basis. These audits may be either:


typically conducted by the Quality Assurance Manager or
Designated Individual.
May be self-inspection audits within groups

conducted by the Human Tissue Authority
Internal audits -
External audits -
The format of each audit type, and what researchers can expect, is set out in NBB-SOP-4.
Audit frequency will be conducted based on a risk analysis. All internal HTA audit reports
conducted by the Quality Assurance Manager will be stored electronically and can be
provided to regulators on request.
Last printed 09/02/2016 05:16
Page 61 of 98
10.7. Training
It is essential that all staff working with human tissue under The Act are appropriately trained
in the techniques relevant to their work and are continuously updating their skills. All staff
should therefore receive appropriate training, which is appropriately documented. The
documentation of training may be managed at the each group’s discretion; however on
inspection this documented evidence must be readily available on request (e.g. records
confirming attendance at training courses). The qualifications of staff (e.g. CV, job
description) should also be readily accessible.
As part of their induction, new starters must be provided access to all relevant SOPs and
procedures, any other associated material (e.g. COSSH assessments), as appropriate. Staff
appraisal/review should be regularly conducted to review competence, and further training
conducted where necessary.
Training can also be obtained from the following sources:
E-Learning
A Newcastle Biomedicine Biobank Human Tissue Act E-Learning package is
due for completion in Summer 2014. For further information, please contact
the QA Manager.
The QA Manager and DI host regular Human Tissue Act training courses.
For training dates, and information on how to register, please refer to the
human tissue pages of the Newcastle Joint Research Office:
http://www.newcastlejro.org.uk/research-governance/research-involvinghuman-tissue-3/newcastle-biomedicine-biobank/
For further information, or to request additional training dates, please contact
the Quality Assurance Manager
In addition to these training sessions, the CLRN (Clinical Research Network)
offer a range of training including Good Lab Practice, and Informed Consent
and Ethics. This is available to research staff working in the NHS who are
Class room
training



working on NIHR Portfolio Studies
or funded by NIHR or its Clinical Research Network
and employed by the NHS or have an honorary contract or a ‘Letter
of Access’
However this may apply to Newcastle University staff in some instances.
Staff should refer to the CLRN training webpage for full information, including
how to register for courses:
http://www.crncc.nihr.ac.uk/about_us/ccrn/ntw/news/training_form
Safety related training can be obtained through the safety office:
https://safety.ncl.ac.uk/training.aspx.
For other University training, please refer to the Staff Development Unit
(SDU): http://www.ncl.ac.uk/staffdev/
Last printed 09/02/2016 05:16
Page 62 of 98
10.8. Communication with stakeholders
To ensure that Human Tissue Act related news, issues and opportunities are communicated
to all staff working with human tissue, it is the responsibility of the Persons Designate to hold
regular, minuted meetings to communicate with staff in their local area.
The Newcastle Joint Research Office website has also been updated to include Human
Tissue Act pages which can be readily accessed by staff, which includes a summary of the
regulations and resources which can be used by researchers.
http://www.newcastlejro.org.uk/research-governance/research-involving-human-tissue-3/
In addition, the Quality Assurance Manager issues regular HTA newsletters, which are
distributed across the University to Persons Designate, Institute Managers and other
relevant parties. Newsletters are also added to the human tissue pages of the Newcastle
Joint Research Office website:
http://www.newcastlejro.org.uk/research-governance/research-involving-human-tissue3/newcastle-biomedicine-biobank/
To facilitate communication and knowledge share between the Persons Designate, a joint
mailing account has also been established that can be used by anyone at the University:
person-designate-res@newcastle.ac.uk
Details of all tissue collections will be provided on the Newcastle Biomedicine Biobank
website (www.ncl.ac.uk/nbb).
Last printed 09/02/2016 05:16
Page 63 of 98
10.9. Governance
10.9.1. Management commitments
To ensure compliance with The Act, the Designated Individual, Persons Designate and
Quality Assurance Manager have ultimate responsibility for the implementation of the Quality
Management System (QMS). These individuals will have oversight of the biobank and will
be responsible for its day to day operation, organisation and policies. It is their role to
provide leadership and demonstrate commitment towards continually reviewing and
improving the QMS.
In the absence of the Designated Individual, a Person Designate will be delegated to
represent the DI.
Bi-annual meetings are held between the management committee, to review and discuss the
University’s licence, and address any issues in line with the biobank management’s
governance policy.
Governance Policy
The objectives of this management review are:
a) To review HTA activity across the facility, including the hub and all satellite sites.
b) To establish that the QMS is achieving the expected results and meeting regulatory
requirements,
c) To establish that the QMS is continuing to satisfy researchers needs and
expectations, and functioning in accordance with the established Standard Operating
Procedures.
d) To expose irregularities or defects in the System, identify weaknesses and evaluate
possible improvements.
e) To review the effectiveness of previous corrective actions, and to review the
adequacy and suitability of the QMS for current and future operations of the Biobank
f) To review any complaints received, identify the cause and recommend corrective
action if required.
g) To review the finding of internal/ external audits and identify any areas of recurring
problems or potential improvements.
h) To review the reports of nonconforming items and trend information to identify
possible improvements.
i) To review any updates in policy from the HTA and their effect on internal systems.
Last printed 09/02/2016 05:16
Page 64 of 98
During management meetings, the biobank management committee will review the progress
reports submitted by research tissue banks. If a collection or sub-collection appears to be
under used this will be further investigated, including a review of the biobanks access policy.
The consent, collection and release of tissue from collections held under the Newcastle
Biomedicine Biobank tissue collections will be managed by the appropriate tissue custodian
in line with local access policies and arrangements for ensuring ethical approval for research.
For research tissue banks, it is the individual curators’ responsibility to maintain the ethical
approval status of the Research Tissue Banks and provide annual progress reports to the
appropriate research ethics committee.
A list of all current approved research tissue banks will be held on the Newcastle
Biomedicine Biobank website (www.ncl.ac.uk/nbb).
These parameters will be assessed during internal HTA audits conducted by the QA
Manager.
10.9.2. Access and governance committee
In addition, an access and governance committee have been established to review
applications for access to tissue from University biobanks. The remit and terms of reference
of this committee are provided below.
I.
Ensure measures are in place to achieve compliance
with the HTA
a. Grant permission to store tissues and withdraw
permission if necessary
b. Undertake review of internal audit reports
c. Oversee the submission of periodic reports to
the HTA (when introduced)
II.
Provide independent oversight of the operation of generic biobanks
a. Approve the constitution of access review committees prior to approval by the
DI of applications to LREC for the establishment of generic biobanks.
b. Facilitate access review if requested
c. Review annual reports to LREC
III.
Oversee interactions with commercial partners
a. Approval of commercial arrangements
b. Oversight of commercial strategy group
The Governance Board will include
I.
II.
III.
IV.
The PVC of Faculty of Medical Sciences (the HTA licence holder) (Chair)
The Designated Individual for the University HTA research licence
The Dean of Research
The Dean of Medicine
Last printed 09/02/2016 05:16
Page 65 of 98
V.
VI.
VII.
VIII.
The Research Operations Manager, Newcastle upon Tyne Hospitals NHS
Foundation Trust and Newcastle University (Secretary)
The HTA Quality Assurance Manager
An external representative
At least one lay member
Meetings will be held approximately every 6 months with additional ad hoc meetings as
required. Between meetings approvals will be circulated to members as required- with a 2week deadline from submission.
10.9.3. Laypersons
Lay persons play a vital role in the activities of the Newcastle Biomedicine Biobank by
providing feedback from a lay perspective, representing the public, and ensuring that
Biobank processes are designed with full consideration of patients and the public. They also
help to make participant information more appropriate and accessible to increase awareness
and participation in research activities, particularly in less easily accessed communities.
To ensure best practice at least one layperson should be a member of any
steering/management/operations or access committees. A laypersons role description and
information pack can be obtained from the QA Manager or DI, and suitable training will be
provided.
Responsibilities include:





Attend the bi-annual Access and Governance meeting and other meetings, as
required
Engage with other lay persons and donors to gain an appreciation of the public
perception of biobanking to allow biobank processes and communications to be
enhanced
Engage with the public, particularly across minority groups, to provide feedback on
different viewpoints in medical research.
Review documents and other resources (e.g. websites) intended for donors to ensure
that suitable language is used, format is appropriate and easily accessible
Provide feedback on applications to use human tissue stored as part of the Biobank
to ensure that the research is ethical. Lay summaries will be provided.
Last printed 09/02/2016 05:16
Page 66 of 98
11. APPENDICES
11.1. APPENDIX A - Minimum and best practice standards for the use of
human samples for research conducted by staff employed by
Newcastle University
The following table provides researchers with the “minimum” and “best” practice standards
for the use of human samples for research at Newcastle University. However researchers
should always strive to achieve best practice, wherever possible.
Furthermore, it is recommended that these standards should be applied to all human
samples, including DNA, regardless if they are included in the scope of the Human Tissue
Act (i.e. relevant & non-relevant material, and samples held with or without research ethics
approval) to promote best practice at all times.
This section is divided into 5 parts
Part 1:
Consent
Part 2:
Quality systems
Part 3:
Governance
Part 4:
Premises, facilities and equipment
Part 5:
Disposal
Last printed 09/02/2016 05:16
Page 67 of 98
PART 1 – CONSENT STANDARDS
Consent Standards
C1
Consent is obtained in accordance with the requirements of the Human Tissue Act (2004)
and as set out in the code of practice
Minimum practice:
 Consent forms comply with the HTA’s
Code of Practice
 Consent forms are in records and are
made accessible to those using or
releasing relevant material for a
scheduled purpose
 Where applicable, there are agreements
with third parties to ensure consent is
obtained in accordance with the
requirements of the HT Act 2004 and the
HTA Codes of Practice
C2
Best practice:
 Researchers should aim to obtain generic
consent wherever possible to avoid the
need to obtain further consent in the
future, and to make the best use of
available samples.
 Where DNA is to be used in genetic
testing/ research, this should be included
in the patient information leaflet and
associated consent form.
 Other options in tiered consent should
also be included where appropriate e.g.
commercial use, export, use in animals
 Copies of blank consent forms should be
obtained as part of the material transfer
agreement to ensure that they comply
with the HT Act 2004 and the HTA’s
Codes of Practice & capture sufficient
information
 As tissue samples and consent forms may
be received at different times for some
tissue banks, consent forms should be
routinely audited to provide further
assurance that valid consent is in place
for all samples.
 Agreements with third parties, including
the location of consent forms and
methods for confirming that consent is in
place, should be documented in a consent
SOP.
Information about the consent process is provided and in a variety of formats
Minimum practice:
Best practice:
 Standard Operating Procedures (SOPs)
detail the procedure for providing
information on consent
 Independent interpreters are available
when appropriate
 Information is available in suitable
formats
Last printed 09/02/2016 05:16
 Where appropriate, information should be
made available in a number of different
formats, such as large font, audio tapes,
videos, computer programmes, Braille
Page 68 of 98
Consent Standards
C3
Staff involved in seeking consent receive training and support in the implications and
essential requirements of taking consent
Minimum practice:
Best practice:
 Standard Operating Procedures (SOPs)
detail the consent process

 Evidence of suitable training of staff
involved in seeking consent
 Records demonstrate up-to-date staff
training
 Competency is assessed and
maintained
Last printed 09/02/2016 05:16
 Training record files should ideally be
available for all staff documenting all
training completed, reading records &
competencies
 Training should be repeated every 3 years
at minimum
Page 69 of 98
PART 2 – GOVERNANCE AND QUALITY SYSTEMS STANDARDS
Governance and Quality Systems Standards
GQ1
All aspects of the establishments work are supported by ratified documented policies and
procedures as part of the overall governance process
Minimum practice:
 Policies and procedures are in place
covering all licensable activities
 Appropriate risk management systems
are in place
 Regular governance meetings are held;
for example health and safety and risk
management committees, with agendas
and minutes
 Complaints system
GQ2
Best practice:
 A Quality Manual is in place for
licensable activities, referencing the
University’s policies on consent, records
management and disposal of human
tissue and the relevant codes of practice.
 The Newcastle Biomedicine Biobank
maintains core quality documents
covering all activities related to the
storage of relevant material for research.
 Documents uploaded into document
management system (e.g. QPulse),version controlled and regularly
reviewed
 A documented back-up/recovery facility
exists in the event of loss of records
 Risk assessments regularly reviewed to
ensure they reflect current practice.
 Risk management approaches are
expanded to cover, for example, the
security and confidentiality of paper
records;
 Agendas and minutes made available
electronically to ensure that they can be
accessed by all appropriate personnel.
 Staff meetings should be held not less
than every 3 months
 Complaints system clearly visible on
website or other suitable visible location
 Complaints system to include internal
complaints (e.g. staff, students) and
external complaints (public)
There is a documented system of quality management and audit
Minimum practice:
Best practice:
 A document control system covering all
documented policies and standard
operating procedures (SOPs)
 All documents should be identified in a
document control database which
records review dates
 Paper versions of quality documents
marked as only valid for 7 days after
printing.
 PDs read quality documents and ensure
these are made available/ highlighted to
Last printed 09/02/2016 05:16
Page 70 of 98
Governance and Quality Systems Standards
GQ3
all relevant research staff
 Systems in place to ensure the regular
review of quality documents (e.g. regular
self-inspection)
 An audit trail should show any changes
to electronic records, who made the
changes and the date
 Self-inspection audits with results fed
back to the NBB QA Manager
 Schedule of audits
 Internal audits conducted every 2 years
at a minimum
The change control system should
incorporate the requirements to
undertake an assessment of the risks
 Change control mechanisms for the
associated with the change, to validate
implementation of new operational
fully any new technique and procedures
procedures
before they are introduced and to
monitor the potential cumulative effects
of multiple minor changes.
Staff are appropriately trained in techniques relevant to their work and are continuously
updating their skills
Minimum practice:
Best practice:
 Qualifications of staff and training are
recorded, including records showing
attendance at training
 CVs and job descriptions available on
request for all staff
 Individuals have their own training record
files with up to date information and
attendance certificates where applicable.
 Reading of quality documents is
recorded
 Orientation and induction programmes
 Documented training programme (e.g.
health and safety, fire, risk
management, infection control)
including development training
GQ4
 All staff should complete HTA training
every 3 years at minimum
 Continuing Personal Development
(CPD) in place
 Basic GCP/GLP training to highlight the
interests of patients at all times.
 Training and reference manuals
 Provision of a quality manual
 Staff appraisal/review records and
personal development plans are in
place
 Competency regularly assessed
There is a systematic and planned approach to the management of records
Minimum practice:
 Documented procedures for the
creation, amendment, retention and
destruction of records
Last printed 09/02/2016 05:16
Best practice:
 All biobank documents should be
identified with the document title, author,
owner, approver, date issued, version
Page 71 of 98
Governance and Quality Systems Standards
number and for paper-based systems, a
copy number.
 Superseded versions of documents
should be archived and copies removed
from circulation.
 A description of changes made should
be included in revised documents.
 Regular audit of record content to check
for completeness, legibility and
accuracy
 Back-up/recover facility in the event of
loss of records
 Review of documents every 2 years at
minimum, with new versions issued.
 Documented back up/recovery systems
made available.
 Systems ensure data protection,
confidentiality and public disclosure
(whistle-blowing)
GQ5
There are documented procedures for distribution of bodies, body parts, tissues or cells.
GQ6
A coding and records system facilitate traceability of bodies, body parts, tissues and
cells, ensuring a robust audit trail
Minimum practice:
Best practice:
 There is an identification system which
assigns a unique code to each donation
and to each of the products associated
with it
 An audit trail is maintained which
includes details of when and where the
bodies/body parts were put, when the
bodies/body parts were transferred and
to whom
Last printed 09/02/2016 05:16
 Process in place to ensure participant’s
wishes are checked before forwarding
their material, and notification given to
receiving organisation of their wishes if
required.
 The audit trail contains full details of
consent (i.e. specific, tiered generic
consent and location of signed consent
form), full details of where samples were
received from and sent to.
 A suitable transfer agreement (e.g. MTA
/SLA) is used where appropriate
 Risk assessment of transportation
method includes verification of
maintenance of cold conditions where
necessary by use of data loggers, with
data retained on file.
Page 72 of 98
Governance and Quality Systems Standards
GQ7
There are systems to ensure that all adverse events are investigated promptly
Minimum practice:
Best practice:
 Investigation check-list completed, and
adverse event report provided to QA
Manager and DI in accordance with
NBB-SOP-03
 PD and associated staff register to
receive e-newsletters from HTA.
 Systems to receive and distribute
national and local information (e.g. HTA  Regular internal HTA newsletter with
communications)
PD distribution to relevant employees
 Use of email distribution lists
Risk assessments of the establishments practices and processes are completed regularly
and are recorded and monitored appropriately
Minimum practice:
Best practice:
Safety office template used
 Documented risk assessments for all
(https://www.safety.ncl.ac.uk/riskassessme
practices and processes
nt.aspx)
 Risk assessments are reviewed when
appropriate
 Staff can access risk assessments and
are made aware of local hazards and
training
 Corrective and preventative actions are
taken where necessary and
improvements in place are made
GQ8
Last printed 09/02/2016 05:16
Page 73 of 98
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
 Policies are in place to ensure that the
premises are secure and confidentiality is
maintained
PFE2
Biobanked samples and associated data
should be in restricted areas (e.g. locked
cabinets, card key access, password
protected databases).
Environmental controls are in place to avoid potential contamination
 Appropriate separation of relevant
material
 Air classification system and maintenance
of air quality including control and
monitoring of environmental conditions
 Documented cleaning and
decontamination procedures
PFE3
 Risk assessment may be in place to
assess risk associated with sample
use/handling
 Staff are provided with appropriate
protective equipment and facilities that
 Visitors don protective garments to
minimise risk of contamination
the same level as staff, even if they
are not in direct contact with the
samples.
There are appropriate facilities for the storage of bodies, body parts, tissues and cells,
consumables and records
 Relevant material, consumables and
records are stored in suitable
 Fridges/freezers are locked when in
environments and precautions are taken
areas assessable to general
to minimise risk of damage or theft and
laboratory personnel.
ensure the security of holdings
 EMS (environmental monitoring
 Critical storage conditions are monitored
systems) in place to facility conditions
and recorded
(e.g. temperature, humidity)
Last printed 09/02/2016 05:16
Page 74 of 98
Premises, Facilities and Equipment Standards

PFE4





PFE5




 Alarm system is checked for correct
working on a minimum once a month
basis.
 Web based
 Freezer temperature is recorded by
an independent device on a 24 hour
basis.
 Records indicate exact location of the
sample including for example building
(storage facility) & freezer
 Fire safes used for backup tapes and
system software for critical equipment
and for critical documentation e.g.
validation documentation, backup
manual procedures for emergency
use.
System to deal with emergencies on a 24
hour basis
 UPS (Uninterruptible Power Supply)
available to storage area
 Provision of formal contingency plan
(e.g. as a SOP) with clear roles and
responsibilities and back-up
arrangements e.g. 3rd party providers
Systems are in place to protect the quality and integrity of bodies, body parts, tissues
and cells during transport and delivery to a destination
Documented policies and procedures for
the appropriate transport of relevant
 MTA or SLA in place
material, including a risk assessment for
transportation
A system is in place to ensure that
traceability of relevant material is
maintained during transportation
Records of transportation and delivery
Records are kept of transfer agreements
with recipients of relevant material
Records are kept of any agreements with
courier or transport companies
Equipment is appropriate for use, maintained, quality assured, validated and where
appropriate, monitored
Records of calibration, validation and
maintenance, including any agreements
with maintenance companies
Users have access to instructions for
equipment and receive training in use and
maintenance where appropriate
Staff aware of how to report an equipment
problem
Contingency plan for equipment failure
Last printed 09/02/2016 05:16
Page 75 of 98
PART 4 – DISPOSAL
Disposal Standards
D1
There is a clear and sensitive policy for disposing of human organs and tissue
Minimum practice:
Best practice:
 Documented storage policy
 Efforts should always be made to
prevent unnecessary sample disposal
(e.g. seek extended consent for use)
to prevent wastage and make best
use of tissue.
 Clinical waste must be disposed of
separately from general waste to
demonstrate respect for material
 Policy is made available to the public
 Compliance with health and safety
recommendations
D2
Disposal is documented
 The reason for disposal and the methods
used are carefully documented
 Tracking database includes all
tracking to exhaustion of sample in
use including any processing
derivatives made, transfer to another
establishment or disposal with
comment.
 Tissue bank databases record the
reason for, and date of, disposal of
tissue samples.
 Standard Operating Procedures (SOPSs)
for tracking the disposal of relevant
material detail the method and reason for
disposal
 Where applicable, disposal arrangements
reflect specified wishes
Last printed 09/02/2016 05:16
Page 76 of 98
11.2. APPENDIX B – Glossary
Acquisition: The collection and receipt of human samples. Consent from the donor must be in
place unless exemptions to the consent provisions under the HT Act apply.
Adverse event/incident: An event or incident that may, or has the potential to, result in the
theft, damage or loss of human samples or may compromise the University’s compliance with
the licensing obligations under the HTA, or with the codes of practice as issued by the HTA, or
the good governance and output of research using human samples.
Appropriate Consent: This must be in place to use and store relevant material, taken from the
living or the deceased for research and to hold bodily material with the intention of analysing its
DNA. The HT Act defines appropriate consent in terms of the person who may give consent.
This is either the consent of the person concerned (the donor of the human samples), their
nominated representative or (in the absence of either of these) the consent of a person in a
qualifying relationship with the donor (e.g. spouse or partner; parent; child; etc.).
Audit: The evaluation of a system, process or procedure in order to ascertain its effectiveness
and the validity and reliability of the information.
Biobank: a collection of human tissues, cells and blood that can be used for medical research,
or for other purposes. It can contain many different types of biological samples (e.g. tissue
samples, DNA and blood) and information (e.g. health records, diet and lifestyle information,
and family history of disease, gender, age, and ethnicity).
Designated Individual (DI): The named individual designated for the licence as the person
under whose supervision the licensed activity is authorised to be carried out. This person is
responsible for ensuring that other persons to whom the licence applies are suitably trained and
qualified; that suitable practices are carried out in the course of carrying-on the licensed activity;
and for compliance with the conditions of the licence. The HTA must be satisfied as to the
suitability of the person nominate as DI.
Disposal: The permanent removal or destruction of human samples previously used and/or
stored for research.
Existing Holdings:
September 2006.
Human samples (relevant material) held immediately prior to 1st
Hub site: HTA term for the main site under a licence, this is the Medical School for the
Newcastle University Research Licence.
Human Tissue: Any and all constituent parts of the human body formed by cells.
Human Tissue Act 2004 (HT Act): Legislation that regulates the removal, storage and use of
human tissue, defined as material that has come from a human body and consists of, or includes,
human cells. The HT Act covers England, Wales and Northern Ireland, although the use of DNA
extends to Scotland. Consent is the fundamental principle of the legislation and underpins the
lawful removal, storage and use of body part, organs and tissue. Different consent requirements
apply when dealing with tissue from the deceased and the living. The HT Act lists the purposes
for which consent is required (Scheduled Purposes).
Last printed 09/02/2016 05:16
Page 77 of 98
Human Tissue Authority (HTA): The independent regulator established by the HT Act to
protect public confidence by ensuring human tissue is used safely and ethically, and with proper
consent. The HTA licenses and inspects organisations that collect, store and use human tissue
for the Scheduled Purposes, for which consent from the donor is required (unless exemptions
apply).
HTA Codes of Practice: Provide guidance and lay down expected standards for each of the
sectors regulated by the HTA (e.g. research) and under the HT Act. They are designed to
support professionals by giving advice and guidance based on real-life experience. The most
recent code for Research, along with revisions of previously published codes, were approved by
Parliament in July 2009 and came into force on 15 September 2009.
HTA Standards: Core standards in four key areas that must be met for an organisation to
obtain an HTA licence, relating to the provisions in the HT Act and the regulatory requirements:
Consent; Governance and Quality Systems; Premises, Facilities and Equipment; Disposal.
Licence Holder: The person or corporate body responsible for applying for the Licence and
who would also apply to vary the Licence e.g. to change or substitute the DI. In the case of a
corporate body, a named individual will act as its representative. The HTA must be satisfied as
to the suitability of this person and prefers individual licence holders to be more senior than the
DI.
Material transfer agreement (MTA): Agreement established between organisations that
govern the transfer of one or more materials from the owner (or authorised licensee) (‘the
provider’) to a third party (‘the recipient’) who may wish to use the material for research
purposes.
Person Designated (PD): A person to whom the Licence applies, and who is named on the
licence. In the Medical School, there is a PD for each group storing human tissue under the
licence. At the satellite sites, there are lead PDs who co-ordinate and monitor compliance
within their site. The PD assists the DI in supervising the licensable activities within their
groups.
Principal Investigator (PI): Is the appropriately qualified individual at each project site who
has responsibility for the conduct of the project at that site.
Procurement: The process by which tissues and cells are made available, including the physical
act of removing tissue and the donor selection and evaluation.
Quality Assurance Manager (QAM): The individual responsible for providing leadership and
drive in coordinating and maintaining the governance support for research using human
tissues, including samples registered under the Newcastle University HTA Research Licence and
across the Faculty of Medical Sciences
Quality Management System (QMS): Centralised governance framework policies, procedures,
training, provision of advice and guidance, documentation and data records relating to all
aspects of acquisition, storage, use and disposal within their organisation.
Relevant Material: Material other than gametes, which consists of or includes human cells. In
the Human Tissue Act, references to relevant material from a human body do not include:
Last printed 09/02/2016 05:16
Page 78 of 98
a) embryo’s outside the human body
b) hair and nail from the body of a living person
c) cell lines
d) any other human material created outside the human body
e) serum, plasma, DNA and RNA.
The HTA has produced a supplementary list of materials on which guidance as to their status as
relevant material has been given. This list (provided in Appendix D) is not intended to be
exhaustive or exclusive.
Research: A study which addresses clearly defined questions, aims and objectives in order to
discover and interpret new information or reach new understanding of the structure, function
and disorders of the human body. Research attempts to derive new knowledge and includes
studies that aim to generate hypotheses, as well as studies that aim to test them or develop
practical applications of new knowledge.
Research Ethics Committee: An National Research Ethics Service committee established to
advise on matters which include the ethics of research investigations on relevant material which
has come from a human body.
Research Tissue Bank: A tissue collection which has gained generic ethical approval for a
broad range of future, yet unspecified research within a given scope.
Sample label: Indelible and unique identification code securely attached to the container
holding each individual human sample which must be appropriate to the storage conditions.
Sample Tracking: Process by which all human samples can be identified and traced from their
acquisition through to their disposal.
Satellite site: Premises within the same organisation on a different site to the main (hub) site,
that is under the same governance processes and quality management system, and supervised
by the same Designated Individual.
Scheduled Purposes: The activities relating to the removal, storage and use of human organs
and other tissue that require consent, listed in Schedule 1 of the HT Act e.g. research in
connection with disorders or the functioning of the human body.
Service level agreement: Agreement that exists between a client and their service provider(s)
detailing the level of service that will be provided.
Standard Operating Procedure (SOP): Detailed, written instructions to achieve uniformity of
the performance of a specific function which is an integral part of the quality management
system. In the context of research using human samples, the centralised SOPs document all the
processes that affect the quality and safety of those samples e.g. acquisition, storage, transfer
and disposal.
Storage: The holding of human samples securely in appropriate facilities and under
appropriate controlled conditions to ensure the integrity and traceability of the samples and
protect the health and safety of the individuals handling them. Samples which are relevant
material and are not subject to licensing exemptions (e.g. held for the purposes of a RECapproved research project) must be held under an HTA licence.
Last printed 09/02/2016 05:16
Page 79 of 98
11.3. APPENDIX C: Role Descriptions
11.3.1. Person Designate (PD)
Last printed 09/02/2016 05:16
Page 80 of 98
Last printed 09/02/2016 05:16
Page 81 of 98
Last printed 09/02/2016 05:16
Page 82 of 98
11.3.2. Human Tissue Act Coordinator (HTAC)
Last printed 09/02/2016 05:16
Page 83 of 98
Last printed 09/02/2016 05:16
Page 84 of 98
11.4. APPENDIX D– Supplementary list of materials
For the most up to date list, please always refer to:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
The following material was accessed from the above website on 28th September 2012.
This list is intended to provide supplementary guidance to the HTA’s broader policy framework
on ‘relevant material’.
The list is not intended as exhaustive or exclusive, but is intended to provide guidance to
stakeholders in respect of a number of materials that guidance on the status of, as relevant
material or otherwise, has previously been sought. The HTA will review and update the list
periodically.
The list currently refers solely to which human body parts, tissues and cells are defined as
‘relevant materials’ for the purposes of the Human Tissue Act 2004, in line with the statutory
definition above. The HTA intends to expand the list in the future to also provide guidance to
the human application sector on which ‘tissues and cells’ are regulated under the Human Tissue
(Quality and Safety for Human Application) Regulations 2007.
Where a material is not included within the following list stakeholders should refer to the policy
framework to formulate their own assessment of the material’s status in line with the guidance
provided in the framework.
Materials classified in the following list as relevant material are done so subject to the following
general caveat that they are relevant material except where:


They have divided or been created outside the human body
They have been treated, processed or lysed through a process intended to render them
acellular. This would include the freezing or thawing of cells only where that process is
intended to render the material acellular.
Material
Relevant materials for
the purposes of the
Human Tissue Act 2004?
Antibodies
No
Artificially created stem cells*
No
Bile
Yes
Blood
Yes
Bone Marrow
Yes
Bones/Skeletons
Yes
Last printed 09/02/2016 05:16
Page 85 of 98
Brain
Yes
Breast Milk***
Yes
Breath Condensates and exhaled gases
No
Buffy coat layer (interface layer between plasma and blood cells
when blood is separated)
Yes
Cell lines**
No
Cells that have divided in culture
No
CSF (Cerebrospinal fluid)
Yes
Cystic fluid
Yes
DNA
No
Eggs*
No
Embryonic stem cells (cells derived from an embryo)**
No
Embryos (outside the body)*
No
Extracted material from cells, e.g. nucleic acids, cytoplasmic
fraction, cell lysates, organelles, proteins, carbohydrates and lipids.
No
Faeces
Yes
Fetal tissue
Yes
Fluid from Cystic lesions
Yes
Gametes*
No
Hair (from deceased person)
Yes
Hair (from living person)
No
Joint Aspirates
Yes
Lysed Cells
No
Mucus
Yes
Nail (from deceased person)
Yes
Nail (from living person)
No
Nasal and Bronchial Lavage
Yes
Non blood derived stem cells (i.e. derived from the body)
Yes
Last printed 09/02/2016 05:16
Page 86 of 98
Non fetal products of conception (i.e. the amniotic fluid, umbilical
cord, placenta and membranes)
Yes
Organs
Yes
Pericardial fluid
Yes
Plasma
No
(Please note: Depending on how plasma is prepared and
processed, it may contain small numbers of platelets and other
blood cells. If any of these cells are present then the plasma must
be regarded as relevant material).
Platelets
Yes
Pleural fluid
Yes
Primary cell cultures (whole explant/biopsy present)
Yes
Pus
Yes
RNA
No
Saliva
Yes
Serum
No
Skin
Yes
Sperm*
No
Sputum (or Phlegm)
Yes
Stomach contents
Yes
Teeth
Yes
Tumour tissue samples
Yes
Umbilical cord blood stem cells
Yes
Urine
Yes
* While outside the definition of relevant material for the purposes of the HT Act, these
materials fall under the remit of the Human Fertilisation and Embryology Act 1990, and are
regulated by the Human Fertilisation and Embryology Authority (HFEA).
** Cell lines and embryonic stem cell lines fall within the regulatory remit of the HTA by virtue
of the Human Tissue (Quality and Safety for Human Application) Regulations 2007, which
regulates the processing, storage and distribution of stem cell lines for human application. Both
Last printed 09/02/2016 05:16
Page 87 of 98
the HFEA and the Medicines and Healthcare products Regulatory Agency (MHRA) also have a
regulatory remit in respect of cell lines and embryonic stem cells lines. A joint position
statement issued by the HTA, HFEA and MHRA provides guidance on the relevant regulatory
remits.
*** Breast milk does not constitute tissue or cells for human application under the (Quality and
Safety for Human Application) Regulations 2007, but is classified as relevant material for the
purposes of the Human Tissue Act 2004 where stored or used for a scheduled purposes.
Last printed 09/02/2016 05:16
Page 88 of 98
11.5. APPENDIX E –Copy of the Newcastle University Research HTA Licence
11.5.1. Hub Licence
Last printed 09/02/2016 05:16
Page 89 of 98
11.5.2. Satellite licences
Last printed 09/02/2016 05:16
Page 90 of 98
Last printed 09/02/2016 05:16
Page 91 of 98
Last printed 09/02/2016 05:16
Page 92 of 98
Last printed 09/02/2016 05:16
Page 93 of 98
11.6. APPENDIX F – Document Revision History
Section
affected
Description of changes
Reason for change
Page 1
Addition of research “Sector” to title
of manual
To clarify that research is the sector
licensed
All
Addition of page number and total
page number on each page
To facilitate information search
Page 5
Table of figures added
Absent in edition 1 – to facilitate
information search
Figure 1
Figure updated to reflect new
structure
Structure of manual has changed
requiring figure change
Page 9
Human Tissue Authority logo added
To enhance awareness of who the
authority are
Section 4
Section renumbered and split into two
sections “What is the human tissue
act?” and “Licensing”
To make the document more user
friendly and easier to source the
information required.
Section 4
Section 4.2 and 4.3 changed to 4.1.1
and 4.1.2 to sit under sections “What
is the human tissue act?”
Restructuring of section to enhance
the flow of information
Section
4.4
Now section 4.2. Extended and split
in to 8 sections (4.2.1 – 4.2.8)
To break the information into sections
to facilitate information search
Section 4
4.2.1. New - Sectors licensed by the
HTA updated to include reference to
other HTA sector licenses held in
Newcastle. Human application details
changed to reference the Human
Tissue (Quality and Safety for Human
Application) regulations 2007.
Removal added as a sector
Contact details for other licenses were
absent in the previous edition leading
to confusion. The Human Application
sector incorrectly stated that it sat
under the HTA (2004) and required
amendment. Removal added as a
new sector on HTA webpage since last
edition.
Section 4
4.2.5. New section describing general
premises rules under HTA licences
Insufficiently explained in edition 1.
Follows feedback from training
sessions.
Section 4
4.2.7. New section on roles and
responsibilities under HTA licence
with redrawn organogram of HT
licence roles.
Organogram redrawn to remove the
colour due to printing issues, and
make it generic for the HTA. A
Newcastle specific organogram has
now been added in another section.
Last printed 09/02/2016 05:16
Page 94 of 98
Section
affected
Description of changes
Reason for change
5
New section 5.1 added “What is
covered by the Newcastle University
research sector HTA licence”
Segregation of information into steps
to facilitate information search.
5.1
Roles and responsibilities moved to
section 5.3. and enhanced to include
an organogram, new figure on the
NBB structure and contact details for
all individuals named on the licence
Organogram added to clarify
Newcastle roles. Previous
organogram contained role
descriptions alongside and was difficult
to relate to the University.
5.3
Implications section moved to section
4.2.8 to sit under licensing section
Information sits best alongside
licensing and should come up front.
Sections
6.1 &
6.1.1
Moved to section 4.2.2. to sit under
Licensing. Enhanced to explain figure
and further elaborate on HTA
exemptions including 7 day rule
Further explanation of licensing
requirements following feedback from
training sessions.
6.2.1.
“How do I apply for a HTA licence”
moved to section 4.2.6 to sit under
new licensing section
Information now sits together with
other licensing information.
Section 7
Has become section 6
Due to renumbering to enhance flow
Section
7.1.1
7.1.1 become 6.1.1. Section split out
into two steps – submitting an access
request and applying for ethical
approval. Section added on “What
are research tissue banks?” and
providing contact details for the NBB
Clarification of the process
summarised in the flow diagram.
Previous edition did not sufficiently
explain it in a stepwise manner.
Section
7.1.2
7.1.2 become 6.1.2. Order of options
changed – option 2 is now to collect
new tissue, option 3 is now to
purchase material
To reflect the flow of decision making –
purchasing would be third choice.
Section
7.1.2
7.1.2 section updated to include three
different methods to collect new tissue
Clarification of options summarised in
figure.
Section
7.1.3
7.1.3. purchasing section updated to
state that purchase of material for
transplantation is illegal
Information missing in previous edition.
Section
7.2
7.2. Section removed. Information
added to new section 5.4 – “what
does this mean for researchers?”
Information on licensing was located in
the wrong section, and fits under
licensing requirements.
Last printed 09/02/2016 05:16
Page 95 of 98
Section
affected
Description of changes
Reason for change
Section
7.3.1
7.3.1. Section deleted and information
moved elsewhere. Broad terms are
moved to the introduction, and
exemptions for consent moved to
section 6.3.5 and enhanced to explain
the flow diagram in written format.
Repetition of information. Consent
exemptions were provided before
consent was explained. Exemptions
have been moved to the end to
enhance the flow of information.
Section
7.3.3
7.3.3 now section 6.3.2. – table
updated to include tiered consent.
Associated text updated to state
requirements to prove type of consent
is in place
Information missing in previous edition.
Section
7.3.5
7.3.5. on withdrawing consent is now
section 6.3.4. Updated to include fact
that in some cases consent cannot be
withdrawn & researcher responsibility
to have processes in place to remove
samples
Information missing in previous edition
7.3.6
7.3.6 What does this mean for
researchers section removed
Information included in preceding
section on consent.
Section 8
Now section 7 in renumbering and
data storage added
Section
8.1
Sample monitoring added to storage
requirements and “what does this
mean for researchers” section
removed.
To stress key requirement this was not
clear in edition 1. Information for
researchers is now contained in other
sections.
/
New section 7.2 on data storage
added
Absent in last edition. Vital for
information governance regulations.
Section
8.2
Options available for storage changed
to simplify information, and express
that samples can be stored at any of
approved tissue banks. Flow diagram
has been updated accordingly.
Previous information was overly
complicated. Information is now
simplified to stress limited storage
locations that can be used to enhance
governance.
8.2.1-8.2.3 removed accordingly.
/
7.4. New section on subcontracting
storage added
Information missing in previous edition
& provides a further option outside the
University
Section 9
Now section 8 in new numbering
Due to renumbering to enhance flow
Last printed 09/02/2016 05:16
Page 96 of 98
Section
affected
Description of changes
Reason for change
system
Section
9.2
Now 8.2 has been renamed from
“sample transfer” to “Material and
Data transfer”. Details on transfer
agreements removed and
summarised. Sections 9.2.1to 9.2.3
deleted.
To reflect that data is also transferred
as well as biological samples.
Information now contained in detail in
a new SOP, and is therefore not
replicated here.
Section
11
Now section 10
Due to renumbering to enhance flow
11.2
Split into two sections “Document
Management System”, “Documents
supporting QMS”. (Section 11.3
“Standard Operating procedures”
renamed). New list of NBB core
SOPs added and list of recommended
topics updated
In line with Confederation of Cancer
Biobank (CCB) standards. List of
SOPs absent in last version due to
review.
/
10.2.3 – new section added on risk
assessments
Absent in previous edition
11.4
Renamed “Adverse events” now as
section 10.3, and information removed
and simply summarised.
Information contained in new adverse
event reporting SOP and no
duplication required here.
11.5
“How do I register a complaint?”
renamed as “Complaints” and
renumbered 10.4
Simplification in line with new
numbering system.
11.7
Equipment maintenance section
removed
Now contained in storage section
11.8
Information removed and simply
summarised. Section 11.8.1- 11.8.2
removed
Information contained in auditing SOP
and no duplication required here.
11.9
Now section 10.7. In-house elearning package information added
To provide information on new training
options
/
10.8 – New section on communication
with stakeholders
Absent in edition 1. In line with CCB
standards on communications.
11.10
Renamed “Governance section” 10.9
and information moved to 10.9.1.
Clarification of governance policy, and
Clarification of different aspects of
governance of the bank structure and
to highlight layperson role.
Last printed 09/02/2016 05:16
Page 97 of 98
Section
affected
Description of changes
Reason for change
addition of Layperson section (10.9.3)
Appendix
A
Update of best practice
In line with CCB standards document
Appendix
E
Provision of copies of satellite
licences
Absent in previous versions
Appendix
F
New. Document revision history
added
Absent in previous version as this was
edition 1.
Last printed 09/02/2016 05:16
Page 98 of 98