Newcastle Biomedicine Biobanks
NBB-POL-02.v2
NBB-POL-02.v2
POLICY NUMBER:
NEWCASTLE BIOMEDICINE BIOBANKS
Disposal of Human Tissue Stored under the Research Human Tissue Act
TITLE
Licence (Ref. 12534)
AUTHOR
Mhairi Anderson
Quality Assurance Manager
Newcastle Biomedicine Biobanks
APPROVAL
Professor Andy Hall
Designated Individual
Newcastle University
EFFECTIVE
DATE:
1st August 2013
REVIEW
DATE:
1st August 2015
Distribution
This document will be approved electronically in the Newcastle Biomedicine Q-Pulse
and retained in the following locations:



Q-Pulse
Newcastle Joint Research Office Website
(http://www.newcastlejro.org.uk/research-governance/research-involvinghuman-tissue-3/newcastle-biomedicine-biobank/)
Newcastle Biomedicine Biobank Website (www.ncl.ac.uk/nbb/governance)
Change control
To request any changes to this document please contact the Quality Assurance
Manager for the Newcastle Biomedicine Biobanks (mhairi.anderson@ncl.ac.uk) or
submit a change request in Q-Pulse according to NBB-SOP-12
Revision Category
Category 1
Category 2
Category 3
Category 4
This is a new/revised document. All personnel required to follow
content must read this version and complete training
This is a revised document in which only the area of applicability
has changed. All newly impacted personnel required to follow
content must read this version and complete training
This is a new/revised document. All personnel required to follow
content must read this version
No significant change to document content – no requirement to read
or train

Page 1 of 6
Monday, 15 February 2016
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above.
Newcastle Biomedicine Biobanks
NBB-POL-02.v2
1. BACKGROUND
The Human Tissue Act (HTA) is a legal framework which regulates the “removal,
storage, use and disposal of human bodies, organs and tissues”. The Act came into
effect on the 1st September 2006 and applies to England Wales and Northern Ireland.
Newcastle University holds a Research Human Tissue Act licence (Ref. 12534) which
licenses the storage of human tissue for research.
As human tissue is a valuable resource it must be treated with due care and respect
and the generosity and rights of the donors acknowledged and taken into
consideration at all times. Any disposal procedure implemented must recognise the
nature of the material being handled, the sensitivities of feelings of donors or their
relatives (particularly of the bereaved), and the need for clarity when providing
information.
Accordingly the Human Tissue Act (2004) states that there must be a clear and
sensitive policy for disposing of human organs and tissue and disposal must be
documented.
This policy sets out the requirements relating to disposal of human tissue in line with
the HTA and the Newcastle Biomedicine Biobank Quality Management System.
2. PURPOSE
The purpose of this policy is to provide information to all personnel working under
the Newcastle University Research Human Tissue Act Licence (Ref. 12534) on the
requirements for disposal of human tissue as covered by the Human Tissue Act
(2004) and the Human Tissue Authority’s Codes of Practice.
Each department responsible for the disposal of relevant material under the Act
should abide by this policy and, where appropriate, have their own designated
disposal SOP/policy detailing the procedure adopted for disposing relevant material
within their local environment.
3. SCOPE
This policy applies to all personnel involved in research activities under the
Newcastle University Research Human Tissue Act licence (Ref. 12534).
This includes material donated from the living, or removed from the body after death,
including existing holdings (those materials obtained before implementation of the
Human Tissue Act in September 2006).
Page 2 of 6
Monday, 15 February 2016
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above.
Newcastle Biomedicine Biobanks
NBB-POL-02.v2
4. DEFINITIONS
Existing Holding Human samples (relevant material) obtained prior to the
implementation of the Human Tissue Act on 1st September 2006
Human Tissue Authority
HTA
Material Transfer Agreement
MTA
A human material included in the scope of the Human Tissue
Relevant
Act (2004) i.e. “Material, other than gametes, which consists of
Material
or includes human cells. This does not include (a) embryos
outside the human body, (b) hair and nail from the body of a
living person”.
Service Level Agreement
SLA
5. PROCEDURE
Although it is best practice for human tissue and materials to be stored indefinitely for
future research there may be instances where it is necessary to dispose of samples.
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.
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.
Where disposal is required, the following procedure must be followed.
5.1. Donor wishes
Human remains should always be disposed of with due respect for the wishes of the
donor of the tissue, including if they withdraw consent. As such, in deciding a
disposal method for human tissue taken from the following must be considered:
Tissue from the living:
Tissue from the
deceased:
the rights and any known wishes of the donors must be
taken into account
the disposal should be handled in accordance with any
reasonable wishes expressed by relatives or the deceased
person, as long as the method of disposal is legal
In addition, any decisions of an Ethics Committee regarding disposal must also be
considered.
Page 3 of 6
Monday, 15 February 2016
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above.
Newcastle Biomedicine Biobanks
NBB-POL-02.v2
To comply with these requirements it is essential that:

Processes are in place to inform individuals, or their relatives, how tissue will
be disposed of after use.

Staff are suitably trained and familiar with the establishment’s arrangements,
including what is available locally, basic legal requirements and the options
available for those wishing to make their own arrangements to dispose of
tissue.

Where a relevant material is obtained from another establishment, disposal is
undertaken in accordance with their disposal policy and/or as detailed in the
Material Transfer Agreement (MTA) or Service Level Agreement (SLA), or
as described in the consent paperwork.

Where consent is required, evidence should exist that the researcher has
considered the donors wishes with regards to disposal.
In instances where consent is not required for the use of the relevant material (e.g.
material is classed as an existing holding) then consideration of donor wishes may not
apply. Samples should however always be disposed of in accordance with good
practice, ensuring a suitable disposal method is selected.
5.3. Method of disposal
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 below (taken from Code of Practice 5: Disposal of Human Tissue).
Figure 1: Disposal options in accordance with the Human Tissue Act (2004)
regulations
Page 4 of 6
Monday, 15 February 2016
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above.
Newcastle Biomedicine Biobanks
NBB-POL-02.v2
The disposal method selected should be conducted in compliance with the local health
and safety guidelines.
In keeping with medical confidentiality, the identity of the individual from whom the
tissue sample was taken must never be disclosed and any identifying information must
be removed from samples prior to disposal.
In addition, to demonstrate respect for human material, unless otherwise specified,
human tissue should be disposed of as clinical waste in accordance with current
legislation and the University Health and Safety Policy. Clinical material should be
disposed of separately from non-clinical waste.
Importantly, disposal records must include the following information:




The date of disposal
The person responsible for the disposal of the tissue
The method of disposal (route used & place)
Reason for disposal
This information should be recorded in tissue tracking databases in accordance with
local policies/procedures and these records 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.
6.
REFERENCES
Human Tissue Act (2004)
http://www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1
HTA Code of Practice 5 – Disposal of human tissue
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code5di
sposal.cfm
Page 5 of 6
Monday, 15 February 2016
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above.
Newcastle Biomedicine Biobanks
NBB-POL-02.v2
7.
DOCUMENT REVISION HISTORY
Section
affected
All
Cover
1
2
/
3
Description of changes
Document transferred into new NBB
SOP template
Change of title from “Disposal of
Human Tissue under Research HTA
storage” to “Disposal of Human Tissue
Stored under the Research Human
Tissue Act Licence (Ref. 12534)”
“Policy Statement” renamed
“background” and updated to have
same structure as other revised NBB
SOPs
Purpose section (section 2) added
before scope (now section 3) and
scope updated to clarify scope with
regards to existing holdings and
Definitions section added as new
section 4.
Procedure changed to section 5
Introduction added
Combined together to form section
3.1 + 3.2 5.1 and bullet points added with all
HTA considerations
Sections combined in new section
5.2 and appendix removed and
updated as a new figure, figure 1.
3.3 + 3.4
Addition of requirements for
disposal records and link to sample
tracking database.
Reason for change
New NBB template now in use
Changed to remove acronym HTA for
clarification, and addition of the licence number.
In line with new policy template and for
consistency with other SOPs.
In line with new policy template purpose
clarifies the need for the SOP. The scope
lacked clarity on exclusion/inclusion criteria
and existing holdings
Definitions were lacking in previous version
and provide clarity on acronyms
To provide further background information
on disposal principles
Clarity of process and inclusion of the need
for staff training, reference to transfer
agreements and evidence of verifying donor
wishes
Clarity of process with figure in main body
text and compliance with HTA standards for
disposal records/sample traceability. Figure
1 is taken from the Quality Manual and
provides consistency with other Newcastle
University documentation.
Page 6 of 6
Monday, 15 February 2016
This document is designed for on-line viewing.
Printed copies, although permitted, are deemed Uncontrolled 7days after the date above.