Human Tissue Act – Research Sector
HTA-POL-01.v1
HTA-POL-01.v1
POLICY NUMBER:
HUMAN TISSUE ACT – RESEARCH SECTOR
Consent of Human Tissue Stored under the Newcastle University Research
TITLE
Human Tissue Act Licence (Ref. 12534)
Mhairi Anderson
Name and role
Quality Assurance and Development Manager
AUTHOR
Signature &
Date
Name and role
APPROVER
Professor Andy Hall
Designated Individual, Newcastle University
Research HTA licence (Ref: 12534)
Signature &
Date
EFFECTIVE
DATE:
1st April 2015
REVIEW
DATE:
1st April 2017
Distribution
This document will be retained in the following locations:
 Newcastle Joint Research Office Website (www.newcastlejro.org.uk)
 Human Tissue Act VRE (https://researchtools.ncl.ac.uk/portal).
Change control
To request any changes to this document please submit a change request using the
following form, in accordance with HTA-SOP-8 “Change Control”.
http://forms.ncl.ac.uk/view.php?id=6528
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
Note: As applicable, documentation of reading and/or training must be completed
prior to performing the procedure.
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Human Tissue Act – Research Sector
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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.
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 the fundamental underlying principal of the
human tissue act. Under the Act, the following key standards must be met:



Consent must be obtained in accordance with the requirements of the Human
Tissue Act (2004) and as set out in the Code of Practice 1: Consent (C1)
Information about consent process must be provided and in a variety of
formats (C2)
Staff involved in seeking consent must receive training and support in the
implications and essential requirements of taking consent (C3)
This policy sets out the requirements relating to consent for the retention and use of
human tissue in line with the HTA and the Quality Management System adopted as
part of the Newcastle University Research Human Tissue Act licence (Ref. 12534).
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
consent requirements under the Human Tissue Act (2004) and the Human Tissue
Authority’s Code of Practice 1, Consent.
Each department working under the Act should abide by this policy and, where
appropriate, have their own designated consent SOP/policy detailing the consent
procedure, or for groups not taking consent themselves, the procedure for ensuring
that consent is in place for samples received, 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 also
includes consent taken from healthy volunteers.
The consent provisions of the HTA do not apply to material that has been imported
therefore this SOP does not include imported material. However it is good practice to
gain assurance that any imported human tissue has been obtained with valid consent.
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Human Tissue Act – Research Sector
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This policy provides a summary of the HTA standards. For full information
researchers should refer to “Code of Practice 1: Consent” and the Quality Manual.
4. DEFINITIONS
the principle that a person must give their permission for their
tissues to be retained or used
Existing Holding Human samples (relevant material) obtained prior to the
implementation of the Human Tissue Act on 1st September 2006
Human Tissue Authority or Human Tissue Act
HTA
The person must be given full information about what the
Informed
treatment involves, including the benefits and risks, whether
consent
there are reasonable alternative treatments, and what will happen
if treatment does not go ahead.
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”.
The decision to consent or not consent must be made alone, and
Voluntary
must not be due to pressure by medical staff, friends or family.
consent
A term used to express willingness to participate in research by
Assent
children who are too young to give informed consent but who are
old enough to understand the proposed research in general, its
expected risks and possible benefits, and the activities expected
of them as subjects. This is classed as “Gillick Competency”
after a legal court case in the 1980s relating to taking consent
from children.
Consent
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Human Tissue Act – Research Sector
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5. PROCEDURE
All staff involved in activities encompassed by the HTA must comply with the HTA
Codes of Practice 1: Consent and the standards set out in the Quality Manual.
A summary of consent requirements is provided below.
5.1. Determining if consent is required
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, as the Act cannot be retrospectively applied, there is no requirement to
obtain consent to store human samples (relevant material) obtained prior to the
implementation of the Human Tissue Act on 1st September 2006. These samples are
classed as “existing holdings”. A number of other exceptions where consent is not
required also exist. The requirements of the Human Tissue Act for consent are set out
in figure 1.
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 1: Requirements for consent under the Human Tissue Act
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It should be noted however that although a number of cases exist where consent is not
required to store human samples; it is best practice to always obtain consent where
possible.
Anyone removing, storing or using material in circumstances for which the Act
requires consent must be satisfied that consent is in place and be able to provide proof
of consent. All researchers working under the University’s research HTA licence
therefore have a responsibility to understand the HTAs requirements for consent.
5.2.
Who can give consent?
Consent should ideally be obtained from the individual themselves, either while they
are living, or after their death, as an expression of their wishes.
For children under 16 years of age, consent must be given by a parent or guardian,
however it is good practice to also obtain assent.

"Assent" is a term used to express willingness to participate in research by
children who are too young to give informed consent but who are old enough
to understand the proposed research in general, its expected risks and possible
benefits, and the activities expected of them as subjects. This is classed as
“Gillick Competency” after a legal court case in the 1980s relating to taking
consent from children.

Assent by itself is not sufficient, however. If assent is given, informed consent
must still be obtained from the subject's parents or guardian.
In the case of the deceased, if the wishes of the deceased are unknown, 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 2.
A summary of the different methods for taking consent is provided in Table 1.
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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 2: Qualifying relationships to provide appropriate consent
Table 1 – Methods for taking consent
Informed/ Express/ Explicit Consent
 Informed consent, also known as valid, express or explicit consent, entails giving
sufficient information about the research and ensuring that there is no explicit or
implicit coercion so that prospective participants can make an informed and free
decision about their involvement. Typically, the information should be provided in
written form. Time should be allowed for the participants to consider their choices
and the forms should be signed off by the research participants to indicate consent.
 Where participants are not legally responsible, their legal representatives or
guardians should be consulted, as well as the participant. Where participants are
not literate, verbal consent may be obtained but this should, wherever possible, be
witnessed and recorded. In other circumstances, for example telephone interviews,
this may not be possible. Where consent is not or cannot be secured, the researcher
must submit a full statement justifying the practice to the appropriate Research
Ethics Committee.
 The primary objective is to conduct research openly and without deception.
Deception (i.e. research without consent) should only be used as a last resort when
no other approach is possible. This principle also requires that research staff need
to be made fully aware of the proposed research and its potential risks to them. In
longitudinal research it may be necessary to explain the need for (and limitations
of) enduring consent; it may also be necessary to re-negotiate consent during the
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Human Tissue Act – Research Sector
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lifetime of the research.
Implicit/Implied Consent
 Implied/implicit consent differs from express/explicit/informed consent in that it is
not gained through formal methods, such as written or verbal approval. An
example of this would be where a person completes a questionnaire. By
completing the form, they imply their consent to participate.
Post-hoc Consent
 Post-hoc consent is consent that has, as the name implies, been sought and granted
after the research has taken place. This is likely to be the case in circumstances
where consent needs to be obtained prior to publication.
Proxy consent
 Proxy consent for research participants may be necessary when the participant is a
vulnerable person. The best interests of the participant must be the highest
importance. In sensitive research involving vulnerable populations, particularly
children, the competence of the researcher to undertake the research should be
considered.
 Proxy consent should only be used when participants are unable to consent
themselves or where it is legally necessary. Care should be taken that consent
cannot be sought from the participants and it should not be assumed that children
are unable to consent because of their age.
 When proxy consent is used, agreed criteria should be used to identify signs that
the participant is unwilling to take part or wishes to terminate the research
interaction, and fully understands to what they are consenting.
5.3.
Taking consent
Consent may be taken personally by Newcastle University staff collecting tissue for
the biobank, or by a third party e.g. member of University staff working as part of
another research group, or for part of another organisation (e.g. NHS Trust,
commercial partner). The procedure to follow in each instance is provided below.
5.3.1. Groups taking consent themselves
In accordance with the Human Tissue Act standards, all groups responsible for taking
consent themselves must ensure that:

Standard operating procedures are in place detailing the consent process
adopted by the group (including the management of signed consent forms) and
the procedure for providing information on consent

Consent is valid. To be valid consent must be:
o Voluntary: obtained voluntarily from the donor (i.e. without coercion)
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o Informed: Appropriate information must be provided (e.g. based on
age/mental capacity) to ensure that the individual is suitably informed
and have a clear appreciation and understanding of the facts,
implications and future consequences of an action. Where necessary
independent interpreters must be made available, and information
made available in suitable formats (e.g. Braille, large print).

Consent forms and patient information leaflets comply with the HTA Code of
Practice 1. Forms must be in records and made accessible to those using or
releasing relevant material for a scheduled purpose.

Consent forms make it clear where samples have the potential to be:
o Exported to another country
o Used in animals
o Passed on to commercial partners (e.g. pharmaceutical companies)
The option to opt-out of these uses should be made available.

Where DNA analysis is to be conducted on the donors samples it should be
made clear to the donor that their bodily material may be used for this
purpose.

The consent forms are carefully selected to ensure that the appropriate level of
consent is obtained. Consent may differ in its duration. It may be enduring or
time-limited. In addition consent may be:
Project specific:
Generic:
Tiered:
Where the patient only consents to the use of their
tissues in a specific research project
Where the patient provides broad consent (in terms of
duration and scope) for the tissue to be used in
unspecified research
Where a patient may opt-out of different activities e.g.
commercial use, DNA analysis, use in animals, export
of donated samples
Therefore researchers should plan carefully to ensure that the consent obtained
is suitable for the intended purposes of the samples. To ensure best practice, it
is recommended to obtain generic consent where ever possible to avoid the
need to return to the donor or their family to request additional consent to use
the samples in further research and avoid the unnecessary disposal of samples
when a research project ends.

Where appropriate, the donor/qualified individuals wishes relating to the
samples at the end of the study are recorded (e.g. return, burial, cremation,
incineration). In instances where the sample cannot be returned (e.g. samples
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are anonymised and the link to the donor removed) this must be made clear to
the donor during the consent process.

There is evidence of suitable up-to-date staff training including competency
assessment, and evidence of honorary contracts, where appropriate.

Although it is easier to demonstrate that consent is in place if it is written, nonwritten 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 written consent cannot be obtained.
The document “Guidance for professionals taking consent for research tissue banks”
can be found on the Newcastle Joint Research Office website alongside this SOP.
This document provides key information that must be understood when taking
consent for research tissue banks, and a check-list of steps to be completed. Please
refer to the following website, or consult the Quality Assurance and Development
Manager for advice:
http://www.newcastlejro.org.uk/
5.3.2. Consent taken by a third party
For groups that do not take consent themselves, consent may be taken by a third party.
For example samples may be stored in the biobank on behalf of other researchers who
are responsible for taking consent. This may include situations where consent has
been taken by an external organisation (e.g. NHS Trust, commercial partner).
In these instances it is best practice to ensure that:




Blank copies of consent forms and patient information leaflets for each
collection are held
Signed copies of the consent form are either held directly by the researcher
(accessible only by individuals with appropriate regulatory approval to do so)
or, the location of the signed consent form is documented in the sample
records and can be retrieved/audited on request.
Where consent is taken by organisations external to Newcastle University,
agreements are in place (e.g. a Service Level Agreement or Material Transfer
Agreement) to ensure that consent has been obtained in accordance with the
requirements of the Act and Codes of Practice.
The procedure for managing consent (i.e. ensuring that valid consent is in
place and traceability to consent forms) is documented in local Standard
Operating Procedures.
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5.4.
Sample use
Any individual using relevant material for an approved purpose is responsible for
ensuring that consent is in place for the activity. Therefore consideration must be
given to the scope and duration of the consent given by the donor (i.e. project specific
or generic) and any specific requests to opt-out from any activities (e.g. use of
samples in animals, export).
5.5.
Withdrawal of consent
Consent may be withdrawn at any time whether it is generic or specific. Withdrawal
should be discussed at the outset when consent is being sought. The practicalities of
withdrawing consent and the implications of doing so should be made clear, for
example, for potential recipients if the donated tissue is for clinical use. Withdrawal
of consent cannot be effective where tissue has already been used.
If someone gives consent for their tissue to be stored or used for more than one
scheduled purpose and then withdraws consent for a particular scheduled purpose
(e.g. research), this does not necessarily mean that the sample or samples have to be
removed or destroyed.
However, the samples may no longer be stored or used for the particular purpose for
which consent has been withdrawn. In addition, if someone withdraws consent for
samples to be used in any future projects, this does not mean that information and
research data should be withdrawn from any existing projects.
Where consent is withdrawn the material should either be returned to the donor or
clinician, or destroyed (in-line with NBB-POL-2) as appropriate. Where the material
has been transferred to a third party, efforts should be made to retrieve the sample,
where possible. Sample tracking information must be updated to reflect the
withdrawal of consent.
6.
REFERENCES
Human Tissue Act (2004)
http://www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1
HTA Code of Practice 1: Consent
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code1co
nsent.cfm
HTA Code of Practice 9: Research
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code9re
search.cfm
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Human Tissue Act – Research Sector
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Newcastle University Quality Manual – HTA Research Licence (Ref. 12534) and
“Guidance for Professionals Taking Consent for Research Tissue Banks”
http://www.newcastlejro.org.uk/
7.
DOCUMENT REVISION HISTORY
Section
affected
Description of changes
All
New SOP code – HTA replacing NBB
This SOP replaces NBB-POL-03.v2
Title
Title changed to include the wording
Newcastle University
5.2
5.3.1
Addtion of table describing different
methods for taking consent, and
addition of description of Gillick
competence, and taking consent from
under 16’s
Inclusion of tiered consent
Reason for change
Due to the rebranding of the Newcastle
Biomedicine Biobank, any reference to NBB
is being removed. Reference will now be
made to the Newcastle University HTA
licence, with HTA as the new SOP code. All
NBB quality documents will now be reissued
under the new code “HTA” and issued as
version 1. Version history can be tracked on
the SOP document log.
To be clear that this policy relates to the
Newcastle University research HTA licence
(Ref. 12534)
Absent in last version. For consistency
with Quality Manual.
Not included in last version.
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