Version3 April 2014
Human Tissue Research at UWE: Operating
Procedures
Guidance for staff and students
Contents:
1)
2)
3)
4)
Introduction
What is the Human Tissue Act?
What is human tissue? What are relevant materials?
Storage of Human Tissue at UWE: Regulatory compliance and ethical
approval.
i.
Ethics approval
ii.
UWE Register of Research using Human Tissue
5) What is good practice?
i.
Consent
ii.
Samples sourced from outside the UK
iii.
Governance and quality systems
iv.
Safe and secure storage.
v.
Using the storage ledger.
vi.
Transportation and transfer of samples.
vii.
Disposal
Glossary of terms
Appendix 1 – Ethics Application Form for Research Using Human Tissue
Appendix A – Request to register a new research project using human tissue
Appendix B – Request to register a research project using imported human
tissue
Appendix C – Request to register a research project using acellular human
tissue
1
Version3 April 2014
1.
Introduction.
This document aims to set out the University’s policy relating to Research
using Human Tissue (HTR). It also outlines the operating procedures related
to the ethical review, oversight and management of HTR. The University is
committed to high quality research and to promoting high standards of
scientific conduct and research practice. As part of the Research Governance
Framework the University aims to ensure that researchers are compliant with
the law in this area, that research is ethical and of the highest scientific
quality.
This is not a guide covering all aspects of the Human Tissue Act as it relates
to HTR. Researchers working on human tissue are expected to follow best
practice on handling, transport and storage and consent as described by the
Human Tissue Authority. Detailed guidelines on the regulatory requirements
and codes of practice are available from the Human Tissue Authority website
at:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.c
fm
2.
What is the Human Tissue Act?
The Human Tissue Act 2004 makes consent the fundamental principle
underpinning the lawful storage and use of body parts, organs and tissue from
the living or the deceased for specified health-related purposes and public
display. It also covers the removal of such material from the deceased and
lists the purposes for which consent is required which includes research as a
‘scheduled purpose’. The Human Tissue Act 2004 made it an offence to store
human tissue without a licence and/or recognised Research Ethics Committee
approval.
The key points of the Human Tissue Act 2004



The Human Tissue Act 2004 regulates the removal, storage and use of
human tissue. This is defined as material that has come from a human
body and consists of, or includes, human cells.
The Human Tissue Act 2004 creates a new offence of DNA ‘theft’. It is
unlawful to have human tissue with the intention of its DNA being
analysed, without the consent of the person from whom the tissue
came.
The Human Tissue Act 2004 makes it lawful to take minimum steps to
preserve the organs of a deceased person for use in transplantation
while steps are taken to determine the wishes of the deceased, or, in
2
Version3 April 2014
the absence of their known wishes, obtaining consent from someone in
a qualifying relationship.
Offences under the Human Tissue Act 2004





Removing, storing or using human tissue for Scheduled Purposes
without appropriate consent.
Storing or using human tissue donated for a Scheduled Purpose for
another purpose.
Trafficking in human tissue for transplantation purposes.
Carrying out licensable activities without holding a licence from the
HTA (with lower penalties for related lesser offences such as failing to
produce records or obstructing the HTA in carrying out its power or
responsibilities).
Having human tissue, including hair, nail, and gametes (i.e. cells
connected with sexual reproduction), with the intention of its DNA being
analysed without the consent of the person from whom the tissue came
or of those close to them if they have died. (Medical diagnosis and
treatment, criminal investigations, etc., are excluded).
The Human Tissue Act (HT Act) is currently regulated by the Human Tissue
Authority (HTA), which issues licences for the storage and use of human
tissue, carries out inspections on licensed premises and promotes good
practice on all aspects of the handling, use, storage and disposal of human
tissue. The Human Fertilisation Embryology Authority regulates research
using human embryos and gametes (see http://www.hfea.gov.uk/ ). A new
‘Health Research Authority ’ was established in December 2011 and is
expected to take on responsibilities relating to human tissue research soon
(see http://www.nres.nhs.uk/hra/).
3.
What is human tissue and what is ‘relevant material’?
The HT Act defines human tissue as ‘material that has come from a human
body and consists of or includes human cells’ and is frequently referred to in
the Act as ‘relevant material’.
The Act defines relevant material as human tissue, other than gametes, which
consists of, or includes cells. Only relevant material is covered by the HT Act.
There are a number of categories of relevant material:
1) Specifically identified relevant material:
 Bodily organs and tissues consisting largely or entirely of
cells and clearly identifiable and regarded as such.
Includes human bodies, internal organs & tissues, skin
and bone.
3
Version3 April 2014
2) Processed material:
 Where a processing technique is generally agreed to
leave the material either always cellular or acellular, the
resulting material should be regarded as such. e.g. the
plastinisation of tissues and body parts retains cellular
structure and would therefore be considered relevant
material, whereas plasma or serum separated from whole
blood, generally, would not (however, depending on the
process used, plasma may contain small numbers of
platelets or blood cells which would be considered
relevant material).
3) Bodily waste products:
 Bodily waste should normally be considered relevant
material as even a single cell may be subject to research.
However, there may be cases where a researcher
believes a particular material to be acellular. In such
cases the researcher should consult the HTA for advice
who would refer the case to a member’s panel if
necessary.
4) Cell deposits and tissue section on microscope slides:
 In general, cell deposits and tissue sections are
considered relevant material.
A list of relevant material can be found on the HTA website at:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofreleva
ntmaterial.cfm
See also the MRC Regulatory Support Centre e-learning module on Human
Tissue at http://www.rsclearn.mrc.ac.uk/ and
MRC Data and Tissues Toolkit:
http://www.dt-toolkit.ac.uk/e-learning.cfm
It is the responsibility of the Principal Investigator/Project Leader to
understand and be familiar with the requirements of the HTA.
4
Version3 April 2014
4.
Storage of Human at UWE : Regulatory Compliance and Ethical
Approval.
UWE does not currently hold an HTA licence for storage of human
tissue.
There are a number of conditions under which an institution is exempt from
HTA licensing:

Where a research project using relevant material has been approved
by a recognised research ethics committee (e.g. NRES) and the
researcher cannot identify the individual from whom the material has
come, the relevant material may be stored without a license for the
duration of the project. At the end of the project, the relevant material
must either be destroyed or returned to the licensed premises.

Relevant material which has been processed to render the material
acellular may be stored without a licence providing that the processing
takes a matter of hours or days and certainly no longer than a week.

Existing holdings of relevant material (those held prior September 1st
2006) are exempt from licensing. However, there may still issues of
consent which prevent the free use of such material for research
purposes.
4.1 Ethical Approval for research
All Research using Human Tissue requires ethical approval.
Researchers are expected to familiarise themselves with the current guidance
provided by NRES on Human Tissue Research to be found at:
NRES Guidance on Human Tissue Research:
http://www.nres.npsa.nhs.uk/applications/guidance/research-guidance/
5
Version3 April 2014
The University’s policy relating to ethical review aligns with NRES Guidance:
1. If your research involves NHS patients (including tissue or organs obtained
from them), you will need to obtain NRES approval.
2. If you intend to collect any relevant material and store it for more than 5days
then you will need NRES approval (this includes research outside the NHS).
3. If you wish to collect human blood from healthy volunteers to analyse intact
cells you will need to apply for NRES approval even if you intend to use it
within a short period of time (this includes research outside the NHS).
4. If you wish to collect human blood from healthy volunteers as control groups
for a study that also uses materials collected from NHS patients then you
should apply for approval to do this at the same time as you submit your
NRES application.
5. If you wish to collect human blood or any other relevant material and render
it acellular before analysis within 5 days you may apply for ethical review
and approval from FREC.
6. If you wish to import human tissue for your research you may apply for
ethical review and approval from FREC.
It is the responsibility of the Principal Investigator/Supervisor/Project Manager
to obtain appropriate ethical approval for the research.
Applications to NRES using the IRAS system should be sent to Research
Administration before submission; Applications will be checked by the Chair
of FREC before the sponsor letter is prepared and authorisation given for it to
be submitted; Research can only proceed when NRES permission has been
received and this permission has been registered with Research
Administration in RBI (see below);
Supervisors of students are responsible for checking and approving a student
application to NRES before sending it to Research Administration.
Applications to FREC should be submitted using the application form at
Appendix 1.
Student applications need prior approval by a supervisor before an
application is sent to Research Administration.
External Review
If you obtain human tissue samples from a licensed Research Tissue Bank
which has generic ethical approval you will need to register your research at
UWE but you may not need to submit your project for further ethical review.
6
Version3 April 2014
See: http://www.nres.npsa.nhs.uk/applications/guidance/researchguidance/#useofhumantissue
If you are a collaborator on a project using human tissue being led by another
institution and for which UWE is not a sponsor, it is essential that you are
aware of the content of any ethics application submitted to an external REC. It
is your responsibility to ensure that your research has appropriate ethical
approval. You should lodge a copy of the ethics application with Research
Administration.
If you are a collaborator on a project which has received ethical approval and
you wish to transfer human tissue samples to UWE you will need to register
your research at UWE and submit a copy of any Material Transfer Agreement,
the ethics application and approval to FREC. (see section 6 below)
M Level Students
Where M Level students will be working on staff projects they may be named
as co-researchers on the application form when the initial project is reviewed.
If M level students are to be added to a project at a later date an application to
the module leader will need to be completed.
4.2 UWE Register of Research Using Human Tissue
From 1st November 2011 all research using human tissue must be
registered on the UWE Register of Research using Human Tissue. To do this
the PI/Supervisor/Project Manager must complete a registration form:



Registration of a new research project using Human tissue
(Appendix A)
Registration of research project using Human Tissue (Imported
tissue). (Appendix B)
Registration of a research project using Human tissue (Acellular
materials) (Appendix C)
a) Research which has NRES approval can only proceed when the
project has been registered with Research Administration and a copy
of the approval submitted;
b) All Research using Human Tissue which has been approved by FREC
will also need to be registered;
c) Research with samples brought in from outside the UK can only
proceed with permission from FREC and must be registered;
7
Version3 April 2014
d) Research on human tissue and relevant materials rendered acellular
requires FREC approval and must also be registered.
5.
What is good practice?
The HT Act includes provisions for codes of practice to be made by the HTA
on a number of issues. The codes are intended to form part of the regulatory
system under the HT Act. Their purpose is to provide guidance to persons
carrying out activities within the HTA’s remit and to lay down the standards
expected in the carrying out of such activities. The codes provide detailed
advice on the matters that they cover and include an explanation of
requirements under the HT Act and the Regulations.
The Codes of practice have been divided into nine documents available to
download from the HTA website at:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.c
fm
Of the nine codes of practice, those of most relevance to the work carried out
at UWE are:
Consent,
Disposal,
Import/Export
Research
All researchers using human tissue are expected to familiarise themselves
with these codes.
(i)
Consent
The HT Act makes consent the fundamental principle underpinning the lawful
storage and use of relevant material.
However, where the relevant material is from a living person, but the
researcher cannot come into possession of information which identifies the
persons donating the material and where the material is to be used for a
specific research project approved by a recognised research ethics committee
(e.g. NRES), specific consent is not required. Researchers should note that
material sourced under the above conditions can only be used for the
8
Version3 April 2014
particular research project for which it was obtained. At the end of the project,
the material must either be destroyed or consent for further research use
obtained from the donors.
Therefore, to facilitate the use of valuable human tissue in research, the HTA
advises, in line with the MRC and NRES that consent should be generic
because this avoids the need to obtain further consents. It is still important
however that consent is valid. If the intention is to store the tissue for an as
yet unknown research purpose or as part of a tissue bank for research then
this should be explained, setting out the types of research that may be
involved, any wider implications and the arrangements for disposal of the
tissue.
Source: http://www.hta.gov.uk
See also ‘Good practice in research and consent to research’ guidance
document published by the Medical Research Council.
(ii)
Samples sourced from outside the UK.
9
Version3 April 2014
The consent provisions of the HT Act do not apply to relevant material which
has been imported into the UK. Nonetheless, the HTA considers it good
practice to ensure mechanisms are in place in the source country for
obtaining consent as part of the process by which the material is obtained.
(iii) Governance and quality systems.
In order to obtain a HTA licence, a facility must demonstrate that it meets a
number of core standards for governance & quality systems, suitable
premises, storage and disposal facilities. Even where a licence is not being
sought, facilities using relevant material in research should strive to meet the
core standards in order to follow good practice.

Institutional processes and systems are in place to support and monitor
good practice

Regular procedural reviews

Clear lines of reporting and responsibility, documented roles and
responsibility, systems of staff training, appraisal and development.

Documented policies and procedures covering all aspects of the
storage and use of relevant material in research.

Records must be kept which document consent and allow traceability
to tissue stored for research. This should include, names of the
principal researcher responsible for the samples use in the project,
sample receipt dates, specific storage locations, scope of consent,
transfer of material to another project (if permitted) and date and
means of disposal.
A key element of adherence to good practice is the maintenance of an
appropriate and functional inventory of relevant material used in research
projects.
Additionally, samples should be logged as they arrive in the laboratory and
accurate records kept of storage locations, processing dates and disposal
dates. It should be possible to track an individual sample from the point at
which it entered the University to the day and means of its’ disposal.
10
Version3 April 2014
Where ethical approval from a recognised ethics committee is not in place,
material can only be stored under the governance of a HTA licence. However,
a licence should not be viewed as an alternative to ethical approval
(iv) Safe and secure storage.
Premises and facilities for storage 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 and secure. for those working under the licence and
preserves the integrity of the tissue. The establishment must have
contingency arrangements in place should there be an emergency situation
that renders the premises unusable for the storage of human tissue for
research. Consideration should be given to protecting workers from infection
and sample security.
(v)
Using the storage ledger.
It is also vital the samples be stored in such a way that they can be readily
identified and retrieved by a third party using information in the sample ledger.
In cases where a researcher has anonymised samples using a coding
system, documentation containing the codes and donor information must be
kept in a locked cupboard, away from the storage facility. The ledger is
intended to hold all the information required to follow good practice on sample
documentation and traceability. Details should be entered as soon as the
relevant material arrives on site and when the material is processed or
disposed of as appropriate. Storage locations must be recorded in sufficient
detail to enable a third party to locate the sample should the need arise. The
ledger is project specific and should contain the relevant information for that
particular project (NRES number, lead worker, etc.). Where a researcher is
involved in two or more different projects, a separate ledger must be
maintained for each project. The ledger may be in a paper or electronic form –
whichever is most convenient for the researcher to allow them to update
records as samples arrive, are processed or disposed of. Ledgers are
available from Research Administration and the Laboratory Manager.
11
Version3 April 2014
All Principal Investigators are responsible for ensuring that a storage ledger is
used.
The ledger may be called in at the end of a project by the Research
Administration for audit purposes.
(vi) Transportation and transfer of samples between UWE and other sites or
organisations.
A system must be in place which ensures that the traceability of tissue is
maintained during transport and delivery. Records should be kept to cover
details of: transport and delivery; material transfer agreements with recipients
of tissue; SLAs with courier or transport companies. The traceability system
should follow the operation of a donor ID system which assigns a unique code
to each sample and to each of the products associated with it. When human
bodies, body parts and tissue are carried by post or courier, the packaging
should conform to the international standards for the transport of hazardous
clinical material.
Under the terms of the Human tissue Act, the giving of consent for the use of
relevant material in research does not automatically permit the transfer of the
material to researchers or projects outside those for which the consent was
originally given.
NRES recommends that wherever possible, researchers should seek generic
consent (i.e. not limited to the scope of the original project) which also permits
the use of the material in future research projects. However, researchers
receiving samples from collaborators or other institutions must never assume
that such generic consent is in place and in all cases, must obtain
documented evidence that consent has been given for the transfer and use of
the relevant material in question.
In order to maintain good practice as defined by the Human Tissue Authority,
it is important that where collaborating researchers wish to share or transfer
12
Version3 April 2014
any relevant material, they must ensure that the following is in place before
the transfer of any material takes place:

Contact UWE Contracts and Legal Team in the Finance Department
Brian.Allen@uwe.ac.uk or Mark5.Jackson@uwe.ac.uk to arrange a
Material Transfer Agreement (MTA).

Check the terms of the consent given by the research participants, to
confirm consent has been given for their donated sample to be sent to
collaborators or other institutions in the UK and/or abroad; and if
appropriate, if they consented for use in future ethically approved
projects. If samples are being transferred to UWE from an external
collaborator, it is the responsibility of the recipient principal investigator
(PI) to obtain the relevant documentation confirming the terms of
consent.

Where the recipient is to use the samples in a different project (i.e. not
the one that they were collected for) and generic consent has not been
given, the recipient must seek NHS Research Ethics Committee
approval for the use of the samples for their project. The recipient must
give written assurance to the sender that ethical approval is in place for
the recipient's project.

If the appropriate consent for transfer is in place, the recipient should
be informed in writing, including the terms of that consent. The sender
should also agree, in writing, the terms of what the recipient is
permitted to do with the samples and stipulate in the agreement that
only the agreed analyses should be performed on the samples.

Samples must in all cases be sent in a coded form, so that no
identifiable information is sent with them, unless there is explicit
consent for transferring identifiable information from the research
participant and this has been approved by an NHS Research Ethics
13
Version3 April 2014
Committee. If identifiable information is sent subject to these
requirements, the recipient must confirm that these data will be treated
The relevant material storage ledger must be updated to show when,
where and to whom the samples are being transferred.

The sender should inform the recipient of what should happen to the
samples following recipient use (i.e. disposal or return). If disposal, the
agreement should stipulate how they should be disposed of.
Arrangements for disposal must also be outlined in the participant
information sheet.

In all cases, stipulate that the recipient is not at liberty to use the
samples for their own commercial gain, or to send the samples to any
other third party.

Records of all correspondence must be retained and lodged in the
UWE Register of Research using Human Tissue held by Research
Administration in RBI.
(vii) Disposal.
Researchers should consider the issue of disposal at the consent stage. The
normal method of disposal is by incineration, but this may not be appropriate
for some cultures or religions. Researchers should be aware of this and offer
alternatives wherever possible, bearing in mind that the choices regarding
disposal are for the individual donor or relative to make. Where practical,
relevant material should be bagged separately from other clinical waste but
does not need to be separately incinerated. The date and method of disposal
must be recorded in the sample ledger.
14
Version3 April 2014
Source: http://www.hta.gov.uk
Professor Julie Kent
Chair of HLS Faculty Research Ethics Committee
On behalf of the UWE Human Tissue Working Group
February 2012
15
Version3 April 2014
6. Glossary of Terms.
Appropriate consent: Defined in the HT Act by reference to the person who
may give consent. This is broadly either the consent of the person concerned,
their nominated representative or (in the absence of either of these) that of a
person in a qualifying relationship to them immediately before they died.
Cells: Individual human cells or a collection of human cells when not bound
by any form of connective tissue. For establishments licensed for human
application this includes cell lines grown outside the human body but not
gametes, embryos outside the human body, or blood and blood components.
Designated Individual (DI): The individual designated on the licence to
supervise the licensable activities being carried out. DIs are trained by the
HTA to carry out this important role and they have statutory responsibilities
they must fulfil.
Donor: Every human source, whether living or deceased, of tissue, cells,
organs or part organs.
Existing holdings: The body of a deceased person, or any relevant material
which has come from the human body, held immediately prior to 1 September
2006.
Licensing: A number of activities can only be carried out where the
establishment is licensed under the HT Act by the HTA. Organisations whose
activities involve the removal, storage or use of relevant material may need to
work under an HTA licence. All establishments working under an HTA licence
must work to specified standards set by the HTA.
Licensed premises: Where the licensed activity takes place. If the licensed
activity will take place at more than one place, a separate licence will be
issued for each place. Premises in different streets or with different postal
codes are considered as being in different places. In contrast, different
buildings on a hospital site could be regarded as the same place.
NRES: National Research Ethics Service – the body with oversight of NHS
based research in the UK that oversees the promotion of ethical research with
a view to protecting those that agree to take part in research studies.
Processing: All operations involved in the preparation, manipulation,
preservation and packaging of tissues or cells intended for human application.
Relevant material: Defined by the HT Act as material other than gametes,
which consists of, or includes, human cells. In the HT Act, references to
relevant material from a human body do not include: (a) embryos outside the
human body, or (b) hair and nail from the body of a living person. See policy
guidance on how to apply this definition on the HTA’s website
16
Version3 April 2014
[
www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.
cfm ].
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.
Recognised Research Ethics Committee:
A Research Ethics Committee (REC) established under and operating to the
standards set out in the governance arrangements issued by the UK Health
Departments
[www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyA
ndGuidance/DH_4005727 ]; or an ethics committee recognised by United
Kingdom Ethics Committee Authority (UKECA), to review clinical trials of
investigational medicinal products under the Medicines for Human Use
(Clinical Trials) Regulations 2004 [ www.opsi.gov.uk/si/si2004/20041031.htm
].
Tissue: Any and all constituent part/s of the human body formed by cells.
Valid consent: Consent which has been given voluntarily, by an appropriately
informed person who has the capacity to agree to the activity in question.
17
Version3 April 2014
APPENDIX 1
APPLICATION FOR ETHICAL REVIEW (using Human Tissue)
This form should be submitted electronically to Leigh Taylor, Secretary of the Faculty
Research Ethics Sub-Committee, (Leigh.Taylor@uwe.ac.uk) together with all supporting
documentation (see below). A paper copy with signatures should be sent to Leigh Taylor,
Secretary of the Faculty Research Ethics Sub-Committee,Faculty Research Office Frenchay
Campus, within 5 working days of the electronic version.
You are advised to read the guidance notes attached to this form.
Please provide all the information requested and justify where appropriate – the spaces will
expand to provide additional space.
For further guidance please contact your AHOD RKE, Dept Ethics Lead, Academic
Supervisor or Leigh Taylor (Leigh.Taylor@uwe.ac.uk) or telephone 0117 328 1170.
Project Details:
Project title
Project funder
Proposed project start date
Anticipated project end
date
Applicant Details:
Name of Principal
Investigator (applicant)
Faculty and School
Status (Staff/ Postgraduate
Student/ Undergraduate
Student)
Email address
Contact postal address
Contact telephone number
Name of co-researchers
(where applicable)
(for completion by SRESC)
Date received:
SRESC reference number:
18
Version3 April 2014
Scrutiny – Cttee/CA
Outcome:
Applicant informed:
Applicant Details continued:
For student applicants only:
Name of Supervisor (for
PG and UG student
applicants)¹
Supervisor’s email address
Supervisor’s telephone
number
Details of course/degree
for which research is being
undertaken
¹For student applications supervisors should ensure that all of the following are satisfied
before the study begins:
The topic merits further research
The student has the skills to carry out the research
The participant information sheet or leaflet is appropriate
The procedures for recruitment of research participants/donors and obtaining informed
consent are appropriate
Appropriate arrangements have been made for the processing, storage and disposal of human
tissue samples.
Supervisor comments:
19
Version3 April 2014
Details of the proposed work:
1 Aims and objectives of, and background to the research:
2 Research methodology to be used (include an explanation of why donated human tissue is required for
your research and describe any information you intend to collect about the research participants/donors.):
3 Selection of participants/donors:
Will the participants be from any of the following groups?(Tick as appropriate)
Children under 18
Adults who are unable to consent for themselves²
Adults who are unconscious, very severely ill or have a terminal illness
Adults in emergency situations
Adults with mental illness (particularly if detained under Mental Health Legislation)
Prisoners
Young Offenders
Healthy Volunteers
Those who could be considered to have a particularly dependent relationship with the investigator, e.g.
those in care homes, medical students
Other vulnerable groups
(² Please note, the Mental Capacity Act requires all intrusive research involving adults who are unable to
consent for themselves to be scrutinised by an NHS Local Research Ethics Committee – Please consult the
Chair of your Faculty Research Ethics Sub-Committee or Ros Rouse (UWE Research Governance Manager)
for advice: ros.rouse@uwe.ac.uk).
If any of the above applies, please justify their inclusion in this research
Note: If you are proposing to undertake research which involves contact with children or vulnerable
adults you will generally need to hold a valid Criminal Records Bureau check. Please provide evidence
of the check with your application.
20
Version3 April 2014
4 Please explain how you will determine your sample size, and identify, approach and recruit your
participants/donors:
5 Please describe how you propose to collect, process, store and dispose of the human biological samples.
6 What risks, if any, do the participants/donors face in taking part in this research and how will you
minimise these risks?
7 How will you seek informed consent from the participants/donors (include copies of participant
information sheets and consent forms)?
8 Please explain how confidentiality will be maintained, and if samples will be anonymised:
9 How have you addressed the health and safety concerns of the participants/donors, researchers and any
other people impacted by this study?:
21
Version3 April 2014
10 Please describe how you will maintain data protection:
11 How will the results of the research be reported and disseminated? (Select all that apply)
Peer reviewed journal
Conference presentation
Internal report
Dissertation/Thesis
Other publication
Written feedback to research participants
Presentation to participants or relevant community groups
Other (Please specify below)
12. Other ethical issues: (please describe and address any ethical issues not already covered in your
application for example relating to the importation or export of human biological samples, any material
transfer agreements.)
22
Version3 April 2014
Checklist
Please complete before submitting form (insert N/A if not applicable)
Is a copy of the research proposal attached?
If you have already obtained other external ethics approval is a copy attached?
Will the human blood or other relevant material be rendered acellular within 5
days?
Have you explained how you will select the participants/donors?
Have you described how you will collect, process, store and dispose of the human
tissue samples?
Have you described the ethical issues related to the well-being of
participants/donors?
Have you considered health and safety issues for the participants/donors and
researchers?
Have you included details of data protection including data storage?
Have you described fully how you will maintain confidentiality?
Is a participant/donor consent form attached?
Is a participant/donor information sheet attached?
Is a copy of any questionnaire/interview or personal data sheet attached?
Yes/No
-
Declaration
Principal Investigator
Signed
Date
Supervisor or module
leader (where appropriate)
Signed
Date
The form should be emailed to Leigh Taylor, Secretary to the HLS Faculty Research Ethics
Committee at Leigh.Taylor@uwe.ac.uk. A paper copy with signatures should be sent to
Leigh Taylor, Secretary of the Faculty Research Ethics Sub-Committee, Faculty Research
Office, Frenchay Campus, within 5 working days of the electronic version.
23
Version3 April 2014
APPLICATION FOR ETHICAL
REVIEW OF HUMAN TISSUE
RESEARCH USING ‘RELEVANT
MATERIAL’: GUIDANCE NOTES
These notes are intended to be read when completing the application form for ethical review of
human tissue research using ‘relevant material’. For a definition of what is meant by ‘relevant
material’ see:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
You should familiarise yourself with the Human Tissue Authority (HTA) Codes of Practice on
Research; Consent; Disposal, Import and Export which can be found at:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm
Please note that UWE does not currently hold an HTA License for storage of human
tissue.
Please ensure that you have considered whether you need approval for your research from a
‘recognised REC’ via the NRES system. If you are uncertain please seek advice from your
Dept Ethics Lead, AHoD RKE or Centre Director in the first instance or contact NRES at
http://www.nres.nhs.uk/.
1. If your research involves NHS patients (including tissue or organs obtained from them),
you will need to obtain NRES approval.
2. If you intend to collect any relevant material and store it for more than 5days then you
will need NRES approval.
3. If you wish to collect human blood from healthy volunteers to analyse intact cells you
will need to apply for NRES approval even if you intend to use it within a short period
of time.
4. If you wish to collect human blood from healthy volunteers as control groups for a
study that also uses materials collected from NHS patients then you should apply for
approval to do this at the same time as you submit your NRES application.
5. If you wish to collect human blood or any other relevant material and render it acellular
within 5 days you may apply for ethical review and approval from FREC using this
form.
6. If you wish to import human tissue for your research you may apply for ethical review
and approval from FREC using this form.
If your project is approved you will need to complete a registration form to register your
research on the UWE Human Tissue Research Register. The registration form may be
obtained from Dr Lynne Lawrance Lynne.Lawrance@uwe.ac.uk or Emma Youde, UWE
Research Governance: Emma.Youde@uwe.ac.uk.
24
Version3 April 2014
External ethics approval
Where the work has already been subjected to ethical scrutiny, for example by an NHS Local
Research Ethics Committee through the National Research Ethics Service (NRES) you should
indicate this on the form.
If your research involves NHS patients (including tissue or organs), or NHS Data you will
need to get NRES approval. The UWE procedures recognise the burden placed on the
researcher in applying for NRES approval. In order to assist PIs in this as far as possible, you
should apply for NRES ethics approval first (using the IRAS form) and submit a copy of the
application and the letter of approval to your FREC or to UREC (as applicable). This
approach has been designed to retain the right of ultimate ‘sign off’ by the University without
having to go through a separate protracted University process. UREC has established a panel
of volunteers to assist staff and students in making applications to the NRES, by supporting
applicants on a one-to-one basis, please contact Leigh Taylor (Leigh.Taylor@uwe.ac.uk ) for
details. However it is important that PIs conducting research in the NHS appreciate that both
UWE and NHS Ethics clearance will be needed and are separate. Achievement of the one
does not guarantee success with the other.
If you have already received ethical approval from an external research ethics committee you
should provide evidence of this with your application to UREC/FREC. You will need to
register your research on the UWE Human Tissue Research Register after you obtain NRES
and UWE approval to proceed.
If you obtain human tissue samples from a licensed Research Tissue Bank which has generic
ethical approval you will need to register your research at UWE but you may not need to
submit your project for further ethical review. See:
http://www.nres.npsa.nhs.uk/applications/guidance/research-guidance/#useofhumantissue
If you are a collaborator on a project which has received ethical approval and you wish to
transfer human tissue samples to UWE you will need to register your research at UWE and
submit a copy of any Material Transfer Agreement, the ethics application and approval to
FREC.
Doctoral and M Level student applications
For student applications the PI is usually the supervisor who should ensure that all the
following are satisfied before the study begins:
 The topic merits further research
 The student has the skills to carry out the research
 The participant/donor information sheet or leaflet is appropriate
 The procedures for recruitment of research participants and obtaining informed
consent are appropriate.
 Appropriate arrangements have been made for the processing, storage and disposal of
human tissue samples.
Declaration
This should be completed once all the following questions have been answered. Where the
application is from a student, a counter-signature from the supervisor is also necessary.
Question 1: Details of the proposed research – Aims and objectives of the research
25
Version3 April 2014
This should provide the reviewer of the application with sufficient detail to allow him/her to
understand the nature of the project and its rationale, in terms which are clear to a lay reader.
Do not assume that the reader knows you or your area of work. It may be appropriate to
provide a copy of your research proposal.
Question 2: Details of the proposed research – Research methodology to be used
You should explain how you plan to undertake your research. Explain why donated human
material is required for your research and describe any information you intend to collect about
the participants/donors. Where applicable a copy of any interview
schedule/questionnaire/personal data sheet should be attached.
Question 3: Participant details – Participants from vulnerable groups
You must indicate if any of the participants in your sample group are in the categories listed.
Any Department of Health funded research involving participants who might not have the
capacity to consent may need to go through the new Social Care Research Ethics Committee,
unless it is already being reviewed through NRES. If your research subjects fall into any of
the specified groups you will need to justify their inclusion in the study, and find out whether
you will require a Criminal Records Bureau check.
Members of staff requiring CRB checks should contact Claire Holmes
(Claire.Holmes@uwe.ac.uk) in Human Resources. CRB checks for students will usually be
organised through the student's faculty, but students in faculties without a CRB
countersignatory should contact John Rushforth the University's lead countersignatory.
Please note: Evidence of a CRB check should take the form of an email from the relevant
CRB countersignatory confirming the researcher has a valid CRB check for working with
children and/or vulnerable adults. It will be the responsibility of the applicant to provide this
confirmation.
Question 4: Participant details – Determination of sample size, identification and recruitment
of participants
In this section you should explain the rationale for your sample size and describe how you
will identify and approach potential participants/donors and recruit them to your study.
Question 5: Collection, processing, storage and disposal of human biological samples
You should explain what samples will be collected, who will collect them and how they will
be collected. Describe the arrangements for processing the samples (eg rendering them
acellular), storing and disposing of them.
Question 6: Risk and risk management – Risks faced by participants/donors
Describe ethical issues related to the physical, psychological and emotional well being of the
participants, and what you will do to protect their wellbeing. If you do not envisage there
being any risks to the participants/donors please make it clear that you have considered the
possibility and justify your approach.
Question 7: Informed consent and withdrawal
26
Version3 April 2014
Informed consent is an ethical requirement of the research process. Applicants should
demonstrate that they are conversant with and have given due consideration to the need for
informed consent and that any consent forms prepared for the study ensure that potential
research participants/donors are given sufficient information about a study, in a format they
understand, to enable them to exercise their right to make an informed decision whether or
not to participate in a research study. You should make clear whether consent being sought is
project specific or generic.
Consent must be freely given with sufficient detail to indicate what donating human tissue for
the study will involve. Withdrawal from future participation in research is always at the
discretion of the participant. There should be no penalty for withdrawing and the participant is
not required to provide any reason. You should explain how you will deal with the human
tissue samples if the donor wishes to withdraw from the study.
You should describe how you will obtain informed consent from the participants/donors and,
where this is written consent, include copies of participant/donor information sheets and
consent forms. Where other forms of consent are obtained (eg verbal, recorded) you should
explain the processes you intend to use. (See also Data access, storage and security below).
Question 8: Confidentiality/anonymity
You should explain what measures you plan to take to ensure that the information provided
by research participants is anonymised and how it will be kept confidential. In the event that
the data are not to be anonymised, please provide a justification.
Question 9: Risk and risk management – Potential risks to researchers
Describe any health and safety issues including risks and dangers for both the participants and
yourself (if appropriate) and what you will do about them. This might include, for instance,
arrangements to ensure that a supervisor or co-researcher has details of your whereabouts and
a means of contacting you when you conduct interviews away from your base; or ensuring
that a ‘chaperone’ is available if necessary for one-to-one interviews.
Question 10 : Data access, storage and security
Describe how you will store the data, who will have access to it, and what happens to it at the
end of the project. If your research is externally funded the research sponsors may have
specific requirements for retention of records. You should consult the terms and conditions of
grant awards for details. For all research the University has recently agreed a policy on
research data management (http://info.uwe.ac.uk/secretariat click on records management,
then guidance) which you are advised to read before completing your application.
It may be appropriate for the research data to be offered to a data archive. If this is the case it
is important that consent for this is included in the participant consent form. For guidance on
ensuring that consent for archiving of data is acquired see [new webpage – under
construction].
The Data Protection Act 1998 requires individuals to be made aware of how information
about them will be managed. For further guidance on the collection of personal data for
research purposes and compliance with the Data Protection Act see
http://www.uwe.ac.uk/finance/sec/dp/intranet/docs/F29.pdf
Question 11: Publication and dissemination of research results
27
Version3 April 2014
Please indicate in which forms and formats the results of the research will be communicated.
Question 12: Other ethical issues
This gives the researcher the opportunity to raise any other ethical issues considered in
planning the research or which the researcher feels need raising with the Committee. This
might include a description and explanation of the import or export of samples. Please
describe and attach copies of any material transfer agreements.
Please address any enquiries about the application process which are not covered in these notes
either to the contact (named below) for the Faculty Research Ethics Sub-committee to which
you are submitting your application or to Leigh Taylor at urec.enquiries@uwe.ac.uk .
28
Version3 April 2014
APPENDIX A
REQUEST TO REGISTER A (NEW OR EXISTING) RESEARCH PROJECT USING
HUMAN TISSUE ‘RELEVANT MATERIALS’
Name of Applicant1:
Name of PhD Student
(if a PhD project):
Title of the Project:
Type of ‘relevant material’ being
used in the study:
NRES Reference Number2
(if applicable):
Start Date of Project:
End Date of Project:
Expiry Date for use of stored
samples:
HLS Reference Number:
Date of Application:
Signed by:
Print Name:
CHECKLIST
Please tick 
if relevant
Have you submitted a completed ethics application form to the Faculty Research
Office?3

Is a copy of the Information Sheet for research participants attached?







Is the Consent Form for research participants attached?
Is a copy of the Approval Letter attached?
Have you notified the laboratory manager of your intention to use imported
human tissue samples in your research?
Have you submitted any relevant Material Transfer Agreement for samples
obtained from another source?
Have you set up a ledger to record the collection, storage and disposal of human
tissue samples?
Have you made appropriate arrangements for the storage and disposal of these
samples?
To be completed by a member of staff from the Faculty Research Office:
Date received by Faculty Research
Office (FRO):
29
Version3 April 2014
APPENDIX B
REQUEST TO REGISTER A RESEARCH PROJECT USING (IMPORTED) HUMAN
TISSUE ‘RELEVANT MATERIALS’
Name of Applicant1:
Name of PhD Student
(if a PhD project):
Title of the Project:
Type of ‘relevant material’ being
used in the study:
Source of imported materials:
NRES Reference Number
(if applicable):
Start Date of Project:
End Date of Project:
Expiry Date for use of stored
samples:
HLS Reference Number:
Date of Application:
Signed by:
Print Name:
CHECKLIST
Have you submitted a completed ethics application form (if applicable) to the
Faculty Research Office?2
Is a copy of the approval letter attached (if applicable)?
Are you satisfied that the imported samples were obtained in accordance with
good ethical practice?
Is a copy of the Materials Transfer Agreement attached?
Have you notified the laboratory manager of your intention to use imported
human tissue samples in your research?
Have you set up a ledger to record the storage and disposal of these imported
human tissue samples?
Have you made appropriate arrangements for the storage and disposal of these
samples?
Please tick 
if relevant







To be completed by a member of staff from the Faculty Research Office:
Date received by Faculty Research
Office (FRO):
30
Version3 April 2014
APPENDIX C
REQUEST TO REGISTER A RESEARCH PROJECT USING (ACELLULAR) MATERIAL
DERIVED FROM HUMAN TISSUE
Name of Applicant1:
Name of PhD Student
(if a PhD project):
Title of the Project:
Type of ‘acellular material’ being
used in the study:
Source of material:
NRES Reference Number
(if applicable):
Start Date of Project:
End Date of Project:
Expiry Date for use of stored
samples:
HLS Reference Number:
Date of Application:
Signed by:
Print Name:
CHECKLIST
Have you submitted a completed ethics application form (if applicable) to the
Faculty Research Office?2
Is a copy of the approval letter attached (if applicable)?
Are you satisfied that the samples were obtained in accordance with good
ethical practice?
Have you notified the laboratory manager of your intention to use acellular
materials in your research?
Have you set up a ledger to record the storage and disposal of these materials?
Have you made appropriate arrangements for the storage and disposal of these
materials?
Please tick 
if relevant






To be completed by a member of staff from the Faculty Research Office:
Date received by Faculty Research
Office (FRO):
31