UCL Eastman Biobank Management Protocol
Version Number:
05
Superseded Version Number & Date:
04 30/5/12
Prepared by:
Dr Paul Ashley
Authorised by:
NRES Committee Yorkshire and the Humber
– Leeds East 12/YH/0111
3/4/12
Date for Renewal
3/4/17
HTA Licence Number:
12277
Designated Individual, UCL Eastman Biobank Vehid Salih
Signature:
Date:
UCL Eastman Dental Institute
256 Grays Inn Rd
London
WC1X 8LD
Telephone: +44 (0) 20 3456 ****
Fax: +44 (0) 20 3456 ****
Email:
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Contents
1. INTRODUCTION ....................................................................................................... 3 2. PROTOCOL SCOPE................................................................................................. 3 3. ROLE AND GOVERNANCE OF THE BIOBANK ...................................................... 3 3.1 Biobank Ethical Review Committee Purpose ..................................................... 4 3.2 Membership of the Ethical Review Committee: ................................................. 4 3.3 Responsibilities of the Ethical Review Committee/its members ........................ 4 3.4 Reporting Structure of Ethical Review Committee ............................................. 6 3.5. Ethical Review Committee Modus Operandi ..................................................... 6 4. BIOBANK RESEARCH PROGRAMME .................................................................... 6 4.1 Principle Research Interests............................................................................... 6 5. TESTS OF POTENTIAL ETHICAL OR CLINICAL SENSITIVITY: APPROVED
AND EXCLUDED USE .................................................................................................. 7 5.1 Potential Clinical Significance to Donors ............................................................ 7 5.2 Analysis and Use of Genetic Material ................................................................ 8 5.3 Cellular Cloning .................................................................................................. 8 5.4 Therapeutic cloning and derivation of stem cells for use in treatment ............... 8 5.5 Reproductive research including reproductive cloning ...................................... 8 6. INCLUSION AND EXCLUSION CRITERIA .............................................................. 8 6.1 Inclusion Criteria ................................................................................................. 8 6.2 Exclusion Criteria ................................................................................................ 8 7. CONTENT OF THE BIOBANK.................................................................................. 8 7.1 Transfer of samples and data from Tissue Collection Centre to the Biobank.... 9 8. CONSENT AND RECRUITMENT OF PARTICIPANTS ........................................... 9 8.1 Existing Biobank holdings.............................................................................. 10 8.2 Acceptance of samples from other sources ..................................................... 11 8.3 Withdrawal of consent ...................................................................................... 11 8.4 Ownership of samples ...................................................................................... 11 9. COLLECTION OF RESEARCH SAMPLES ............................................................ 12 10. BIOBANK STAFF: REQUIRED TRAINING AND EXPERIENCE ......................... 12 10.1 Obtaining consent ........................................................................................... 12 10.2 Tissue collection and administration .............................................................. 12 10.3 Safe Handling of Human Biological samples ................................................. 12 11. SECURITY AND CONFIDENTIALITY .................................................................. 13 11.1 Linked-anonymised/pseudoanonymised samples ......................................... 13 11.2 Physical security of samples and data ........................................................... 13 12. ACCESS POLICY AND NEW COLLECTIONS .................................................... 13 12.1 Process for requesting samples and new collections .................................... 13 12.2 Conditions for sample and data release to researchers ................................ 14 13. BIOBANK ADMINISTRATION .............................................................................. 14 13.1 Protocol amendments..................................................................................... 15 13.2 Governance policy, operating procedures and quality systems..................... 15 13.3 Reporting serious protocol non-compliance or breach of policy .................... 16 13.4 Clinical adverse event reporting ..................................................................... 16 13.5 Record retention ............................................................................................. 16 13.6 Funding ........................................................................................................... 16 13.7 Financial implications for donors .................................................................... 16 13.8 Communication and publication policy ........................................................... 16 13.9 Progress reports and accountability ............................................................... 16 Management Protocol (Version 5, 30/5/12)
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1. INTRODUCTION
The UCL Eastman Biobank will act as a physical repository for collections of biological
samples and data for research purposes from consented patients at the Eastman Dental
Institute and Hospital, University College London and University College London Hospitals
Foundation Trust (Eastman). This will incorporate prospective collections of stored samples
and new collections. It provides a unique opportunity to advance dental and medical
research by making access to tissue surplus to requirements easier, and more efficiently,
and with a high level of governance compliant with HTA standards.
The Biobank will support projects principally involved in the study of human disease and the
normal functioning of the human body. The Biobank will store normal and pathological
specimens from relevant tissues and bodily fluids. Tissue will be stored in a variety of
formats.
The establishment of a core programme will enable a centralised approach to the
management and integration of all research groups working within these institutions,
providing appropriate structure and support.
The Biobank aims include:
1. Facilitate research
2. Enhance availability of UCL holdings to researchers. The aim is to support primarily
research in the Eastman but it will also support UCLH partners, as well as researchers
nationally and internationally
3. Assistance with regulatory compliance (principally the HTA)
4. Improve research governance
2. PROTOCOL SCOPE
This protocol defines:

A management, operational, and ethical framework for the UCL Eastman Biobank

The scope and content of potential future research using the Biobank
3. ROLE AND GOVERNANCE OF THE BIOBANK
The Biobank has policies and guidelines to guarantee compliance with HTA legislation and
to ensure quality standards will be maintained (http://www.ucl.ac.uk/Biobank).
The Biobank will be governed by the Ethical Review Committee which will represent a range
of stakeholders who will work together to maximise the potential of the samples stored or
registered with the Biobank. The Committee will ensure that there is good governance,
appropriate links to the relevant communities, and that progress, output and the
development of the Biobank is regularly monitored. It will consider the concerns of sample
donors and the tissue depositors and make recommendations to ensure direct benefit of the
Biobank to ongoing medical and dental research. The Committee will also review requests
for new sample collections and applications for use of samples/data for research, including
those which do not have ethical approval and ensure they satisfy conditions laid down by
IRAS before giving approval for the release and use of tissue.
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3.1 Biobank Ethical Review Committee Purpose
The following terms of reference have been produced for the Ethics Review Committee to
ensure the Committee fulfils its role.
3.1.1 The Committee represents a range of stakeholders who will work together to maximise
the potential of the samples stored or registered with the Biobank.
3.1.2 The Committee should ensure that there is good governance, appropriate links to the
relevant communities, and that progress, output and the development of the Biobank is
regularly monitored.
3.1.3 The Committee will consider the concerns of sample donors and the tissue depositors
and make recommendations to ensure direct benefit of the Biobank to ongoing medical and
dental research.
3.1.4 The Committee will review requests for new sample collections and also requests for
use of samples/data for research, including those which do not already have ethical approval
and ensure they satisfy conditions laid down by NRES for the release of tissues by the
Research Tissue Bank.
3.2 Membership of the Ethical Review Committee:
3.2.1 The Biobank Ethical Review Committee will be chaired by an elected member of the
Review Committee
3.2.2 Members
 Designated Individual for HTA/Biobank licence for the Eastman
 UCL Biobank Facilitator
 Representative from UCL EDI Director of Research
 Representative from Eastman Dental Hospital (UCLH)
 Representative from sample users
 Lay member
 External member (eg charity or other Biobank)
3.2.3 Individuals will be invited to be members of the Ethical Review Committee for a term of
3 years from the date of acceptance of the invitation. This can be extended for a further
three years as required by agreement of the Management Committee. The Chair of the
board will be reviewed every 2 years.
3.3 Responsibilities of the Ethical Review Committee/its members
3.3.1 To attend Ethical Review Committee meetings.
3.3.2 To ensure that at all times the Biobank follows regulatory (Human Tissue Act 2004)
and ethical guidelines and fulfils the standards of best practice. Including:
 Maintenance of the Appropriate Human Tissue Authority Licences
 Controlled and monitored storage of all samples within the Biobank at the appropriate
temperature
 Quality and safety of all technical and administrative procedures
 Policies on data protection
 Policies for withdrawal of tissue
 Policies for disposal of tissue
 Policies for transfer of tissue
3.3.3 Approving and ensuring that the Biobank has appropriate agreements in place with
those depositing collections and requesting samples to guarantee that:
 Appropriate consent is documented for the banking of all samples/data along with
written protocols to support the same
 Samples being transferred to the Biobank follow regulations governing the transport
of biological samples
 Samples and data being transferred to the Biobank follow agreed protocols
 Receipt of samples is confirmed by Biobank
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

Payment for services (where appropriate) is provided by Biobank
Appropriate disposal of any samples released to users by the Biobank. This includes
any material passed on to a third party for ethically approved research studies, which
should be covered via a Material Transfer Agreement with the third party stating
disposal or return options.
 Intellectual property and commercial rights are appropriately addressed in contracts,
particularly in relation to tissue requests from commercial companies.
 Compliance with the Biobank's policies on storage, health & safety, security, quality
management, data protection, access, training, consent and audit of compliance.
These policies have been put in place to ensure HTA compliance.
3.3.4 To provide independent review and advice
 To review the services provided by the Biobank to ensure specified targets, agreed
with the depositor for receipt, processing and dispatch of samples are maintained
 Ensuring systems and resources are such to enable widespread use by the relevant
scientific community
 Ensuring respect of the dignity and rights of donors
3.3.5 The status of the Biobank as a Research Tissue Bank requires that the Ethical Review
Committee reviews and approves requests from researchers for use of samples and data in
research, for which they do not have project-specific ethical approval. This will be carried out
under conditions laid down by IRAS in its ethical review of the Research Tissue Bank.
Projects will only be reviewed if the sample/data collector agrees in principle to supply the
relevant samples and data.
3.3.5.1 Researchers will make a formal application to the Biobank Ethical Review
Committee via the Biobank administrator using the application form (See Request form for
samples/data). The form will require the following information
 The Principal Investigator’s contact details
 The type and amount of material required
 The data required to accompany the material
 The title of the project
 A short summary of the proposed research
 The justification that the research presents no material ethical issues
3.3.5.2 The application will be considered by the Biobank Ethical Review Committee,
to determine whether it is ethically valid. The process for reviewing applications for ethical
approval by the Committee will be as follows:
 All Committee members will be sent an electronic copy of the application
requesting samples or data from the Biobank
 Committee members will be asked to return their views in writing within a
specified 2 week timeframe
 The views of individual members will be circulated to the entire Committee with
the aim of reaching a consensus decision. Where appropriate, applications will be
discussed at a scheduled Committee meetings
 Response and agreement of all members of the Committee will be required to
reach an approved decision. Committee members who have not responded
within the designated time will be given an additional 3 days to comment on the
decision before it is ratified
 If there is disagreement a telephone, electronic conference or a meeting will be
held and a note taken of the decision. Alternatively, if a Committee meeting is
scheduled proposed applications will be discussed at the next appropriate
meeting.
 Where ethical considerations are not straightforward, the Committee may require
that the person to come to a meeting to explain the project. If a decision still
cannot be made, the applicant will be required to seek full project-specific REC
approval
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
Where the Committee believe an application is of a particularly specialised
nature, beyond the scope of the Committee, they may seek an expert opinion on
the research and may require additional information to be submitted
 Once the request has been approved, if appropriate the applicant will be required
to sign a material transfer agreement for receipt of the samples
 Sample recipients will be required to send reports and copies of publications to
the collector of the samples, as agreed in the material transfer agreement
3.3.6 To provide assistance in any enquiry, audit or investigation related to the Biobank.
3.4 Reporting Structure of Ethical Review Committee
3.4.1 The Ethical Review Committee will report to the Research Governance Committee
(UCL and UCLH) and to the UCL HTA Compliance Committee. In addition an annual report
will be sent to the NRES Committee that approved this Biobank.
3.4.2 Reporting to these committees will ensure dissemination of information about the
Biobank to the wider community and allow comment on operational aspects of the Biobank.
3.5. Ethical Review Committee Modus Operandi
3.5.1 If the Chair is not present, the Vice-Chair will preside
3.5.2 The Chair may invite an individual(s) to attend a specific meeting or meetings to
provide specialist advice to the Committee.
3.5.3 Meet three times a year.
3.5.4 For each meeting a quorum of 4/5th of the committee membership must be present.
4. BIOBANK RESEARCH PROGRAMME
The Biobank will support the Research Programme and scientific needs of UCL research
groups, primarily in the UCL Eastman Dental Institute. Many of the tissue samples collected
will be for specific projects, however the consent proposed will permit long term storage of
samples to be used for future projects.
The Research Programme will include:
4.1 Principle Research Interests
Although we are not intending to have an exhaustive list of research interests, they all should
contribute to advancements in the understanding and treatment of oral and general disease
They will include the following:
1. Search for biomarkers, molecular targets and profiles related to prognostic and
predictive markers of disease but also disease progression and disease outcome.
2. Investigating the causes of disease, damage and degeneration in hard and soft
tissues.
3. Establishing novel culture methodologies for generating distinct cell types from
sources including dental pulp, periodontal ligament and alveolar bone. Cells obtained
from these sources may have stem cell properties and therefore can be manipulated
to produce a variety of tissues (e.g. bone, cartilage, tendon, muscle, brain cells)
4. Establishing methods to discriminate structure/function relationships based on
mechanical testing and biochemical composition of tissues
5. Understanding disease related biology and testing drug response prior to clinical
trials.
6. Developing and validating 3-dimensional models of tissue explanted intact or
reconstructed on grafts and implants for studying novel therapies prior to clinical
trials.
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7. Developing and validating models to predict responses to novel adjuvant
treatments and agents.
8. Searching for evidence of age and disease relevant epigenetic modifications in
tissue and investigating the mechanisms.
9. Developing non-invasive measuring tools to assess mechanical properties and
early damage or repair markers to target more appropriately preventative strategies
for rapid assessment of response to novel treatments and side effects on tissues.
10. Pharmacodynamic and pharmacokinetic evaluation and monitoring of drugs or
therapeutic agents in target or surrogate tissue in early phase clinical trials.
11. Evaluate the association between molecular characteristics and profiles of tissue
with therapeutic modulation.
12. Examine the influence of genetic variation on disease progression and response
to therapeutic interventions to develop rational means to optimise diagnosis and
treatment.
13. Develop and validate new materials for the repair of hard and soft tissues
5. TESTS OF POTENTIAL ETHICAL OR CLINICAL SENSITIVITY: APPROVED
AND EXCLUDED USE
In order to deliver the programme, many available tests/assays may be performed. At
present these include, but are not limited to, the following:
 Immunohistochemical, molecular biology and biochemical studies
 Immunoassays and flow cytometry
 Genetic analysis including whole human deep genomic sequencing
 Genotyping and epigenetic typing, including genome wide searches
 Gene expression profiling
 Proteomics
 Metabonomics
 Imaging
 Quantification of RNA and other cellular molecules
 Genetic Modification: not reproductive cloning
 Cell/explant culture and biochemistry (including stem cells)
 Mechanical testing of specimens and of explants / scaffolds
 Microbiological assay
Research samples will not be collected from donors who wish to impose conditions of use on
their samples. Samples will only be released in a pseudoanonymised format for approved
research projects.
Material will not be used from fetuses and embryos
Material will not be collected from the deceased
Material will not be used for the purpose of cloning individuals
5.1 Potential Clinical Significance to Donors
Patients will be informed that their samples will be used in research intended to develop
advances in disease management in the future. During the consent process, it will be
brought to the attention of the patient that their samples may be stored for many years and
used in future research that may not be predicted at this time. There would be no feedback
of results to the donor, their families or their health care providers, as much of the research
will be performed in laboratories that are not accredited for diagnostic work.
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5.2 Analysis and Use of Genetic Material
The research programme will examine genetic factors in order to develop improved tools for
establishing prognostic and predictive factors for disease, including factors influencing
response to treatment. Specific analyses may produce information that includes genetic
sequence data, single nucleotide polymorphism data, genetic "fingerprint" data, ploidy data
or cytogenetic data including the detection of mutations or genetic variants.
Research may generate information on genetically transmissible disease (e.g. identifying
genes that may be passed on within families). The research does not qualify as genetic
testing as defined by insurance companies. The Biobank will not feedback results to the
donor, their families or their doctor. Information generated from the research will be
published in peer-reviewed journals, and presented at national and international scientific
meetings.
5.3 Cellular Cloning
The Biobank will support the collection of surplus fresh tissue taken during routine medical
(therapeutic/diagnostic) procedures, which ensures prompt delivery to researchers who wish
to grow cell lines.
5.4 Therapeutic cloning and derivation of stem cells for use in treatment
These activities are excluded from the Research Programme portfolio and the Biobank will
not supply material for this purpose.
5.5 Reproductive research including reproductive cloning
These activities are excluded from the Research Programme portfolio and the Biobank will
not supply material for this purpose.
6. INCLUSION AND EXCLUSION CRITERIA
6.1 Inclusion Criteria
Potentially all patients referred to the Tissue Collection Centres (initially the Eastman) for
diagnosis and/or treatment. Children under the age of 16 years will be included.
In some instances the Biobank may seek patients’ permission to contact their family
members in order to arrange for samples to be used for research. This contact will be via the
family member, members of UCL staff must NOT contact family members independently.
This will allow investigation of the effect that environmental and genetic factors may have on
the development of a disease. Furthermore, healthy volunteers may be recruited from within
the hospital to donate samples for research purposes. This will be done in line with relevant
UCLH procedures and protocols.
6.2 Exclusion Criteria
 Approached donor (or qualified representative where necessary) is unwilling or incapable
of giving informed consent to all the research conditions
 Patients known to be HIV, Hepatitis B or C positive. No formal testing will be undertaken
by the bank
 Specimen samples damaged intra-operatively or specimen size is inadequate
 Other factors that in the opinion of the responsible clinician might jeopardise the safe and
ethical conduct of patient care, Research Programme operations or dependent research
projects
 Patients who wish to stipulate specific restrictions for use of their tissue for research
7. CONTENT OF THE BIOBANK
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The Biobank will act as a physical repository for biological samples and data collected from
patients attending the Eastman and possibly other Tissue Collection Centres including
UCLH. This will incorporate existing collections and new material collected prospectively.
The Biobank will support projects principally involved in the study of human disease and
functioning of the human body, in particular the research programmes of the UCL Eastman
Dental Institute. To meet this need the Biobank will store normal and pathological
specimens, surplus to diagnostic requirements, from relevant tissues and bodily fluids.
Stored tissues will include; snap-frozen or cryopreserved tissue, formalin-fixed tissue,
paraffin-embedded tissues, and slides prepared for histological examination. Tissues will
include teeth or resection specimens obtained surgically or by needle core biopsy. Bodily
fluids will include; whole blood and blood products, serum, plasma, urine, saliva and buccal
smears and cytological specimens such as sputum. Where appropriate the Biobank will also
store separated cells, protein, DNA and RNA isolated from collected tissues and bodily fluids
described above. Some of the tissue and aspirated samples will be stored in the diagnostic
archive.
Snap frozen tissue will be stored in -80 degree C freezers or liquid nitrogen dewars, fixed
tissue will be fixed in 10% formalin and processed and embedded in paraffin-wax where
appropriate. Blood will be stored in -80 or -20 degree C freezers. All these samples can
potentially be kept indefinitely if storage protocols are adhered to and optimal storage
conditions maintained.
7.1 Transfer of samples and data from Tissue Collection Centre to the Biobank
The samples and data collected for the Biobank will be from participants visiting the Tissue
Collection Centres – initially the Eastman or UCLH. This data and samples will be
transferred between the Tissue Collection Centre and the institution responsible for the
Biobank (UCL) under a material transfer agreement between the Hospital Trust and the
University.
8. CONSENT AND RECRUITMENT OF PARTICIPANTS
The Biobank will operate under the guidance of the Biobank Research Ethics Committee to
assure compliance with current best ethical practice. The underlying principle is that
participants should give consent for access to their case notes, imaging, and to the use of
their tissue surplus to diagnostic requirements for medical research to be used in any
ethically approved research. The Biobank will not accept individuals’ participation in studies
subject to conditions that exclude use in specific areas of research such as genetic testing,
or add stipulations to the use of their tissue. The participant will retain no rights to the
samples after acquisition other than the ability to withdraw consent for further storage and
use. Patients may also withdraw to consent to giving access to their case notes and imaging
for research purposes.
Consent to use human tissue in research will be obtained via the generic Biobank consent
forms and Patient Information Sheet. The consent form is separate to the NHS Trust
"Consent to Investigation or Medical Procedure Form". Consent forms have been developed
in line with National and Local guidelines on best practise.
Targeted patient groups referred to the Eastman for a diagnostic/therapeutic procedure will
be invited to consent to give access to their notes and imaging for research and to donate
tissue for the Biobank. The majority of patients attending for treatment at the Eastman will
have several appointments before the clinical diagnostic procedure. The relevant patient
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information sheets will be given to the patient at their initial appointment, so that patients will
have at least 24 hours to consider the information given to them. At subsequent
appointments they will meet an individual who has knowledge of the Biobank and related
research programmes who will be able to answer any questions that the patient may have.
This trained staff member will assess the patient's ability to understand and retain the
information provided in the Patient Information Sheet and if they believe the patient is
appropriately informed they will ask the patient to sign the consent form. If patients are
unlikely to have several appointments before treatment, the patient information sheets will be
sent out with the new patient appointments.
The consent form is specific to the Biobank but is broad in scope and enduring. The patient
is asked to consent to their clinical notes and imaging being accessible for approved
research projects, and for tissue samples and data to be stored indefinitely and used in
future projects that have not yet been planned. If the patient asks for any conditions to be
placed on the use of their tissue, e.g. not to be used for genetic analysis, the patient will not
be asked to sign the consent form.
The consent form is signed and dated by both the patient and an individual who is
appropriately trained in taking consent. A copy of the consent form is given to the patient, a
copy is retained in the patient's medical notes and a third copy accompanies the sample to
the Biobank.
The patient will also be asked to consent specifically to allow access to his/hers clinical
notes and imaging investigations, so that information can be linked to the tissue for future or
current ethically approved research projects. Strict confidentiality will be observed in such
studies. If information about a patient is documented, the patient’s identity will be coded and
linked to the clinical information so that the researchers will then not have direct access to
the patient’s identity but additional information can be later accrued from patients’ notes by a
member of staff who has access and permission to unlocking and relocking the code. This
will prevent patient data falling into the wrong hands, and will prevent patients being
recognized when results are published.
If a blood sample is required for research purposes, if at all possible, the sample will be
taken at the same time as a blood sample is being collected as part of the patient’s
management.
However, if neither of the above is possible, an appropriately trained person will approach
the patient and ask them if they are willing to have a blood sample taken. This will be done
at the discretion of the trained individual; if for instance, a patient is very nervous, a decision
may be made not to approach the individual. In the case of children, specific permission
would be required for a particular project to take blood at a time when a sample was not
being taken for treatment / diagnostic purposes.
The consent procedure will take place in the normal course of healthcare provision and no
extra appointments will be required. Blood samples from family members and other
volunteers will be obtained by appointment at a time that is convenient to the participant.
Participants under 11 who assent will be asked to re-consent once they reach the age of 16.
If participants cannot be contacted samples will remain in the Biobank.
8.1 Existing Biobank holdings
The existing research collections of tissue stored at the Eastman have informed consent for
their use in research, or were collected prior to enforcement of the HTA in 2006.
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Tissue stored in the diagnostic archive will also be available for research provided that
surplus material is available. In some cases, consent for use of this material for research will
not have been requested, as the samples have been stored primarily for diagnostic
purposes. However, as they represent a large valuable resource for research which is often
unforeseen, access to these samples, where a surplus exists, is desirable. Obtaining
retrospective consent in these circumstances is not feasible. In these circumstances such
tissue would be available to researchers as long as they meet the following HTA-approved
criteria;



The tissue was collected from the living and is surplus to diagnostic requirements.
The researchers obtain ethical approval (in this case from the Biobank Ethics
Committee).
Tissue and patient data will be released in a linked-anonymised form.
It is not proposed to seek consent for material stored in the diagnostic archive if the patient
has not been consented.
8.2 Acceptance of samples from other sources
The consent forms that are being submitted with this application request patients to consent
to giving access to tissue that is surplus to diagnostic requirements, case notes and imaging.
Acceptance of such samples will be carefully considered in order to ensure that storage and
use is covered by the terms of the original consent.
8.3 Withdrawal of consent
A permanent link between the sample and the donor will always be maintained via the
Biobank. The patient/participant information sheet provides information on what to do if the
donor decides they no longer wish to participate in the Biobank Research Programme. The
donor can either contact the clinician in charge of their care or they can contact the individual
listed on the patient information sheet. The participant will be sent a "Withdrawal of Consent"
form to sign. This step is in place to ensure the person withdrawing consent is the same as
the person who originally gave consent, however it is not essential and if someone wishing
to withdraw consent refuses to complete the form then they will still have their samples
withdrawn from the study. The database manager, who is authorised to view the linked data
of all samples held in the Biobank and can therefore establish where the donor’s samples
are being held and/or by whom they are being used, then has 5 working days to contact
researchers involved and request that the samples are removed from the Biobank and
disposed of as per local regulations on tissue disposal. A confirmation of this action is signed
by database manager and sent to the participant. A copy of the confirmation is retained in
the participant's medical notes. The participant's research record is amended accordingly
and although their data can no longer be seen by researchers, it is not entirely deleted as an
audit trail must be maintained. This is fully explained to the donor. It will also explained to the
donor that most data obtained from his/her samples may be used although if requested
genetic data from closed access databases will be removed and destroyed. It will not be
possible to remove the data from open access databases.
8.4 Ownership of samples
Those samples collected from UCLH patients and stored as surplus diagnostic material
would be expected to be 'owned' by the Biobank and to remain as part of the Biobank if the
person responsible for a particular sample collection moved to another Institution or leave
the employ of UCL/UCLH.
For material that has been transferred in to the Biobank from other Institutions, ownership of
the samples would be agreed with the collector of the samples before they were accepted by
the Biobank.
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Where funding bodies support the collection of material to be banked, the collector of the
samples would be expected to have agreed the conditions of ownership of the samples with
the funding body and Institution, before the samples are accepted by the Biobank.
In each case samples would only be released from the Biobank following the directions
issued by the HTA for compliance with the HTAct 2004, i.e. to another HTA licensed premise
or for ethically approved research.
9. COLLECTION OF RESEARCH SAMPLES
Collection of samples for research is organized through collaboration and communication
between research staff and clinical staff. Samples that are removed during surgical
procedures for the purpose of diagnosis in the majority of cases will be first be assessed by
a Consultant Histopathologist, although a case can be made if it is deemed that this is not a
requirement. Researchers collecting research samples from the Biobank must register
themselves prior to collecting their first sample. Registration involves providing evidence of
REC approval. Only tissue that is surplus to diagnostic requirements will be released for
research and patient diagnosis should never be compromised. The sample will be logged
onto the research inventory system prior to release and all personal identifiers will be
removed. The sample will be given a unique research code that will enable tracking and
audit.
Samples for research that do not require histological assessment and tissue to be discarded
without pathology analysis (e.g. teeth, cartilage, bone) can be acquired directly from
operating theatres. If this happens it is the responsibility of the clinician collaborating in the
research project to ensure that the sample is logged on to the inventory database and that
personal identifiers are removed. Consent forms must be delivered to the Biobank where
they are stored centrally on a scanned electronic form, accessible to authorized staff.
Some projects may require extra samples such as blood, and saliva to be collected from
patients with certain conditions or healthy donors. Collection of blood, and saliva will
normally take place in the pre-assessment clinic, in the outpatient department or in the
wards for inpatients and only after appropriate consent has been obtained. Every effort will
be made for blood samples to be taken from patients when a blood sample is being taken for
diagnostic purpose or when a patient in under anaesthetic. However, exceptions to this can
be made on a study by study basis.
10. BIOBANK STAFF: REQUIRED TRAINING AND EXPERIENCE
10.1 Obtaining consent
All members of staff involved in the consent process will be trained appropriately. Specific
training will be given on maintaining, and avoiding breaches of, patient confidentiality.
Annual review of training status will be performed by the Designated Individual. Staff training
records are maintained and regularly updated.
10.2 Tissue collection and administration
All members of staff involved in the operation and running of the Biobank are appropriately
trained. Areas of training include sample tracking, laboratory health and safety and risk
management.
10.3 Safe Handling of Human Biological samples
As part of their induction when they join the UCL, all clinical and research staff are made
aware of the health and safety policies of UCL. All guidance that issued by the Biobank will
be done so in accordance with these key documents. Risk assessments are conducted for
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all activities involving human tissue samples. Standard Operating Procedures (SOP) exist for
all tasks involving human tissue samples.
All sample handling, processing, transfer and disposal will be logged on the inventory
database.
11. SECURITY AND CONFIDENTIALITY
11.1 Linked-anonymised/pseudoanonymised samples
Data collected and stored for linkage with samples will include patient diagnosis, relevant
clinical information including imaging, demographics and clinical outcome. Data will be
derived from health records.
All personal identifiers will be held securely within the facility. This information will be linkedanonymised, by numerical code to the sample, which will not include personal identifiers.
The database holding information about the samples will be hosted on a secure UCL server,
which will be regularly backed up. Only authorised personnel who have registered for
access will be granted access to the database and ‘end use researchers’ will only receive
coded samples and data. Authorised personnel will consist of Biobank staff and Research
and Development staff members. The link to patients’ identifiable data is maintained in order
to remove and dispose of the patients’ samples/data if they ever choose to withdraw their
consent and to allow addition of outcome measures. In addition, if a researcher requires
further clinical data (including imaging studies) they can apply to the Biobank for this data.
The Biobank can disclose this information without disclosing any personal identifiers.
11.2 Physical security of samples and data
The ‘banked’ tissue will be held in a secure, HTA-licensed research facility at the UCL
Eastman. All electronic data are stored on computers that are housed in lockable rooms. All
computers are password protected. Storage facilities are protected by lock, keypad and
entry phone
12. ACCESS POLICY AND NEW COLLECTIONS
The Biobank will support projects principally involved in study of human diseases and the
normal functioning of the human body. The Biobank will be open to requests for
samples/data from any research team investigating either within UCL, and UCLH, as well as
from other researchers in the UK and abroad. The research projects must comply with the
areas of research set out by the Biobank in this application. The open access policy will
apply to academic, private or public sector researchers, whether they are, or work with not
for profit or for profit organisations.
12.1 Process for requesting samples and new collections
All researchers that wish to use the Biobank must apply via the Biobank administrator. Only
projects that are covered by the scope of the Research Tissue Bank ethics application will
be authorised. In addition to obtaining appropriate approval, if a researcher wishes to start
their own sub collection or enter an existing collection under the cover of the Biobank, the
researcher must provide evidence that they comply with the Biobank's policies on storage,
health & safety, disposal, security, quality management, data protection, access, training and
consent and audit of compliance. These policies have been put in place to ensure HTA
compliance.
Access to human biomaterials stored in the Biobank in the first instance will be, either via
contact with the Biobank administrator who can direct enquiries to the collector of the
samples, or directly to person who has collected the materials. The purpose of this is to
ensure that appropriate samples are available for the proposed project. If a researcher
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wishes to gain access to the histopathological material held in the diagnostic archive, the
researcher will be directed to the pathologist who has a specialist interest in the disease /
tissue of interest. A list of pathologists with specialist interests will be held by the Biobank
administrator.
In the first instance the interested researcher obtains agreement of the collector or by an
interested party, for instance, the histopathologist or clinician involved in the collection or
diagnosis of that tissue.
1) If the person requesting access to the Biobanked samples already has a project –specific
ethical approval for the proposed research project via NRES/IRAS, the samples will be
released from the Biobank under the conditions stated below.
2) In the case where the person requesting the samples does not have ethical approval or
local peer review for the project for which they are requesting samples, applications will be
made using the Request Form to the Biobank Ethical Review Committee. The request form
for use of samples (see attached information) requests information on the nature of the
research project. The Biobank Ethical Review Committee, will where appropriate, seek
additional expert guidance regarding a request. If the Biobank Ethical Review Committee do
not feel they can review an application, the applicant will be advised to apply for ethical
approval via NRES/IRAS.
On receipt of requests for new collections or use of samples by the Biobank Administrator,
the application will be assigned a reference number that will serve to identify all
documentation which will also serve to track dissemination of material. The Biobank
administrator will submit the application to the Ethical Review Committee for approval, where
appropriate and will convey the decission of the Committee to the applicant.
12.2 Conditions for sample and data release to researchers
The terms of reference for the Biobank Ethical Review Committee require electronic
submission of requests so that the Board can review the applications within a 2-3 week time
period. The Biobank committee will consider applications from all scientists wishing to
perform research using the Biobank samples and information related to them. Researchers
may include those in the UK and abroad, in the NHS and in commercial companies. Simple
provision of tissues cannot constitute an intellectual event, as IP, by its very definition,
requires intellectual input into an invention. Where tissues are provided as part of a wider
research collaboration the provider may make an intellectual contribution to the discovery
and would thus be a co-inventor under normal law, in this case UCL will enter into
negotiations over IP and a suitable contract before tissue will be released.
The researcher must satisfy the Committee that their research falls within the scope of the
IRAS-approved Biobank and research programme, and is ethically sound and provide
evidence that it is likely to make a contribution to scientific/medical knowledge. Applications
to the Biobank Ethical Review Committee would be turned down if the applicants decline to
provide sufficient information as to the nature of the research, the research is deemed not to
advance research, applicants require unrealistic amounts of tissue, or they decline to accept
the terms and conditions for tissue supply.
Samples/data will only be released from the Biobank to external research groups when
appropriate approval is in place and when a material transfer agreement has been signed.
The material transfer agreement must ensure compliance with the UCL's policies on storage,
data protection, health and safety, disposal, security, training, audit and HTA compliance.
13. BIOBANK ADMINISTRATION
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13.1 Protocol amendments
 Substantial amendments of this protocol or associate documents will be notified to the
REC and approval sought before any amendments are implemented. The following
should always be notified as substantial amendments:
 Any significant change to the policy for access and use of information in the clinical
notes and imaging, and access to tissue in research, including changes to the types of
research to be undertaken or supported by the Biobank
 Any significant change to the types of biological material to be collected and stored, or
the circumstances of collection
 Any significant change to informed consent arrangements, including new/modified
information sheets and consent forms
 A change to the conditions of generic approval
 Any other significant change to the governance of the RTB
13.2 Governance policy, operating procedures and quality systems
The Biobank seeks to work to the following standards as defined by the human tissue
authority.
 Consent
Full consent to be taken by trained individuals.
 Governance & quality systems
Policies, procedures and quality management systems to be in place and fully implemented
for all licensed activities. All human-derived materials are to be traceable from collection to
eventual use or disposal.
 Premises, facilities and equipment
Materials should be kept in appropriate storage conditions that are regularly monitored and
maintained. Contingency plans to be in place.
 Disposal
Appropriate disposal procedures with consideration of the wishes of the donor (living
person).
A number of policies to which staff members are expected to adhere are in force. Areas
covered by Biobank policies include:
 Linking patient consent to use in ethically approved studies
 Health and safety
 Staff training
 Security of data and samples
 Quality management
 Access to human material
 Governance, communication and feedback
 Disposal
So that the Biobank Ethical Review Committee can be satisfied that its researchers are
complying with Biobank policies it is a requirement that they register their collections on an
annual basis and submit standard operating procedures which cover the areas noted below:
 Patient recruitment and consent: Process of obtaining consent for medical research
that is both generic and enduring
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Sample and data collection: Process for collecting samples, acquiring and updating
clinical data and ensuring data security
Sample preparation and quality management: Methods for processing samples for
different research and quality assurance procedures
Sample tracking: System for linking consent to use in ethically approved projects
Storage, inventory and disposal: Systems for inventory control, monitoring storage
conditions and maintaining facilities and security. Procedures for disposal
Request and allocation: Process for recording requests for samples and monitoring
use
Retrieval, packaging and distribution: System for removing samples, recording
removal and transportation
Use in ethically approved projects: Procedure for reviewing requests for samples and
ensuring that use is ethically approved, appropriate and that potential users are
legitimate. Agreements for material transfer, future use of research data and
acknowledgment.
Feedback: Systems for returning results (where appropriate) of experiments carried
out on banked material. Reporting adverse events.
Regular audits will be conducted to ensure quality is maintained.
13.3 Reporting serious protocol non-compliance or breach of policy
The REC will be notified as soon as possible of any serious adverse event or reaction, any
serious breach of security or confidentiality, or any other incident that could undermine public
confidence in the ethical management of the tissue. The Human Tissue Authority will also be
notified following standard procedure.
13.4 Clinical adverse event reporting
The Tissue Collection Centres have clinical adverse event reporting system in place. This
will be used if required.
13.5 Record retention
Records of all samples are kept indefinitely and following appropriate regulation. An audit
trail will be maintained for all samples including those that have been withdrawn. Certain
records will only be accessible to the database manager for audit purposes. Record keeping
will be done in a manner ensuring complete confidentiality of patients’ personal details.
13.6 Funding
The cost of operating the Biobank will be met by either internal financial support or via grant
monies from external sponsors.
13.7 Financial implications for donors
There are no financial implications for donors.
13.8 Communication and publication policy
Results obtained from research on these tissue samples will be presented at national and
international meetings and published in peer reviewed journals. The Biobank expects to be
acknowledged in all relevant publications.
13.9 Progress reports and accountability
An annual report, including a financial breakdown, will be produced and submitted to the
Biobank Ethical Review Committee, listing all projects for which tissue has been collected
and/or released in the previous year. The list will provide the full title of each project, the
name of the Chief Investigator, the sponsor, the location of the research and the date of
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approval by the Committee. This report will also be copied to the NRES Committee as
described in 3.4.1.
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