Middlesex University HTA Quality Manual · The Human Tissue Authority (HTA) is the governing body...
Transcript of Middlesex University HTA Quality Manual · The Human Tissue Authority (HTA) is the governing body...
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Middlesex University HTA Quality Manual
Version Number : 3
Review Date: September 2015
Authors: Position
Lucy Ghali Designated Individual
Celia Bell Head of Department
Approved by:
Graham Shennan Deputy Technical Manager
Licence No: 12533
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School of Health and Social Sciences
Middlesex University
POLICY AND QUALITY MANUAL: RESEARCH USING HUMAN TISSUE.
CONTENTS
1. Background. ...................................................................................................................... 4
2. Middlesex University research licence ............................................................................ 5
3. Governance........................................................................................................................ 5
4. Middlesex University HTA Quality Manual: ................................................................. 8
Information for All Staff Working Under the HTA Licence. .............................................. 8
4.1. Purpose ....................................................................................................................... 8
4.2. Staff Training............................................................................................................. 8
4.2.1. Staff Requiring Training ................................................................................... 9
4.2.2. Consent training ............................................................................................... 10
4.2.3. Methods of Delivering Training ..................................................................... 10
4.2.4. General Training .............................................................................................. 10
4.3. Relevant Material .................................................................................................... 11
4.4. Consent ..................................................................................................................... 11
4.4.1. Training in taking consent .............................................................................. 13
4.3.2. Useful Links ...................................................................................................... 13
4.5. Ethical approval for research................................................................................. 13
4.6. Storage ...................................................................................................................... 14
4.6.1. Temporary Storage of Tissue .......................................................................... 14
4.6.2. Methods of Storage .......................................................................................... 15
4.6.3. Traceability ....................................................................................................... 16
4.6.4. Record Retention ............................................................................................. 16
4.6.4. Security of authorised Areas ........................................................................... 16
4.7. Transportation, Import and Export ...................................................................... 17
4.8. Disposal .................................................................................................................... 18
4.8.1. Disposal of Relevant Material ......................................................................... 18
4.8.2. Disposal of Records .............................................................................................. 18
4.9. Risk Assessment....................................................................................................... 19
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4.9.1. Completion of LabRAT ................................................................................... 19
4.9.2. Working with Blood and Tissue ..................................................................... 19
4.10. Licence Exemptions ............................................................................................. 20
5. Review of the Policy and Quality Manual .................................................................... 21
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1. BACKGROUND.
The Human Tissue Act 2004 (HT Act 2004) is a framework for regulating the storage and use
of human organs and tissue from the living, and the removal, storage and use of tissue and
organs from the deceased, for specified health-related purposes including medical research.
The HT Act 2004 replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the
Human Organ Transplants Act 1989. The Human Tissue Act 2004 (HT Act 2004) is
applicable in full to England, Wales and Northern Ireland; there is a separate legislation for
Scotland. The Act was fully implemented on 1st September 2006.
The Human Tissue Authority (HTA) is the governing body set up to regulate activities that
come under the HT Act. The HTA provides advice and guidance about two laws: the HT Act
and the EU Tissue and Cells Directive (Quality and Safety for Human Application) 2007.
The HTA aim is to have a regulatory system for the removal, use and disposal of human
tissue. The human tissue is referred to in the act as relevant material (RM) and the regulated
activities are referred to as scheduled purposes. The HTA issues licences to organisations
that store and use human tissue for purposes such as research, patient treatment, post-mortem
examination, teaching, and public exhibitions. Nine Codes of Practice provide guidance and
lay down expected standards for each of the sectors regulated. Further information on the
HTA Codes of Practice can be found at:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm.
The HTA is responsible for licensing institutions to store and use human tissue for scheduled
purposes which fall under five headings:
• teaching about or studying the human body
• carrying out post-mortem examinations
• using human tissue to treat patients
• carrying out research on human tissue
• displaying human bodies or tissue in public (e.g. in a museum)
An HTA licence is granted to an organisation if it shows it will comply with certain essential
standards as set down by the HTA.
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2. MIDDLESEX UNIVERSITY RESEARCH LICENCE
The University has been granted a single licence by the HTA (Licence No 12533) for the
purposes of research. The storage and use of human organs and tissue from the living, and
the removal, storage and use of tissue and organs from the deceased, for specified health-
related purposes including medical research will potentially be covered by the licence,
subject to a satisfactory demonstration of compliance with HTA requirements. A copy of the
licence can be downloaded from the following link
http://hssc3.middlesex.wikispaces.net/home update with new one
The licence authorizes the storage of relevant material for the following scheduled purposes:
• Determining the cause of death
• Establishing after a person’s death the efficacy of any drug or other treatment
administered to him
• Obtaining scientific or medical information about a living or deceased person which
may be relevant to any other person (including a future person)
• Public display
• Research in connection with disorders, or the functioning of the human body
• Clinical audit
• Education or training relating to human health
• Performance assessment
• Public health monitoring
• Quality assurance
3. GOVERNANCE.
In order to ensure proper governance of the acquisition, storage, use and disposal of human
samples for research the following roles and responsibilities are identified:
i. Licence Holder (LH) and Licence holder’s representative
• Must have the consent of the DI for the application
• Pay the Licence fees
• The licence is held by the University as the corporate body
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• The named representative must have direct contact to the corporate body
• Has the right to apply to the HTA to vary the licence with regard to changing the
DI
ii. Designated individual (DI)
• The person who is responsible for ensuring that robust systems and processes are
in place to ensure compliance with the relevant licence
• Under whose supervision the licensed activity is conducted. They have the
primary (legal) responsibility under Section 18 of the HT Act to guarantee:
• That suitable practices are used in undertaking the licensed activity;
• That the other persons who work under the licence are suitable;
• That the conditions of the licence are compiled with
iii. Person (s) Designate (PD)
• A person to whom the licence applies and are named on the licence
• Supports the DI in providing advice about the procedures and systems that ensure
compliance with the HT Act and the terms of the University HTA licence.
The responsibilities of the PDs include:
• maintaining a list of projects that are storing human tissue in their area and
whether they are under Licence or covered by REC/NRES approval;
• visiting each project to ensure compliance with documentary and physical
requirements;
• checking and holding copies of risk assessments and staff training records
relating to HTA;
• checking storage facilities and their maintenance;
• assisting in the internal audit of other Schools;
• following up any recommendations made during the internal audit or HTA
inspection of their relevant School/Unit;
• notifying the Human Tissue Act steering group of any new projects that come
under the HTA Licence;
• participating in HTA Governance team group meetings.
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iv. Chief Investigator/Principal Investigator (CI/PI), researchers and those working
in research using human samples
In addition, all those involved in using relevant materials, although not named on the
license, must register as an individual working with human samples and work with the
PD and DI to ensure compliance with the terms of the licence. They are responsible
for:
• informing the PD of any projects involving the use of relevant material and that
the project is compliant with the HTA Licence;
• ensuring that MTAs for tissue transfers are in place for any incoming/outgoing
tissue (see MTA SOP Section ?);
• completing and maintaining records for Holdings and make them available for
inspection and auditing. (see Records keeping SOPSection ?);
• drafting and updating risk assessments (see Risk assessment SOP Section ?);
• adverse event reporting (see Adverse event reporting SOP (see Section ?Section
?);
• implementing recommendations made following internal audit or HTA
inspections;
• ensuring all staff working on projects involving human tissue have relevant training
required by the HTA to comply with their requirement for the collection, use, storage
and disposal of Human tissue.
v. Human Tissue Authority Governance Team
The HTA steering Group, chaired by the DI and comprise the PDs and the
departmental manager (Health& safety) and head of department. The remit of the
Governance Team is to discuss issues relating to the HTA Licence requirements and
to take the required measures to address any issues in relation to the maintenance and
control of the Quality Management System, including drafting and updating
documentation and performing internal audits. Other responsibilities include
conducting annual survey of holdings and to maintain an up-to-date accurate Register
of Holdings.
The Middlesex University structure for managing the governance of the licence can be
found at: http://hssc3.middlesex.wikispaces.net/home
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4. MIDDLESEX UNIVERSITY HTA QUALITY MANUAL:
INFORMATION FOR ALL STAFF WORKING UNDER THE HTA LICENCE.
4.1. PURPOSE
The purpose of this quality manual is to provide information for all staff working under the
licence and to ensure compliance with the HT Act in line with the standards and guidance set
by the HTA. This must be read by all staff and students working on research projects
involving human tissue. This quality manual should be read in conjunction with the HTA
Code of Practice 9: Research
(http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code9research.
cfm)
The licensed activity should be carried on only at the licensed premises specified and under
the supervision of the Designated Individual.
In seeking clarity on any HTA issues staff should:
• Contact the person(s) Designated (PD) for the relevant information If the PD is unable
to answer the query he/she will pass to the DI
• If the DI cannot answer he/she will contact the HTA in writing to seek clarity on the
issue
4.2. STAFF TRAINING
All staff (and students) involved in human tissue activities should undertake training on HTA
legislation, including training on informed consent. This is to ensure that all staff has the
necessary knowledge and skills to carry out their roles and responsibilities in compliance
with the HT Act and HTA Codes of Practice. Middlesex University will provide training
covering the requirements of the Human Tissue Act, which includes what researchers need to
do in order to comply with the HTA Licence. The Medical Research Council also has an on-
line course related to HTA activities, which would satisfy the terms of the HTA Licence.
Certificates of completion of any on-line courses must be retained as proof of completion.
Under the HT Act, anyone taking consent for the collection of human tissue must be trained
to do so in order to comply with the HTA Licence. Middlesex University runs a training
course on consent. Consent is also covered on two taught modules both at the undergraduate
and postgraduate level. For more details see Consent SOP
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Middlesex University is committed to the provision of staff development and training
opportunities for all. It is committed to develop its staff both for their current roles and to
equip them to face the challenges and changes of the future. The University seeks to create an
identifiable link between the development needs of individuals, schools/services and the
organisation in support of the achievement of the University’s corporate objectives.
The University is committed to providing every member of staff with an appropriate
allocation of time to be dedicated to development activity in order to acquire or update
knowledge and skills relating to their employment. It is strongly recommended that all staff
engage annually in a minimum of 5 days staff development related to CPD, not all having a
direct budget implication. Part time staff should engage in a pro-rata number of days
depending on their hours of work. Schools and Services should allocate and spend a sum
equivalent to a minimum of 0.5% of their salary budget specifically for staff development.
Staff that requires training will be identified and recommendation for training will be done
through their line mangers. Full records should be maintained of all training undertaken by
employees.
4.2.1. STAFF REQUIRING TRAINING
Designated individual (DI): The DI is required to complete accredited training provided by
the HTA. This is available as an e-learning package or in a face-to-face setting.
Person (s) Designate (PD): The PD must be fully compliant with the HT Act and the terms
of the University's License. It is therefore essential that the PD is familiar with the human
tissue legislation and all Codes of Practice through appropriate and agreed mechanisms.
Research Student Supervisors: Training is run regularly by the Research and Knowledge
Transfer Office. It is a requirement for every member of staff to attend before taking on any
supervisory role. Training includes ethics and related issues.
New Staff: The University’s Induction policy is designed to ensure that all new members of
staff are provided with the necessary information and support to aid the smooth transition into
their role. The University holds a general induction and then a Department will provide a
more local induction. Training will be identified and discussed at the initial meeting with the
line manager. Before any work involving human tissue is undertaken, new staff involved in
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HTA activities must become familiar with the human tissue legislation and all Codes of
Practice through appropriate and agreed mechanisms.
Students: All students working with human tissue should receive appropriate training in the
requirements of the HTA before any work involving human tissue is undertaken.
4.2.2. CONSENT TRAINING
Any person involved in taking consent from research participants for the removal, storage
and use of human tissue should receive training in the implications and statutory
requirements for consent under the HT Act. A taught research module which includes ethics
and law related to research should be undertaken by all research students’ and can also be
accessed by staff.
Untrained or inexperienced staff or students should not take consent.
4.2.3. METHODS OF DELIVERING TRAINING
The DI and PDs will manage a process for staff and students working under the HTA license
to become familiar with HTA legislation and to ensure compliance with the HT Act. Guided
learning can cover courses and reading relevant documents. Where necessary, staff
development funds are available to pay for courses. Records of completion of courses should
be kept by the DI who should ensure that staff is fully conversant with the HT Act. Local
training sessions can be organized when necessary, to distribute all current and new
information that staff need to be familiar with. These sessions can be co-ordinated and
delivered by the DI. As the number of staff working under the HT Act increases, these roles
may be delegated by the DI to the relevant PD.
Methods for delivering training should be kept under evaluation and reviewed; if the
number of staff working under the licence increases, more formalised training needs will
need be put into place.
4.2.4. GENERAL TRAINING
A list of general training expected to be undertaken by staff is given below and is intended to
be indicative and not exhaustive:
• Health and Safety training
• Research Governance procedures
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• Informed Consent
• HT Act & HTA requirements
• Adverse Event Reporting
• Risk assessment and management of risk
• Data Protection and Confidentiality
• Records keeping
• Research Ethics
4.3. RELEVANT MATERIAL
The Human Tissue Act (2004) governs the collection, storage and disposal of relevant
material (RM). Relevant material is defined by the HT Act (2004) as material that contains
or consists of human cells. The act is clear that if material contains or may contain just one
human cell then it is RM. Therefore this includes, but is not limited to: saliva, urine, blood,
skin & organs.
Relevant material is largely human tissue but there are some exceptions, for example gametes
(governed by the Human Fertilisation and Embryology Act), hair and nails from the body of a
living person. Relevant material does not include acelullar material; for example extracted
DNA, RNA, plasma and serum.
Cell cultures are considered to be relevant material if they contain cells that were created
inside the human body e.g. if the culture contains original cells from a biopsy or blood
sample. Once cells in culture have undergone one full cell-division cycle, the culture no
longer contains original cells and the tissue does not have to be held under Licence.
Relevant material also includes microscope slides of human tissue (e.g. skin) and bodily
secretions (e.g. nasal fluids, urine, saliva, sweat). For the HTA Supplementary List of
Materials go to http://hssc3.middlesex.wikispaces.net/home.
4.4. CONSENT
It is a requirement that those donating tissue for the purposes of research are made aware of
and agree to the uses to which their tissue will be put. This is informed consent and is
fundamental to the Act.
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“At the heart of the Act lies the need to obtain consent for the removal, storage
and use of human tissue or organs” (Human Tissue Authority Code of
Practice: Consent. Paragraph 15).
The code also notes that “the giving of consent is a positive act – absence of
refusal is not evidence of consent” (paragraph 17).
The Human Tissue Authority has issued a Code of Practice in respect of consent:
http://www.hta.gov.uk/_db/_documents/2006-07-04_Approved_by_Parliament_-
_Code_of_Practice_1_-_Consent.pdf
A standard consent form is used across the School of Science & Technology (S&T). These
consent forms comply with the HTA’s Code of Practice and are made accessible to all
research staff and students whose projects involve human participants or their information.
These consent forms are accessible and are part of S&T ethics application forms */0
*8(http://ethics.middlesex.wikispaces.net/Home).
Participants must be given clear information about the reason that they have been asked to
provide a sample. Consent must be a process and therefore researchers must allow
participants TIME to consider whether they wish to provide a tissue sample. Researches
should use a version of the Participant information sheet that has been approved by the ethics
committee (http://ethics.middlesex.wikispaces.net/Home).
i. Participants must be given sufficient time to consider whether they wish to participate
in the research.
ii. Participants must be provided with the approved participant information sheet in a
language they understand and in an appropriate format e.g. printed, large font etc.
iii. The participant information sheet must include information about the use of tissue
samples in language appropriate to the participants
iv. ----Researchers must also be available (in person, via phone or email etc) to answer
any concerns regarding the research.
v. Participants must be informed that their participation is voluntary.
vi. Participants must be informed that they can withdraw from the study.
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vii. Signed Informed Consent should be obtained using a version of the template consent
form that has been approved by the ethics committee
(http://ethics.middlesex.wikispaces.net/Home).
viii. Researchers must store the signed informed consent sheets
ix. Where consent is given but later withdrawn, this must be respected. No further use
may be made of the tissue and the sample fate must be discussed with the individual
and options for destroying/disposing or returning the sample must be explained.
4.4.1. TRAINING IN TAKING CONSENT
As stated above, staff or students involved in taking consent from research participants for
the removal, storage and use of human tissue should receive training in the implications and
statutory requirements for consent under the HT Act. A taught research module which
includes ethics and law related to research should be undertaken by all research students’ and
may also be accessed by staff.
Untrained+9+*++ or inexperienced staff or students should not take consent.
4.4.2. USEFUL LINKS
NRES: http://www.nres.npsa.nhs.uk/rec-community/guidance/#InformedConsent
MRC: 2004, MRC Ethics Guide “Medical Research Involving Children”
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
2007, MRC Ethics Guide “Medical research involving adults who cannot
Consent: http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC004446
4.5. ETHICAL APPROVAL FOR RESEARCH
It is the Universities position that all research projects that include the procurement and use
of tissue from the living must be reviewed by an appropriate ethics committee.
For the purposes of the HT Act, recognised ethics committees include:
• a Research Ethics Committee (REC) established under and operating to the standards
set out in the governance arrangements issued by the UK Health Departments
• 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
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Researchers wishing to use RM for which ethical approval from an ethics committee as
recognised for the purposes of the HT Act is not required should seek approval from the
University Ethics Committee. A university ethics committee is not, for the purpose of the
consent exception considered to be a recognised research ethics committee. Consent is
required for tissue to be used in a research project approved by the university ethics
committee. For avoidance of doubt, all researchers proposing to use RM should seek advice
from the DI regarding ethical approval and consent to inform their practice.
If a specific research project has REC/NRES approval there is no need for it to come under
the HTA Licence. However, if the tissue is retained following the end date of the ethics
approval, it then has to be stored under the University’s Licence. As good practice, all
projects, even if exempt from the HTA licence should adhere to the codes of practice
published by the HTA and internal University processes as detailed in this policy.
Research tissue banks still need to be held on HTA Licensed premises, even if REC approval
is in place.
4.6. STORAGE
Human tissue must be stored securely, in line with health and safety guidelines and with
appropriate record keeping. Under the Human Tissue Authority license at Middlesex
University, all RM should be stored in authorised areas within the Hatchcroft building,
Hendon Campus. Human tissue cannot be stored outside of the authorized areas. The DI will
designate authorized areas and will inform researchers of these areas.
Each authorized laboratory must have an identified Laboratory Manager who can act as a
Person Designated under the license. The Laboratory Manager is responsible for the
implementation of the policy within their laboratory.
4.6.1. TEMPORARY STORAGE OF TISSUE
Under section 16(7) of the HT Act, "storage" does not include transient storage incidental to
transportation. The HTA defines storage as incidental to transportation if tissue is held for a
matter of hours or days (but never weeks) pending transfer to a licensed establishment.
Where this applies, a licence is not required.
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Where human tissue is being held whilst it is processed with the intention to extract DNA or
RNA, or other sub-cellular components that are not relevant material (i.e. rendering the tissue
acellular), the HTA views this as analogous to the incidental to transportation exception. A
licence is therefore not required, providing the processing takes a matter of hours or days and
certainly no longer than a week (see HTA Code of Practice 9: Research).
However, where a researcher holds tissue for a short period for the purpose of a project (e.g.
to conduct analysis prior to discarding the tissue), this is storage for a scheduled purpose (i.e.
research). Such storage requires either a licence from the HTA or ethical approval for the
project.
4.6.2. METHODS OF STORAGE
The following methods of storage should be adhered to:
• Tissue should be stored in securely locked storage areas and containers e.g. rooms and
buildings, freezers, fridges and other storage containers.
• Appropriate labeling of the tissue specimen is required. Labels should not contain patient
identifying information.
• Records should detail the location of the materials; health and safety, including
appropriate containment levels for the storage and handling of materials that may pose a
risk to others.
• Storage records should be maintained that conform to HTA guidance on traceability (see
below 4.6.3).
• Human tissue must be stored in a licensed area that must be locked at all times when not
in use. A copy of the HTA Licence should be displayed in any area storing human tissue.
• A risk assessment relating to the storage of human tissue should be made and should
cover what would be done in the event of failure of storage provision, consideration of
what emergency/contingency procedures should be in place, and details of possible
alternative storage. (see section 4.8).
Any adverse event or ‘near-miss’ involving the storage of human tissue should be
reported using the University Health and Safety Unit Guidance Note 43: Accident/Near
Miss/Undesired Occurrences: Reporting and Investigation.
http://www.intra.mdx.ac.uk/Assets/HAS_GN43.pdf.
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The Designated Individual is responsible for ensuring that records are maintained in the area
covered by the licence. Holdings must be reviewed annually and reported to the DI.
4.6.3. TRACEABILITY
To comply with the Human Tissue Act (2004) authorized laboratories must document the
arrival, storage and destruction of all samples that enter the laboratory.
i) Labeling of stored human tissue samples: wherever possible all human tissue
samples should have unique label/ number attached to identify them. Normally
this will be a unique number.
ii) Each sample must be added to a database record together with tissue type, date
acquired and location.
iii) Samples entering an authorized laboratory: details of every tissue sample/RM that
enters the laboratories or leaves the laboratories must be recorded.
iv) The database must be securely backed up to ensure minimal data is lost in case of
system failure. Electronic records and records management systems should be
kept in a secure area on the University’s shared drive which is backed up nightly.
v) When tissue samples are disposed of, moved off site or out of an authorised
laboratory the database must be adjusted (e.g. disposed of, moved to new location
etc).
vi) The DI is responsible for checking the database and consent forms on a regular
basis to ensure that the records are appropriately maintained. However, all PDs
and PIs have a responsibility to notify the DI and PD of any adjustment needed to
the database of holdings of RM and this must be done in a timely fashion.
4.6.4. RECORD RETENTION
Records that enable traceability must be maintained at least until the tissue has been disposed
of, used to extinction or otherwise brought outside of the regulatory framework, or will never
be used again in research. All those working with human tissue should adhere to the
University ‘Code of Practice for Research’ (http://www.intra.mdx.ac.uk/working-
here/policies/Research/index.aspx) and to any relevant external requirements for retention.
4.6.4. SECURITY OF AUTHORIZED AREAS
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Restricted access to authorized areas is required to conform to the terms of the Human Tissue
Act (2004) for which part of Hatchcroft is a designated licensed premises in which tissues
can be held for the express purpose of medical research and education. Only authorized staff
and students should have access to the laboratory. No unauthorized access to the laboratory
should be permitted.
The ‘Hatchcroft Science Building Access Policy and Procedures’ is available at
http://hssc3.middlesex.wikispaces.net/file/view/Hatchcroft%20Access%20Policy%20%28De
c%202009%29.pdf/120964359/Hatchcroft%20Access%20Policy%20%28Dec%202009%29.
pdf.
The lists of those granted access to the authorized areas should be reviewed at regular
intervals and former staff and students should regularly be removed from the access system
by inactivating their access cards.
Access to key pieces of equipment should be restricted to authorised and trained individuals.
Any equipment used to store human tissue (e.g. fridges, freezers) should be locked at all
times when not in use.
4.7. TRANSPORTATION, IMPORT AND EXPORT
Human tissue can only be transported from one establishment to another within England,
Wales or Northern Ireland if both establishments have an HTA Licence or the tissue is
covered for transportation under NRES approval.
A Material Transfer Agreement (MTA) must be in place for all tissue transfers. For incoming
tissue, the supplier will usually provide the MTA. For outgoing transfers, the University will
provide the MTA. Appropriate modes of transport, suitable routes and arrangements with
people involved must be planned and arranged in advance and records kept of all tissue
movements and risk assessment must be made.
In terms of research, the consent provisions of the HT Act do not apply to imported material.
However, the HTA considers it good practice for there to be mechanisms in place to provide
assurance that the tissue has been obtained with valid consent. Guidance for those wishing to
import human bodies, body parts and tissue from abroad into England, Wales and Northern
Ireland, is set out in HTA Code of Practice 8: Import and export of human bodies, body parts
and tissue.
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4.8. DISPOSAL
4.8.1. DISPOSAL OF RELEVANT MATERIAL
The HT Act makes it lawful to treat as ‘waste’ any relevant material which has come from a
person who was:
• in the course of receiving medical treatment,
• undergoing diagnostic testing, or
• participating in research.
Material no longer required for use, or stored for use, for any scheduled purpose can be dealt
with as human tissue waste. The HTA stipulates that relevant material held for scheduled
purposes must be disposed of by incineration, burial or cremation.
The following Guidance on disposal should be followed and is available at
http://hssc3.middlesex.wikispaces.net/Health+%26+Safety#Guidance for Personnel Working
in the West Zone of the Hatchcroft Building:
• HSSc Waste Disposal Guidance Note
• Laboratory Waste Disposal Guidance Note
• Disposal of Human Tissues
Relevant material for disposal should be placed in a separate sealable container labelled
‘human tissue’ to separate it from other clinical waste. The labelled container must then go
into the orange ‘for incineration’ waste bag/bin. Any waste that has or may have come into
contact with potentially infectious materials must be autoclaved before disposal. All
consumables used in laboratory work that involves potentially infectious material must be
autoclaved e.g. gloves, pipette tips, test tubes etc.
4.8.2. DISPOSAL OF RECORDS
At the end of the agreed retention period, records should be destroyed in a confidential
manner either through the University’s confidential waste service or using local shredding
facilities. Secure facilities are provided on all campuses for the disposal of confidential
information in line with BS EN 15713:2009. Any electronic equipment used should be wiped
before disposal or reuse.
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4.9. RISK ASSESSMENT
4.9.1. COMPLETION OF LABRAT
As part of the HT Act risk should be assessed and mitigation of risk carried out in connection
with the storage and handling of relevant material. All members of Middlesex University
staff that handle or work with human tissue under the Licence should carry out a risk
assessment in relation to their activity. A risk assessment should be completed for each
practice and process involving human tissue, including transportation, use, storage and
disposal, before the activity takes place.
The following should be taken into consideration in relation to risk and mitigation of risk:
risk to the tissue from all reasonable relevant events e.g. in the event of a failure of a freezer
or other storage where the tissue is held, or for the transportation of tissue to another location.
All risk assessments must be completed using the ‘LabRAT’ template available on the
laboratory wiki (http://hssc3.middlesex.wikispaces.net/Risk+Assessments); a hard copy
should be kept in the relevant laboratory and an electronic copy should be made available on
http://hssc3.middlesex.wikispaces.net/Risk+Assessments. A copy should also be forwarded
to anyone who may require it, e.g. technical staff (for completion of their own RA with
regard to preparations), research students, line-manager, colleagues, EFMS staff etc.
Risk assessments must be reviewed on regular bases if procedures/circumstances change and
any changes documented with the date. Risk assessment must be reviewed before the start of
any new activity in connection with handling or using human tissue for a scheduled purpose.
Risk assessments must also be reviewed and updated before the start of each new academic
year.
In the event that any serious adverse event occurred, the risk assessment should be revisited
and reassessed to identify any further potential hazards or reduce the risk rating of hazards
previously identified.
4.9.2. WORKING WITH BLOOD AND TISSUE
All staff working with human tissue should adhere to the University Code of Practice for
Working with Blood & Human Tissues which can be found on the laboratory wiki
(http://hssc3.middlesex.wikispaces.net/Health+%26+Safety)
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4.10. LICENCE EXEMPTIONS
The research licence held by Middlesex University allows for the removal, storage, use and
disposal of human tissue for the purposes of research. There are a number of exemptions to
the HTA licence. These are detailed below;
4.10.1. REC/NRES Approval
If a specific research project has REC/NRES approval there is no need for it to come under
the HTA Licence. However, if the tissue is to be retained following the end date of the ethics
approval, it then has to be stored under the University’s HTA Licence and the PI must adhere
to the standards and requirements set out by the HTA.
Research tissue banks need to be held on HTA Licensed premises, even if REC approval is in
place. Research projects approved by University Ethics Committee come under the licence
and will need to comply with the regulations set out by the HTA.
4.10.2. Storage Incidental to Transportation
Under the HT Act, where human tissue is in storage pending transfer elsewhere, providing it
is held for a matter of hours or days and certainly no longer than a week, the HTA takes the
view that the storage is incidental to transportation and an HTA licence is not required.
4.10.3. Intention to Extract DNA/RNA
Where human tissue is being held whilst it is processed with the intention to extract DNA or
RNA, or other subcellular components that are not relevant material (i.e. making the tissue
acellular), a licence is not required, providing the processing takes a matter of hours or days
and no longer than a week.
4.10.4. Cell Cultures
Cell cultures are relevant material if they contain cells that were created inside the human
body e.g. if the culture contains original cells from a biopsy or blood sample. Once cells in
culture have undergone one full cell-division cycle, the culture no longer contains original
cells and the tissue does not have to be held under HTA Licence.
4.10.5. Acellular Material
Tissue that has been made acellular does not come under the HT Act and therefore is not
stored under the HTA licence.
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4.10.6. Deceased for More Than 100 Years
An HTA Licence is not required to store tissue from a deceased person who has been dead
for more than 100 years
.
5. REVIEW OF THE POLICY AND QUALITY MANUAL
This policy and quality manual has been prepared by the Designated Individual in
consultation with relevant staff, including the University occupational Health and Safety
Manager, lead research staff in the school and the Laboratory Technical Manager.
Review Date: September 2014