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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