1
QUALITY MANUAL
Acquisition, Storage, Use and Disposal of
Human Tissue
Title
AUHTA Quality Manual
Version
9
Superseded Version Number and
Date
Version 8 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
Quality Manual – Acquisition, Storage, Use and Disposal of Human Tissue: Version 9, April 2016
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CONTENTS
1. Introduction
6
2. Aston University Human Tissue Act (2004) License
6
3. Legislation and Regulation
7
3.1 Background
7
3.2 Scope of the Act
7
3.3 Consent
9
4 Personnel, Premises and Equipment
4.1 Responsibilities of Individuals using Human Tissue
10
4.2 Premises
10
4.3 Equipment
11
5 Approval for Research using Human Tissue
12
5.1 Research Ethics Committee
12
5.2 Designated Individual
12
5.3 Aston Sponsorship
13
6 Transfer of Human Tissue
7
10
13
6.1 Material Transfer Agreements
13
6.2 Transport of Human Tissue
13
Documentation of Research with Human Tissue
13
7.1 Site Files
13
7.2 Human Tissue Records
14
8 Storage of Human Tissue
14
9 Disposal of Human Tissue
14
10 Training
14
11 Adverse Event Reporting
14
12 Monitoring, Auditing and Inspection
15
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12.1
Monitoring
15
12.2
Internal Audit
15
12.3
Inspection
15
13 Complaints
16
14 Archiving
16
15 Human Tissue Act Compliance Oversight Group
16
16 Amendments to the Quality Manual
17
17 Appendix one
19
Quality Manual – Acquisition, Storage, Use and Disposal of Human Tissue: Version 9, April 2016
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Standard Operating Procedures and Forms
AHRIC001
Due Diligence Process for Approving Suppliers/Recipients of Human Tissue
(Version 1) - April 2016
Form AHRIC001 – Version 1:
Application for Due Diligence to be Undertaken in a Supplier/Recipient of Human
Tissue
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
(Version 1) - February 2016
Form AHRIC002 - Version 1:
Application for Designated Individual Approval for Research With Human Tissue
Form AHRIC003 - Version 1:
Application for Designation of a Laboratory for the Storage and Use of Human Tissue
Form AHRIC004 - Version 1:
Application for Designation of a Freezer for the Storage of Human Tissue
AHRIC003
Material Transfer Agreements for Human Tissue (Version 1) - April 2016
AHRIC004
Transport of Human Tissue (Version 1) - April 2016
Form AHRIC005 - Version 1:
Transport Risk Assessment
AHRIC005
Human Tissue Records (Version 1) - April 2016
AHRIC006
Storage of Human Tissue (Version 1) - April 2016
AHRIC007
Cleaning and Decontamination Procedures for Laboratories working with
Human Tissue (Version 1) - April 2016
AHRIC008
Disposal of Human Tissue (Version 1) - April 2016
AHRIC009
Training Records for Research with Human Tissue (Version 1) - April 2016
Form AHRIC006 - Version 1:
Human Tissue Research Training Record
AHRIC010
Thinktank Human Brain (Version 1) - April 2016
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Form AHRIC007 - Version 1:
Transfer of the Human Brain from the Thinktank to Aston University
Form AHRIC008 - Version 1:
Transfer of the Human Brain from Aston University to the Thinktank
AHRIC102
Obtaining consent from Research Participants (Version 1) - April 2016
AHRIC103
Site File Management (Version 1) - April 2016
AHRIC104
Adverse Event Reporting (Version 1) - April 2016
Form AHRIC101 - Version 1:
Adverse Event Report
AHRIC105
Internal Audit (Version 1) - April 2016
AHRIC106
Archiving (Version 1) - April 2016
AHRIC107
Protocol Amendments (Version 1) -
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1. Introduction
Aston University operates a quality management system for the governance of the
acquisition, storage, use and disposal of human tissue.
This system ensures that all work involving human tissue is conducted in accordance with
“good practice” and complies with the Human Tissue Act (2004).
Quality manual procedures are applicable to all research involving human tissue at Aston
University.
This manual sets out the operating procedures for the system.
2. Aston University Human Tissue Act (2004) License
Aston University is licensed by the Human Tissue Authority for:
“storage of relevant human material for a scheduled purpose”
License Number:
12381
License Holder:
Aston University
Licensed Premises:
Aston University
Designated Individual (DI):
Dr N J Seare
n.seare@aston.ac.uk  0121 204 3325
Persons Designate:
Professor C J Bailey
c.j.bailey@aston.ac.uk
 0121 204 3898
Dr J E P Brown
j.e.p.brown@aston.ac.uk
 0121 204 45039
Under the Act the Designated Individual (DI) is responsible for licensed activities and
supervising compliance with the licensing arrangements.
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3. Legislation and Regulation
3.1 Background
The Human Tissue Act (HTA) came into full effect on 1st September 2006, replacing existing
laws by setting an updated legislative framework for regulating body donation, and the
removal, storage and use of human organs or tissues.
The Act is set out at: http://www.opsi.gov.uk/ACTS/acts2004/ukpga_20040030_en_1
The Act makes informed consent the fundamental principle underpinning the lawful removal,
storage and use of human tissue from the living and from the deceased. It requires that all
procedures involving human tissue be conducted with full respect for the dignity of the donor.
It sets up an overarching Authority (the Human Tissue Authority) to regulate activities
through licensing and to introduce supplementary directions and guidance.
3.2 Scope of the Act
The Act applies to any work on, or storage of, “relevant material”. Relevant material is
defined in the Act as: “material, other than gametes, which consists of or includes human
cells” but does not include: “embryos outside the human body, or hair and nail from the body
of a living person”.
More information on the definition of relevant material can be found in Table 1 and at:
www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm.
All studies with human tissue for which living participants have given informed
consent that have NHS Research Ethics Committee approval are outside the scope of
the Act.
However, if tissue is to be stored for a future undefined project as part of a Tissue Bank the
Act applies to storage and use of the tissue even if NHS Research Ethics Committee
Approval has been given.
The Act covers use of material from a deceased person for clinical audit, education, training,
testing medical devices, health monitoring, quality assurance, or using tissue to obtain
genetic information that may be relevant to any other person.
Special allowance is made to preserve organs pending consent for transplantation.
For a living person, consent is required to store tissue for information about that person that
may be relevant to any other person (now or in the future), for public display or
transplantation.
It is not permitted to have any human tissue for DNA analysis without the consent of the
individual or an appropriate representative.
The Act does not apply to cultured cell lines or surplus or residual tissue from a diagnostic or
surgical procedure used “anonymously” for ethically (NHS Research Ethics Committee)
approved research.
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Table 1 Relevant Material*
SOURCE
PRODUCT
HTA
W HOLE BLOOD
W HOLE BLOOD
INCLUDED
DNA
INCLUDED
SERUM**
NOT INCLUDED
PLASMA
NOT INCLUDED
CELLS
INCLUDED
CELL LINES
AFTER 3RD PASSAGE
NOT INCLUDED
OTHER BODY FLUIDS
URINE
INCLUDED
CSF
INCLUDED
SALIVA
INCLUDED
JOINT FLUID
INCLUDED
TEARS
INCLUDED
SMALL BIOPSIES
INCLUDED
IDENTIFIABLE BODY PART
INCLUDED
BODY PARTS
*This Table does not contain an exhaustive list of relevant material please see:
www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm for further information
** Double spun or prepared with gel
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3.3 Consent
The following flow chart summarises the requirements for consent for storage and work on
human tissue from the living:
* Clinical trials Regulations 2004 http://www.uk-legislation.hmso.gov.uk/si/si2004/20041031.htm
** Mental Capacity Act 2005 http://www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1
For a deceased person, consent is required under the Act if consent has not already been
given for an anatomical examination, post mortem, removal of organs/tissues during the
foregoing, storage or public display, or research on specimens.
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More detailed information can be found in the Human Tissue Authority Code of Practice 1:
Consent: https://www.hta.gov.uk/code-practice-1-consent
Procedures for obtaining consent are outlined in:
SOP: AHRIC102 – Obtaining Consent from Research Participants.
4. Personnel, Premises and Equipment
4.1 Responsibilities of Individuals using Human Tissue
Principal Investigators (PIs) – the PI is the individual who is responsible and accountable
for conducting work using human tissue at Aston University in accordance with the Quality
Manual.
It is the responsibility of PIs to ensure that any proposed research studies or teaching
activities involving human tissue have: an appropriate ethical committee favourable opinion;
DI approval; and that the acquisition, storage, use and disposal of the tissue is undertaken in
accordance with the procedures within this Quality Manual.
Additionally it is the responsibility of PIs to ensure that all staff and students engaged in such
activities have undertaken appropriate training to allow them to comply with the requirements
of this Quality Manual.
Co-investigators; Teaching and Technical Staff; and Students – it is the responsibility of
co-investigators; teaching and technical staff; and students to ensure that all work that they
undertake using human tissue is carried out in accordance with the procedures within this
Quality Manual.
4.2 Premises
The following areas within Aston University have been designated for research with human
tissue and as appropriate for research which falls within the Human Tissue Act 2004:
Main Building Laboratories: MB334, MB356, MB358, MB633, MB634c, MB351,
MB326/324
Freezer Room: MBLG59
Liquid Nitrogen Facility
Aston Day Hospital: all theatres, associated rooms and laboratories
Vision Sciences Clinics – collection of Tear samples and packaging for transport ONLY
Biomedical Facility
Access to these areas is restricted to authorised University personnel only in line with
University policy.
The laboratories are Class II compliant and operate according to Good Laboratory Practice.
Advice relating to Class II compliance and Good Laboratory Practice and associated training
can be obtained from The School of Life and Health Sciences (LHS) Technical Manager Mr
Michael Robinson, e-mail, m.w.robinson@aston.ac.uk  0121 204 3091.
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Each laboratory/research group should have in place risk assessments and Standard
Operating procedures for the use of human tissue.
Requests for designation of additional laboratories for the storage and use of human tissue
should be made to the DI using Form AHRIC003 – Application for Designation of a
Laboratory for the Storage and Use of Human Tissue.
4.3 Equipment
Freezers for the Storage of Human Tissue
Freezers designated for storage of human tissue are:
Location
Make
Serial Number
NBS U725
1016-0279-0410
Sanyo MDF-U3386S
08060005
NBS U535
F535EK630324
Sanyo MDF-U5411
20708164
Sanyo MDF-U74V
10020180
Sanyo MDF-U73V
70208789
Sanyo MDF-U74V
11020256
MB334
NBS U535
F535EI330289
MB659
Revco 8925
830046-80
Forma 905
40975374
NBS U360
1005-9408-0413
NBS U360
F360CQ830026
NBS U725
1016-0356-0410
NBS U725
F725EL531849
MB633
MB634C
MB326
MB358
Phlebotomy Room
(Aston Day Hospital)
MBLG59
Freezer Room
Freezers containing human tissue must remain locked, or be in a locked room to which
access is controlled and monitored as part of the University external monitoring contact with
Tutela Monitoring Systems. They must not be used for storing animal tissue.
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Requests for designation of additional freezers for the storage of human tissue should be
made to the DI using Form AHRIC004 – Application for Designation of a Freezer for the
Storage and Use of Human Tissue.
Storage of Paraffin Embedded Tissue Blocks and Slides
Cupboards containing human tissue must remain locked, or be in a locked room to which
access is controlled. They must not be used for storing animal tissue.
Laboratory Equipment
All laboratory equipment used for research with human tissue must be maintained according
to manufacturer’s requirements and records of: decontamination; servicing; and calibration
maintained. These records must be made available for audit and HTA inspections.
5. Approvals Required for Research using Human Tissue
All research projects and teaching activities involving human tissue require a “favourable
opinion” from an appropriate Research Ethics Committee (University or NHS REC) and
Designated Individual approval.
In addition for projects where Aston University is the Sponsor (as defined in the Research
Governance Framework for Health and Social Care1) Sponsors approval for the project is
also required.
5.1 Research Ethics Committee
University REC
For projects that do not involve the NHS proposals should be submitted to the University
Ethics Committee following the procedure set out at the University website:
http://www1.aston.ac.uk/registry/for-staff/regsandpolicies/ethics-policy-and-procedures/
NHS REC
Guidance on making an application to a NHS REC can be found on the Health Research
Authority website:
http://www.hra.nhs.uk/research-community/applying-for-approvals/
Details of the Integrated Research Application System (IRAS) can be found at:
https://www.myresearchproject.org.uk/Signin.aspx
5.2 Designated Individual
SOP: AHRIC002 – Designated Individual Approval to Undertake Research with Human
Tissue
1
Research governance framework for Health and Social Care: https://www.gov.uk/government/publications/researchgovernance-framework-for-health-and-social-care-second-edition
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To apply for Designated Individual approval you should complete Form AHRIC002 –
Application for Designated Individual for Research with Human Tissue and submit it to
the AHRIC Office (A.PATEL10@aston.ac.uk).
5.3 Aston Sponsorship
To apply for University Sponsorship of a project investigators should contact AHRIC
(A.PATEL10@aston.ac.uk 0121 204 4963).
6. Transfer of Human Tissue
6.1 Material Transfer Agreements
Transfer of human tissue to and from the University should only be undertaken with HTA
licensed establishments or organisations on which the DI has undertaken due diligence and
approved as a supplier/recipient.
The Due Diligence process is outlined in:
SOP: AHRIC001 – Due Diligence Process for Approving Suppliers/Recipients of
Human Tissue
A Material Transfer Agreement must govern all tissue transfers to and from the University.
Procedures for the development and approval of Material Transfer Agreements (MTAs) are
outlined in:
SOP: AHRIC003 – Material Transfer Agreements for Human Tissue
6.2 Transport of Human Tissue
Procedures for the transport of tissue to and from the University are outlined in:
SOP: AHRIC004 – Transport of Human Tissue
The scope of SOP: AHRIC004 is limited to the physical transfer of tissue. Additional
procedures associated with documentation of the process can be found in SOP: AHRIC005
– Human Tissue Records.
7. Documentation of Research with Human Tissue
7.1 Site Files
A Site File must be maintained for all projects in the standard Aston University format.
Site Files are issued by AHRIC once DI (and as appropriate Sponsor approval to commence
the project) has been granted.
Information on Site File Management can be found in SOP: AHRIC103 – Site File
Management
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7.2 Human Tissue Records
All records relating to the receipt, storage, use, transfer and disposal of human tissue should
be stored electronically on the University server.
Normally this should be undertaken using Pro-curo (www.pro-curo.com/) software but where
a project involves a limited amount of data (e.g. a single test or set of tests on all of the
samples) a spreadsheet can be used subject to DI approval.
The location of the records should be recorded in the Site File.
SOP: AHRIC005 – Human Tissue Records describes the procedures to be followed to
ensure Quality Manual compliance in the management of Human Tissue Records.
8. Storage of Human Tissue
SOP: AHRIC006 – Storage of Human Tissue describes the procedures to be followed to
ensure Quality Manual compliance in the storage of human tissue.
9. Cleaning and Decontamination
SOP: AHRIC007 – Cleaning and Decontamination Procedures for Laboratories
working with Human Tissue describes the procedures to be followed to ensure Quality
Manual compliance in the cleaning and decontamination of laboratories working with human
tissue.
10. Disposal of Human Tissue
SOP: AHRIC008 – Disposal of Human Tissue describes the procedures to be followed to
ensure Quality Manual compliance in the disposal of human tissue.
11. Training
All staff and students proposing to undertake work with human tissue must complete
appropriate competency based training prior to commencement of the work. This will
include familiarisation with relevant documentation (codes of practice, standard operating
procedures, and risk assessments) and undertaking training courses where required.
Completion of the Aston University Human Tissue Act Training Programme is a mandatory
requirement.
Training requirements are determined according to the role of the individual within the
proposed programme of work. Training requirements for PIs are advised by the DI and
those of the Research Team by the PI.
Training records relating to the use of human tissue for research form part of an individual’s
overall training record. Copies of records for all staff and students working on a project
should be filed in the Site File for the project.
SOP: AHRIC00– Training Records for Research with Human Tissue describes the
procedures to be followed to ensure Quality Manual compliance.
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12. Adverse Event Reporting
12.1 Adverse Event Definition
For the purpose of this Quality Manual an Adverse Event is defined as:
“Any event that affects or has the potential to affect the integrity of human tissue or
the programme of work in which it is being used”
And/or
“Any event which has resulted in a deviation from an Aston University Quality Manual
SOP or its associated policies and procedures”
Examples include:







Damage to the integrity of the tissue during transport, storage or use
Loss of data
Freezer failure
Failure to maintain and calibrate equipment in accordance with manufactures
requirements or local laboratory SOPs
Loss of power supply to laboratories (freezers) – even if the freezer maintains its
temperature during the loss of power
Any injury to staff or students whilst working with human tissue
Withdrawal of ethical approval
All adverse events should be reported to the DI as soon as possible after they occur in
accordance with the procedures for the reporting of adverse events outlined in:
SOP: AHRIC104 – Adverse Event Reporting
If researchers are unsure how they should appropriately deal with the Adverse Event they
should contact the DI for advice.
In addition any Adverse Event that falls within the requirements of the Aston University
Adverse Event Reporting Policy should be reported through appropriate processes.
12. Monitoring, Auditing and Inspection
12.1 Monitoring
All projects will normally be monitored to ensure Quality Manual (and as appropriate GCP)
compliance following collection/receipt of the first sample.
12.2 Internal Audit
All research projects involving the use of human tissue will be subject to internal audit on an
annual basis and at three months following the completion of the project.
Audits will comprise a review of documentation and data, and a laboratory visit.
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Internal audit procedures are outlined in SOP: AHRIC105 – Internal Audit.
Additionally projects where human tissue is being collected in a NHS organisation may be
audited by the NHS REC and/or the NHS organisation where the tissue is being collected.
12.3 Inspection
All research projects involving the use of human tissue may be subject to Inspection by the
Human Tissue Authority.
13. Complaints
Any complaints in relation to the storage and use of human tissue at Aston University should
be made in writing to the DI. The complaint will then be investigated by the DI and, if
appropriate action taken to resolve the issue raised by the complainant.
The DI will provide a written response to complaints within one month of receiving the
complaint.
In the event of the DI being unable to resolve the complaint it will be escalated to the
University Executive who will deal with it through the formal University complaints process.
14. Archiving
On completion of studies using human tissue all documentation and data relating to the
project should be transferred to AHRIC for archiving.
Archiving procedures are outlined in SOP: AHRIC106 – Archiving
15. Human Tissue Act Compliance Oversight Group
Governance of the acquisition, storage, use and disposal of human tissue at Aston
University is overseen by the Human Tissue Act Compliance Oversight Group:
The purpose of the group is to:
1.
Provide oversight of activities to ensure compliance with the Human Tissue Act 2004
2.
Support the Designated Individual in the development of University wide policies,
procedures and processes to support compliance
Membership
Designated Individual (Chair)
HTA Licence Holder
Persons Designate
Head of Legal Services
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School of Life & Health Sciences Chief Technician
School of Engineering and Applied Science Technical Manager
Head of the Biomedical Unit
Chair Life & Health Sciences Ethics Committee
Chair Engineering and Applied Sciences Ethics Committee
Co-opted members – as required to support specific projects/initiatives
Terms of Reference
1. To ensure that the “Aston University Quality Manual: Acquisition, Storage, Use and
Disposal of Human Tissue” and associated policies, procedures and processes support
compliance by the University with the Human Tissue Act 2004.
2. To monitor the effectiveness of operational structures that support compliance with the
Human Tissue Act 2004.
3. To ensure a Communications Framework is in place to enable all staff and students and
any visiting research staff to be aware of and operate in accordance with the “Aston
University Quality Manual: Acquisition, Storage, Use and Disposal of Human Tissue”.
4. To keep under review national and international directives on human tissue.
5. To review any adverse events in relation to the use of human tissue.
6. To review internal and external monitoring visit and audit reports relating to projects
using human tissue.
7. To receive reports on the monitoring of equipment and facilities for the storage of human
tissue.
8. To make recommend to the Executive Operation Group for new facilities; equipment;
resources; and staffing to ensure Human Tissue Act 2004 compliance.
Frequency of Meetings
Once a term, and additionally as required to ensure the terms of reference are met.
16. Amendments to the Quality Manual
Any proposed amendments to the Quality Manual and the associated SOPs should be
drafted by the DI. The amendment must then be formally approved by the HTA Compliance
Oversight Group before a new version of the document is issued.
Additionally the Quality Manual and Standard Operating Procedures will be reviewed
annually.
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Changes to the Quality Manual and Standard Operating Procedures will be communicated in
the following ways:





All Principal Investigators who are undertaking work with human tissue will be informed
of changes by the DI. They will be asked to confirm that they have communicated the
changes to all staff and students involved in the project and implemented the required
changes
All staff and students who have completed the Aston University Human Tissue Act
Training Programme will be informed of the changes by the DI
Via the weekly “all staff e-mail” that is sent out by the central marketing department
Notification of changes will be put onto the staff intranet site in a position where it is seen
prior to accessing the Quality Manual and SOPs and also prior to making a University
Ethics Committee application
Via other relevant communication channels within the University for example, the School
of Life and Health Sciences All School e-mail
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Appendix One
Standard Operating Procedures and Forms
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DUE DILIGENCE PROCESS FOR
APPROVING SUPPLIERS/RECIPIENTS
OF HUMAN TISSUE
Standard Operating Procedure
Title
Due Diligence Process for Approving
Suppliers/Recipients of Human Tissue
Reference Number
AHRIC001
Version
1
Superseded Version Number and
Date
N/a
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out the process for seeking Designated Individual approval
for the supply or receipt of human tissue by Aston University where the supplier/recipient
does not have a Human Tissue Authority licence.
As a holder of a Human Tissue Authority licence Aston University must ensure that all
organisations to which it supplies or from which it receives human tissue operate according
to procedures which are of at least equal quality to those described in the Aston University
Quality Manual.
Areas that must specifically be considered are: donor consent; donor confidentiality; sample
quality; quality management procedures within the organisation; and if appropriate disposal
of human tissue.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Due Diligence with respect to the Human tissue Act (2004) – an investigation of an
organisation to ascertain that they comply with the requirements of the Aston University
Quality Manual: Acquisition, Storage, Use and Disposal of Human Tissue
Supplier – an organisation supplying human tissue to Aston University
Recipient – an organisation receiving human tissue from Aston University
Scope (of this SOP)
All human tissue receipts from and transfers to organisations who do not have a Human
Tissue Authority licence.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC003
Material Transfer Agreements for Human Tissue
AHRIC004
Transport of Human Tissue
AHRIC005
Human Tissue Records
AHRIC006
Storage of Human Tissue
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AHRIC008
Disposal of Human Tissue
AHRIC102
Obtaining Informed Consent from Research Participants
AHRIC103
Site File Management
Responsible Personnel
Designated Individual
Head of Legal Services
Principal Investigators
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
Application Process
An application for due diligence to be undertaken on a potential supplier or recipient of
human tissue should be made by submitting:
Form AHRIC001 – Application for Due Diligence on a Supplier/Recipient of Human
Tissue (Appendix 1) and associated supporting documentation/evidence to the AHRIC
Office (a.patel10@aston.ac.uk).
Review of Applications
AHRIC Staff validate the application and if required request further information
↓
DI reviews the application for evidence that the organisation has appropriate quality
procedures in place to meet the Aston University Quality Manual standards
↓
If the organisation’s quality procedures are assessed as compliant, that organisation is
added to the Aston University list of approved suppliers/recipients of human tissue in the
HTA Central File
↓
The applicant is informed of approval of the supplier/recipient
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Form AHRIC001: Application for Due Diligence on a Supplier/Recipient of Human Tissue
Form AHRIC001
Application for Due Diligence on a Supplier/Recipient of Human Tissue
Organisation on which due diligence is to be undertaken
Name:
Address:
Contact Name:
Position:
Contact Details:
Telephone:
E-mail:
Website:
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Operating Procedures
Procedure
SOP in place
Supporting Evidence
YES/NO
(Please describe supporting evidence and attach a copy
to the application)
Ethical Committee Approval
Consent
Confidentiality, Data Protection
and Data Storage
Sample Storage
Quality Assurance/Governance
Material Transfer Agreements
Funding Arrangements
Funder:
Funded until (date):
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Signature on behalf of Supplier/Recipient Organisation:
Name:
Signature:
Date:
Principal Investigator:
Name:
Signature:
Date:
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DESIGNATED INDIVIDUAL APPROVAL
TO UNDERTAKE RESEARCH WITH
HUMAN TISSUE
Standard Operating Procedure
Title
Designated Individual Approval to Undertake
Research with Human Tissue
Reference Number
AHRIC002
Version
1
Superseded Version Number and
Date
N/a
Effective Date
February 2016
Review Date
February 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out the process for seeking Designated Individual (DI)
approval to: collect and/or receive and/or store and/or undertake research with and/or
transfer human tissue to another organisation.
All of these activities at Aston University must have approval of the DI.
Approval via this process must be obtained before undertaking any of these activities at
Aston University.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
All instances where human tissue is collected and/or received and/or stored and/or used in
research and/or transferred by Aston University.
Related SOPs
AHRIC001
Due Diligence Process for Approving Suppliers/Recipients of Human Tissue
AHRIC003
Material Transfer Agreements for Human Tissue
AHRIC004
Transport of Human Tissue
AHRIC005
Human Tissue Records
AHRIC006
Storage of Human Tissue
AHRIC008
Disposal of Human Tissue
AHRIC009
Training Records for Research with Human Tissue
AHRIC102
Obtaining Consent Informed Consent from Research Participants
AHRIC103
Site File Management
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Responsible Personnel
Designated Individual
Principal Investigators
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
Application Process
An application for DI approval to undertake work with human tissue at Aston University
should be made by submitting:
Form AHRIC002 – Application for Designated Individual Approval for Research with
Human Tissue (Appendix 1) and associated supporting documentation/evidence to the
AHRIC Office (a.patel10@aston.ac.uk).
The Form collects the following information:

Details of the Principle Investigator – the individual who will take responsibility for ensuring that
the management and use of the human tissue at Aston University complies with Quality Manual
procedures

Details of the samples to be used in the research

Proposed tissue management arrangements – from collection/receipt to disposal/transfer

Details of staff, students and visiting researchers who will be working with the tissue at Aston
University

Ethical Committee approval for the research

Ownership of Intellectual Property
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Review of Applications
1. AHRIC Staff validate the application and if required request further information
↓
2. AHRIC Staff review the application to ascertain if the proposed research complies
with Quality Manual procedures
↓
3. If there is a requirement for any of the following to support Quality Manual
compliance AHRIC Staff facilitate the required process:
Designation of new facilities (laboratory and/or freezer) by the DI
Research Team training
Material Transfer Agreements
↓
4. Once all requirements to meet Quality Manual procedures are in place AHRIC issues
a letter confirming DI approval to undertake the research
The research should not commence until DI Approval has been confirmed in writing.
For projects where Aston University is the Sponsor Applications for DI Approval are
undertaken in parallel with other Governance process and DI Approval will be
confirmed when Sponsors Approval to commence the project is given.
Amendments to the Approval
Requests to make an amendment to the approval for projects where Aston University is not
the Sponsor of the project should be made by e-mailing the AHRIC Office
(a.patel10@aston.ac.uk) with the following information:



Project Reference Number and Title
Details of the proposed amendment(s)
Copies of any supporting documents to support review of the amendment(s) e.g. Transport
Risk Assessments, Training Records etc.
The request will then be processed as described in the process for review of applications
described above.
The amendment(s) should not be implemented until DI Approval has been confirmed
in writing.
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For projects where Aston University is the Sponsor requests for amendments to the approval
should be made as part of a Protocol Amendment for the study (SOP: AHRIC107 –
Protocol Amendments).
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Form AHRIC002: Application for Designated Individual Approval for Research with Human
Tissue
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Form AHRIC002
Application for Designated Individual Approval for Research with Human Tissue
1. Title of Study
Expected start date:
Expected completion date:
2. Principal Investigator
Name:
E-mail:
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Telephone:
33
3. Tissue Management
Sample Details
Tissue Type
Number of
Samples
Site of Collection
Format of Sample
Storage Location
(Fresh, Frozen, Block etc.)
(Laboratory and if applicable
freezer number)
Location of
Experiments
Records Management
Please provide details of how the Human Tissue Records will be maintained for this study – ProCuro arrangements or proposed Spreadsheet (SOP: AHRIC005 – Human Tissue Records):
Quality Manual – Acquisition, Storage, Use and Disposal of Human Tissue: Version 9, April 2016
Duration of Storage
at Aston
34
If you are proposing to use a Spreadsheet please attach a copy
Transport
Please identify all transfers of human tissue to be undertaken during the project and if required attach a Risk Assessment for the transfer (SOP: AHRIC004 – Transport of Human Tissue):
Tissue to be Transferred
Transfer from:
Transfer to:
Method of Transfer
Risk Assessment attached
Yes/No
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End of Study Arrangements
Please tick the appropriate option(s) and provide further information if requested:
□ No tissue remaining following experiments undertaken during the study
□ Tissue to be transferred to an external organisation during and/or at the end of the research
Please provide the following details:
Organisation Tissue Being Transferred To
□ Disposal in accordance with the Aston University Quality Manual
□ Return to Supplier
□ Retention at Aston for future studies
Please provide details of the proposed arrangements including governance arrangements:
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Tissue Sample(s) Being Transferred
36
4. Research Team
Please list all staff/students working with the tissue at Aston and their role/responsibilities and provide: an Aston HTA Training Certificate, Training Record (Form AHRIC006 - SOP: AHRIC009 – Training records
for Research with Human Tissue) and evidence of Hepatitis B immunisation:
Name of Research Team Member
Role & Responsibilities
HTA Training
Certificate
HTA Training
Record
Yes/No
Yes/No
Evidence of
Hepatitis B
Immunisation
Yes/No
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Please Note: DI approval will not be issued until the documentation associated with all members of the research team has been received.
5.
Intellectual Property
Please provide details of: who will own the results of the research and any associated intellectual property; rights to publication; and any licencing arrangements:
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6. Supporting Documentation
Please attach the supporting document set that is relevant for you project. Details of the documents required for a given project can be found in the table below:
Tissue Source
Supporting Documentation Required
Tissue collected as part of a study with NHS REC
Favourable Opinion where Aston is the Sponsor
This Form is part of the document set required for Governance Approval of the project and should be
submitted as part of the application for Governance Approval
Tissue collected at Aston with Aston REC
Favourable Opinion
Aston REC Favourable Opinion Letter
REC approved Participant Information Sheet(s) & Consent Form(s)
Study Protocol
Tissue collected as part of a study with 3rd Party
NHS REC Favourable Opinion
REC Favourable Opinion Letter
REC approved Participant Information Sheet(s) & Consent Form(s)
Protocol for research to be undertaken at Aston
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Tissue collected as part of a Tissue Bank with a
NHS REC Favourable Opinion
REC Favourable Opinion Letter
REC approved Participant Information Sheet(s) & Consent Form(s)
Application for tissue from the Tissue Bank & Confirmation of approval of release of tissue
Protocol for the research to be undertaken at Aston
Tissue collected/supplied by a UK organisation
with a HTA licence (not associated with a NHS
REC Favourable Opinion)
HTA licence number of the organisation
Protocol for the research to be undertaken at Aston
and
REC Favourable Opinion letter – Aston or external
REC approved Participant Information Sheet(s) & Consent Form(s)
or
Details of Commercial services in relation to Human Tissue offered by the organisation
Tissue collected outside the UK
Documents that support compliance with Quality Manual Procedures as identified in the Due
Diligence process – SOP: AHRIC001
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Form AHRIC003
Application for Designation of a Laboratory for the Storage and Use of Human Tissue
Laboratory Room Number:
SOPs to support designation:
Please attach a list of the SOPs that are in place for the use of
human tissue within the laboratory application*
Individual responsible for the storage and
use of human tissue:
Name:
Telephone:
Out of Hours Contact:
Deputy:
Name:
Telephone:
Out of Hours Contact:
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Form AHRIC004
Application for Designation of a Freezer for the Storage of Human Tissue
Serial Number:
Make:
Location of the Freezer:
Please provide details
Remote Temperature Monitoring:
Maintenance and Decontamination
Custodian
Please attach the SOP for Maintenance and Decontamination
of the freezer to the application
Name:
Telephone:
Out of Hours Contact:
Deputy
Name:
Telephone:
Out of Hours Contact:
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MATERIAL TRANSFER AGREEMENTS
FOR HUMAN TISSUE
Standard Operating Procedure
Title
Material Transfer Agreements for Human Tissue
Reference Number
AHRIC003
Version
1
Superseded Version Number and
Date
Previously AUHTA002 Version 5 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to describe the requirements for Material Transfer Agreements
between Aston University and external organisations relating to the transfer of human tissue
to and from Aston University.
Additionally it outlines the process for the development and approval of Material Transfer
Agreements.
Definitions
Human Tissue - any, and all, constituent part/s of the human body
Material Transfer Agreement – a contract that governs the transfer of tangible research
materials between two organisations, when the recipient intends to use it for his or her own
approved research purposes. The MTA defines the rights of the provider and the recipient
with respect to the materials and any derivatives
Scope (of this SOP)
All human tissue being transferred to and from Aston University.
Any transfer of human tissue to and from Aston University must be formally approved and
documented in a Material Transfer Agreement (MTA) prior to transfer of the tissue.
Transfer must only be undertaken to and from HTA licensed organisations or organisations
that have been approved as suppliers or recipients by the Designated Individual via the due
diligence process outlined in SOP AHRIC001 – Due Diligence Process for Approving
Suppliers/Recipients of Human Tissue.
Related SOPs
AHRIC001
Due Diligence Process for Approving Suppliers/Recipients of Human Tissue
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC004
Transport of Human Tissue
AHRIC008
Disposal of Human Tissue
AHRIC102
Obtaining Informed Consent from Research Participants
AHRIC103
Site File Management
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Responsible Personnel
Designated Individual
Head of Legal Services
Principal Investigators
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedure
Aston University has developed a suite of MTA templates to govern the transfer of human
tissue to and from the University. Templates are available for transfers within the UK and to
and from overseas.
The template to be used for a given transfer will depend on:




The ethical approval route for the project
If it is a transfer into or a transfer out of Aston University
If the recipient/donor has a HTA licence
Project specific details, e.g. ownership of the tissue; intellectual property arrangements; end of project arrangements
etc.
All transfers from Aston University and transfers associated with NHS projects where
Aston University is the Sponsor of the project must be undertaken using an Aston
University template MTA.
If a supplier wishes to use their MTA template this must include all of the elements that are
included in the Aston University template MTAs and be approved by both the Designated
Individual and Aston University Legal Services.
The requirement for MTA is identified as part of the Designated Individual Approval for a
research project process. This process is described in SOP AHRIC002 – Designated
Individual Approval to Undertake Research with Human Tissue.
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AHRIC identifies the need for MTA(s)
↓
AHRIC requests project specific information from the Principle Investigator
↓
AHRIC drafts MTA(s)
↓
AHRIC and/or PI obtain Supplier/Recipient signature(s)
(Agreeing if required amendments with the DI and Legal Services)
↓
AHRIC obtains signatures of the DI and the Dean of the School in which the research is
taking place
↓
AHRIC files the original (“wet ink signature”) copy in the HTA Central File and issues a Copy
in the Site File for the project
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TRANSPORT OF HUMAN TISSUE
Standard Operating Procedure
Title
Transport of Human Tissue
Reference Number
AUHTA004
Version
1
Superseded Version Number and
Date
Previously AUHTA003 Version 5 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out the procedures for the transport of human tissue to and
from Aston University.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Courier – a commercial company contracted to undertake the transport of human tissue
Risk Assessment – a systematic process of evaluating the risks that may be involved in a
projected activity or undertaking (and devising where necessary controls to reduce the risks)
Scope (of this SOP)
All human tissue transfers to and from Aston University where Aston University is
responsible for arranging the transport of the tissue, with the exception of tissue transferred
to SRCL for disposal (SOP AHRIC008 – Disposal of Human Tissue).
Transport may be undertaken by a member of University Staff, a Student or by a Courier.
The scope of this SOP is limited to the physical transfer of tissue. Procedures associated
with documentation of the process can be found in SOP AHRIC005 – Human Tissue
Records.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC003
Material Transfer Agreements for Human Tissue
AHRIC005
Human Tissue Records
AHRIC102
Site File Management
AHRIC104
Adverse Event Reporting
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Responsible Personnel
Designated Individual
Principal Investigators
Aston Staff and Students undertaking human tissue transfer
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
Packaging and Labelling of Human Tissue
All human tissue should be packed into a sealed container prior to transport and labelled
with the following information:
Human Tissue Sample
Sample Reference Number(s):
Tissue Type:
Details of medium/preservative (if applicable):
Date of packing:
UN 3373 warning label
If applicable, the container should be labelled with hazard warning symbols relating to the
medium/preservative.
The container should then be packed into a box and labelled with an approved human tissue
sample hazard warning label – UN 3373.
If applicable, the box should also be labelled with hazard warning symbols relating to the
medium/preservative.
Containers, boxes and labels for human tissue transfer can be purchased from general
laboratory suppliers.
Transport of human tissue to and from the University by Couriers
If human tissue is to be transferred to or from the University by a courier it is the
responsibility of the Principal Investigator (PI) to ensure that the courier has been approved
by the Designated Individual and that arrangements are put in place in the contract with the
courier to ensure the required integrity of the human tissue during transfer.
Transport of human tissue to and from the University by Aston University Staff and Students
Transport of human tissue to and from the University by Aston University staff and students
can only be undertaken if the risk associated with the transfer has been evaluated as
acceptable via a risk assessment. The PI must be satisfied that procedures to be put in
place to minimise risk are adequate and that the residual risk is acceptable.
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Designated Individual approval for the transfer must be sought as part of the Designated
Individual approval process for the project as described in SOP: AHRIC002 – Designated
Individual Approval to Undertake Research with Human Tissue.
The risk assessment should be undertaken using Form AHRIC005 – Transport of Human
Tissue Risk Assessment (Appendix 1) and include consideration of the following:




Personal risk to the individual undertaking the transfer
Risk to the public during transfer (chemical and biological hazard)
Integrity of the sample
Patient confidentiality
Individuals involved in the transfer of human tissue are reminded that transfers should
respect the dignity of the donor.
Undertake and document a risk assessment of the proposed method of transport
↓
Risk Acceptable
↓
Unacceptable Risk
↓
Document Procedure
↓
Contract Specialist Courier
↓
Put MTA in place
↓
Make arrangements for the transfer
↓
Pack and label tissue
↓
Transfer tissue and document
Whilst this SOP only covers the transport of human tissue where the University has
responsibility for the transportation, all tissue to be transported from the University should be
packed and labelled as described above.
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Appendix 1
Form AHRIC005 - Transport of Human Tissue Risk Assessment
Form AHRIC005
Transport of Human Tissue Risk Assessment
Guidance on how to carry out the risk assessment and complete the
Risk Table
1
First describe please your PROTOCOL for transporting tissue. (The plan may need
amendments and additions following the risk assessment, before submission)
2
Then please consider the following threats relating to the Protocol: concerns about:
i.
ii.
iii.
iv.
Integrity of samples;
People involved in transporting samples;
Third parties (eg, the ‘public’);
Anything else you think might go wrong.
3
Think hard about all the things that might go wrong for each of the above, listing these
‘adverse events’ or ‘adverse situations’ in the Risk Table below. [Tip: visualise the activities
actually going on and think of possible divergences from the protocol. Best is to have
‘accidents’ in one’s imagination.]
4
Describe in the Risk Table, for each adverse event, your planned precautions to reduce the
likelihood and/or the consequences of the event (or situation).
5
Estimate with the planned controls in place the:


6
Likelihood that things could still go wrong (ie, the chance of an adverse event or situation);
Consequences if they do.
The likelihood of a hazardous event (or situation) is the same for each of the issues listed at
2 above – from very improbable to almost certain/certain:
1
Very improbable
Up to 1% chance - may occur at most on one transport in
100
2
Improbable
2 – 10% chance - between one in 50 to one in 1 in 10
3
Likely
11 – 33% chance - >1in 10 and < 1 in 3
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7
4
Very likely
34 – 50 % chance -> 1 in 3 to 50/50%
5
Almost certain - to
certain
greater than 50% chance - may occur more than once in
every 2 transports, or even on every transport
The consequences of a hazardous event involving integrity of samples are:
1
Very low
No impact on sample(s)
2
Low
Minor impact on sample(s) – study not affected
3
Medium
Moderate impact on sample(s) – sample(s) lost to study
4
High
Major impact on sample(s) – significant loss of sample(s)
5
Very high
All sample(s) lost
The consequences of the other threats are the same:
1
Very low
No significant impact on individuals or groups
2
Low
Minor harm
3
Medium
Significant harm
4
High
Substantial harm
5
Very high
Life threatening harm or death
8
Calculate for each adverse event the risk level (likelihood (L) multiplied by consequence (C).
9
Review each risk level using the Risk Level Matrix:



If a risk level falls in the RED zone, improvements in the controls are essential;
If a risk level falls in the YELLOW zone, improvements in the controls are desirable, but only
where reasonably practicable (i.e. proportionate; not excessive);
If a risk level falls in the GREEN zone, no additional precautions are necessary.
Example 1: with all controls in place, the ‘loss of all samples’ would (or should) be ‘very
improbable’, though with very high consequences (so in the YELLOW zone). The risk is only
accepted because no further precautions are judged ‘reasonably practicable’.
Example 2: a ‘very likely’ prediction of a low consequence (GREEN zone) might enter the YELLOW
zone if the consequences are under-estimated.
Risk Level Matrix
Consequences
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10
1
Likelihood of
adverse event
(or situation)
Very
Low
2
3
4
5
Low
Medium
High
Very high
Very improbable
1
2
3
4
5
Improbable
2
4
6
8
10
Likely
3
6
9
12
15
Very likely
4
8
12
16
20
Almost certain to certain
5
10
15
20
25
Determine what monitoring is required to check that the controls are being implemented.
More checks are required if a risk level increases substantially when the controls are not
being followed. For example while the controls to prevent the ‘loss of all samples’ leave a
residual risk of 5, the risk level may enter the red zone if the precautions are not observed.
Note that monitoring depends on the reporting of near misses without sanction.
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Risk Assessment Proforma
Proposed Protocol
Please describe the proposed methods to be used for transporting tissue; including: packaging and labelling of
the tissue; temperature requirements to ensure sample integrity; journey details; transport arrangements; and
personnel involved.
The Protocol may need amendments and additions following the risk assessment below before the
application is submitted for approval.
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Risk Assessment Table
DESCRIBE all the things that might go wrong (or be wrong) AND the controls in place to prevent them.
These might include mislabelling; transit delays; accidents; theft
List the nature and frequency of monitoring to check that control measures are complied with, and are effective. (More rigorous checks are necessary when, in the
absence of effective controls, the risk level goes up substantially.)
Residual risk level
(controls in place)
Threats to:
i)
Integrity of
samples
ii)
People
involved in
transportin
g samples
What might go wrong?
Control measures
iii) Third
parties
(e.g. the
public)
iv) Other
threats not
listed
above
(write in)
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Likeliho
od
Consequen
ce
L: 1 to 5
C: 1 to 5
Monitoring
Score
L*C
(See
Matrix)
implementation &
effectiveness of
controls
55
Signatures
Principal Investigator
Name:
Signature:
Date:
Designated Individual Approval
Dr N J Seare:
Signature:
Date:
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HUMAN TISSUE RECORDS
Standard Operating Procedure
Title
Human Tissue Records
Reference Number
AHRIC005
Version
1
Superseded Version Number and
Date
N/a
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out the procedures for the management of records relating
to the acquisition, storage, use and disposal of human tissue.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Pro-curo – a software solution for the management of records relating to the acquisition,
storage, use and disposal of human tissue with an integrated barcoded label design and
printing function (www.pro-curo.com)
Scope (of this SOP)
All work with human tissue undertaken at Aston University.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC004
Transport of Human Tissue
AHRIC006
Storage of Human Tissue
AHRIC008
Disposal of Human Tissue
AHRIC103
Site File Management
Responsible Personnel
Designated Individual
Principal Investigators
Aston Staff and Students undertaking work with human tissue
Aston Health Research & Innovation Cluster (AHRIC) Staff
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Procedures
Human Tissue Records should be managed using Pro-curo (www.pro-curo.com/) software
unless the project involves a limited amount of data (e.g. a single test or set of tests on all of
the samples) when subject to Designated Individual approval a spreadsheet can be used.
The Records Management method for a project is identified and approved as part of the DI
approval for the project (SOP: AHRIC002 – Designated Individual Approval to Undertake
Research with Human Tissue).
The records must be managed on the University server and the location of the record should
be recorded in the project Site File as outlined in SOP: AHRIC 103 – Site File
Management.
Pro-curo
A sample record should be created for each sample with a unique identifier. The record
should then be used to record:







Receipt of the sample
Sample details
Storage location
Aliquoting of the sample (if undertaken)
Use of the sample in experiments (multiple entries as required)
Disposal of the sample (if undertaken)
Transfer of the sample (if undertaken)
Each activity should have a user and date associated with it.
Researchers can request that Pro-curo is loaded onto their computer through IT Services.
Pro-curo offers barcode facilities for large sample collections.
Spreadsheets
Spreadsheets should record: unique sample references numbers; receipt; storage location;
use; and transfer or disposal of samples. All entries should be dated and the individual
undertaking the activity should be recorded. For example:
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Project Title:
Project Reference Number:
Storage Location:
Names of Research Team and Initials:
Name:
Sample
Number
Initials:
Date
Received
Initials of
Recipient
Analysis
undertaken
Date of
Analysis
Initials of
Person
Undertaking
the Analysis
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Date of
Disposal or
Transfer
Initials of
Person
Undertaking
Disposal or
Transfer
60
STORAGE OF HUMAN TISSUE
Standard Operating Procedure
Title
Storage of Human Tissue
Reference Number
AHRIC006
Version
1
Superseded Version Number and
Date
Previously AUHTA005 Version 5 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out the procedures for the storage of human tissue within
Aston University.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Designated Laboratory – a laboratory has been approved by the Designated Individual for
research with and/or storage of human tissue
Designated Freezer – a freezer that has been approved by the Designated Individual for the
storage of human tissue
Scope (of this SOP)
All human tissue stored within Aston University.
The scope of this SOP is limited to the physical storage of human tissue within the
University. Additional procedures associated with documentation of storage can be found in
SOP: AHRIC005 – Human Tissue Records.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC005
Human Tissue Records
AHRIC007
Cleaning and Decontamination Procedures for Laboratories working with Human
Tissue
AHRIC008
Disposal of Human Tissue
AHRIC103
Site File Management
Responsible Personnel
Principal Investigators
Aston Staff and Students undertaking work with human tissue
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Procedure
All human tissue samples must be stored in a laboratory/facility designated for research with
human tissue.
Sample Storage Procedures
Sample Labelling
Individual samples should be stored in a sealed container and labelled with a barcode label
produced in association with Pro-Curo or a unique sample reference number.
The samples relating to a study should be stored in a sealed container(s) and labelled with
the following information:
Human Tissue Sample
Study Reference Number:
Sample Reference Numbers: (Unique sample reference number allocated on transfer of the
sample to Aston University)
Tissue Type:
Details of medium/preservative if applicable:
Date of transfer to Aston University:
Custodian and contact details:
Additionally, if applicable it should be labelled with hazard warning labels relating to the
medium/preservative.
For each tissue sample there must be a clear record of transfer of the tissue to the University
or its collection at the University; its issue from and return to storage (including information
on what it was issued for); and its subsequent disposal or transfer to another organisation
(for more details please see SOP AHRIC005 – Human Tissue Records).
Freezer and Storage Cabinet Labelling
All freezers and storage cabinets designated for the storage of human tissue should be
labelled with the following information:
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Human Samples are Stored in this Freezer/Cabinet*
Custodian:
Contact Details:
Office:
Laboratory:
Telephone:
Out of hours contact:
Deputy:
Contact Details:
Office:
Laboratory:
Telephone:
Out of hours contact
*Delete as applicable
Freezers and storage cupboards which are used for the storage of human samples must
not be used for the storage of animal tissue.
Frozen samples must be stored within a designated freezer or in the liquid nitrogen facility.
Designation of laboratories for the storage of human tissue
Designation of a freezer for the storage of human tissue must be made by the Designated
Individual.
Applications for designation of a laboratory for the storage of human tissue should be made
on: Form AHRIC003 – Application for Designation of a Laboratory for the Storage of
Human Tissue (a copy of the form can be found in Appendix 1 of this SOP).
All laboratories designated for the storage of human tissue are recorded on the register of
designated laboratories held by the Designated Individual. The record includes details of:
the location of the laboratory and the individual responsible for the use of human tissue in
the laboratory.
Designation of freezers for the storage of human tissue
Designation of a freezer for the storage of human tissue must be made by the Designated
Individual.
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Applications for designation of a freezer for the storage of human tissue should be made on:
Form AHRIC004 – Application for Designation of a Freezer for the Storage of Human
Tissue (a copy of the form can be found in Appendix 2 of this SOP).
Only freezers that are: monitored externally under the University contract with Tutela
Monitoring Systems; and within a laboratory designated for the storage and use of human
tissue will be considered for designation.
All freezers designated for the storage of human tissue are recorded on the register of
designated freezers held by the Designated Individual.
Upon designation the freezer must be labelled with the unique identifier issued by the DI and
a maintenance decontamination record created if there is not one already in place.
The number of freezers for the storage of human tissue will be kept to an absolute minimum
in order to maintain a high level of expertise and good practice.
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CLEANING AND DECONTAMINATION
PROCEDURES FOR LABORATORIES
WORKING WITH HUMAN TISSUE
Standard Operating Procedure
Title
Cleaning and Decontamination Procedures for
Laboratories working with Human Tissue
Reference Number
AHRIC007
Version
1
Superseded Version Number and
Date
AUHTA008 Version 4 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out procedures for the cleaning and decontamination of
areas where human tissue samples are used and stored.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
All areas within Aston University where human tissue samples are used and stored.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC004
Transport of Human Tissue
AHRIC005
Human Tissue Records
AHRIC006
Storage of Human Tissue
AHRIC008
Disposal of Human Tissue
AHRIC009
Training Records for Research with Human Tissue
AHRIC104
Adverse Event Reporting
Responsible Personnel
Principal Investigators
Aston Staff and Students undertaking work with human tissue
Aston Health Research & Innovation Cluster (AHRIC) Staff
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Procedures
Policies, Procedures and Standard Operating Procedures
It is the responsibility of Principal Investigators (PIs) to ensure that policies, procedures and
Standard Operating Procedures (SOPs), based on risk assessment are developed for the
cleaning and decontamination of areas and equipment where human tissue is used and
stored. Accidental spillage and routine cleaning and decontamination should be addressed.
The policies, procedures and SOPS should comply with established good practice in the
handling of biological samples.
Before a freezer or laboratory is designated for storage and/or use of human tissue the PI is
required to submit SOPs relating to their cleaning and decontamination in relation to human
tissue.
Applications for designation of a freezer for storage of human tissue are made using: Form
AHRIC003 Application for the Designation of a Freezer for the Storage of Human
Tissue.
Applications for designation of a laboratory for storage and/or use of human tissue are made
using: Form AHRIC004 – Application for Designation of a Laboratory for the Storage
and Use of Human Tissue.
Additionally it is the responsibility of PIs to ensure that appropriate personal protective
equipment is available in areas where human tissue is used and stored.
Cleaning and Decontamination
Decontamination of areas where accidental spillage has occurred, disposal of
contaminated/infected materials and the routine cleaning of equipment used in experiments
with human tissue should be undertaken by trained laboratory staff.
Records should be kept of all cleaning and decontamination activities.
Accidental Spillage:
Any spillage of human materials should be documented and managed as an Adverse Event
in accordance with SOP: AHRIC104 – Adverse Event Reporting.
Disposal of any human tissue as a result of a spillage should be undertaken in accordance
with SOP: AHRIC008 – Disposal of Human Tissue.
Routine Cleaning and Decontamination:
Routine cleaning and decontamination should be undertaken and documented as described
in local policies, procedures and SOPs.
The records associated with these policies, procedures and SOPs will be reviewed as part of
Internal Audits and Human Tissue Authority Inspections.
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Isolation and disposal of contaminated/infected material:
Spilled and contaminated material should be separated and contained using disposable
items of equipment that may be autoclaved.
To avoid cross contamination contaminated/infected material should be double sealed,
labelled with appropriate hazard warning labels and taken to the autoclave unit for separate
autoclaving. If appropriate, disposal should then be undertaken in accordance with SOP:
AHRIC008 – Disposal of Human Tissue.
Cleaning and decontamination of non-disposable equipment:
Non-disposable equipment used for studies on human tissue should be decontaminated
(according to manufacturer’s instructions) on completion of each procedure or experiment.
Cleaning and decontamination of freezers:
Freezers should be cleaned and decontaminated as part of the routine defrosting
procedures.
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DISPOSAL OF HUMAN TISSUE
Standard Operating Procedure
Title
Disposal of Human Tissue
Reference Number
AHRIC008
Version
1
Superseded Version Number and
Date
Previously AUHTA007 Version 5 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Mr W A Fleary - Head of Biomedical Facility
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out the procedures for disposal of human tissue.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
The disposal of all human tissue within Aston University.
The procedures within this SOP relate to disposal by SRCL Ltd of tissue on behalf of Aston
University.
If the Principal Investigator for a project wishes to use another disposal method they should
contact the Designated Individual to seek approval of the proposed method of disposal.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC003
Material Transfer Agreements for Human Tissue
AHRIC005
Human Tissue Records
AHRIC006
Storage of Human Tissue
AHRIC007
Cleaning and Decontamination Procedures for Laboratories working with Human
Tissue
AHRIC103
Site File Management
AHRIC104
Adverse Event Reporting
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Responsible Personnel
Designated Individual
Head of the Biomedical Facility
Principal Investigators
Aston Staff and Students undertaking work with human tissue
Biomedical Facility Staff
Procedure
The University has a contract with SRCL Limited for the removal and disposal of human
tissue:
Account Manager:
Mr Chris Westwood
07931 747362
E-mail – cwestwood@srcl.com
SRCL Ltd
Knostrop Treatment Works
Knowsthorpe Lane
Leeds
LS9 0PJ
All human tissue for disposal must be transferred to SRCL Limited. SRCL is contracted to
dispose of human tissue on behalf of the University.
Further information relating to the SRCL contract and the associated University procedures
can found in the HTA Central File or obtained from:
Head of the Biomedical Facility - 0121 204 3943; w.a.fleary@aston.ac.uk
Storage of Human Tissue for Disposal
Once human tissue has been identified for disposal, either because it is no longer viable
following use in experiments or the project for which it has been stored has been completed,
it should be transferred to storage prior to disposal.
The tissue should be stored in a sealed container and labelled with the following information:
Human Tissue Samples for Disposal
Project Reference Number:
Sample Reference Number(s):
Custodian:
Contact Details of Custodian:
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Human tissues awaiting disposal should be stored within a freezer designated for the
storage of human tissue (for details please refer to SOP: AHRIC006 – Storage of Human
Tissue).
Documentation of the Disposal of Human Tissue
The disposal of human tissue either as a result of non-viability following experimentation or
at the end of a project should be recorded in/on:

Laboratory books
And

Pro-Curo or the project spreadsheet
When tissue disposal is being undertaken at the end of a project the Principal Investigator
(PI) should inform the organisation from which the tissue originated in writing if this is
required as part of the MTA. When this is the case a copy of the letter should be filed in the
Site File (SOP: AHRIC103 – Site File Management).
Transfer of Human Tissue to SRCL Limited for Disposal
Prior to commencement of the project the PI should inform the Head of the Biomedical
Facility that during the course of the project there will be a need to transfer human tissue to
SRCL for disposal. This will ensure that the PI or a member of his team with designated
responsibility for tissue disposal will be informed of dates of tissue collection by SRCL. It is
important that the notification is undertaken prior to commencement of the project to ensure
timely disposal of any human tissue.
The PI or his designate will be informed a few days before a collection is due to take place of
the date of collection and asked to transfer the tissue for disposal to the Biomedical Facility
MB637 on the day before collection date. The Head of the Biomedical Facility will then take
responsibility for the tissue transfer to SCRL in accordance with University policy.
Storage of Human Tissue in the Biomedical Facility Prior to Transfer to SRCL
On receipt of the human tissue the Head of the Biomedical Facility will place the tissue in the
waste cart which is designated for human tissue and lock the cart. The cart will then be
BioTrack tagged and a Waste Consignment Notice prepared in accordance with SRCL
procedures.
Further details relating to the BioTrack system are held in the Aston University HTA Central
File by the Designated Individual and the Head of the Biomedical Facility.
Transfer of Tissue to SRCL Limited
On transfer of the tissue to SRCL by the Head of the Biomedical Facility its transfer and
transfer of responsibility for the tissue to SRCL is recorded on the Waste Consignment Note.
Disposal of Human Tissue by SRCL
Human tissue disposal by SRCL is by individual incineration.
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SRCL PROCEDURE FOR WASTE COLLECTION
Purpose
To ensure that all appropriate checks are undertaken and records completed before waste is
collected from customer’s site.
Scope
This procedure applies to all waste collection operations operated by or on behalf of SRCL.
Responsibilities
General Managers –
Have overall responsibility for ensuring transport operations for
their site are carried out compliantly
Transport Managers –
Are responsible for ensuring drivers are appropriately trained
and adhere to the waste collection procedure
Drivers –
Are responsible for collecting waste in accordance with this
procedure
Documentation and Records
The following documents and records arise from this procedure:
Ref.
F 6.1.1
Document / Record
Responsibility
Location
Waste Consignment Note – Carriers
Transport Manager Transport Office
Copy
Retention
3 years
F 6.1.1
Waste Consignment Note –
Disposal site copy
General Manager
Site Office
Indefinite
n/a
BioTrack Operating Manual /
Instructions
IS Director
Site Office
Indefinite
WI 6.2.3
Sample Hazardous Waste
Consignment Note
Head of Compliance
Compliance
Office
Until
updated
All records must be disposed of by shredding, incineration, or other secure means at the end
of the specified retention period.
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START
Driver arrives at collection
point
Waste cannot be collected unless: -
NO
Is WCN
available?
-
WTN is available
WTN is completed correctly
WTN is signed by the customer
Waste is correctly packaged
Waste carts are able to be closed and
locked
- Carts are BioTrack tagged. Note: Whole
load does not have to be tagged to allow
collection. Just leave any untagged carts
YES
NO
Is WCN
correct?
YES
Waste packed
correctly?
Attempt to contact customer
NO
YES
NO
NO
Is
customer
Are carts
securely
closed?
YES
YES
Carts BioTr’k
tagged?
Customer fixes
problem?
NO
NO
YES
Is
customer
YES
Driver enters amount of
waste to be collected in
Part B of WCN
Driver completes and
signs Part C of WCN
Customer completes and
signs Part D of WTN
DO NOT COLLECT
WASTE
NO
Driver scans tags &
enters required info
into PDT. See
BioTrack manual.
Driver loads vehicle with
820/770 ltr bins. If loose
waste must be decanted
litter pickers must be used
Secure load and close and
lock/secure doors.
Advise line manager of
missed collection
Continue collection round
Articulated trailer doors must be
padlocked shut
END
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75
TRAINING RECORDS FOR WORK WITH
HUMAN TISSUE
Standard Operating Procedure
Title
Training Records for Work with Human Tissue
Reference Number
AHRIC009
Version
1
Superseded Version Number and
Date
Previously AUHTA009 Version 5 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
Date:
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out procedures for the development and documentation of
training for individuals working with human tissue.
Definitions
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
All individuals undertaking work with human tissue at Aston University.
Related SOPs
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC103
Site File Management
Responsible Personnel
Designated Individual
Principal Investigators
Aston Staff and Students undertaking work with human tissue
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
All individuals proposing to undertake research with human tissue must complete
appropriate competency based training prior to commencement of the work. This will
include familiarisation with relevant documentation (codes of practice, standard operating
procedures, and risk assessments) and undertaking training.
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Areas to be considered in relation to training include:

COSHH

Risk Assessment

Accident and Incident Reporting

Decontamination and Waste Disposal

Local Laboratory SOPs, Procedures and Protocols:

Equipment Operation

Quality Manual procedures and associated SOPs
Training requirements are determined according to the role of the individual and should be
reviewed before the commencement of each new project/activity.
Training requirements for Principal Investigators should be advised by the Designated
Individual (DI) and those of Research Teams by the Principal Investigator.
It is expected that all individuals undertaking work with human tissue will complete the Aston
University Human Tissue Act Internal Training Programme and refresher training every three
years. In exceptional circumstances the DI may give approval for individuals to undertake
work without attending a course but this must be confirmed in writing.
The training requirements of individuals and subsequent achievement of the required
competencies should be identified and recorded using: Form AHRIC006 – Human Tissue
Research Training Record (Appendix 1).
Completed forms form part of the individuals overall training record of the individual and
should be filed as part of that record.
Copies of Form AHRIC006 for all individuals working on a project must be filed in the Site
File (SOP: AHRIC103 - Site File Management)
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Appendix 1
Form AHRIC006: Human Tissue Research Training Record
Form AHRIC006
Human Tissue Research Training Record
Name:
Position:
E-mail:
Telephone:
Qualifications and experience relevant to work with Human Tissue:
Laboratory based training:
Competency:
Assessed by:
(Name and Signature)
COSHH
Risk Assessment
Accident and Incident Reporting
Decontamination and Waste Disposal
SOPs, Procedures and Protocols:
List
Equipment Operation:
List
Other:
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Date:
79
Please specify
Training Courses:
Course:
Provider:
Date:
HTA Course
Aston University
Compulsory
Please specify
Please specify
Project Based - Competency Assessment
Aston University
HTA Unique
Project
Reference
Number
Principal Investigator / Designated Individual
(assessing appropriate competency achieved)
Name and signature
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Date:
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RECEIPT & STORAGE OF THE HUMAN
BRAIN FROM THE Thinktank
Standard Operating Procedure
Title
Receipt & Storage of the Human Brain from the
Thinktank
Reference Number
AHRIC010
Version
1
Superseded Version Number and
Date
Previously AUHTA012 Version 6 (May 2014)
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Human Tissue Act Compliance Oversight Group
Authorisation
Dr N J Seare
Designated Individual
…………………………………………
Date ………….
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Background
Aston University has a quality management system for the governance of the acquisition,
storage and use of human tissue. This system ensures that all work is carried out to the
highest standard and that the University complies with the licensing obligations of the
Human Tissue Act (2004).
This SOP forms part of a suite of SOPs that support implementation of the quality
management system and should be used as directed in the Quality Manual.
Purpose
The purpose of this SOP is to set out procedures for the receipt, storage, return and if
appropriate disposal of the Human Brain from the Thinktank.
Definitions
Human Brain – the Human Brain which is on display at the Thinktank
Scope (of this SOP)
Evacuation to and storage by Aston University of a Human Brain that is currently on display
at the Thinktank in the case of an emergency arising at the Thinktank.
Return of the Human Brain to the Thinktank once they are in a position to return it to display.
If required by the Thinktank disposal of the Human Brain.
Related SOPs
AHRIC003
Material Transfer Agreements
AHRIC004
Transport of Human Tissue
AHRIC008
Disposal of Human Tissue
Related External Documents
COSHH Assessment: Thinktank - EC3A (Appendix 1)
Responsible Personnel
Thinktank Designated Individual
Thinktank staff undertaking evacuation of the Human Brain
Aston University Designated Individual
Aston University HTA Licence Holder
Aston University Head of Security and Emergency Planning
Aston University Security Staff
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Procedures
Notification of the need to evacuate the Human Brain to Aston University in the case of an
emergency at the Thinktank
In the case of an emergency arising at the Thinktank that requires the Human Brain to be
transferred to Aston University for temporary storage the Thinktank Designated Individual or
their representative will telephone the Aston University Security Control Room (0121 359
2922) to inform them that they will be transferring the Human Brain.
Security staff will then inform the Aston University Designated Individual (DI) of the transfer
or in her absence Mr Walter (Licence Holder) or Mr Sutton (University Head of Security and
Emergency Planning).
Receipt of the Human Brain
The Human Brain will be delivered to the Aston University Main Building Security Desk by
Thinktank staff in appropriately labelled protective packaging.
The member of staff taking receipt of the Human Brain will confirm receipt by signing two
copies of: Form AHRIC007 – Transfer of the Human Brain from the Thinktank to Aston
University (Appendix 2).
The Forms should then be transferred to the Designated Individual (Dr Nichola Seare,
n.seare@aston.ac.uk; (0121 204 3325; 07545420721)) who will ensure that one copy is filed
in the HTA Central File and one copy is sent to the Thinktank Designated individual.
Transfer of the Human Brain to storage
The Human Brain will be stored in Room SW023A at Aston University.
Prior to storage a label with the following information should be attached to the Human
Brain:
HUMAN TISSUE SAMPLE
Sample Reference Number:
Thinktank Human Brain
Tissue Type:
Human Brain – Mounted for Display
Medium/Preservative:
Glycerine, Water and Potassium Acetate
Date of transfer to Aston University:
To be completed
Custodian:
Dr N J Seare
Telephone: 0121 204 3325; 07545420721
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Return of the Human Brain to the Thinktank
When the Thinktank are in a position to return the Human Brain to display they will inform
the Aston University DI of the proposed arrangements for its transfer.
The Aston University DI will then undertake a risk assessment of the proposed method of
transfer to ensure that it complies with the Human Tissue Act (2004).
Provided that the Aston University DI is satisfied that the proposed method of transfer is
compliant she will then arrange for the return of the Human Brain to the Thinktank to take
place.
At the point of transfer the Aston University DI will ensure Form AHRIC008 – Transfer of
the Human Brain from Aston University to the Thinktank (Appendix 3) is completed and
filed in the HTA Central File.
Disposal of the Human Brain
In the unlikely event of there being a requirement to dispose of the Human Brain the
Thinktank will inform the Aston University DI in writing that they wish Aston University to
dispose of the Human Brain in accordance with the Human Tissue Act (2004).
In this event the Aston University DI will arrange for disposal of the Human Brain in
accordance with Aston University SOP: AHRIC008 - Disposal of Human Tissue.
The Aston University DI will then confirm disposal to the Thinktank Designated individual in
writing and file a copy the confirmation in the HTA Central File.
Communication of the SOP to Security Staff
The SOP will be communicated to security staff via both printed copy and email, instructions
will also be verbally issued by the Head of Security and Emergency Planning to the Senior
Security Officers who will then pass to all staff on their section/shift. Copies will also be kept
within the emergency procedures file and the general file 10 which contains all standing
orders and operational orders.
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Appendix 1
COSHH Assessment: Thinktank - EC3A
THE CONTROL OF SUBSTANCES
HAZARDOUS TO HEALTH
Risk Assessment Reference No: EC3A
Name of Substance / Product:
Substance to be used for:
Brain fixed in 10% formal calcium and mounted
in a solution of glycerine, water and potassium
acetate
Brain mounted for display
Supplier / Manufacturer:
Duration of activity: (max. hours/week exposure)
Permanent exhibition in Medicine Matters gallery
Pathology Museum
Queens Medical Centre
University Hospital NHS Trust
Nottingham
NG7 2UH
Persons Exposed:
Collections Team members
Hazardous ingredient(s): (details from data sheet)
Brain: fixed in 10% formal calcium; contains 10%
formaldehyde
Mounting solution: contains glycerine and
potassium acetate
Risk Phrases: (risk phrases from data sheet)
Classification of Substance: (i.e. harmful, flammable etc)
Irritating to eyes.
Irritating to respiratory system.
Irritating to skin.
Flammable.
Very toxic by inhalation.
Very toxic in contact with skin.
Very toxic if swallowed.
Causes burns.
Limited evidence of a carcinogenic effect.
Risk of serious damage to the eyes.
May cause sensitization by skin contact.
Irritant
Flammable
Toxic
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Controls:
YES
Does the substance have to be used?
NO
Control Measures
Used at very low concentrations and
in low quantities which do not pose
a risk.
Can the substance be substituted for a safer
alternative?
Can engineering controls be introduced?
- Ventilation
- Enclosure
Has Personal Protective Equipment been
issued?
Permanently sealed in container.
Disposable gloves and safety glasses
available if container is broken
Protective clothing or equipment issued:
Gloves
Apron
Respirator
Eye protection
Overalls
Boots
Dust mask
Face shield
Other ...
Action to be taken in the event of a spillage:
Should the container be broken there is no risk from infection or chemical injury. Concentrations and
quantities of hazardous chemicals are too low to pose a threat. The mounting fluid is sticky and should be
cleaned away with copious amounts of hot water and washing up liquid.
First Aid Requirements:
First aid measures:




Eye contact: rinse immediately with plenty of water.
Inhalation: Remove from exposure.
Skin contact: Drench the skin thoroughly with water. Removed contaminated clothing and wash
before reuse.
In case of accident or if you feel unwell, seek medical advice immediately
Storage Requirements:
No special requirements.
YES
NO
Are all relevant staff aware of the contents of this
assessment?
THE ABOVE INFORMATION HAS BEEN MADE AVAILABLE TO EVERYONE CONCERNED
Elisabeth Chard
16/07/2013
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Appendix Two
FORM AHRIC007
Transfer of the Human Brain from the Thinktank to Aston University
Project Title:
Receipt and Storage of the Human Brain from the Thinktank
Principal Investigator:
Dr N J Seare
MTA Reference Number:
Thinktank Human Brain MTA
Sample Reference:
Thinktank Human Brain
Sample Details:
Type of Tissue:
Human Brain – Mounted for Display
Amount of Tissue:
One Human Brain
Carrier Medium:
Glycerine, Water and Potassium Acetate
Member of Aston staff receiving the Human Brain:
Name:
Signature:
Date:
Location of tissue:
SWO23A
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Appendix 3
FORM AHRIC008
Transfer of the Human Brain from Aston University to the Thinktank
Project Title:
Receipt and Storage of the Human Brain from the Thinktank
Principal Investigator:
Dr N J Seare
MTA Reference Number:
Thinktank Human Brain MTA
Sample Reference:
Thinktank Human Brain
Sample Details:
Type of Tissue:
Human Brain – Mounted for Display
Amount of Tissue:
One Human Brain
Carrier Medium:
Glycerine, Water and Potassium Acetate
Member of Thinktank staff receiving the Human Brain:
Name:
Signature:
Date:
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OBTAINING CONSENT FROM
RESEARCH PARTICIPANTS
Standard Operating Procedure
Title
Obtaining Consent from Research Participants
Reference Number
AHRIC102
Version
1
Superseded Version Number and
Date
N/a
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Previous Informed Consent SOP AUHTA013 Version 3 (May
2014) in HTA Quality Manual
Mrs A Patel
Authorisation
Dr N J Seare
Director AHRIC & Designated Individual
Date:
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Background
Aston University has quality management systems to ensure:


Compliance with the Research Governance Framework for Health & Social Care2 and
Good Clinical Practice Standards3
Governance of the acquisition, storage and use of human tissue
These systems ensure that all work is carried out to the highest standard and that the
University complies with the Good Clinical Practice Standards and/or the licensing
obligations of the Human Tissue Act (2004)4.
This SOP forms part of a suite of SOPs that support implementation of the quality
management systems and should be used as directed in the Quality Manuals.
Purpose
The purpose of this SOP is to set out procedures for obtaining consent from research
participants.
Definitions
Good Clinical Practice – an international quality standard that is provided by the
International Council for Harmonisation (ICH), an international body that defines standards
for clinical trials involving human subjects
Informed Consent – an ongoing agreement by a person to receive treatment, undergo
procedures or participate in research, after the risks, benefits and alternatives have been
adequately explained to them
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
All instances where Aston University staff and students are responsible for receiving
informed consent from research participants.
Related SOPs
AHRIC103
Site File Management
AHRIC107
Protocol Amendments
2
https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition
3
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
4
http://www.legislation.gov.uk/ukpga/2004/30/pdfs/ukpga_20040030_en.pdf
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Responsible Personnel
Chief Investigators
Principal Investigators
Individuals who are responsible for receiving consent from research participants
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
Requirements for Informed Consent
Informed consent is a process rather than a “one off event” and should be sought in advance
of any research procedure.
It should be supported by a Participant Information Sheet (PIS) and the provision of any
further information that is requested.
For research it is generally expected that consent will be confirmed by the signatures of the
participant and the individual receiving consent on a Consent Form.
The PIS and Consent Form must have been reviewed by a Research Ethics Committee
(REC). The versions of the PIS and Consent Form being used to deliver a project must be
listed in the REC Favourable Opinion Letter for the project or a REC letter confirming
approval of a Substantial Amendment.
For consent to be valid it must be: given voluntarily; by an appropriately informed
person; who has the capacity to give consent.
The individual seeking consent should be suitably trained and qualified and have sufficient
knowledge of the proposed investigation or treatment. For research where several areas of
specialist knowledge are involved participants should be offered access to specialists if they
require additional information.
Provision of Participant Information
Guidance on preparing Participant Information Sheets can be found within the Aston
University Ethics Committee Policies and Procedures (REG/11/205):
http://www1.aston.ac.uk/registry/for-staff/regsandpolicies/ethics-policy-and-procedures/
and on the Health Research Authority website:
http://www.hra.nhs.uk/resources/before-you-apply/consent-and-participation/consent-andparticipant-information/
Further assistance in preparing Participant Information Sheets can be obtained by contacting
AHRIC – a.patel10@aston.ac.uk, 0121 204 4963.
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Documenting Consent
Research participants should confirm their consent by: initialling the boxes to say that they
agree with the statements on the Consent Form; printing their name; signing; and dating the
Consent Form. The individual receiving consent should confirm that informed consent has
been given by: printing their name; singing; and dating the Consent Form.
A copy of the signed Consent Form should be given to the Participant and the original
should be placed in the Site File. For research involving participants who are recruited in the
NHS the consent should also be documented in the participants’ medical notes and a copy
of the Consent Form filed.
Guidance on preparing Consent Forms can be found within the Aston University Ethics
Committee Policies and Procedures and on the Health Research Authority website:
http://www1.aston.ac.uk/registry/for-staff/regsandpolicies/ethics-policy-and-procedures/
http://www.hra.nhs.uk/resources/before-you-apply/consent-and-participation/consent-andparticipant-information/
Further assistance in preparing Consent Forms can be obtained by contacting AHRIC a.patel10@aston.ac.uk, 0121 204 4963.
Consent for Research with Human Tissue
If human tissue is to be used for DNA analysis and/or future research and/or transferred to
another organisation(s) the arrangements should be described in the Participant Information
Sheet and specific consent for these activities sought via the Consent Form.
RECs may require that individuals be allowed to participate in a project without giving their
consent for these activities.
Groups Where Additional Consent Requirements Apply
There are specific requirements for obtaining consent for certain groups which include:



Children under 18 years of age
Adults without capacity to give consent
Individuals who first language is not English
For research involving these groups it is important that all relevant legislation and
requirements are considered when developing the consent process and associated
documentation.
Further advice on obtaining consent from these groups can be obtained by contacting
AHRIC - a.patel10@aston.ac.uk, 0121 204 4963.
Training
It is a requirement of the Aston University quality management systems that all staff and
students involved in the process of receiving informed consent (including those involved in
the provision of information to support the process) have undergone appropriate training and
competency assessment.
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Evidence of training and/or competency assessment and/or relevant experience should be
included in CVs which are submitted to support Quality Manual compliance.
Procedure for obtaining informed consent
Provide a copy of the Participant Information Sheet
(The latest Version that has been approved by the Research Ethics Committee and Sponsor)
Inform the potential participant that they do not have to participate and do not have to give a
reason why they do not wish to participate
↓
Answer any questions that the potential participant has about the project
↓
Allow the potential Participant time to decide if they wish to participate in the project
↓
Answer any further questions that the potential Participant has
↓
If the potential Participant is willing to give consent confirm the consent by completing,
signing and dating two/three copies the Consent Form
(Individual receiving consent and Participant signatures and date are required)
↓
Give one copy of the Consent Form to the Participant and file one copy of the Consent Form
in the Participant’s Research Record
(For consent taken in the NHS a signed copy of the consent form should be filed in the Participant’s hospital notes)
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SITE FILE MANAGEMENT
Standard Operating Procedure
Title
Site File Management
Reference Number
AHRIC103
Version
1
Superseded Version Number and
Date
N/a
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Mrs A Patel
Authorisation
Dr N J Seare
Director AHRIC & Designated Individual
Date:
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Background
Aston University has quality management systems to ensure:

Compliance with the Research Governance Framework for Health & Social Care5 and
Good Clinical Practice Standards6

Governance of the acquisition, storage and use of human tissue
These systems ensure that all work is carried out to the highest standard and that the
University complies with the Good Clinical Practice Standards and/or the licensing
obligations of the Human Tissue Act (2004)7.
This SOP forms part of a suite of SOPs that support implementation of the quality
management systems and should be used as directed in the Quality Manuals.
Purpose
The purpose of this SOP is to set out the procedures for management of Site Files.
Definitions
Good Clinical Practice – an international quality standard that is provided by the
International Council for Harmonisation (ICH), an international body that defines standards
for clinical trials involving human subjects
Site File – the collection of documentation that supports: the conduct of the project; accurate
data collection; and compliance with legislation, regulation and local SOPs at a given
research site
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
All projects that are required to be conducted in accordance with Good Clinical Practice
(GCP) and all projects involving work with human tissue at Aston University.
Related SOPs
AHRIC001
Due Diligence Process for Approving Suppliers/Recipients of Human Tissue
AHRIC002
Designated Individual Approval to Undertake Research with Human Tissue
AHRIC003
Material Transfer Agreements for Human Tissue
5
https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition
6
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
7
http://www.legislation.gov.uk/ukpga/2004/30/pdfs/ukpga_20040030_en.pdf
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AHRIC004
Transport of Human Tissue
AHRIC005
Human Tissue Records
AHRIC006
Storage of Human Tissue
AHRIC008
Disposal of Human Tissue
AHRIC009
Training Records for Research with Human Tissue
AHRIC102
Obtaining Consent from Research Participants
AHRIC104
Adverse Event Reporting
AHRIC105
Internal Audit
AHRIC106
Archiving
AHRIC107
Protocol Amendments
Responsible Personnel
Designated Individual
Chief Investigators
Principal Investigators
Aston Staff and Students undertaking projects in accordance with GCP and/or work human tissue
Aston Health Research & innovation Cluster (AHRIC) Staff
Procedures
Issue of Aston University Site Files
For projects where Aston University is the Sponsor and therefore responsible for ensuring
the project is undertaken in accordance with GCP AHRIC issues a Site File(s) when it
confirms Sponsor’s approval for the project to commence.
For projects involving the use of human tissue for which Aston University has no
Sponsorship responsibilities AHRIC issues a Site File when Designated Individual approval
to commence the project is confirmed.
A Site File is issued for each site where a project is taking place.
Site File Contents
The contents of a Site File is dependent on the research being undertaken but a Site File will
always contain the following:
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For studies being undertaken in accordance with GCP:
1. A copy of the current version of the Protocol – with a “wet ink” signature of the Principal
Investigator
2. A copy of the REC Favourable Opinion letter
3. A copy of the current version of the Participant Information Sheet(s)
4. A blank copy of the current version of the Consent Form(s)
5. A copy of the current version of all other documents that form part of the REC Favourable
Opinion for the study
6. If applicable - Copies of all superseded versions of the documents listed in 1-5 – marked as
superseded as described below
7. NHS Permissions for the study to take place at the site
8. If applicable - Protocol Amendments – to include: amendment request(s); amended
documentation (tracked changes); and Sponsor, REC and NHS letters confirming approval(s)
9. A “wet ink” signed delegation of Duties Log with an associated record for each individual named
on the log – to include: a CV; GCP Training Certificate; and if required evidence of
training/competency to undertake specific tasks
10. Signed Participant Consent Forms
11. A blank Case Report Form
12. Study Data
13. If applicable - Adverse Event Reports
14. If applicable – Monitoring/Audit/Inspection Reports
15. REC Annual and Final Reports and association confirmation of receipt from the REC.
16. Correspondence/Contracts
AND for projects involving the use of human tissue at Aston University:
17. Form AHRIC002 – Application for Designated Individual Approval for research with Human
Tissue
18. If applicable - Material Transfer Agreement(s)
19. If applicable - Transport Risk Assessments
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For projects involving the use of human tissue for which Aston University has no
Sponsorship responsibilities:
1. A copy of the Protocol for the human tissue studies to be undertaken at Aston University – with a
“wet ink” signature of the Principal Investigator
2. A copy of the Application for Designated Individual Approval to Undertake Research with Human
Tissue Form (Form AHRIC002) and the associated supporting paperwork
3. If applicable – Material Transfer Agreement(s)
4. If applicable – Transport Risk Assessments
5. A “wet ink” signed delegation of Duties Log with an associated record for each individual named
on the log – to include a CV, HTA Training Certificate; HTA Training Record; and if required GCP
Training Certificate
6. Information about the location of Human Tissue Records
7. If applicable - Adverse Event Reports
8. If applicable – Monitoring/Audit/Inspection Reports
9. Correspondence/Contracts
AHRIC will ensure that the Site File(s) that is issued contains all the required sections to
ensure compliance with Quality Manual procedures and SOPs. All the documentation
required to commence the study will be provided in the Site File(s).
Site File Maintenance
Consent Forms (if applicable)
The signed Consent Forms should either be filed in the Site File or a File Note added to say
where they are filed to ensure added security.
Project Data
The project data should either be stored in the Site File or a File Note added to say where it
is filed e.g. on the University Server.
Amendments to the Delegation of Duties Log
Sponsor approval must be sought for all changes to the Delegation of Duties Log.
Requests for changes should be made by e-mailing AHRIC (a.patel10@aston.ac.uk) with
the following information:
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Project Reference Number:
Description of the proposed changes:



Addition of a new member to the research team and/or
Removal of a current member of the research team and/or
Change of duties for member(s) of the research team
Where the change relates to the addition of a new member to the research team their CV,
GCP Certificate and if required evidence of training/competency to undertake specific tasks
should be attached to the e-mail
Where the change relates to a change of duties - if required a new CV demonstrating
training/competency to undertake new tasks should be attached to the e-mail.
Once AHRIC has confirmed Sponsors approval for the change(s) the Delegation of Duties
Log should be updated and a copy sent to AHRIC.
Amendments to REC Approved Study Documentation
Before an amendment to any study document can be made it must have appropriate
approval. For studies where Aston University is the Sponsor approval on behalf of the
University by AHRIC is always required. In addition NHS Trust approval is required and
generally REC approval is also required.
Information on processing Protocol Amendments can be found in SOP: AHRIC107 –
Protocol Amendments.
Amended documentation should not be used until all required approvals are in place.
Once approval has been obtained for the use of an amended document the previous version
of the document should be marked as superseded by drawing a line across the document
and writing superseded. The individual making the change in the Site File should sign and
date the document that is being superseded.
The superseded document must be retained in the Site File and filed behind the current
version.
It is the responsibility of the Principal Investigator to ensure that on introduction of a
new version of a document all unused copies of the previous version are destroyed.
Adverse Event Reports (if applicable)
All Adverse Event Reports and information relating to follow up of the adverse event to its
closure should be filed in the Site File.
Information about Adverse Event reporting and management can be found in SOP:
AHRIC104 – Adverse Event Reporting.
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Monitoring/Audit/Inspection Reports (if applicable)
Copies of any Monitoring/Audit/Inspection/Reports relating to the project should be filed in
the Site File along with any associated Action Plans.
Information about Internal Audit procedures can be found in SOP: AHRIC105 – Internal
Audit.
REC Annual and Final Reports and association confirmation of receipt from the REC
REC reports and the associated confirmation of approval should be filed in date order.
Correspondence/Contracts (if applicable)
Any correspondence should be filed in date order.
Contracts should be filed in date order.
Amendments to Designated Individual Approval for projects where Aston University
is not the study Sponsor
Requests for Designated Individual (DI) approval for changes to the Protocol and/or project
management arrangements should be made by e-mailing AHRIC (a.patel10@aston.ac.uk)
with the following information:
Project Reference Number:
Description of the proposed change(s):




Additional tissue and/or
New tissue management arrangements and/or
New Supplier/Recipient and/or
New Transport Risk Assessment
Once AHRIC has put in place any arrangements/contracts that are required and confirmed
Designated Individual approval for the change(s) the Site File should be updated to reflect
the change(s).
The amendment(s) should not be implemented until DI approval has been confirmed.
File Notes
It is essential that all activities associated with the delivery of a project are recorded in the
Site File.
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The File Note Template (which is provided in Site Files) should be used to record any
information relating to the project and its delivery that is in addition to information collected in
forms and/or correspondence.
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ADVERSE EVENT REPORTING
Standard Operating Procedure
Title
Adverse Event Reporting
Reference Number
AHRIC104
Version
1
Superseded Version Number and
Date
N/a
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Previous Adverse Event reporting SOP AUHTA010 Version 4
(May 2014) in HTA Quality Manual
Mrs A Patel
Authorisation
Dr N J Seare
Director AHRIC & Designated Individual
Date:
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Background
Aston University has quality management systems to ensure:

Compliance with the Research Governance Framework for Health & Social Care8 and
Good Clinical Practice Standards9

Governance of the acquisition, storage and use of human tissue
These systems ensure that all work is carried out to the highest standard and that the
University complies with the Good Clinical Practice Standards and/or the licensing
obligations of the Human Tissue Act (2004)10.
This SOP forms part of a suite of SOPs that support implementation of the quality
management systems and should be used as directed in the Quality Manuals.
Purpose
The purpose of this SOP is to set out the procedures for reporting Adverse Events.
Definitions
Good Clinical Practice – an international quality standard that is provided by ICH, an
international body that defines standards for clinical trials involving human subjects
Sponsor - the individual, company, institution or organisation, which takes on ultimate
responsibility for the initiation, management (or arranging the initiation and management) of
and/or financing (or arranging the financing) of a project. The sponsor takes primary
responsibility for ensuring that the design of the study meets appropriate standards and that
arrangements are in place to ensure appropriate conduct and reporting
Adverse Events:

Any event which has resulted in a deviation from an Aston University Quality Manual
SOP or its associated policies and procedures and/or

Any untoward medical occurrence in a clinical research participant which may or may not
have a causal relationship with the research and/or

Any event that affected or had the potential to affect the integrity of human tissue or the
programme of work in which it was being used
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
8
https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition
9
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
10
http://www.legislation.gov.uk/ukpga/2004/30/pdfs/ukpga_20040030_en.pdf
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All Adverse Events occurring during projects for which Aston University is the Sponsor
and/or all Adverse Events relating to the use of human tissue at Aston University.
Related SOPs
AHRIC004
Transport of Human Tissue
AHRIC005
Human Tissue Records
AHRIC006
Storage of Human Tissue
AHRIC007
Cleaning and Decontamination Procedures for Laboratories working with Human
Tissue
AHRIC008
Disposal of Human Tissue
AHRIC102
Obtaining Consent From Research Participants
AHRIC103
Site File Management
AHRIC107
Protocol Amendments
Responsible Personnel
University Research Ethics Committee Chair
Director of Governance
Designated Individual
Chief investigators
Principal investigators
Aston Staff and Students undertaking work in accordance with Aston University quality
management systems
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
All Adverse Events should be reported using: Form AHRIC101 – Adverse Event Report
(Appendix 1) or a project specific Adverse Event Report Form approved as part the
Sponsors approval for the study.
Completed forms associated with adverse events should be sent to the AHRIC Office
(a.patel10@aston.ac.uk) as soon as possible after the Adverse Event has occurred.
AHRIC staff will then work with CI and/or PI to follow up the adverse event to conclusion.
The Adverse Event Form and subsequent correspondence/documentation should be filed as
part of the project record (SOP: AHRIC103 - Site File Management).
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Adverse Event Management Process
Adverse Event (AE) identified
↓
If required: immediate action taken to support: Research Team/Participant Safety and/or
human tissue sample integrity
↓
Adverse Event reported to AHRIC Office (Form AHRIC101 – Adverse Event Report)
↓
AHRIC Team work with CI and/or PI to:
If required: report the AE to host institution and/or Research Ethics Committee
Identify any corrective action to be taken
If required: agree and seek approval for any amendments to the project Protocol and/or
Procedures/SOPs
Document AE follow up
↓
Director AHRIC or Designated Individual confirms the AE is closed in writing
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Appendix 1
Form AHRIC101: Adverse Event Report
Form AHRIC101
Adverse Event Report
Project Reference Number:
Project Title:
Principal Investigator:
Description of adverse event:
who, when, where, how ….
Description of any immediate action taken to support: Research Team/Participant safety
and/or human tissue sample integrity:
Description of any proposed changes to the study protocol and/or study management:
Research Team Member reporting the Adverse Event
Name:
Signature:
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Date:
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INTERNAL AUDIT
Standard Operating Procedure
Title
Internal Audit
Reference Number
AHRIC105
Version
1
Superseded Version Number and
Date
N/a
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Previous Internal Audit SOP AUHTA011 Version 4 (May 2014)
in HTA Quality Manual
Mrs A Patel
Authorisation
Dr N J Seare
Director AHRIC & Designated Individual
Date:
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Background
Aston University has quality management systems to ensure:

Compliance with the Research Governance Framework for Health & Social Care11 and
Good Clinical Practice Standards12

Governance of the acquisition, storage and use of human tissue
These systems ensure that all work is carried out to the highest standard and that the
University complies with the Good Clinical Practice Standards and/or the licensing
obligations of the Human Tissue Act (2004)13.
This SOP forms part of a suite of SOPs that support implementation of the quality
management systems and should be used as directed in the Quality Manuals.
Purpose
The purpose of this SOP is to describe the process of Internal Audit for projects being
conducted in accordance with Good Clinical Practice and/or projects using human tissue.
Definitions
Good Clinical Practice – an international quality standard that is provided by ICH, an
international body that defines standards for clinical trials involving human subjects
Internal Audit - an examination of records, policies, and procedures that is conducted to
ensure best practice and compliance with the Quality Manual procedures and SOPs
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
All research for which Aston University is the Sponsor as defined in Research Governance
Framework and/or research involving human tissue carried out at Aston University.
Related SOPs
All SOPs associated with the Aston University Quality Manuals:


Good Clinical Practice Compliance
Acquisition, Storage, Use and Disposal of Human Tissue
11
https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition
12
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
13
http://www.legislation.gov.uk/ukpga/2004/30/pdfs/ukpga_20040030_en.pdf
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Responsible Personnel
Director AHRIC
Designated Individual (for projects involving human tissue)
Chief Investigators
Principal Investigators
Aston Staff and Students involved in projects being conducted in accordance with Good
Clinical Practice and/or projects involving human tissue
Aston Health Research & Innovation Cluster (AHRIC) Staff
Procedures
Selection of Projects
One project per month for which Aston is the Sponsor (as defined in the Research
Governance Framework) will be selected randomly for Internal Audit.
All research projects involving the use of human tissue will be subject to Internal Audit on an
annual basis and at three months following completion of the project.
Internal Audits may also be triggered if a significant concern is raised about the conduct of a
project.
In addition to Internal Audit of individual projects involving human tissue Aston University
premises and equipment designated for research with human tissue are audited on a six
monthly basis by the Designated Individual and her representative(s).
Scope of Audits
Documentation
Chief Investigators (CIs)/Principal Investigators (PIs) will be asked to make available the Site
File(s) for the project and associated documents to be audited.
For projects being undertaken at a NHS site the PI may also be asked to make available
Patient Case Notes for Source Document verification.
In addition for projects involving human tissue CIs/PIs will be asked to make available
laboratory risk assessments, policies and procedures and SOPs which support Quality
Manual compliance.
SOP Compliance
SOP compliance will be audited using a template in which all the SOPs required to meet the
Quality Management System(s) with which to project is required to comply have been
identified.
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Laboratory Visit
For projects involving human tissue a laboratory visit and sample tracebility exercise will be
undertaken.
Staff Interviews
Auditors may wish to interview staff listed on the Delegation of Duties Log.
Internal Audit Notification
Unless the audit has been “triggered” as the result of a concern being raised CIs/PIs will be
given at least 10 days’ notice of an Internal Audit,
Auditors
Good Clinical Practice compliance audits will be undertaken by AHRIC staff who may be
accompanied by representatives of the host NHS organisation if the project involves a NHS
Trust.
Internal Audits of projects involving human tissue will be undertaken by the Designated
Individual and/or her representative(s).
Audit Reports
A formal Audit Report will be issued to the CI/PI within one week of the audit detailing any
corrective action that is required and a timeframe for its implementation.
If corrective action is required the CI/PI is required to submit an Action Plan to the AHRIC
Office (a.patel10@aston.ac.uk).
AHRIC staff will then work with the CI/PI to ensure that all the actions are completed. Once
all actions have been completed the Director of AHRIC/Designated Individual will confirm all
corrective action required has been implemented in writing.
Documentation associated with Internal Audits should be filed in the Site File (SOP:
AHRIC103 – Site File Management)
Internal Audit Reports relating to projects involving human tissue are reviewed by the HTA
Compliance Oversight Group.
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ARCHIVING
Standard Operating Procedure
Title
Archiving
Reference Number
AHRIC106
Version
1
Superseded Version Number and
Date
Not Applicable
Effective Date
April 2016
Review Date
April 2017
Authors
Dr N J Seare
Mrs A Patel
Authorisation
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Dr N J Seare
Director AHRIC
Date:
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Background
Aston University has quality management systems to ensure:

Compliance with the Research Governance Framework for Health & Social Care14 and
Good Clinical Practice Standards15

Governance of the acquisition, storage and use of human tissue
These systems ensure that all work is carried out to the highest standard and that the
University complies with the Good Clinical Practice Standards and/or with licensing
obligations of the Human Tissue Act (2004)16.
This SOP forms part of a suite of SOPs that support implementation of the quality
management systems and should be used as directed in the Quality Manuals.
Purpose
The purpose of this SOP is to describe the process to be followed by Chief and Principal
Investigators when archiving research projects.
Definitions
Good Clinical Practice – an international quality standard that is provided by ICH, an
international body that defines standards for clinical trials involving human subjects
Archiving – the process of moving information that is no longer actively used to storage for
long-term retention
Human Tissue – any, and all, constituent part/s of the human body
Scope (of this SOP)
Aston University Sponsored projects except:



Clinical Trials of Investigational Medicinal Products 17
Projects involving Medical Devices which fall within the Medical Devices Regulations
Projects identified as having specific archiving requirements e.g. certain trials involving
children
And
14
https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition
15
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
16
http://www.legislation.gov.uk/ukpga/2004/30/pdfs/ukpga_20040030_en.pdf
17
http://www.hra.nhs.uk/resources/before-you-apply/types-of-study/study-types/
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Projects involving the use of human tissue at Aston University
Related SOPs
AHRIC103
Site File Management
Responsible Personnel
Chief Investigators
Principal Investigators
Aston Health Research & Innovation Cluster (AHRIC) Staff
R&D offices of collaborating NHS organisations
Procedures
Requests for Project Documentation/Data to be Archived
On completion of a project the Chief Investigator (CI)/Principal Investigator (PI) notifies the
AHRIC Office that the project documentation and data needs to be transferred to the AHRIC
Archive. The notification should be made by e-mail (a.patel@aston.ac.uk).
AHRIC then issues a project specific Archive Checklist to support preparation of the
documentation/data to be archived.
Collation of Documents/Data for Transfer to AHRIC
Once they have received the Archive Checklist the CI/PI collates the documentation/data
listed and transfers it to the AHRIC Office.
If Consent Forms and/or data are to be archived outside the AHRIC Archive this must be
agreed in writing by the Director of AHRIC. Requests for alternative archive arrangements
should be made by e-mailing the AHRIC Office (a.patel@aston.ac.uk) with details of the
documents/data to be externally archived and the proposed arrangements. Arrangements
must be in place to ensure that the documents/data are retained for 6 years.
Validation of the Documents and Data
AHRIC validates the Documents/Data submitted by the CI/PI against the Archive Checklist
and if required requests missing documents/data and/or confirmation of external archive
arrangements.
Transfer to the AHRIC Archive
Once a validated document/data set has been complied the AHRIC: prepares an Archive
Pack; creates an Archive Record; transfers the Archive Pack to the AHRIC Archive; and
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emails the CI/PI and any Collaborating Organisation(s) to confirm the project has been
archived.
Destruction of Archived Documents
At the end of the standard 6 year archiving period AHRIC e-mails the CI/PI and any
Collaborating Organisations to confirm that they have no objection to the destruction of the
archived documents and data.
Once confirmation of no objection to document/data destruction has been received the
documents and any electronic data are destroyed using a University approved confidential
shredding service and if applicable a University approved protocol for the destruction of
electronic data.
Destruction of the documents and data is then recorded on the Archive Record for the
project and the CI/PI and any Collaborating Organisations are notified that the
documents/data have been destroyed.
Process Flow Chart
CI/PI notifies AHRIC that they wish to archive a project
↓
AHRIC produces an Archive Checklist and sends it to the CI/PI
↓
CI/PI provides AHRIC with the documents/data on the Archive Checklist
↓
AHRIC validates document/data set
(Additional documents/data are requested as required)
↓
AHRIC prepares an Archive Pack
↓
AHRIC transfers the Archive Pack to the AHRIC Archive
↓
AHRIC creates an Archive Record for the project
↓
E-mail sent to CI/PI and any Collaborating Organisation(s) to confirm the project has been
archived
↓
After 6 years AHRIC e-mails the CI/PI and any Collaborating Organisations to confirm they
have no objection to document/data destruction
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↓
Confidential document/data destruction
↓
AHRIC records document/data destruction in the Archive Record for the project
↓
AHRIC informs CI/PI and Collaborating Organisations that the project documents/data have
been destroyed
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