Storage of Human Tissue Samples - Central Manchester University ...

DOCUMENT CONTROL PAGE 

Title 

Title: Human Tissue Act 2004 Standard Operating Procedure:- 

Storage of Human Tissue Samples (Research) 

Version: 1 

Reference Number: HTA009 

Supersedes 

Supersedes: N/A 

Description of Amendment(s): N/A 

Originator or 

modifier 

Originated By: Dr Jay Brown 

Designation: Human Tissue Project Manager 

Modified by: 

Designation: 

Approval 

Approval by: Research Governance Operational Group 

Application 

All staff using human tissue, blood and body fluid samples for research 

Circulation 

Review 

Issue Date: 02/10/2009 

Circulated by: Trust Intranet and Internet 

Issued to: Refer to list 

Review Date: 02/10/2011 

Responsibility of: Human Tissue Project Manager 

HTA009 - Storage of human tissue samples (research). Page 1 of 8 

See the Intranet for the latest version. Version Number:- 1: 02/10/2009

POLICY CONTROL PAGE (2) CIRCULATION DOCUMENT 

Circulation List: 

DI, Persons Designate and staff working under their supervision 

For Information 

Trust: Research Office Staff, Division Research Managers, Division Research Leads 

Central Manchester and Manchester University Hospitals NHS Trust is committed to 

promoting equality and diversity in all areas of its activities. In particular, the Trust wants 

to ensure that everyone has equal access to its services. Also that there are equal 

opportunities in its employment and its procedural documents and decision making 

supports the promotion of equality and diversity. Refer to section 5 for more detail on 

undertaking equalities impact assessment. 

This document must be disseminated to all relevant staff, refer to section 7: Dissemination 

and Implementation 

The document must be posted on the intranet. 



Section Contents Page 

1 Introduction 3 

2 Purpose 3 

3 Roles and Responsibilities 3 

4 Procedure 4 

5 Equality Impact Assessment 5 

6 Consultation, Approval and Ratification Process 5 

7 Dissemination and Implementation 6 

8 Review, Monitoring Compliance With and the 

6 

Effectiveness of Procedural Documents 

9 References and Bibliography 7 

10 Associated Trust Documents 7 

11 Appendices 8 

Appendix A: HTA Master File Contents List 

1 Introduction 

1.1 This document has been produced in accordance with The Human Tissue 

Act 2004 (HT Act) 1 . It should be read in conjunction with the Trust ‘Policy on 

compliance with the Human Tissue Act in research’ (HTA004), and the 

Human Tissue Authority’s (HTA) Codes of Practice 2 . The procedures 

represent good practice for the handling of all tissue samples and other types 

of ‘relevant material’ as defined by the HTA. They must be followed by all 

researchers working under the Trust’s Research Licence from the HTA and 

those transferring tissue as part of an ethically approved research project. 

The procedures outlined in this document represent best practice for the 

handling of all research tissue samples on CMFT premises in accordance 

with the Human Tissue Act 2004. 

1.2 To comply with the HT Act it is necessary to ensure that there is a clear and 

robust audit trail from the collection of human material, through processing, 

storage, use and distribution, to final use / disposal. All human material 

collected by CMFT personnel for storage under a HTA license must be 

recorded and its use, distribution and disposal accounted for. 

2 Purpose 

2.1 This document aims to provide guidance for Persons Designate (PD), and 

staff working under their direction so that they are fully aware of the 

procedures needed to ensure that the requirements for storage of human 

material under the HT Act and HTA Codes of Practice are met. 

3 Roles and Responsibilities 



3.1.1 Designated Individual (DI) - Accountable to the Human Tissue Authority 

for Research Tissue Stored under the authority of the Trust Licence and 

for making relevant Trust staff aware of this document. 

3.1.2 Persons Designated (PD) - Accountable to the DI and responsible for 

ensuring that this document is observed in respect of human tissue for 

which they have responsibility and is stored under the authority of the 

Trust Licence. This includes making all staff that collect, store or use such 

tissue aware of this document. 

3.1.3 All staff collecting, storing or using human tissue for research under the 

Trust Research Tissue Licence are accountable to the relevant PD(s) and 

the DI for undertaking work in compliance with this document. In 

compliance with the Research Licence issued by the HTA, CMFT expects 

all persons operating on the CMFT sites to comply with the HT Act and its 

subsequent amendments, and to seek to comply with all Codes of Practice 

issued by the HTA and relevant Trust Wide and/ or local Standard 

Operating Procedures (SOPs). 

4 Procedure 

4.1 Premises, staff and safety 

4.1.1 Access to the licensed premises/collection must be restricted to authorised 

persons to preserve the integrity of the collection and its records. 

4.1.2 Storage sites (freezers etc) must be clearly labelled as containing human 

tissue samples being held under the HTA licence. 

4.1.3 Equipment used for storage should be covered by an annual maintenance 

contract. As a minimum this should include -80 °C freezers and cryogenic 

storage tanks. 

4.1.4 All staff handling human tissue must be appropriately trained. They will 

need to be aware of the risks of handling human tissue and measures in 

place to reduce any risk. 

4.1.5 All staff handling human tissue should be immunised against Hepatitis B 

(and other infectious diseases as applicable) and their immune titre 

monitored at regular intervals by Occupational Health, as advised. 

4.1.6 Laboratory attire e.g. lab coat and latex\nitrile gloves and other applicable 

protective wear, must always be worn when handling human tissue and 

specimen containers which hold human tissue. Care must be taken to 

examine specimen containers. Where there are problems e.g. with 

leakage or broken containers, these incidents must be logged as an 

adverse event or incident and follow-up action taken. 

4.1.7 Storage and handling of tissue must be done in compliance with the Trust 

Health and Safety Policies available at: 

http://intranet.xcmmc.nhs.uk/directorates/depthumanres/HealthandSafety/ 

draft.asp 



4.1.8 Adverse events must be reported directly to the DI or Human Tissue 

Project Manager. (See HTA SOP HTA012: Adverse event/incident 

reporting and Trust document RM002: Incident reporting policy). Adverse 

events and corrective action plans are discussed at HTA Persons 

Designated Meetings. 

4.1.9 Risk assessments must be carried out for all processes covered by the 

licence. As a minimum this must include collection, handling, storage, 

transfer and disposal of relevant material. (Trust document RM003: Risk 

Identification and Analysis Policy). Risk assessments must be performed 

annually and are reviewed periodically by the DI or HT Project Manager. 

4.1.10 All data should be recorded on an electronic system that is restricted and 

backed-up centrally. 

4.2 HTA Master File Documentation 

4.2.1 Any department / laboratory storing relevant material under the HTA 

Licence must maintain a HTA Master File. 

4.2.2 Any department / laboratory intending to store material under the licence 

in the future (e.g. material for which ethics approval is due to expire) must 

prepare a HTA Mater File 6 months in advance. This is to enable the DI to 

assess the suitability of the laboratory prior to any material being stored 

and ensure compliance with the terms of the licence. 

4.2.3 Contents of the HTA Master File are given in Appendix A. 

4.2.4 The Human Tissue Project Manager will produce standard templates for 

data required and these will be controlled according to SOP HTA007: 

Human Tissue Act Document Control (Research). 

5 Equality Impact Assessment 

5.1 This document has been equality impact assessed by the author using the 

Trust’s Equality Impact Assessment (EqIA), which has been submitted to the 

Equality and Diversity Department for ‘Service Equality Team Sign Off’. 

5.2 The EqIA score fell into low priority (0 – 9); no significant issues in relation to 

equality, diversity, gender, colour, race or religion are identified as raising a 

concern. 

6 Consultation, Approval and Ratification Process 

6.1 Consultation and Communication with Stakeholders 

6.1.1 All Trust-wide Human Tissue Act documents are written by a member of 

staff with relevant expertise and experience. Additional advice is sought 

from members of the research community within the Trust or external 

advisors, as necessary. 



6.1.2 Consultation on this policy was provided by Designated Individuals, 

Persons Designated, Principal Investigators and relevant research staff. 

6.2 Document Approval Process 

6.2.1 Approved by Research Governance Operational Group. 

6.2.2 Ratified by Research Governance Committee. 

7 Dissemination and Implementation 

7.1 Dissemination 

7.1.1 When approved, this document will be posted on the Human Tissue Act 

pages of the CMFT Clinical Governance and Research & Innovation 

intranet sites. Only the current version will be available. 

7.1.2 All Persons Designate will be notified by email when the latest version of 

the document is available. 

7.1.3 Persons Designate will notify staff in their research areas. 

7.2 Implementation of Procedural Documents 

7.2.1 Training covering the contents of this document is included in the Human 

Tissue Act training course delivered by the Research Office. 

7.2.2 Support and advice on the implementation of this document can be 

obtained via the Human Tissue Project Manager or Designated Individual. 

8 Review, Monitoring Compliance With and the Effectiveness of Procedural 

Documents 

8.1 Process for Monitoring Compliance and Effectiveness 

8.1.1 The DI/HT Project Manager will monitor compliance through regular audits 

of tissue holdings. Including audit of tissue transferred on/off site. 

8.1.2 Document contents will be reviewed against any changes to the applicable 

guidelines and regulations and taking into account any feedback received 

from researchers or via the Monitoring Programme. 

8.1.3 The outcome of the review – and any resulting amendments - will be 

reported to the Research Governance Operational Group. 

8.2 Standards and Key Performance Indicators ‘KPIs’ 

8.2.1 This document will be available on the Trust intranet. 

8.2.2 This document must be reviewed at least every two years or when there 

are significant changes. 



8.2.3 Awareness of the document will be delivered at Trust HT Act training 

sessions. 

9 References and Bibliography 

9.1 1. The Human Tissue Act 2004 

http://www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1 

9.2 2. The Human Tissue Authority Codes of Practice 

http://www.hta.gov.uk/guidance/codes_of_practice.cfm 

10 Associated Trust Documents 

HTA004:- Policy on compliance with the Human Tissue Act 2004 in research 

HTA005:- Human Tissue Act 2004 Standard Operating Procedure:- Disposal of 

Human Tissue Samples (Research) 

HTA006:- Human Tissue Act 2004 Standard Operating Procedure:- Transfer of 


HTA007:- Human Tissue Act 2004 Standard Operating Procedure:- Human Tissue 

Act Document Control (Research) 

HTA008:- Human Tissue Act 2004 Standard Operating Procedure:- Management 

of Records (Research) 

HTA009:- Human Tissue Act 2004 Standard Operating Procedure:- Storage of 


HTA010:- Guidance on Human Tissue Act 2004 consent requirements for the 

removal, storage and use of human tissue samples in research 

HTA011: Human Tissue Act 2004 Standard Operating Procedure:- 

Coding/Tracking of Human Tissue Samples (Research) 

HTA012: Human Tissue Act 2004 Standard Operating Procedure:- HTA Adverse 

Event/Incident Reporting (Research) 

HTA013: Human Tissue Act 2004 Standard Operating Procedure:- Audit Of 

Licenced Tissue Holdings (Research) 

HTA014: Human Tissue Act 2004 Standard Operating Procedure:- Consent 

Recording (Research) 

RM003: Risk Identification and Analysis Policy 



11 Appendices 

11.1 Appendix A: HTA Master File Contents List 

1. Organizational Structure 

a. Roles and responsibilities 

b. Organizational flowchart 

c. Staff List 

d. Local Staff List 

2. Policies, Guidance and SOPs 

a. HTA Codes of practice 

b. Generic (Trust-wide) 

c. HTA specific 

d. Local 

3. Tissue Holdings 

a. Tissue Holdings List 

4. Staff 

a. Local Staff Details 

5. Facilities and equipment 

a. Description of facilities and equipment 

b. Facilities list 

c. Facilities maintenance details 

d. Copies of maintenance records 

e. Temperature logs 

6. Data and IT 

a. Description of data storage/record keeping 

b. Data storage details 

c. Maintenance of computers 

7. Risk assessment 

a. Risk assessment schedule 

b. Risk assessments 

8. Adverse events 

a. Adverse events 

9. Audit 

a. Audit schedule 

b. Audit reports 

10. Staff Meetings 

a. List of staff meetings 

b. Minutes

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