This Document Will Be Retained in the Following Locations

/ Human Tissue Act – Research Sector
HTA-SOP-02.v1
STANDARD OPERATING PROCEDURE NUMBER: / HTA-SOP-02.v1
HUMAN TISSUE ACT – RESEARCH SECTOR
TITLE / Organisational Structure, Management and Roles and Responsibilities - TheNewcastle University Research Human Tissue Act Licence (Ref. 12534)
AUTHOR / Name and role / Mhairi Anderson
Quality Assurance and Development Manager
Signature & Date /
APPROVER / Name and role / Professor Andy Hall
Designated Individual, Newcastle University
Research HTA licence (Ref: 12534)
Signature & Date /
EFFECTIVE DATE: / 1st April 2015 / REVIEW
DATE: / 1st April 2017

Distribution

This document will be retained in the following locations:

• Human Tissue Act VRE (
• Newcastle Joint Research Office Website (

Change control

To request any changes to this document please submit a change request using the following form, in accordance with HTA-SOP-8 “Change Control”.

Revision Category

Category 1 / This is a new/revised document. All personnel required to follow content must read this version and complete training
Category 2 / This is a revised document in which only the area of applicability has changed. All newly impacted personnel required to follow content must read this version and complete training
Category 3 / This is a new/revised document. All personnel required to follow content must read this version / 
Category 4 / No significant change to document content – no requirement to read or train

Note: As applicable, documentation of reading and/or training must be completed prior to performing the procedure.

1. BACKGROUND

The Human Tissue Act is a legal framework which regulates the “removal, storage, use and disposal of human bodies, organs and tissues”. The Act came into effect on the 1st September 2006 and applies to England Wales and Northern Ireland.

Under the terms of this Act, in order to store human organs, tissues and cells for research purposes other than for a specific ethically approved research project, a Research Human Tissue Act (HTA) licence is required. On this licence, key individuals from the licensed institution must be named to undertake a number of roles to ensure compliance with Act.

In addition, in order to comply with the Biobank Quality Standards (devised by the Confederation of Cancer Biobanks) there should be an organisational plan in place that defines the organisation and management of the biobank, including its relations to any partner organisations, including funders. The organisational plan should include the responsibilities, authority and interrelationships of all organisations involved.

This SOP provides information on the organisational structure under the Newcastle University research sector HTA licence (ref. 12534), the associated roles and responsibilities and the management committees established to oversee activities conducted under the licence.

2. SCOPE

This SOP applies to all personnel involved in research activities under the Newcastle University Research Human Tissue Act licence (Ref. 12534).

3.DEFINITIONS

Designated Individual (DI) / The individual named on the Human Tissue Act Licence who has ultimate legal responsibility for compliance with the Act.
HTA / Human Tissue Act/Human Tissue Authority
Human Tissue Authority / The governing body set up to regulate activities that come under the Human Tissue Act.
Licence Holder (LH) / The person or corporate body (organisation / institution) responsible for applying for the licence, and under whose name the licence is associated.
Person Designate (PD) / A person named on the Human Tissue Act licence who supports the Designated Individual by directing others in relation to the Human Tissue Act within their local environment
QADM / Quality Assurance and Development Manager
REC / Research Ethics Committee
SOP / Standard Operating Procedure

4. PROCEDURE

4.1. Organisational Structure

The Newcastle University research sector HTA licence (Ref. 12534) is run by the Designated Individual (DI), who has overall responsibility for the management of activities conducted under the licence. The DI has the authority to oversee and manage the full scope of activity conducted under the licence.

Newcastle Universityholds a research sector Human Tissue Act licence (2004). This licence extends to cover one “Hub licence” at the Medical School, and 4 “satellite licences”, which are located at:

-The Centre for Ageing and Vitality (CAV)

-The Freeman Hospital

-The International Centre for Life (ICfL)

-The School of Agriculture, Food and Rural Development

Within each of these 5 locations a number of tissue collections and housed, including Research Ethics Committee (REC) approved Research Tissue Banks.

A Licence Holder and Designated Individual and a number of Persons Designate have been assigned to oversee compliance with the terms and conditions of the HTA licence. In addition, a Quality Assurance and Development Manager has been appointed to ensure sound governance and support the quality management system. These roles and the associated responsibilities are summarised in section 4.2.

An organisational chart is provided in the HTA Master File, Section 1. This can also be found in the HTA Virtual Research Environment.

Details of management committees that have been adopted to support the licence are provided in section 4.3.

Newcastle University also works closely with Newcastle upon Tyne NHS Foundation Trust (NUTH) for sample provision and storage. A separate HTA Licence covers material stored on NUTH premises (ref. 12193) with a separate management structure. However to oversee activities between the two organisations, a Joint Access and Governance Committee (JAG) has been established (see section 5).

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/ Human Tissue Act – Research Sector
HTA-SOP-02.v1

4.2. Roles and responsibilities

Three compulsory roles are required under the terms and conditions of a HTA licence, as shown in figure 2:

1.Licence Holder (LH)

2.Designated Individual (DI)

3.Persons Designate (PD).

Figure 2: Roles under the Human Tissue Act

The names of the individuals that have undertaken these three key roles on the Newcastle University Research HTA licence (ref. 12534)are provided to the Human Tissue Authority and added to the licence.

In Newcastle, two additional roles have also been implemented in support of the HTA licence.

• A Quality Assurance and Development Manager has been appointed to ensure compliance with the terms and conditions of the licence, and support the Designated Individual.

• The role of “Human Tissue Act Coordinator” has been created at Newcastle University to support the Person Designate. This is not a compulsory role under the Act, but has been adopted to support the Persons Designate role and ensure compliance within their local environment.

To ensure compliance with the HTA, the Designated Individual, Persons Designate and Quality Assurance and Development Manager have ultimate responsibility for the implementation of the Quality Management System (QMS). These individuals will have oversight of the biobank and will be responsible for its day to day operation, organisation and policies. It is their role to provide leadership and demonstrate commitment towards continually reviewing and improving the QMS.

A list of the personnel that have undertaken these roles is provided in the HTA Master File. This can also be found in the HTA Virtual Research Environment.

Furthermore, under the National Research Ethics Service (NRES) researchers may establish Research Tissue Banks, and become “Research Tissue Bank Managers” (also referred to as Chief Investigators). This role is distinct from the HTA; however as research tissue banks storing relevant material must be stored under a HTA licence, Research Tissue Bank Managers may only store their tissue banks under the jurisdiction of a local Person Designate.

A list of the approved Research Tissue Banks and their associated Curators is provided in the HTA Master File. This can also be found in the HTA Virtual Research Environment.

These roles and the associated responsibilities are described in section 4.2.1 and 4.2.6 respectively. The responsibilities of all other staff operating under the HTA licence are summarised in section 4.2.7.

4.2.1. Licence Holder

The Licence Holder (LH) is the person, or corporate body (organisation/institution) responsible for applying for the licence, and under whose name the licence is associated. Where acorporate body wishes to act as the licence holder, an individual must be named as a point of contact for correspondence, to represent the corporate body and the HTA must obtain written acknowledgement from the LH to allow the licence to become valid.

The role of this individual is to:

• Appoint/change the Designated Individual (DI - see section 3.2) –the individual should therefore be more senior than the DI to allow the LH toappoint/substitute the DI where necessary.
• Apply for any changes to the licence - The HTA are required to provide all notices of licence decisions to both the LH and the DI.
• Along with the DI, receive all relevant Notices of licence decisions from the Human Tissue Authority (HTA),

However, the LH is not under any duty comparable to the DI to supervise the activities concerned. Where the DI must be substituted, the LH must also have the consent of the proposed new DI to be named on the Licence prior to application for the variation.

A Licence Holder role description is provided in section 1 of the HTA Master. This can also be found in the HTA Virtual Research Environment.

4.2.2. Designated Individual

The Designated Individual (DI) is the person under whose supervision the licensed activity is authorised to be carried out. They have the responsibility under the Human Tissue Act to ensure:

• that suitable practices are used in undertaking the licensed activity
• that the other persons who work under the licence are suitable
• and that the conditions of the licence are complied with

The DI needs to have knowledge and understanding of the Human Tissue Act (2004) and the relevant Codes of Practice issued by the HTA, and to keep up to date with any changes that come into force. Failure to undertake the responsibilities expected of the DI could lead to prosecution of the DI, and/or the revocation of the licence.

Further details on the responsibilities of the DI are provided below:

• The DI should ensure that a standard set of procedures are in place to ensure the requirements of the HT Act are met.

• The DI keeps a record of the consent of the individuals to the role of the Person Designated.

• The DI should ensure that a programme for audits is available and adhered to.

• The DI should ensure that personnel are being given training and development opportunities to update their skills.

• The DI should ensure the safety of staff undertaking research, by documented risk assessments.

• Any Adverse Events reported to the DI should be classified and any considered severe in nature must be reported to the HTA.

• If relevant material is stored for use in a specific project, the HTA consider it advisable that the DI has a log of the relevant material so that he is aware of when the relevant material will need to be stored under a HTA licence.

• The DI should ensure that where necessary to reduce the risk of contamination, there should be environmental controls and appropriate equipment available.

• The DI must consider the risks to the relevant material such as theft or damage, and the measures put into place to mitigate these risks.

• The DI will delegate responsibilities to a PD when absent on business or vacation.

A Person Designate role description is provided in section 1 of the HTA Master. This can also be found in the HTA Virtual Research Environment.

4.2.3. Person Designate

As the University is spread over a large campus, the DI relies on the support of a number of key individuals to supervise the licensable activities within their groups to ensure compliance with the Act. These persons are called “Person Designate” (PD).

Persons Designate are assigned to supervise each tissue collection stored for research under the licence and is accountable to the Designated Individual on behalf of the Licence Holder for ensuring that the requirements for licensing relevant activities under the Human Tissue Act are met.

Importantly, the role of PD does not impose any legal responsibility.

Each Person Designate must however record their formal written acceptance of the role to allow the DI to provide the HTA with an official list of the University’s assigned Persons Designate. These names will then be added to the University’s HTA licence and a copy of the PDs acceptance of the role retained by the QA and Development Manager.

The HTA do not need to approve the names of the individuals put forward, however the DI is responsible for ensuring that suitable persons are chosen.

The PD may be substituted at any time, as required, however a PD cannot be substituted or added without prior notification to the HTA. Once approved, the name of the new PD will be communicated to all relevant personnel and the HTA Master File and other associated documentation updated.

A Person Designate role description is provided in the HTA Master. This can also be found in the HTA Virtual Research Environment.

4.2.4. Quality Assurance and Development Manager

The role of Quality Assurance and Development Manager (QADM) is to act as an expert in the Human Tissue Act (HTA) regulations, proactively supporting staff to discharge their responsibility, and independently providing professional consultancy support to researchers based locally and elsewhere.

The QADM also conducts periodic internal audits to assess compliance with the Human Tissue Act and any other relevant legislation (see HTA-SOP-04), supports research tissue banks, develops a communication strategy to raise awareness of HTA issues, and is responsible for the Quality Management System.

In addition, the QADM must meet at least annually with the DI to review the quality management system. This annual management review shall include a comprehensive review of the quality management system and its continued suitability and effectiveness. Any necessary changes or improvements shall be introduced using the biobanks change control procedure.

4.2.5. Human Tissue Act Coordinator

The role of Human Tissue Act Coordinator” has been implemented at Newcastle University to support the Person Designate. This is a locally appointed role only, and the names of these individuals do not need to be provided to the HTA.

The main purpose of the HTAC is to operate at a local level to help coordinate and maintain the governance support for research using human tissue within their local research environment. This role does not impose any legal responsibility, but plays a vital function in assisting the PD to help meet the HTA regulatory requirements.

A Human Tissue Act coordinator role description is provided in section 1 of the HTA Master. This can also be found in the HTA Virtual Research Environment.

4.2.6. Research Tissue Bank Manager

Organisations responsible for the management of research tissue banks (RTB) anywhere in the UK may apply for ethical review of their arrangements for collection, storage, use and distribution of tissue. A “research tissue bank” (or “biobank”) is defined as:

“A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending”.

Whilst it is not law to have Ethics approval for a Research Tissue Bank, it is strongly recommended. Organisations responsible for the management of research tissue banks anywhere in the UK may apply for ethical review of their arrangements for collection, storage, use and distribution of tissue. This allows the applicant to seek generic ethical approval prospectively for a range of research purposes on the samples collected by the RTB. Such approval may be given for a period of up to five years and is renewable after this period.

Applications to establish RTBs are not restricted to collections of human tissue within the definition of 'relevant material' under the Human Tissue Act 2004 i.e. research tissue banks may be established to store non-relevant under the HTA (such as DNA, plasma). However research tissue banks which store relevant material under the Human Tissue Act must be approved by the relevant Designated Individual and material must be stored under the oversight of an assigned Person Designate in an approved storage location.

The Research Tissue Bank Manager (also known as the “Chief Investigator”) is the individual who applies to establish the bank and is responsible for the banks conduct.

The main purpose of the Research Tissue Bank (RTB) Curator is to supervise the research effectively and be readily available to communicate with the Research Ethics Committee (REC) and other review bodies during the application process and where necessary during the conduct of the research.

The responsibilities of the Research Tissue Bank Curators are to:

• Operate in compliance with the “Conditions of Ethical Approval” determined by the Research Ethics Committee that approved the bank.

• Establish an access committee & policy: An Access Committee should be established to review any applications to use the RTB, in accordance with the banks access policy, which must be formally documented. The access policy must contain details on the procedures for processing applications to use the bank, the conditions of access and any governance requirements. The access policy must be provided to the Designated Individual and added to the biobank website.

• Maintain a record of all research projects to which tissue has been supplied. The record should contain at least the full title of the project, a summary of its purpose, the name of the Research Tissue Bank Curator/Chief Investigator, the sponsor, the location of the research, the date on which the project was approved by the Bank, details of the tissue (sample numbers and types) and data released, including any relevant reference numbers.

• Submit an annual progress report:A progress report should be submitted to the REC which gave the favorable opinion for the research tissue bank 12 months after the date on which the favorable opinion was given i.e. on the anniversary of approval of the bank. Annual progress reports should be submitted thereafter until the bank ceases to exist (i.e. is closed). Reports should list all projects for which tissue has been released in the previous year – including all details documented above. Report templates can be found on the HRA website (

• Communicate with the Research Ethics Committee and other review bodies during the application process and where necessary during the conduct of the research.

• Submit a notice of amendment should any changes be required to the conditions of generic approval

• Notify the Research Ethics Committee as soon as possible of any:
• Serious adverse event or reaction, any serious breach of security or confidentiality, or any other incident that could undermine public confidence in the ethical management of the tissue. The criteria for notifying the Committee will be the same as those for notifying the Human Tissue Authority in the case of research tissue banks in England, Wales and Northern Ireland.
• Change in the contact details for the applicant (Research Tissue Bank Curator) or where the applicant hands over responsibility for communication with the Committee to another person at the establishment
• Plans to close the Bank (at least two months before closure). The Committee should be informed what arrangements are to be made for disposal of the tissue or transfer to another research tissue bank. Where tissue is transferred to another research tissue bank, the ethical approval for the Bank is not transferable. Where the second bank is ethically approved, it should notify the responsible Research Ethics Committee. The terms of its own ethical approval would apply to any tissue it receives.
• Breach of these approval conditions.

For banks storing relevant material under the HTA, the following additional responsibilities also apply: