The Licence is held by the University and the licence holder’s representative is a named individual in a senior managerial role who should be senior to the Designated Individual (DI) and able to substitute for the DI where necessary. Although the role of the Licence Holder does not impose duties that are expected of the DI, the Licence Holder has the right to apply to the HTA to vary the licence, which may include recommending a new DI where, for example, the DI is unable to continue their role.
For further information on the role of the Licence Holder, see:
DIs and Licence Holders under the Human Tissue Act
The Licence Holder will meet regularly with the DI to monitor the operation and compliance with the licence, will have a named nominee as a member of the Human Samples Steering Group (HSSG) and receive the minutes and reports from the Group.
Licence Holder’s Representative: University Registrar
The DI must:
be in a position within the licensed organisation to ensure that the activities are conducted properly by individuals who are suitable (and appropriately trained) to carry out those activities and that all necessary legislative and regulatory requirements are complied with;
have time to carry out the role of DI in addition to their substantive role;
ensure compliance with licence conditions;
demonstrate managerial capability, ensuring quality and supervisory responsibility to effect change;
have links to senior management/board level;
know when to seek specialist advice to perform his/her role.
In addition, the DI will:
- act as a key point of contact for enquiries to the HTA;
- be responsible for investigating and reporting adverse events (including to the HTA, as appropriate);
- act as Chair to the Human Samples Steering Group (HSSG);
- meet regularly with the Licence Holder’s Representative to provide briefings and updates as part of the monitoring of the operation and compliance with the licence;
- be informed of and authorise, as appropriate, all research and related activities in the University using human tissue, in accordance with the Standard Operating Procedures (SOPs).
For further information on the role of the DI, see:
DIs and Licence Holders under the Human Tissue Act
|Designated Individual:||John Davey, Professor of Biomedical Cell Biology, Warwick Medical School|
Deputy Designated Individual (Deputy DI)
An inidividual can be nominated by the DI to act as a Deputy DI, to support the DI and ensure that there is continuity of support for researchers, specifically at times when the DI may be unavailable, for eaxmple, on leave or during other short periods of absence. The Deputy DI will be a member of academic staff and have knowledge and understanding of the HT Act, the relevant HTA's Codes of Practice and compliance with licence conditions.
The Deputy DI will not automatically replace the DI should the DI no longer be able to continue the role, as a formal application to undertake the role of DI must be made by the licence Holder's Representative to the HTA for HTA Approval.
Person Designated (PD)
Individuals can be nominated as Person Designated (PD) by the DI to work under the direction of the licence in support of the DI. PDs do not have the legal duties of the DI as set out in the HT Act (Section 18) but the role of the PD carries with it the ability to “direct” others in relation to the HT Act, e.g. to assist in developing and implementing the SOPs and offering advice and guidance to those working with human samples at a satellite site. This means other individuals working under the direction of the PD are advised about how and why they need to follow procedures and systems agreed by the DI to comply with the HT Act.
The PDs will be senior technical staff at each site, appropriately qualified to ensure that laboratory practice in relation to research using human smaples is adopted
PDs and the DI together play an important role in the monitoring of activity and the effectiveness of the SOPs in the working environment, to give the University and external agencies, including the HTA, assurance of compliance with the licensing obligations under the HT Act and HTA standards. Ongoing dialogue, active engagement with and feedback from the researchers, technical and support staff and students, is vital to underpin the ongoing development and successful implementation of the QMS.
Person Designated: Cathy Parry, Technical Support Manager, Warwick Medical School
Person Designated: Rebecca Allen, Technical Assurance Manager, School of Life Sciences
Principle Investigator or Person Responsible
Principle Investigators drive the research activity and have overall responsibility for their research projects – the governance and management of the research and their team, including responsibility for the use of human samples. This may be delegated to a named, suitably trained colleague (Person Responsible) who will be the custodian of those samples.
The Principle Investigator or Person Responsible will be responsible for conducting research using human samples in accordance with the SOPs and related HTA standards and Codes of Practice, and must maintain and make available for internal monitoring and audit by the DI and others, in addition to external audit and inspection requirements, all appropriate and required records and documentation.
All researchers, and those working in research, using human samples must:
- register as an individual working with human samples;
- undertake the appropriate training;
- receive and maintain awareness of training support materials;
- have access to advice and guidance;
- understand and adhere to the University’s Quality Management System;
- comply with the requirements of the related policies and Standard Operating Procedures (SOPs);
- maintain a Personal Training Portfolio (PTP) to record related training and development activities undertaken.
The University maintains a register of all researchers working with human samples. Registration requires the researcher to undertake training appropriate to their immediate research needs and to maintain a training programme that demonstrates they are competent to perform duties appropriate to their role in each research project. The responsibility for ensuring the accuracy and completeness of ongoing personal development rests with the individual researcher.
Completion of the registration process is achieved when a Declaration of Registration is completed by the researcher and authorised by the Designated Individual.
All staff and students involved in research using human samples will be required to renew their registration every 4 years.
For more information on registration for all staff and students undertaking research using human samples, see: Registration and Training.
It is important for the continuation of research, the reputation of its researchers and that of the University more broadly, that the University adheres to its HTA licence and adopts best practice, including robust and effective quality management, to its activities involving human tissue. If any staff or students knowingly breach the Human Tissue Act, 2004, the provisions of the HTA licence, the HTA Directions or Codes of Practice, or the University’s related policies and Standard Operating Procedures, detailed in the Quality Manual, they may be subject to the University’s Code of Practice for the Investigation of Research Misconduct and to the University’s Disciplinary Regulations for staff and students.
Governance and Management Structure
Please see page 11 of the Quality Manual.