This term is primarily used in relation to HTA Licence 12217. Collection responsible officers (CROs) assist principal investigators (PIs) in the day-to-day governance and curation of samples. They are named staff members who serve as liaison between the DI of HTA Licence 12217/Human Tissue Governance team and the PIs and to whom responsibilities will be frequently delegated to perform actions related to HTA compliance and/or compliance with the terms of registration under the licence. PIs may act as CROs if necessary.
An existing holding is defined as relevant material from a human body (whether living or dead) held before the day on which the Human Tissue Act commenced (1 September 2006) for use for a scheduled purpose. Such holdings are exempt from the consent requirements of the Human Tissue Act. However, researchers are still bound by the terms of any consent which was obtained from donors before this date, under common law. Existing holdings are subject to licensing requirements and HTA standards related to traceability, governance and quality and premises, facilities and equipment.
The largest HTA research licences held by the University of Oxford. This licence covers a wide range of premises primarily used by staff in the Medical Sciences Division. The premises covered by licence 12217 include all buildings at the John Radcliffe Hospital, all buildings at the Nuffield Orthopaedic Centre, all buildings at the Churchill Hospital, all buildings at the Old Road Campus (excluding the Oxford BioEscalator), the Pharmacology building on Mansfield Road, and the Peter Medawar building on South Parks Road.
Details of the scope, purpose and governance of the licence can be found in the licence constitution (HTA008).
Persons designated (PDs) assist the DI in carrying out the legal duty of complying with the conditions of the licence and the Human Tissue Act. Persons designated direct others in relation to the Human Tissue Act, assist in developing and implementing procedures to provide the DI with assurance of compliance. For example a person designated offers advice and guidance to those working in their department about how and why they need to follow procedures and systems agreed by the DI to comply with the Human Tissue Act.
For the purpose of the licence, a person is considered as working under licence 12217 if any aspect of their work comprises collecting, using or storing samples which are registered under the licence. This would include PIs, technicians, research nurses, project managers and administrative staff, those working with data and/or samples from collections registered under the licence. Persons working on licensed premises, but whose samples are used/stored under a licensing exemption are not considered as working under the licence, nor are persons working under another HTA licence. For further information see the HTA licence policy (HTA007).
Under the HTA standards ethical approval which qualifies for exemptions under the act can only be given by a recognised REC, which is either:
a REC recognised or established by, or on behalf of, the HRA under the Care Act 2014 or any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by, or on behalf of, the Welsh Ministers or the Department of Health in Northern Ireland; or
an ethics committee recognised by United Kingdom Ethics Committee Authority to review clinical trials or investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.
University research ethics committees and overseas ethics committees are not considered as recognised RECs under the act.
Relevant material under the Human Tissue Act (2004) is defined as ‘material, other than gametes, which consists of or includes human cells’. Note that this does generally include cell deposits and tissue sections on slides, but not lysed cells, or samples which have been processed to remove cellular components. Cell cultures comprised of cells which have divided outside the human body are not considered relevant material. Please refer to the Human Tissue Authority (HTA) website for the full list of relevant material and exemptions.
The Human Tissue Act defines the purposes requiring consent as scheduled purposes. Research is a scheduled purpose under the Human Tissue Act. In addition, for samples collected from deceased donors, scheduled purposes include: clinical audit, education and training relating to human health, performance assessment and quality assurance. Samples stored for a scheduled purpose must be stored under the governance of an HTA licence unless an exemption applies, such as current and valid ethical approval from a research ethics committee recognised by the HTA.