The PNH Research Tissue Bank (Renewal 1)

• Research type

  Research Tissue Bank

• IRAS ID

  299416

• Research summary

  The Paroxysmal Nocturnal Haemoglobinuria (PNH) Research Tissue Bank (RTB)

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  21/YH/0156

• Date of REC Opinion

  25 Aug 2021

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  Patients over the age of 16 attending the Department of Haematology in Leeds under the supervision of the National PNH Service may be approached by a member of the clinical team to ask if they would like to participate in the PNH RTB. An information sheet will be provided and the process will be fully explained by a trained member of staff. If a patient provides consent, samples for the RTB will be collected at the same time as routine clinical samples and may include: blood, bone marrow, mouth swabs/saliva and urine. Excess diagnostic tissue may also be incorporated into the RTB. Patients may be asked to contribute further samples when they attend follow up appointments and during routine care.

  Control donors accompanying patients as well as staff/students from the University of Leeds and Leeds Teaching Hospitals NHS Trust will be recruited and invited to provide samples after giving informed written consent.

  Tissue samples will be stored in secure laboratory and dedicated cold storage areas in a University building at St James's Hospital in Leeds. The storage locations are registered with the Human Tissue Authority and are covered by the research licence and its governance framework. Data will be stored on a secure database. Both data and tissue will be stored in a coded format so that they remain anonymous (linked anonymised).

• Research programme

  The primary objective of the PNH RTB is to create a collection of tissue samples and data from patients with PNH and related disorders, in order to support researchers conducting studies into these areas with the aim to improve understanding and treatment of these rare diseases. In order to fully understand the disease process, normal controls are also studied. Access to samples and linked anonymised data will be provided to researchers within Leeds and to external researchers. Applications for material will be reviewed by the PNH RTB Committee, who will determine whether the proposed research has scientific merit, complies with the terms of consent and ethical approval and whether the requested samples are available.

• Storage license

  12352

• RTBTitle

  The Paroxysmal Nocturnal Haemoglobinuria (PNH) Research Tissue Bank (RTB)

• Establishment organisation

  The University of Leeds

• Establishment organisation address

  Leeds Institute of Medical Research

  Wellcome Trust Brenner Building, St James's Hospital

  Beckett Street, Leeds

  LS9 7TF