Human Tissue Act sample biobank during the COVID-19 pandemic

• Research type

  Research Tissue Bank

• IRAS ID

  287469

• Research summary

  Human Tissue Act sample COVID-19 biobank

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  21/EE/0003

• Date of REC Opinion

  5 Feb 2021

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  Clinical samples from deceased persons are sent by clinicians to PHE’s Virus Reference Department (VRD) for diagnostic SARS-CoV-2 testing for establishing causality of death. Upper respiratory tract swabs are also planned for collection through a national PHE post-mortem surveillance study.
  All such samples tested for SARS-CoV-2 in the VRD will be included in the biobank. A combination of samples already existing (from the start of the UK COVID-19 pandemic in January 2020) and those prospectively received will be included. Samples will be retained at -80°C for 10 years. Any further requests for specimen retention must be accompanied by further REC approval.
  Sample types will include: upper respiratory tract samples - swab, aspirate, biopsy, tissue; lower respiratory tract samples - swab, aspirate, biopsy, tissue; blood, serum, cerebrospinal fluid, faeces, placenta, urine, organ tissue, other tissue, other fluid, other swabs.
  The biobank will consist of specimens received for SARS-CoV-2 testing from people who have died, and for which explicit consent to store and retain samples is not available. This is because the samples were originally taken for diagnostic purposes or for surveillance, where consent would not normally be required.
  Clinical and demographic information is provided by the clinician on the sample request form. This is routinely inputted and stored in PHE’s Laboratory Management Information System (Molis), and linked to the relevant specimen. All such information will be retained in the biobank. This will include patient identifiable information including name, date of birth, age, address, postcode, NHS number, gender, ethnicity, and may include clinical information including date of death, presenting symptoms, date of illness onset, details of recent travel. Patient identifiable information will be required to link to other datasets such as PHE SGSS (Second Generation Surveillance System).

• Research programme

  This application is for the establishment of a PHE national biobank of samples submitted from deceased persons who were tested for SARS-CoV-2infection. The SARS-CoV-2 pandemic is the most significant global public health crisis in a century. Samples collected during this period represent a unique biological resource, which may underpin strategies to mitigate future epidemics both of SARS-CoV-2 and other severe respiratory infections. The primary purpose of the biobank is to create a national repository for publicly funded surveillance work on respiratory infections, which underpins intervention and vaccine strategies. The Hine Report (2010) (an independent review of the UK response to the 2009 swine flu pandemic) commented on inadequacies in UK surveillance of severe acute respiratory infection (SARI) and there is a need to address this for current and future infectious disease pandemics. Establishing a national biobank during the COVID-19 pandemic in a centre of expertise in surveillance of respiratory infections will enable virological surveillance and research that is of value for understanding the epidemiology and natural history of SARS-CoV-2 infection or other respiratory viral pandemics. The samples will also be used for development, verification, validation and on-going quality assurance of SARS-CoV-2 diagnostic tests including PCR-based or serological assays and virus isolation work. Examples of possible developmental work which biobanked samples may support include culture of SARS-CoV-2 RNA positive tissue to confirm or exclude infectivity, or development of assays for the detection of SARS-CoV-2 antibodies in non-venous compartments.

• Storage license

  12549

• RTBTitle

  Human Tissue Act sample COVID-19 biobank

• Establishment organisation

  Public Health England

• Establishment organisation address

  61 Colindale Avenue

  London

  NW9 5EQ