BioAID (2019-2024)

• Research type

  Research Tissue Bank

• IRAS ID

  259776

• Research summary

  BioResource in Adult Infectious Disease (2019-2024)

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  19/SC/0116

• Date of REC Opinion

  12 Apr 2019

• REC opinion

  Favourable Opinion

• Data collection arrangements

  The Bioresource for Adult Infectious Diseases (BioAID) is a collaborative project between multiple NHS Hospitals in partnership with closely affiliated UK Universities. BioAID aims to collect biological samples and clinical information from 10,000 episodes in which patients present to hospital with a suspected infectious disease. Participants will be asked to give consent to have their samples and clinical information collected within BioAID. The samples will be used to obtain RNA and serum from blood samples at various time points during the illness. In addition, the samples will be used to obtain the participants genetic code and the germ causing the illness where possible. The samples and clinical information collected within BioAID will be held within the participating sites. Access to these collections will be provided to research investigators under the terms of material and data sharing agreements. Identifiable patient information will not be disclosed.

• Research programme

  Infectious diseases in adults remains an important burden for health care in the UK. Further research is needed in order to improve the diagnosis of these diseases, and improve our understanding of the factors which are responsible for severe disease and failure to respond to current treatments. We aim to establish a registry of 10,000 episodes in unselected adult infectious diseases across major biomedical research centres within the NHS, linking information about each patient’s illness with samples that can be used to investigate the patient’s genetic (DNA) profile, their response to infection and the microbial organism. This will provide an invaluable bioresource to evaluate new strategies for diagnosis of infectious diseases and predicting the outcome of specific diseases in individual patients. We will also establish the framework for research sampling and data collection to complement existing studies in infectious diseases, and inform the design of new studies as well as provision of NHS services for infectious diseases.[COVID-19 amendment – 09/04/2020] In the present protocol we specify inclusion of participants presenting to the Emergency Department. In view of changes to patient triage/flow, we seek to amend this wording to the following: “Routine blood culture sampling in adult patients (>16 years of age) presenting to the hospital Emergency services will be used to identify potential participants.”. This will enable to recruit from additional entry pints into the hospital. Initial research sampling occurs using deferred consent. We already have approval to invite potential participants by in person, by telephone and by email. We also have permission to obtain next of kin telephone assent for inclusion of samples from deceased individuals. In the present amendment we request permission to obtain telephone consent from any individuals who are discharged from hospital before they are able to provide consent in person. We have amended the study protocol accordingly and provided an additional participant telephone declaration form.In the present protocol, we aim to obtain consent within 7 days of presentation to hospital. In this amendment, we seek to extend this time window to 10 days reflecting time pressures. In order to extend the value of the current blood samples, we seek an amendment to add collection of peripheral blood mononuclear cells at a single time point after obtaining consent. This is critical to allow more in depth cellular immunology that is not possible with the current sample set. Importantly, in the amended protocol we acknowledge that cellular material subject to the conditions of the Human Tissue Act will only be retained during the time period for which the tissue bank has ethical approval. On expiry of the ethical approval, all cellular samples will be destroyed.

• Storage license

  N/A

• RTBTitle

  BioResource in Adult Infectious Disease (2019-2024)

• Establishment organisation

  University College London

• Establishment organisation address

  Gower Street

  London

  WC1E 6BT