Manchester Allergy, Respiratory & Thoracic Surgery Biobank

• Research type

  Research Tissue Bank

• IRAS ID

  180280

• Research summary

  Manchester Allergy, Respiratory and Thoracic Surgery (ManARTS) Biobank

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  15/NW/0409

• Date of REC Opinion

  14 Aug 2015

• REC opinion

  Further Information Favourable Opinion

• Data collection arrangements

  ManARTS will be housed within the North West Lung Research Centre at the University Hospital of South Manchester NHS Foundation Trust (UHSM). Storage of samples may also occur within at other locations of UHSM or external locations (University of Manchester, Manchester Cancer Research Centre and Royal Manchester Children’s Hospital), but will remain under the custodianship of the Biobank steering committee until released.\nThe aim of the tissue bank is to collect biological samples and data from patients (adults and children) with respiratory and allergic diseases and other related conditions, from patients undergoing thoracic surgery and from healthy (adult) volunteers. Full informed consent/parental consent will be taken before any samples are collected.\nSamples collected may include blood and/or saliva, sputum, urine, exhaled breath, endobronchial biopsy, bronchoalveolar lavage samples (BAL) and bronchial brushings, gastroscopy biopsy samples, surgical lung samples and nasal brushing samples. Not all samples will be collected from every participant. Samples may be collected over a series of visits or timepoints.\nClinical data will be collected, predominantly from patients’ medical records for the interpretation of laboratory sample analysis. Any data released to researchers will be anonymised. Data will be stored on a secure server in a password protected database.\n

• Research programme

  The primary objective of ManARTS Biobank is to facilitate research of the highest quality into lung and allergic diseases to benefit patients by clinicians and researchers. ManARTS Biobank will also accept applications for access to tissue and data from non-contributory members, such as researchers from other hospitals, universities and commercial organisations. [COVID-19 amendment – 31/03/2020] The protocol has been updated to clarify the process we will need to follow (for infection prevention reasons) for patients recruited with COVID-19 who have capacity. This is because the PIS/consent form will have to stay in the room due to potential contamination with virus.\nIn such circumstances, the person taking consent (consenter) and a second health care professional (witness) will approach the patient. The consenter will confirm eligibility and receive verbal consent from the patient. Following this (and outside of the clinical area), the consenter and witness will agree that the patient fully understood what was said to them and that informed consent had been given. The consenter and witness will document this in the notes\nand sign and date.\nThis is a change to the information provided in question 46 on the original application form.\nA copy of the current approved version of the adult Patient Information Sheet and Consent form (3 dated 02 Oct 2019) will be provided along with the amendment submission documents for information. This has been not been updated as it will still be provided to the subjects with capacity.\n\n[COVID-19 amendment – 18/05/2020]\n\nAt the request of investigators, the following key changes have been made:\n• To include collecting samples from hospitalised patients when they have follow up appointments after discharge from hospital in order to investigate recovery.\n• To include the collection of swab samples\n• To ask for permission for surplus clinical samples (including blood, sputum, BAL and swabs) to be used for the Biobank\n• Where clinical follow up is based around telephone consultations (usually for infection control reasons) or consent is only required to access data or samples already collected for clinical reasons and/or for the collection of quality of life questionnaire data, we request permission for telephone consent or postal consent to be obtained. New postal and telephone Participant Information sheets and consent forms have been submitted.\n• A new Participant Information sheet and consent form for use for adults with capacity who have an acute respiratory\ninfection has been submitted for use (to be used instead of our standard adult core consent form).\n• Clarification has also been added that repeated (longitudinal) blood (and/or saliva) sampling may be done for hospitalised patients as well as outpatients\n• The Covering statement and consultee declaration form and Participant Information Sheet and consent form for Participants with recovered capacity have been updated to reflect the above protocol changes.\n\nThis is a change to Questions 8, 44 and 46 on the original application form.\n

• Storage license

  12149

• RTBTitle

  Manchester Allergy, Respiratory and Thoracic Surgery (ManARTS) Biobank

• Establishment organisation

  Manchester University NHS Foundation Trust

• Establishment organisation address

  Trust Headquarters, Cobbett House, Manchester Royal Infirmary

  Oxford Road

  Manchester

  M13 9WL