Pathogenesis of Lung Disease II
Research type
Research Study
Full title
An Investigation into the Molecular Pathogenesis of Lung Disease II
IRAS ID
245471
Contact name
Sam Janes
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/06/24, UCL Data Protection Registration
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This ethics application seeks to cover the acquisition of research samples from the respiratory tract of patients, identified by the hospital thoracic department, which are used by laboratory based researchers in Sam Janes’ group at UCL for the purpose of advancing the understanding of airway cell biology in health and disease.\n\nThe airway, from the nose to the alveoli (air sacs where oxygen is taken up by the body) is lined by a sheet of cells termed ‘epithelium’. In addition, the lining of the lung surface is made up of epithelial cells and is termed the ‘parietal and visceral pleura’. These are the cells on which our research is primarily focused.\n\nThrough constant exposure to the environment, the airway can become damaged. Two examples of this include cigarette smoke, which can cause chronic obstructive pulmonary disease (COPD) and lung cancer, and asbestos, which can cause a type of cancer of the lung lining called mesothelioma and lung fibrosis.\n\nOur group is working to understand how the respiratory epithelium functions in normal subjects and the changes that occur with the development of lung disease. We are looking at the way that cells respond to injury and attempt to repair & regenerate. We are also evaluating the ‘field of injury’ effect, which looks at how cells respond to inhaled carcinogens.\n\nOur hope is that through gaining a clearer understanding of how these cells function in health and alter in disease, that we will be able to identify novel biomarkers and therapeutic targets. In this way, we will be able to develop treatment approaches for diseases, such as lung cancer, COPD, asthma and lung and airway fibrosis. COVID 19 amendment 18/05/2020 Our study seeks to understand the pathogenesis of lung disease with the aim of developing detection and treatment strategies using the knowledge we gain. At the current time, COVID-19 poses the greatest burden to our healthcare\nsystem and bears a particular threat to global health as we currently have no vaccination nor approved drug therapy.\nWe therefore seek to amend our protocol to enable us to collect samples from patients with COVID-19 to enable us to participate in the global effort to understand and eradicate this disease. This effort fits within the aims of our study and any knowledge we gain from research into COVID-19 may aid in furthering our understanding of other lung diseases. We therefore seek to amend the type of research samples we are able to take, the number of research samples we are able to take and the type of patients we are able to take research samples from. The additional research sample types we would like to add are minimally invasive or would otherwise be discarded: oropharyngeal brushings, saliva samples and tissue that is removed during the formation of a tracheostomy. In addition, in order for us to investigate the course of the disease, we would like to be able to take serial samples from the same patient (at present we are only able to take one sample). The types of samples we would like to be able to take in a serial manner are oropharyngeal/nasal/buccal brushings, blood, sputum and saliva. In our current protocol we have the option to take these samples from individuals who are attending a hospital appointment (such as a clinic) and who are not otherwise having a procedure. We would like to clarify the wording to recruit patients who have been admitted to hospital.\nIn order for us to take excess tissue from tracheostomy formation or airway samples via upper airway intervention procedures (the latter we have existing ethical approval for) from patients with COVID-19 who are intubated and lack the capacity to consent, we need to consider how we could best understand their wishes. In these instances, we would firstly consult with a family member/friend or, if that were not possible, from a member of their clinical team, unrelated to the research. We would provide them with a consultee PIS and, if willing, ask them to sign a consultee consent form. We would then make all reasonable efforts to obtain informed consent from the patient themselves should they regain consciousness, allowing them the option to withdraw from the study as they wish. Based on how the pandemic unfolds and the need for ongoing research efforts, we understand that if we wish to continue collecting samples from patients who lack the capacity to consent after September 2020, we would seek approval from the Confidentiality Advisory Group.\nFinally, we have made a couple of minor amendments to our patient information sheets and consent forms to clarify the nature of potential collaborations in which we may want to use these samples, to now clearly include academic as well as commercial collaborations, as this was somewhat ambiguous. In light of GDPR legislation, we have also taken this opportunity to add language to our patient documents to clarify the use and processing of data and to correct some errors.\n
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0514
Date of REC Opinion
5 Dec 2018
REC opinion
Further Information Favourable Opinion