STH-ObS (renewal 2018)

• Research type

  Research Tissue Bank

• IRAS ID

  248890

• Research summary

  The Sheffield Teaching Hospitals Observational Study of Patients with Pulmonary Hypertension, Cardiovascular and Lung Disease

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  18/YH/0441

• Date of REC Opinion

  17 Dec 2018

• REC opinion

  Favourable Opinion

• Data collection arrangements

  Samples to be stored include blood, urine and tissue.\nParticipants will include patients with pulmonary hypertension and other associated cardiovascular disease, lung disease, or connective tissue disease. In addition we will collect samples from healthy volunteers to acts as “controls“ to make comparisons.\nSamples will be collected from participants who have given their informed consent, and this will take place at Sheffield Teaching Hospitals NHS Foundation Trust, primarily in the Sheffield Pulmonary Vascular Disease Unit, with the support of the Sheffield NIHR clinical Research Facility.\nSamples will be stored in the Sheffield Biorepository facility which has a Human Tissue Authority License.

• Research programme

  STH-ObS is a study that has been established within Sheffield Teaching Hospitals since 2008. A central element of the study is a Biobank (a place where samples can be safely and securely stored long-term) of samples from patients with pulmonary hypertension, lung disease, cardiovascular disease and connective tissue disease, and a database to store clinical information collected from those patients. We also collect samples from healthy volunteers for comparison. The aim is to increase understanding of the causes of these conditions, how they cause symptoms and illness, and help us to develop new ways to diagnose, treat, and prevent diseases.\nThe samples and data are used in research primarily by the STH and University of Sheffield research team (Donald Heath Pulmonary Hypertension Research Programme) but also by collaborators and other investigators around the UK and internationally. COVID 19 amendment 14/05/2020 This amendment encompasses a number of changes. Mostly clarifications and additional relating to the recruitment\nof participants with proven or suspected COVID-19. A number of questionnaires have also been added and a slip with additional information for patients who receive equipment for home activity monitoring. An additional PIS has been added for COVID patient, this has some more specific details relating to how their samples may be used and the details of the additional optional tests have been removed to a separate PIS/CF to keep the PIS/CF concise. The main patient and healthy volunteers PISs have been updated in line with the general changes to the protocol.

• Storage license

  12182

• RTBTitle

  The Sheffield Teaching Hospitals Observational Study of Patients with Pulmonary Hypertension, Cardiovascular and Lung Disease

• Establishment organisation

  University of Sheffield

• Establishment organisation address

  New Spring House (Research Services)

  231 Glossop Rd

  Sheffield

  S10 2GW