FAQs for patients
- What are the potential benefits of taking part?
- What are the possible disadvantages and risks of taking part?
- Will I get paid?
- What will happen if I don’t want to carry on with the study?
- What if something goes wrong?
- Will my taking part in this study be kept confidential?
- What will happen to the results of the research study?
- Patients may benefit from having a CT scan of the chest, free of charge. If any abnormalities are found, these will be communicated to your general practitioner and followed-up by the National Health Service.
- Patients may benefit from being closely monitored by and having access to a research team experienced in the field of COPD.
- Patients may benefit from having access to stop smoking support through the study if they want it.
- The information we get from this study may help us to treat future patients with prior disease better.
- You may develop slight bruising after we take a blood sample.
- Producing a sputum (Phlegm) sample may cause coughing and sometimes shortness of breath. You will be monitored to ensure your safety and minimal discomfort.
- The lung function tests are not painful but some people find the complete tests strenuous.
- A CT scan involves exposure to x-ray but the amount of radiation is kept to a minimal. You would not have this scan if you did not take part in the study.
- The effective radiation dose from a high resolution CT scan of the chest is estimated at 7 mSv. This is equivalent to about 2.6 years of background radiation (in the UK we receive about 2.7 mSv per year from naturally occurring radiation, called “background” radiation.)
- X-rays can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. Taking part in this study will increase the chances of this happening to you from 50% to 50.03%.
- If we find a condition of which you were unaware of, this will be explained to you and further investigations will be carried out and/or you will be referred to your General Practitioner.
Yes, you will be compensated for your time.
Travel expenses to and from your home/work place and the hospital will be reimbursed. This includes taxi fares, train tickets, parking and fuel costs.
Taking part in this study is voluntary and up to you. You may choose not to take part or you may leave at any time. Choosing not to take part or leaving the study will not result in any penalty. You will not lose any benefits to which you are otherwise entitled. Your decision will not affect your access to medical care in the future. All information you gave to us before you leave the study will still be used for the study unless you request this to also be withdrawn. Upon withdrawal from the study, samples already taken may be analysed as planned – it may be possible for them to be destroyed if you request this at the time of leaving the study.
Imperial College London is the lead centre for the project and holds Public Liability (“negligent harm”) and Clinical Trial (“non-negligent harm”) insurance policies which apply to this study. If you can demonstrate that you experienced harm or injury as a result of your participation in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault. If the injury resulted from any procedure which is not part of the trial, Imperial College will not be required to compensate you in this way. Your legal rights to claim compensation for injury where you can prove negligence are not affected.
If you have any concerns about your lung condition or any possible adverse effects from procedures carried out in the research clinic, please contact one of the research team. If you have a complaint about a person or standard of care you have received you should approach the Principal Investigator at your site. Alternatively, you may approach the Patient Advice and Liaison Service at your local hospital.
All information which is collected about you during the course of the research will be kept strictly confidential. We will send you a report of your lung function at no cost. We may pass on information to your general practitioner necessary for your medical care. Information on your date of birth, gender, name and address may be sent securely to the Health and Social Care Information Centre (HSCIC). In the unlikely event that you die death registration data can be collected by the Office of National Statistics to determine the cause even after you have left the study. With these exceptions, any other information about you which leaves the hospital or the research team will have your name and address removed so that you cannot be recognised from it.
All procedures for handling, processing, storage and destruction of their data are compliant with the Data Protection Act 1998.
The results of this research will be presented at national and international medical conferences and published in peer reviewer scientific and medical journals. Medical abstracts are usually available from the internet at no cost. Medical journals can provide full publications at a cost. You will be able to find publications on the internet, or we will provide you with copies of any appropriate publications. You will not be identifiable in any report or publication as all of the results will be anonymous and present group data.
More information can be found in the Patient Information Sheet COPD (PDF) or by contacting the study team.