► What are the possible benefits?
There is no immediate benefit for you as an individual taking part in this study. We hope that by studying people with your condition using these investigations, we may be able to improve understanding of this condition and help to inform management of future patients.
► What happens when the research study stops?
Your participation in the study would end. Copies of any publications connected to this study are available on request from the OXAMI investigators.
► What if relevant new information becomes available?
Sometimes we (the study investigators) get new information about the procedures being studied. If this happens, we will discuss with you whether you should continue in the study. If there is sufficient evidence to suggest you may be harmed by participating in this study, the study could be stopped.
► Unexpected findings during the study
In the event of any unexpected findings that come to light as part of the research procedures in this study, a designated clinical specialist will discuss the implications with you and may arrange for further investigations as necessary. However, it is important to note that this research is not for diagnostic purposes, and is not a substitute for a clinical appointment. If we find anything unusual, we will discuss with you and ask your permission to contact your GP so that they can arrange on-going clinical care for you.
► What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time. With your permission, we will make use of the information we already have about you. If your samples and information are used for future research this will be done entirely anonymously. Alternatively, we can destroy any identifiable samples or information we hold about you. Even if you are not able to take part in every aspect of the study, the information we collected from you will still be extremely useful to the overall scientific value of the study.
► What if something goes wrong or I have a complaint?
If you wish to comment about any aspect of the way in which you have been approached or treated during the course of this study, please contact Prof Keith Channon (Tel: 01865 572783) or the University of Oxford Clinical Trials and Research Governance (CTRG) office (Tel: 01865 572221 or email firstname.lastname@example.org). The University has arrangements in place to provide for harm arising from participation in the study for which the University is the Research Sponsor. NHS indemnity operates in respect of the clinical treatment with which you are provided.
► Will my taking part in the study be kept confidential?
If you take part in the study, this will be indicated on your hospital medical records. We will also send a letter to your GP, with a copy of this patient information sheet, to inform them that you have agreed to participate in this study. Some parts of your medical records and the data collected from the study will be looked at by authorised persons from the University of Oxford, to check that the study is being carried out correctly. They may also be looked at by authorised persons from the NHS Trust. All investigators have a duty of confidentiality to you as a research participant and nothing that could reveal your identity will be disclosed outside the research site. The data collected from the study will be recorded anonymously and you will not be identifiable from this. We also ask for your permission to allow the researchers access of your medical records during the study period so that we can look up the necessary medical information.
► Participation in future research
We will ask if we can contact you about future studies. This is optional i.e. you can take part in this study but decline to be contacted again. If you consent, we will keep your contact details separately from research data you have provided. Both your details and data will carry the same unique ID. This means your data is anonymised but that we can “link” details to data. In this way we can approach patients about studies relevant to their particular healthcare status. You can withdraw your consent for future contact at any time.
► What will happen to any samples I give?
All samples will be retained in a secure environment for future analysis and they will be stored in an anonymous format at sample storage facilities used by the University of Oxford. Samples collected during this study may be sent to other centres, including those outside the UK, for specific analysis according to the availability of specialist techniques. We will also ask for your consent for the samples will be stored for 5 years after the end of the study period, to be used in future research as our understanding of heart function grows. We may also seek approval from a recognised ethics committee for use of the samples in future research. This future research may include genetic research (see below). Samples will be destroyed by the research team after the end of ethical approval.
► Will any genetic tests be done?
It is possible that some samples will be used for genetic research. This research may be conducted by the study research team or collaborating research teams. The samples will be stored anonymously but a record of who donated the samples will be kept so that we can relate any findings to your medical history. Keeping these records ensures that if you decide to withdraw your consent, we will be able to destroy your samples. Genetic tests involve looking at common variations in genes that affect how blood vessels work. We will not test for inherited genetic diseases, or for conditions that will involve any other members of your family. There is no evidence to suggest that the results of these genetic studies are likely to have significant implications for you personally.
► What will happen to the results of the research study?
We anticipate that the results will be published in a scientific journal for the benefit of the wider medical community. Social media (e.g. twitter) and this study website may also be used to inform participants about the study and its progress. However, individual patients will not be identified and your personal and clinical details will remain strictly confidential. Any scientific publications arising from the study will be available on request to all participants. You would have no legal right to a share of any profits that may arise from the research.
► Who is organising and funding the research?
The investigators are Prof Keith Channon, Prof Adrian Banning, Prof Robin Choudhury, Dr Raj Kharbanda, Dr Andrew Lucking, Dr Jeremy Langrish and Dr Vanessa Ferreira. If you wish to know more about any aspect of the study, please contact us. The research is funded by NIHR Biomedical Research Centre, Oxford.
► Who has reviewed the study?
The South Central – Oxford C Research Ethics Committee has reviewed and approved the study.
► Where can I find independent information about taking part in research?
You can contact local branches of the NHS Patient Advisory Liaison Service (PALS). Here is their website: http://www.pals.nhs.uk/.