CAMPATH, Calcineurin inhibitor reduction and Chronic allograft nephropathy trial
PATIENT INFORMATION SHEET
Part 2: Further details for patients who want them
What if relevant new information becomes available?
Sometimes during the course of a research project, new information becomes available about the treatments that are being studied. If this happens, your doctor will tell you about it and discuss whether you want to or should continue in the study. If you decide not to carry on, your doctor will make the necessary arrangements. On receiving new information your doctor might consider it to be in your best interests to stop the study treatments. They will explain the reasons and arrange for your care to continue. If the study is stopped for any other reason, you will be told why and your continuing care will be arranged.
What if I don’t want to carry on with the study?
You are free to withdraw from study treatment at any time. If you wish to withdraw please call Freefone 0800 585323 so we can discuss your concerns with you. There are 4 levels of withdrawal:
- No study treatment: you may wish to stop your study treatment, but be willing to attend study visits. We would advise you to do this in consultation with your doctor so they can arrange other suitable treatment.
- No further contact: you would no longer attend study visits and we would not contact you directly. We would still have your permission to retain and use information provided previously, and to obtain and use further information from your health records.
- No further access: we would not contact you or obtain further information from your health records in the future. We would still have your permission to use the information provided previously.
- No further use: in addition to the above, any information collected previously would no longer be available to researchers.
What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak with the researchers who will do their best to answer your questions (at your local transplant centre or on the 24 hour Freefone service 0800 585323). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from your hospital.
The University of Oxford provides insurance cover in the unlikely event that something goes wrong and you are harmed during the research study. In addition, you retain the same rights of care as any other patient treated in the National Health Service.
Will my taking part in this study be kept confidential?
All information collected about you during the study will not be passed on to anyone else unless it is required for the purposes of the study. The coordinating centre will seek information from your doctors and from NHS and other central registries about any serious illnesses that may occur. This requires your name, date of birth and NHS number. All information received will be used, in confidence, only for medical research purposes and for routine regulatory and audit purposes. Authorised individuals from regulatory agencies, the University of Oxford and NHS bodies may look at the study information to ensure that the study is being carried out correctly but they will be bound by rules of confidentiality.
Involvement of your General Practitioner (GP)
Your GP will be notified of your participation in the trial. You should make other medical practitioners not involved in the research but who may be treating you aware of your participation in this trial.
What will happen to any samples I give?
Blood samples will be taken as part of your routine clinical care following a transplant. The relevant results will be noted for trial purposes. No specific samples are taken for the study alone.
Will any genetic tests be done?
No.
What will happen to the results of the research study?
It is intended to publish the results of the research study in an appropriate medical journal. No patient will be individually identified in any report or publication.
Who is organising and funding the research?
The 3C Study has been designed, and is coordinated, by the University of Oxford. It involves the collaboration of many doctors and nurses around the UK. Some of the funding for the research has been provided by two pharmaceutical companies: Wyeth and Novartis. The study is conducted independently of the pharmaceutical companies who have no influence in its day-to-day running or the analysis and publication of the results.
Who has reviewed the study?
This study was given a favourable ethical opinion for conduct in the NHS by the Nottingham 2 Research Ethics Committee.
