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Frequently Asked Questions (FAQs)

Is it safe to be involved in research?

Some studies involve no inventions so there is minimal or no risk from partcipating. If you are involved in a clinical trial you may be helping to investigate new treatments and/or medicines. When this kind of study is set up there is a rigorous process to minimize risks to participants as far as possible. All Trust research staff anre trained in and adhere to the principles of Good Medical Practice, which is an internationally agreed set of principles that safeguard the wellbeing of patients in clinical trials and the scientific integrity of the data collected.

Whilst involved in any kind of clinical research the doctors and nurses running the study will keep a very close eye on you. Therefore if there are any problems these will be picked up on very quickly. However, as with all treatments there can be some expected side effects that your doctor will be able to warn you about, and with new treatments there may be some side effects that are unknown. If it becomes apparent that any part of the treatment is at all unsafe or not as effective as current treatments, the doctors running the trial will stop it and make sure you are given the best treatment. Also if you find the side effects of any treatment at all difficult to tolerate you can ask to withdraw from a trial at any point without affecting your future care.

What will it involve?

Depending on what kind of study you volunteer for it can go from filling out a simple questionnaire to testing new drugs and treatments with extra hospital visits and tests.  The clinical staff running the trial will be able to let you know and you will be given time to think about it before committing yourself. You can also withdraw from a trial at any stage without giving a reason or your decision affecting your future care.

Who will have access to my records?

The Trust follows very strict guidelines on data protection and only those people directly involved in your care or those involved in running the study will have access to your records. If the study is being carried out in more than one hospital the results may need to shared between the doctors and staff running the study at the different hospitals or organisations. However, if this happens any details that could potentially identify you (i.e. your name, address, date of birth, hospital or NHS number) are removed to protect your confidentiality.

Will I be told the results of the study?

The doctors and staff running the study will keep you regularly updated on the progress of the study and as soon as they can they will feedback the results. The results will also be presented and published so other patients can access them allowing them to make the right decisions about their care.

If I decide to take part and then change my mind, will this affect my care?

No, absolutely not. You have the right to withdraw from any study at any time without giving reasons and without further care being refused or compromised. If the medication you are taking is part of the trial it may be changed and you may see a different doctor but the Trust will continue to provide you with the best care for your condition.

Will I be paid?

If your study is being run through the NHS there is generally no payment made, although this depends on the particular study. For example, if the study involves extra visits to the hospital there may be provision for refunding travel and other out-of-pocket expenses expenses. Ask the doctors and nurses running the study.

Will I have to decide straight away if I would like to be involved?

No. As part of the consent the research team carrying out the research team carrying out the study will give you information about it and then let you go away and decide whether you want to be involved. At subsequent visits you can ask any questions you have.  If you would then like to be involved you will then be asked to sign a consent form indicating your willingness to participate in the study. 

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