Clinical Trails - Frequently Asked Questions
What is research and how does it affect me?
You may already have been invited by your nurse or doctor to become involved in research. Research is the manner
in which groups of specially trained individuals and clinicians work out what are the best treatments and support
for patients. In order to do this national and international projects are set up called ‘clinical trials’ or
‘audit’. Without patient involvement the information your doctor and nurse have to treat patients will not develop
or improve. The ways in which the research is done can vary but there are certain rules which your doctor or nurse
need to follow in order to involve you.
Do I have to agree to take part?
You are a key member of the health care team and it is completely up to you whether you want to be involved in
research or trials. You have a right to say no or withdraw at any time without your ongoing care or treatment
being affected.
In order to enter you or your details into a research project your doctor or nurse must first gain your consent.
Before agreeing to participate in any research your doctor or nurse should tell you enough information for you to
feel able to decide whether to take part or not. Sometimes it is difficult to know what questions to ask to gain
this information, particularly if you feel anxious. To help you the Department of Health has outlined some examples
of questions which might help you get a better idea of what is being suggested by your health team.
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What are the main treatment options?
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What are the benefits of each of the options?
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What are the risks, if any, of each option?
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What is the success rate for different options - nationally, for this unit or for you (the health team)?
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Why do you think an operation (if suggested) is necessary?
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What are the risks if I decide to do nothing for the time being?
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How can I expect to feel after the procedure?
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When am I likely to be able to get back to work?
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Will I need long- term care?
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Will my mobility be affected?
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Will I still be able to drive?
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Will it affect the kind of work I do?
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Will it affect my personal/ sexual relationships?
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Will I be able to take part in my favourite sport / exercises?
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Will I be able to follow my usual diet?
You might find it helpful to write down the questions before you meet with your health care team to make sure you
get the chance to cover all the topics which are important to you.
If you would like more information on consent follow this link:
Department of Health Policy & Guidance.
If I take part in a study will my personal information be kept confidential?
Another important rule which the health team should follow is to uphold your confidentiality. To trust another
person with private and personal information is a significant matter and the health care team is expected to
exercise good judgment as to what information about you can be, or should be disclosed. As a member of this team
you have a right to know how all information about you will be used. All of the information collected about you
during a trial will be kept strictly confidential. However, each trial uses the information it collects in a
slightly different way and your doctor or nurse should give you details about how your personal and clinical
information will be used in the particular trial you’re consenting to.
What if something goes wrong?
Research and clinical trials are carefully monitored. However, in the unlikely event that something goes wrong with
your care the normal routes of complaint should be followed. If at any time you feel at all concerned about the
progress of your care you should speak to your doctor or nurse. Remember you can withdraw from a trial at any
point during the trial without this affecting your ongoing treatment and care.
Who pays for research and trials?
There are lots of different ways of funding and organising research and trials and all of the organising bodies
have many years experience. There is usually a British University supervising the running of the trial and your
health team should be able to tell you who this is. No-one involved in your health care team receives any payment
of any kind for asking you to be part of any study.
What happens to the results of research?
Once any trial is complete the results need to be spread as widely as possible so that other professionals can
see the results and use the information in the care of other patients with medical problems similar to your own.
This is usually achieved through publishing the results in a medical journal or report. The published results don’t
include any information which could identify anybody or any individual’s personal details. If you would like to
read any report coming from a trial you are involved in you can ask your doctor or nurse for a copy.