A lot
of care is taken to ensure that clinical trials are as safe as
possible. Click on the links below to jump to a topic:
All trials conducted at the MRC Clinical Trials Unit are
scientifically reviewed before the trial is agreed. The plan
for the trial (called the protocol) is sent to a number of
independent scientists for comment. The protocol may also be
sent to patients, to ask for their comments. Both patients
and researchers must be independent of the trial.
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If a trial is taking place anywhere in the NHS (for example at a
hospital or GP surgery, or in the community through a district
nurse), it must be approved by an ethics committee. This
committee includes members of the public, researchers and health
care professionals. A trial cannot go ahead if an ethics
committee has not approved it, and the protocol for a trial cannot
be changed without the approval of the ethics committee.
Researchers must tell the ethics committee if people experience
unexpected and serious side effects during the trial.
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Most trials have a Data Monitoring Committee that looks at how
the trial is progressing. The people on the Data Monitoring
Committee must be independent of the trial. An independent
group of people like this are able to look at the interim results
of a trial and decide if a clear result has been reached.
They can also ensure that the trial is safe. If the Data
Monitoring Committee thinks that a trial should not continue,
perhaps because people are experiencing serious side effects that were not
expected, this Committee can recommend that a trial is stopped.
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There are guidelines to ensure that trials in
the UK are run properly. European Law agreed in 2004 means
that all organisations that run trials must ensure there are
arrangements in place in case people are harmed during a trial of a
drug. This might be through insurance or, in trials funded by
the Medical Research Council or the Department of Health, by
ensuring that public funds would be available if things go wrong.
More information on Good Clinical Practice (GCP) from the
Department of Health is available here.
The
Research Governance Framework developed by the Department of
Health sets out standards of good practice in the conduct of health
research.
Ethics committees check these arrangements are
in place when they make decisions about whether to agree that a
trial can go ahead in the NHS - whoever is running the trial.
If you agree to join a trial and you're not
happy about the way it is going, you can leave the trial at any
point without having to give a reason and without it affecting your
health care.
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Before you join a trial, the researcher must explain the trial
to you and get your agreement to take part. The researcher
must explain:
- The aim of the trial – why is it taking place?
- The treatments that are being compared
- The number of times you will be asked to attend a clinic (for
example to have extra blood tests)
- Possible benefits and risks involved
You should receive a patient information sheet
explaining all of these things.
You will usually be asked to sign a form giving your informed
consent to take part in a trial. Informed consent means that
you have been given the important facts about a trial, you
understand them and that you have decided to take part in the trial
of your own free will.
For children, a parent or guardian has to give consent for them
to take part in a trial. Older children should also
understand and agree themselves.
You can change your mind after you have signed the informed
consent form. You can withdraw from a trial at any
stage. Whether or not you decide to join a trial, or if you
decide to leave a trial, you have the right to receive the same
medical treatment that any other person receives.
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If you agree to take part in a trial, the people who will be
told you are part of a trial are:
- With your permission, your GP, as she or he is responsible for
your health care on a day–to–day basis
- Your doctor and the team looking after you – the fact that you
are taking part in a trial will be written in your medical
notes
Researchers cannot tell anyone that you are taking part in a
trial unless you give your permission.
In a trial, all of your medical records will be confidential, as
with any other medical records.
Your name will not be used in any reports
about the trial. Information about you will be held by CTU
researchers, who are required to keep this information
confidential, in the same way that hospital staff are. This
information is kept securely, and only a very limited number of
people have access to it.
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Last Update Date : 7/6/2009
