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STEP BY STEP FAQ's
VOLUNTEER FEEDBACK
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Who
Is Chiltern (Early Phase)?
What Does The
Company Do?
Why Do We Do
It?
How Do We Do
It?
What Kind Of
People Become Volunteers?
What Is Involved
At The Screening Medical Check?
I've Heard Lots
Of Scary Stories About Medical Research,
How Do I Know It's Safe To Volunteer?
What Type Of
Studies Are There?
What If I Change
My Mind?
Do I Make A
Lot Of Money Doing Studies?
If I Like It
Can I Do More?
What Is There
To Do?
Can I Have
A Look Around The Unit Before Deciding?
Can I Volunteer
Without Anybody Knowing About it?
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 Who
Is Chiltern (Early Phase)?
Chiltern (Early Phase), formerly DDS, is a Contract
Research Organisation (CRO), a company which
undertakes research for pharmaceutical companies
into new medicines or new versions of existing
medicines. Based in Ninewells Hospital, Dundee,
Chiltern (Early Phase) is completely independent of pharmaceutical
companies and the work we carry out subject
to ethical approval and strict government
regulations. This allows us to be entirely
objective in our assessments.
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What
Does The Company Do?
Once a new medicine has been thoroughly tested
and reviewed at pre- clinical and laboratory
stages, it is important to test the medicine
on healthy volunteers. This is to see how
the medicine behaves in the body, before used
for further testing in patients. The research
that Chiltern (Early Phase) conducts is a vital phase of human/drug
interaction, providing essential information
in the development of the medicine. The majority
of information found on drug packaging comes
from this type of research, ie. how much of
the medicine to take, when to take it, what
you can and cannot take it with etc.
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Why
Do We Do It?
At Chiltern (Early Phase), we are committed to improving the
understanding and advancement of medical research
and education. It is essential to thoroughly
check drugs during their development before
ever treating the illness for which they are
intended, in a safe and controlled environment.
This is how we contribute to the safe development
of new medicines, helping to improve the quality
of life of millions of people around the world.
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How
Do We Do It?
By using fully informed, consenting, paid,
healthy volunteers we conduct a variety of
trials. Every study we conduct is different,
although the majority of studies involve administering
a measured amount of the medication being
tested and thoroughly monitoring the volunteers
over an agreed period of time. This may involve
a residential stay, outpatient visit(s), or
a combination of both, plus a final visit
at the end of the trial. The results of this
are then sent on to the pharmaceutical companies
developing the medicine.
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What
Kind Of People Become Volunteers?
People from all walks of life volunteer with
Chiltern (Early Phase). In the initial stages of contact, we
would make a general assessment of your suitability
based on information provided from yourself
and your GP. If suitable, you will become
part of our database of volunteers and are
contacted regarding forthcoming studies and
general volunteering issues. In assessing
whether volunteers are suitable for individual
studies, we rigorously screen volunteers.
This is a process conducted through medical
checks at our unit, prior to each study. Volunteer
safety is our most important consideration,
therefore only people who meet our strict
criteria become eligible to take part in a
trial. Once a volunteer has been assessed
as suitable to take part in studies, their
details are stored securely on our database,
and they are informed of any exciting opportunities
to take part in our studies. Many of our volunteers
enjoy the experience that volunteering at
Chiltern (Early Phase) offers, and repeatedly participate in
our trials.
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What
Is Involved At The Screening Medical Check?
Each study has its own criteria and this will
dictate exactly what happens at the screening
medical. Every screening examination however,
includes the following basic tests: taking
a medical history; physical examination; vital
signs (pulse, blood pressure, temperature,
ECG, full blood count, blood biochemistry,
urinalysis and blood tests for HIV, hepatitis
B and C). In the unlikely event of a positive
result being discovered, for any condition
the volunteer may not have been aware of,
they will be counselled by a Chiltern (Early Phase) physician.
Further, with the consent of the volunteer,
they will be referred back to their own GP
and possibly will not be eligible to take
part in any future studies. All data is treated
as highly confidential and protected by the
data protection act.
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I've
Heard Lots Of Scary Stories About Medical
Research, How Do I Know It's Safe To Volunteer?
No study is undertaken without the consent
of an Ethics Committee, usually the ÎTayside
Committee on Medical Research Ethicsâ. This
is a committee of people from varied professions,
including medicine, along with representatives
of the public. The committee reviews all information
for the proposed study, to ensure that previous
research work and safety limits are satisfactory
and that the volunteer is not being placed
at any undue risk. International research
is carried out to standards known as ÎGood
Clinical Practiceâ (GCP). There is strict
control and monitoring of the study. The health
of our volunteers is of prime importance and
we would remove someone from the study if
we observed that an unacceptable side effect
was developing, or stop the whole study, depending
on the circumstances. We do not undertake
studies where there is an unacceptable risk
to human health based on evidence from laboratory
work previously carried out.
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What
Type Of Studies Are There?
The majority of studies are residential for
a short period, eg. one day and two nights.
That may be all, or the stay may be repeated
at intervals of one or two weeks. Other studies
may have a longer residential period, usually
7-10 days. Please remember that long studies
may not suit everyone. Some studies combine
being resident, with continuing medication
as an outpatient and coming back to the unit
periodically. It is important that you give
some thought to the type of study which will
suit you best ö not just in terms of the fee,
but in terms of your commitment to the study.
This is particularly important if you are
a smoker and choose to stop to comply with
DDS non-smoking restrictions.
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What
If I Change My Mind?
You can change your mind at any time, and
are not bound to complete a study or even
start a study if you have second thoughts.
Obviously, it is better to iron out any doubts
at the screening visit, or before starting.
Our fully-trained and experienced staff are
on-hand to answer any questions you may have,
at any stage of the process, and ensure you
are fully informed and understand what will
happen at each stage.
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Do
I Make A Lot Of Money Doing Studies?
At Chiltern (Early Phase), all volunteers get paid to participate,
based on a wage-payment model, depending on
the length and type of the study. Details
of individual fees are sent to volunteers
prior to screening medicals. Along with this,
all travel expenses are reimbursed.
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If
I Like It Can I Do More?
Yes, after a minimum period of three months,
volunteers are free to once again, get paid
to participate with us. Most of our volunteers
do exactly this, over and over again.
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What
Is There To Do?
If you are on a residential study, it is important
for our analysis of the study that we monitor
you during the course of the stay. It is for
this reason that we require you to stay within
the unit, for the duration of the residential
period. During your stay with us we have many
recreational activities to keep you entertained,
such as televisions in each bay, with access
to Sky, along with an extensive DVD and video
catalogue. We also have a recreation/chill
out room in each ward, with darts, pool, table
tennis and internet access. Along with this,
we will provide you with daily newspapers
(of your choice) and there are game consoles,
should you wish to bring in your own games.Ê
If you are a student, this is an excellent
opportunity to spend some quality time on
revision, whilst being paid to participate.
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Can
I Have A Look Around The Unit Before Deciding?
Of course you can! Usually on a first visit
to the unit for screening, you will be shown
around. Should you wish to see the unit earlier,
we can arrange for a visit at a convenient
time. Additionally, if you do not already
know someone who takes part in our trials,
we can arrange for you to speak to one of
our regular volunteers.
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Can
I Volunteer Without Anybody Knowing About
it?
Certainly! All information regarding volunteers
is strictly confidential and identities protected,
as covered by the data protection act. We
do, however, need to inform your GP to receive
a brief medical history prior to attending
a medical with us, as well as after the study,
to inform them of your participation. It is
entirely your choice whether you wish to tell
friends and family about your experience.
Most of our volunteers, however, do wish to
inform friends and family of our studies,
as you can earn £200 per Îfriendâ you recommend
who completes a residential study.
WE HOPE THIS INFORMATION HAS BEEN HELPFUL |
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