Obtaining ethical approval is necessary for almost any type of medical
research. The following paragraphs (taken from - Jones RG, Payne RB.
Clinical Investigation and Statistics in Laboratory Medicine.
London: ACB
Venture Publications, 1997) indicate the usual approach and provide
some useful examples of information sheets which may be needed for human
volunteers.
The basic ethical question is whether the risks to the patient of the
work can be justified by the potential benefits. This can be a vexed question
and proof or refutation of the argument may demand much of the effort
of developing the study in the first place.
Most local Ethics Committees will issue guidelines on what studies require
ethical approval and how this should be carried out. Ethical considerations
for human studies are based on the Helsinki Declaration (1975) which has
been adopted globally as the yardstick for clinical research trials. It is best
to err on the side of caution and submit any study involving patients,
human volunteers or human material for ethical approval. If it is unnecessary
the local committee will say so. Animal experimentation is also subject
to strict controls, by the Home Office in the UK, as is embryological
(Human Embryo and Fertilisation Authority) and genetic research.
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Ethical Issues
There are many instances where seemingly straightforward routine laboratory
studies throw up unexpected ethical problems. For example, using surplus
routine clinical material to establish reference ranges, though accepted
practice, can lead to dilemmas if unexpected abnormal results are identified.
Is it the duty of the laboratory scientist to report such a finding to
the patient's physician or to the patient themselves or to ignore it?
Similarly, if such material is used for method development, what is the
position if such work involves commercial support or sponsorship? It should
be remembered that the sale of human material is forbidden and all patient
data must be treated as strictly confidential. Routine material will not
have been obtained with informed consent for extra scientific procedures.
With proper planning these should be anticipated at the outset. Clearly,
there is a common sense position which suggests that research work is
necessary and would be fatally inhibited were all such studies be subject
to the full rigours of clinical research trial regulation. However it is better
to be proactive and seek approval, openly, at the outset than to suffer
potential embarrassment and even litigation or prosecution should the
unexpected occur.
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Consent
At a practical level the issue of informed consent can raise many problems.
There has been a vigorous debate of this matter in relation to clinical
practice and the problem becomes more difficult in the area of research.
Where new treatments are concerned it may be that patients will be unable
to make an informed choice as the evidence is simply unavailable. Special
measures may be necessary to ensure that consent is fairly obtained, possibly
by someone who is not attached to the investigation team. For a detailed
examination of the issue the reader is encouraged to read one of the newer
texts on medical ethics.
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We have provided an example of a Information
Sheet checklist and a Consent
form as well as examples of a consent form
and a patient information sheet modelled
on ones used in an actual research trial. These can be taken as models on which
to develop ones suitable for new research trials. Patient information sheets
ensure that patients are better informed about the nature of proposed
research than has been usual in the past when consent was often obtained
verbally. Analysis of patients understanding of what they had agreed
to has shown that they were ill-informed in many cases and might have
refused consent had they been given written information. However, it
should not be felt that formal information sheets necessarily make patients
more likely to refuse consent as such sheets can increase their confidence
in the value of the work to be undertaken and increase their willingness
to participate.
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PATIENT CONSENT FORM FOR ALCAP RESEARCH TRIAL IN METASTATIC
PROSTATE CANCER
Hospital Number:
I ..........................................................................................................,
of .........................................................................................................,
agree to take part in a research trial of treatment in prostate
cancer. I understand that treatment will be randomly allocated to me
but that if my doctor or I feel the treatment to be inappropriate, standard
treatment will be given.
I understand that if I not agree to enter this research trial, my rights to treatment
will not be affected.
I understand that I may withdraw from this research trial at any time if I wish,
and withdrawal will not affect my rights to treatment and appropriate
care.
I have been given a full explanation of the research trial, and have received
a written explanation.
Signed ................................................... Date
.................................................
Confirmation of Explanation by Clinician
I, ..................................................,(position held
.......................................)
confirm that I have given a full explanation of the research
trial to..............................................and have also
given him/her a written explanation.
Signed ................................................... Date
.................................................
Witness to the Signature
I, ..................................................,(position held
.......................................)
confirm that a full verbal explanation of the research trial
has been given to ......................................................
I consider that he/she has understood the explanation. He/she has had
opportunity to ask questions
Signed ................................................... Date
.................................................
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Patient information sheet for the ALCAP research trial in metastatic prostatic
carcinoma.
Your doctor has already explained that you have cancer of the prostate
gland and that some cancer cells have spread into your bones. The doctor
will also have explained what this means for you.
You will be commencing or have already received the standard therapy
for your disease. Some doctors believe that by altering the composition
of bone the cancer cells will find it harder to grow and cause damage.
This has not been tested in large numbers of patients yet. Finding a medicine
that will penetrate bone and stay there without causing any harm is difficult.
There are, however, medicines already available which do get into bone.
Such a medicine is called antileukin. It is already used in patients who
may have problems due to the spread of their cancer.
You have been invited to take part in a research trial in which we want to find
out whether by giving antileukin to men like you we can prevent or at
least slow down the consequences of the cancer cells in bones. We must
compare what happens to patients who take antileukin with patients who
do not take the medicine. This will take a few years.
Patients who agree to participate in this research trial will be allocated by
chance (basically "drawing the treatment out of a hat") to either antileukin
or a placebo (a non-active form) in addition to the standard treatment
you are getting now. For every patient who participates this means taking
four tablets per day every day, for up to three years. Some patients who
have taken antileukin have had mild diarrhoea and felt sick and occasionally
experienced a mild skin rash, a low white blood cell count or a low calcium
level. If this happens to you, your tablets will be reduced or stopped
altogether. Your other treatment will be exactly the same whether you
enter the research trial or not.
You must be aware that by agreeing to take part in this study you may
not directly gain any benefit from it. The results will, however, be of
value to other patients in the future.
If you do not wish to take part in this research trial or if you wish to withdraw
at any time you will continue to receive the standard treatment. Your
relationship with your doctors will not be affected in any way. If you
do agree to take part and you subsequently wish to withdraw from the research trial
at any time, again you will be free to do so. This will not affect your
treatment
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