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Medical Law - Clinical Research
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Comprehensive notes compiling lecture notes, textbook reading, case law summaries and further reading. Includes legal and ethical evaluation and critique.
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CLINICAL RESEARCHWithout research, medical progress would be impossible. New treatments can be tested on animals, but animals
experiments are an imperfect way to predict how a treatment will affect human beings. While we all want the
medical care we receive to have been rigorously tested on human beings, serving as a research subject is
daunting and poses risks to an individual’s health.
One of the most basic questions raised by regulating clinical trials is how to balance the competing interests of
society and the individual research subject. Although research on human subjects is not the only time when the
interests of society have to be weighed against the welfare of individuals, this balancing exercise offers a good
example of the conflict between deontological (duty-based) and teleological (consequentialist) reasoning.
If a strict utilitarian perspective is adopted, conducting research on a small number of people – with or without
their consent – in order to benefit the rest of society might be justifiable, even if it poses a considerable risk to
their health. The example of Edward Jenner injecting a small boy with cowpox and smallpox without consent for
non-therapeutic reasons has saved the lives of millions and led to the virtual eradication of smallpox.
Those who take a deontological approach feel that any course of action which disregards the wellbeing of
research subjects should be condemned, regardless of its benefits to the rest of society. Hans Jonas goes
further and argues that research on humans involves treating subjects as ‘things’ and he argues we should rule
this out even if it slows down medical progress.
The ethics and politics of human experiment
Paul M McNeill (1993)
The researcher’s interest in his or her own advancement and standing may be an added pressure which
causes them to cut corners in a way that is unsafe.
Whilst blatant disregard gains the most attention, it is likely more harm has been caused by researchers who
mean no harm but are unaware of the extent of risks to their patient.
Bias towards achieving goals may lead to them minimising the inherent risks in their heads.
Scientists are as capable as any other group of pursuing their own interests to the exclusion of the interests
of others.
Solomon Benatar also points out that sponsors of research also have a lot at stake in clinical research,
describing it as a burgeoning activity which is driven by the desire to make vast sums of money. Why make
drugs for sick people who cannot afford them when one can make drugs for people with resources who seek
marginal improvements or those who are well and will pay for the possibility of a healthier old age.
TYPES OF RESEARCH: USE OF ANONYMOUS DATA OR SAMPLES
A great deal of medical research is carried out without any direct contact with patients. Epidemiology is a good
example, which is the study of the occurrence and distribution of diseases and other health-related conditions in
populations.
For these types of studies it would be very difficult if patients always had to give informed consent to the use of
information from their medical notes. The process of tracking down every patient and asking their permission
would be incredibly time-consuming and might cause unnecessary harm.
TYPES OF RESEARCH: INNOVATIVE THERAPY
, Ordinary medical treatment must satisfy the Bolam test, as modified by Bolitho, that is that it must reach a
standard of care which is;
a) Accepted as proper by a responsible body of medical opinion; and
b) Capable of withstanding logical analysis.
Usually this means that doctors should only provide treatments that have been properly tested and are known to
be effective. If all orthodox treatments have been exhausted however, and the patient’s condition is extremely
serious, it might be acceptable to try a treatment which has not yet been licensed for use in humans. This is
consistent with the Helsinki Declaration which sanctions the use of unproven treatment where no other options
exist.
Simms v Simms [2002]
An 18-year-old boy and 16 year-old-girl who were in the advanced stages of variant Creutzfeldt-Jakob disease, a
rare, fatal and incurable neurodegenerative disorder, ask the courts to declare that experimental treatment would
be in their best interests.
Dame Butler-Sloss explained that where there is no alternative treatment available and the disease is
progressive and fatal, it seems to me to be reasonable to consider experimental treatment with unknown benefits
and risks, but without significant risks of increased suffering to the patient, in cases where there is some chance
of benefit to the patient.
TYPES OF RESEARCH: NON-THERAPEUTIC AND THERAPEUTIC RESEARCH
After satisfactory evidence from animal trials has been gathered, there are usually three phases of trials on
humans;
Phase I A small number of healthy volunteers are given the drug so that researchers can study its toxicity and
the way it is absorbed.
Phase II The drug is given to a group of people (few hundred) suffering from the condition it is intended to treat,
in order to evaluate its effectiveness and identify common side effects.
Phase III Testing the drug on a larger group (several thousand) of patients who take it under supervision for a
longer period of time.
A license may then be granted upon satisfactory completion of these 3 phases. After licensing, the drug will
continue to be monitored before it can be categorized as an ‘established’ medicine – this is sometimes referred
to as Phase IV or a ‘pragmatic trial’ as it is no longer purely research because the intention is now to treat
patients rather than generate knowledge.
Therapeutic research is an activity designed to produce generalisable knowledge through the application of
procedures of potential diagnostic or therapeutic value to those involved as patient-subjects. As the patient-
subjects in Phases II & III will usually have the condition concerned, they may hope to receive some health
benefit from participation.
Non-therapeutic research on the other hand is an activity designed to produce generalisable knowledge through
the application of procedures without the intention of directly benefiting those involved as subjects. Phase I trials
are generally non-therapeutic. The potential danger of non-therapeutic Phase I trials came to the forefront in
2006 following the catastrophic at Northwick Park Hospital. 8 healthy male volunteers had been enrolled in a
Phase I trial for a substance thought to have potential uses in treatment for arthritis, leukaemia and MS. 6 of the
men immediately suffered life-threatening multiple organ failure and the other 2 were given a placebo.
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