Chapter 128

2114 PART 6 ■ Specific Considerations
if inadequate information was given, then the doctor may be held
to be negligent. Thus, if inadequate information about risk is
given, and the child suffers harm, then the parents may claim that
the doctor is responsible because they never gave “informed
consent” in the first place. The question therefore is how closely
does the law match the ethical description of informed consent
given above?
The Different Legal Standards of Disclosure
The reality is that different legal systems in different countries
utilize different standards of disclosure. There are three different
standards:
The professional standard test is the standard of disclosure that
the profession would be expected to tell the patient. Thus, based
on the old English case of Bolam, 42 a doctor would not be guilty of
negligence if he acted in accordance with a practice accepted as
proper by a responsible body of medical opinion skilled in that
particular art. The same test applies to the disclosure of risk. If a
responsible body of medical opinion would not have disclosed
what was omitted by the defendant the doctor would not be found
guilty of negligence. Thus, even a significant minority of doctors
in agreement will leave the plaintiff in difficulties.
The patient standard, on the other hand, can be subdivided into
two: a particular patient standard and a prudent patient standard,
corresponding to subjective or objective standards. The particular
patient (subjective) test defines what the actual patient would have
done if notified of all relevant facts. This test suffers from the
necessity of hindsight, and since the relevant facts only exist in the
mind of the individual, an accusation is very hard to refute. It is,
however, a desirable standard insofar as it embodies personal
factors, including many that are nonmedical, which might affect
a particular person’s decision. The prudent patient test requires
the plaintiff to establish that a reasonable person would not have
undergone a recommended procedure after having been advised
of all significant risks. This also is problematic, as it is impossible
to define what a reasonable person is, specific to each case.
However, it appears fair to both sides in that a reasonable doctor
and a reasonable patient are meeting on comparable terms. 43
The Bolam test for medical negligence still carries significant
weight in the United Kingdom. That is, “a doctor is not negligent
if he acts in accordance with a practice accepted at the time as
proper by a responsible body of medical opinion.” This ruling
arose out of a case in 1957. Bolam, who consented to electroconvulsive
treatment but suffered fractures in the course of the
treatment (he was not given any muscle relaxants), argued that he
had not been informed of the risks. The judge held that the
amount of information given had accorded with generally
accepted medical practice and the case was dismissed. The Bolam
test corresponds to the professional medical standard test—that
“the doctor knows best.” This accords with the principles of
benevolence and nonmaleficence: “do good and do no harm.”
The professional standard test has been attacked by many,
including some judges in the United Kingdom such as Lord
Scarman. Although he would permit the medical experts to
establish the standard of care in relation to diagnosis and treatment,
44 he found it unacceptable in relation to informed consent.
He has commented that the legal standard is, in effect, set by the
medical profession. If a doctor can show that his advice or his
treatment reached a standard of care which was accepted by a
respectable and responsible body of medical opinion as adequate,
he cannot be made liable in damages if anything goes wrong. It is
a totally medical preposition erected into a working rule of law. 45
Since then, the Bolam test, with respect to information
disclosure, has been modified following the case of Bolitho. 46 In
this case, it was decided that a doctor is not negligent if he acts
in accordance with a practice rightly accepted at the time as
proper by a responsible body of medical opinion. The key word
here is “rightly.” In effect, this allows a court to decide if the
“responsible body of medical opinion” is correct. It transfers the
final decision from the medical profession to the legal system.
However, it still remains that the legal doctrine of informed
consent in the United Kingdom is primarily a law of disclosure
based on a general obligation to exercise reasonable care by giving
information.
Giesen in turn states: 47
“The law in most jurisdictions seeks to ensure the full and consistent
protection of the patient’s rights … this goal requires that
objective and judicially determined standards of care be imposed
upon doctors. In relation to consent to medical treatment the primary
value of individual autonomy implies that the informational
needs of the particular patient must determine the legal standard
of disclosure. In so far as English judges have privileged the medical
profession, above all others, by unquestioningly ratifying its
practices in relation to treatment and disclosure, they may be said
to have abandoned their constitutionally mandated tasks of adjudication
and the development of law on an objective basis. This
position is at odds with that in most other common law countries
and is notably isolated within the context of the European
Community.”
In other parts of the world, the “patient-based materiality risk
standard” is well established. In the United States, the landmark
case of Canterbury v. Spence 48 and in Australia the case of Rogers
v. Whitaker 49 imply that doctors must disclose any material risk
about a procedure before informed consent has been given. The
important concept here is an understanding of the meaning of the
word “material.” It implies that, provided knowledge of a particular
risk will be important to the decision making process of the
patient, then such a risk needs to be disclosed, irrespective of
the likelihood of it occurring. This could mean anything from the
simplest to the most life-threatening complication. The issue is
how much importance the patient attaches to the risk of the
complication occurring.
RESEARCH IN CHILDREN
Overview and General Considerations
The issue of undertaking research in children raises many legal
and ethical dilemmas. Apart from the fact that they are vulnerable
to being used to further adult interests, questions such as what
level of maturity is required to consent to a research proposal still
arise. Furthermore, harm, pain, and distress may arise out of any
research, including such simple procedures as taking blood
samples.
Research can conveniently be divided into therapeutic and
nontherapeutic, although in many cases it may be difficult to
differentiate the two. In therapeutic research it is probable (or
at least the aim should be) that the research will directly benefit
the patient. Nontherapeutic research, on the other hand, will
not benefit that particular patient, although the results may be