Chapter 128

Consent, Research, and
Withdrawing Treatment
Nicholas Pace and David A. Blacoe
128
CHAPTER
INTRODUCTION
Ethical and legal principles have always been of paramount
importance to the medical profession, because they determine
how it ought to behave. Ethical principles can be summarized into:
respect for autonomy, beneficence (do good), nonmaleficence (do
not harm) and justice (resources have to be distributed fairly)
(Table 128–1). Of these, the principle of respect for autonomy is
now generally regarded as the central ethical principle in medical
practice. Society today places great emphasis on the value and
dignity of the individual and gives issues of consent and selfdetermination
an emphasis they have never previously been
afforded. This has arisen from the concept of natural rights, which
dictate that a competent person should decide what happens to
his or her body.
These principles and issues are not just applicable to adults. The
United Nations Convention on the Rights of the Child (UNCRC)
is an international human rights treaty that grants all children
and young people (aged 17 years and less) a comprehensive set
of rights. It is presently the most widely ratified international
human rights treaty and has been signed by all UN member states
except for the United States and Somalia. It came into force in
September 1990.
The UNCRC is the only international human rights treaty to
include civil, political, economic, social, and cultural rights, and
sets out in detail what every child needs to have a safe, happy,
and fulfilled childhood. It also takes into account children’s
need to have special assistance and protection because of their
vulnerability.
The convention gives children and young people more than 40
substantive rights. In particular, it includes the right to be informed
about and participate in achieving their rights in an accessible and
active manner. Thus, it gives children greater autonomy and an
increased role in decision-making.
This chapter will examine the ethical and legal implications of
consent, informed consent, research, and withholding and withdrawing
treatment relating to pediatric anesthesia. It will also
briefly discuss the controversial issue of fetal rights. For simplicity
in this chapter, a child is referred to as female.
CONSENT IN CHILDREN
Legal Definition of Consent and Competence
Doctors and other healthcare staff cannot do anything to
competent patients without their consent, because the right to
consent or refuse treatment is grounded in the ethical principle of
respect for autonomy and the right to self-determination. Consent
is the patient’s voluntary agreement to treatment, examination, or
any other aspect of health care. 1 There are legal consequences for
an unauthorized invasion of bodily integrity. If no legally effective
consent has been given, a doctor will be liable for civil or even
criminal charges of assault if he makes contact with the patient. 2
However, such consent does not provide a defense to a claim that
the doctor negligently advised a particular treatment or negligently
carried it out.
The common law has long recognized the principle that every
person has the right to have his bodily integrity protected against
invasion by others. The classic expression underlying this
sentiment is that of Justice Cardozo:
“Every human being of adult years and sound mind has a right to
determine what shall be done with his own body; and a surgeon
who performs an operation without the patient’s consent commits
an assault.” 3
In order for the consent of any individual to be valid, five
conditions need to be met. The patient must be competent,
information needs to be disclosed and understood, the consent
must be given voluntarily, and finally, the patient must give
authorization (Table 128–2).
Competence is fundamental to the practice of obtaining
consent. It means the ability to perform a task and involves the
ability to understand information, retain that information, and
use that information to come to a decision. It is not an allor-nothing
phenomenon and relates to a particular situation. A
patient may thus be competent in one setting—for example, taking
a hearing test—but not in another, such as consenting to heart
surgery. A patient may not be competent to make a decision (and
● Justice ● Authorization given by patient
TABLE 128-2. Conditions for Valid Consent
TABLE 128-1. Ethical Principles
● Competent patient
● Respect for autonomy
● Information disclosure
● Beneficence
● Information understood by patient
● Nonmaleficence
● Voluntary consent

2110 PART 6 ■ Specific Considerations
therefore not able to give consent) because of unconsciousness or
because they are too young. In such situations, a proxy may give
consent. However, proxy consent is legally valid only when the
patient gives express authority to another person to give or
withhold consent on his or her behalf or when the law invests a
person with such power. The commonest example of the latter is
that of parent and child. However, when proxy consent of this sort
is available, the person vested with that power must use it
reasonably. Consent for treatment of a minor can be obtained
from one of three authorities: the competent child, the child’s
parents or guardians, or the courts. Where medical and parental
opinion differ, the doctor administering emergency life-saving
treatment without parental consent will traditionally be supported
by common law. In all but the most urgent of circumstances,
disputes over care should be referred to the courts. 4
Recent statutory reforms in England and Wales (Mental Capacity
Act 2005) and in Scotland (Adults with Incapacity (Scotland)
Act 2000) have simplified the management of consent issues with
respect to incapable adults. 1 No such legislation exists in regard to
consent in children and it should therefore be immediately clear
that this raises many legal and ethical dilemmas.
Age of Competence to Give Consent
The first matter to be decided is at what age a child becomes an
adult. This age, in most European jurisdictions, is 18 years old.
A person older than this age, provided they are not mentally
incapacitated, has the right to make decisions regarding their
medical treatment and, indeed, may refuse what is offered. Thus,
even if the treatment proposed is clearly in that patient’s interests
and may even save that patient’s life, the patient has a right to
refuse it. Once a child reaches this age, she is given legal rights to
make decisions and may give or refuse consent to whatever
medical treatment she wishes.
This does not mean that a child that has not yet reached this age
has no legal or ethical rights. Various legal systems throughout the
Western world have embraced the concept of the “mature” or
“emancipated” minor, with the consequent legal capacity to consent
to medical treatment. That is, beyond a certain age and level
of mental maturity, a child is able to make a decision regarding
her own treatment. This is in keeping with the UNCRC as
described earlier. This asserts a child’s right to have her views
accorded due weight in relation to her age and maturity. 5
In the Canadian case of Johnston v. Wellesley Hospital, 6 the
plaintiff sued for damages caused to the skin of his cheeks and
forehead by the treatment used by the defendant, Wellesley. One
of the questions raised was whether a 20-year-old person could
consent to treatment when at that time the age of majority in
Canada (the magical age described earlier) was 21 years. The judge
stated that if a minor was old enough to appreciate fully the nature
and consequences of the proposed treatment, then he could give
effective consent. In another Canadian case the trial judge took
into account the child’s sincerity, maturity, and forthrightness
and respected the child’s wishes rather than those of her legal
guardians. 7
The consequences of the Johnston decision were far-reaching
and it has been directly quoted in a number of cases in other
jurisdictions. It had a direct bearing on the widely known English
case of Gillick v. West Norfolk Area Health Authority. 8 Before this
case, despite the age of majority being 18 years, the Family Law
Reform Act, section 8, subsection 1 (1969), had decreed that once
a person reached the age of 16 years, he or she could consent to any
surgical, medical, or dental treatment. In other words, adult status
was reached at 16 for the purpose of medical treatment and it was
therefore not necessary to obtain consent from the parent. The
Gillick case concerned the validity of consent, without parental
knowledge, to contraceptive treatment from a child who was
younger than 16. The House of Lords ruled that a child younger
than 16 years could give valid consent to medical treatment
without parental consent, provided the child, in the opinion of the
doctor, was of sufficient maturity and intelligence to understand
the implications of the treatment proposed.
It would therefore be up to the individual doctor to decide
whether a child younger than 16 years of age could give valid
consent. The basis on which this decision is to be made is, unfortunately,
ill defined. It is unlikely this decision will be challenged if
made in good faith. However, should it be challenged, then the
normal rules of negligence will apply. So, in the United Kingdom,
if a responsible body of medical opinion, which also withstands
logical judicial analysis, 9 agreed that the child was competent to
give consent, the action against the doctor will fail. Thus, in difficult
cases, advice from colleagues should be sought. In certain situations,
such as various heart or neurologic operations, it would be
highly unlikely that a child could give effective consent. Giesen, an
authority on medical malpractice law, believes that when the
minor’s own future welfare is at stake and the consequences of the
procedure might be serious, traumatic, or irreversible, physicians
should generally seek parental cooperation. 10
In principle, however, the age at which a minor is considered
competent to give, but not necessarily to withhold, consent varies
across Europe from 14 to 18 years of age. The assessment of
competence is dependent on the nature of the proposed procedure,
the complexity of the decision process, and the gravity of associated
implications. Thus, the graver the impact of the decision, the
commensurately greater the competence needed to make it. 11
Even if the child is deemed not to be of sufficient maturity to
consent, it is important that the child participates in the decisionmaking
process. Thus, in Canada, a child over the age of 8 years
must discuss the decision regarding treatment, although the
final decision is not hers. A similar situation exists in the United
Kingdom 12 and almost certainly applies in other countries, at least
from an ethical if not legal standpoint.
Refusal of Consent by a Minor
Autonomy means that a competent adult patient has the right to
give or withhold consent to investigation or treatment, irrespective
of any untoward consequences. Furthermore, an adult patient is
not restricted to accept or refuse what is on offer, but should be
allowed to choose the type and scope of treatment and to base this
inadequate information about success rates and risks and what
impact they may have on daily living. A competent adult is
perfectly entitled to reject medical advice. If contemplated by a
minor, however, it is understandably much more problematic,
especially if the consequences are serious. Following decisions
such as Gillick, it would appear logical that a child has every right
to refuse treatment, provided she has sufficient maturity and
intelligence to understand the implications of refusing the
treatment proposed. If one is legally entitled to consent, one must
be legally entitled to dissent, 13 a situation analogous to the adult

CHAPTER 128 ■ Consent, Research, and Withdrawing Treatment 2111
situation. Once again, as discussed above, the judgment regarding
competence is to be made by the physician, with advice from
colleagues in difficult cases.
However, it would appear that in many jurisdictions a minor
cannot refuse treatment that in the opinion of the medical profession
or courts is in her best interests. Several test cases have
established this precedent. 14
The English case of Re R 15 concerned a 15-year-old whose
disturbed behavior required sedation. However, when lucid and
competent, she refused her medication. The judges held that the
court could override the refusal of treatment if that was considered
to be in her best interests. Further, the judges suggested that the
parental right to give consent in the face of the child’s refusal was
retained. This was further considered in the case of Re W. 16 This
concerned a 16-year-old suffering from anorexia nervosa who was
refusing all treatment. Lord Donaldson stated:
“No minor of whatever age has power by refusing consent to
treatment to override a consent to treatment by someone who has
parental responsibility for the minor …”
Clearly, in both cases, the judges were concerned of the need to
protect the medical profession from litigation. However, both
cases were unusual in that they dealt with diseases that could
impair reasoning. The case of Re M 17 demonstrates the furthest
extremes to which these powers have been tested. M, a 1-year-old
girl, refused consent for a heart transplant in the face of lifethreatening
disease. Justice Johnson emphasized the need to take
account of the mature minor’s wishes, but that these wishes were
in no way determinative, and held that the proposed treatment
was in the minor’s best interest and should proceed. M agreed to
comply after this ruling so the final need to enforce treatment was
averted, although Justice Johnson still expressed concern at the
gravity of his decision.
Thus, it would appear that a child is mature enough to make a
decision regarding treatment only if her decision agrees with that
of the courts and medical profession. This is arguably illogical, and
such decisions have been widely criticized. The counter argument
is that the potential consequences of refusal of consent (such as
immediate harm or limitation of future choices) are not necessarily
equal to those of giving consent. The implications of refusal
may, therefore, be more serious, and on these grounds refusal of
treatment may require a greater understanding and comprehension
than does acceptance of medical advice: the two conditions
therefore cannot be regarded as being on a par.
From an ethical viewpoint, the focus is changing from a
doctor’s obligation to disclose information to the quality of the
patient’s understanding. Understanding the information provided
is a more important element than the mere disclosure of that
information. Many conditions, such as illness, can limit a patient’s
understanding. Most important from this chapter’s perspective is
the fact that immaturity can also limit understanding.
In all the above cases, the judges emphasized the importance of
respecting the minor’s wishes and of giving them increasing value
with increasing maturity. The concept of the mature minor should
therefore be breached only in exceptional circumstances. 18
In summary, at least in England, when a child reaches the age
of 16, his or her consent will be valid for treatment. This will be
overturned if the patient is not competent to consent. Below the
age of 16, doctors must assess the particular child‘s capacity to
consent in relation to the proposed intervention. This involves the
ability to understand that there is a choice and that choices have
consequences. There must be a willingness and ability to make a
choice. There must be an ability to understand the nature and
purpose of the proposed procedure and the available alternatives,
including a proper assessment of the risks and side effects 19
inherent in these alternatives.
To confuse the issue, the above does not apply to Scotland. In
Scotland, if a competent child refuses treatment or investigations,
this should be accepted in the same way as an adult refusal. The
only reported case is that of a 15-year-old boy with a psychotic
illness who refused to remain in hospital for treatment. Despite
his mother giving consent, the sheriff ruled that logic demanded
that the decision of a competent young person could not be
overruled by a parent. 20 Treatment was, however, subsequently
enforced under the Mental Health (Scotland) Act of 1984, 20 and as
such the sheriff was able to avoid the immediate implications of
the decision. The Scottish courts have made no definitive ruling
on this matter, and a case falling out with the remit of the Mental
Health Act has yet to be tested.
It is therefore clear that practitioners should review each case
carefully and in cases of doubt seek legal advice. The problem
revolves around the evaluation of competence. Unfortunately,
there do not appear to be any guidelines on how this can be
measured and utilized. It is for the doctor to decide whether a
minor is competent or not, and it would appear that if this is
challenged, the final arbiter would be whether a responsible body
of medical opinion would support the decision. Clearly this is very
much a gray area in terms of legal obligations, but it appears that
the law is taking a back seat and allowing the medical profession
to make these decisions. Such a situation, clearly, may change if a
controversial case comes before the courts.
Parental Refusal of Consent
for Life-Saving Treatments
The question of parental refusal of treatment also creates uncertainty,
especially because frequently there are religious reasons for
this. It is of particular concern to anesthesiologists, because such
examples include refusal of blood transfusions by parents who are
Jehovah’s Witnesses. It should be remembered that overriding
religious convictions is a major step to take in a free society. It also
significantly interferes with the principle that parents should have
the freedom to choose the religious and social upbringing of their
children. 21 However, as mentioned earlier, the person vested with
the power of proxy consent must use it reasonably, and in these
cases the well-being of the child is paramount. Thus, parental
refusal of life-saving treatment is routinely disregarded and the
law has virtually always given consent for the transfusion, overriding
parental objection. It is suggested that the approval of a
court of law should be sought before such an administration. It is
also suggested that two doctors of consultant status should make
an unambiguous, clear, and signed entry in the clinical record that
blood transfusion is essential, or likely to become so, to save life or
prevent serious permanent harm. 22 The parents should be given
the opportunity to be properly represented and be kept fully
informed of the doctor’s intention to apply for a court order. 23 In
an emergency, where there is no time to obtain court approval,
health professionals should proceed with life-saving treatment
under the doctrine of necessity.
Despite the assumption that life saving treatment can be
administered against the wishes of the parents, several cases have

2112 PART 6 ■ Specific Considerations
also established the precedent that, in some situations, parents can
legally refuse consent to treatment of their child. In one case, a
mother refused chemotherapy for her 3-year-old child who was
suffering from cancer. The hospital took the mother to court. The
court upheld the mother’s decision, because the judges felt there
was only a small chance of recovery and also because of the severe
side effects that would result from chemotherapy. 24 Thus, it is
impossible to set hard and fast rules. Each case should be analyzed
on its own merits. What is clear is that if treatment is immediately
necessary to preserve life, doctors should proceed with treatment.
If treatment is not immediately required, then referral to a court
of law should be undertaken. Doctors can only act in defiance of
parental views in the emergency situation.
Nontherapeutic Circumcision
An issue directly applicable to anesthesiologists is that of nontherapeutic
circumcision. Female circumcision, which involves
suffering, mutilation, and serious health risks, is illegal under U.K.
law 25 and will not be discussed further. The issues surrounding
male circumcision, on the other hand, are less clear and require
further analysis. In children, this virtually always relies on parental
consent and is usually carried out for ritual, social, or cultural
reasons. Brazier has commented that male circumcision is a matter
of medical debate and for Jewish and Muslim parents it is an article
of faith. She argues that the child suffers momentary pain and,
although medical opinion may not necessarily regard circumcision
as positively beneficial, it is in no way medically harmful if
properly performed. The community as a whole, she claims,
regards it as a decision for the infant’s parents. 26
These arguments can be challenged. Firstly, there is extensive
literature on the harms of circumcision. 27,28 It is also not clear from
her argument how the operation can be justified legally and
ethically. If the principal starting points are that everyone has a
right to bodily integrity and that proxy consent has to be used
reasonably and in the interests of the child, then it is possible that
the procedure cannot be justified. It is also self-evident that any
future choice is limited once the procedure is undertaken.
The ethical justification for circumcision is that it is in the
child’s best interests because it facilitates social acceptance rather
than exclusion and enhances cultural identity and belonging. The
degree of social acceptance or exclusion inferred is variable, and
this should be considered when weighing up what is in the boy’s
best interest: the child in an orthodox Jewish or Muslim culture
has a very different perspective from one whose parents wish him
to be circumcised simply to be like his father. Parental preference
alone would not pass the “best interests” test. On a practical level,
there is an argument that denying access to medical circumcision
will result in greater harm by encouraging illegal circumcision in
an unhygienic environment by unskilled practitioners. This is a
weak argument, however, as it can also be used to justify very
harmful practices, such as female genital mutilation and ritual
sacrifice, which should be prevented by law rather than by the
permission of a lesser evil.
As previously argued, it is clear that parental rights are derived
from parental duty and exist only so long as they are needed for
the protection of the person and property of the child. Giving
consent to medical treatment of a child is a clear example of
parental responsibility arising from the duty to protect the child. 29
The rights reside in the child with the parents acting as agents for
the child to enforce those rights. 30 Even the argument utilized later
in nontherapeutic research, that it may be acceptable as long as it
is not against the interests of the child, fails because of the potential
harms caused.
In Australia, the Queensland Law Reform Commission stated:
“Unless there are immediate health benefits to a particular child
from circumcision, it is unlikely that the procedure itself could be
considered therapeutic … The circumcision is invasive, irreversible
and major. It involves the removal of an otherwise healthy organ
part. It has serious attendant risks … On a strict interpretation of
the assault provisions of the Queensland Criminal Code, routine
circumcision of a male infant could be regarded as a criminal act.
Further, consent by parents to the procedure being performed may
be invalid in the light of the common law’s restrictions on the ability
of parents to consent to the non-therapeutic treatment of children.”
In the United Kingdom, male nontherapeutic circumcision is
generally assumed to be lawful provided it is performed
competently, there is valid consent, and it is believed to be in the
child’s best interests. Judicial review has shown that this is “an
exercise of joint parental responsibility” and as such both parents
must give consent. 31,32 The term “best interest” encompasses
medical, emotional, and all other welfare issues, and it should be
noted that, at least for incapable adults, it is for a judge, not the
doctor, to finally determine what is in the best interests of the
person concerned. 33
The legal standing on nontherapeutic circumcision may be
affected by the Human Rights Act, which, in 2000, incorporated
Articles of the European Convention on Human Rights 34 into U.K.
Law. Rights that may be relevant are:
●
●
●
●
●
Article 3: “No one shall be subjected to torture or to inhuman or
degrading treatment or punishment.”
Article 5(1): “Everyone has the right to liberty and security of
the person.”
Article 8: “Everyone has the right to respect for his private and
family life” except for the “protection of health or morals, or for
the protection of the rights and freedoms of others.”
Article 9(1): “Everyone has the right to freedom of thought, conscience
and religion.”
Article 9(2): “Freedom to manifest one’s religion or beliefs shall
be subject only to such limitations as are prescribed by law and
are necessary in a democratic society in the interests of public
safety, for the protection of public order, health or morals, or for
the protection of the rights and freedoms of others.”
As yet, the full impact of the Human Rights Act on medical
decision-making is still to be determined. If medical evidence were
conclusive in showing that circumcision is prejudicial to a child’s
health or welfare then it is likely a legal challenge on human rights
grounds would be successful, and indeed that there may be obligations
on the state to proscribe it. 35 As always, legal advice should
be sought if there is any doubt over the legality of proceeding with
treatment.
Finally, those in favor of continuing with this practice need to
answer one further question; why can’t the procedure wait until
the child is old enough to make his own decision?
Parental Presence in the Anesthetic
and Resuscitation Rooms
The issue of parental presence in the anesthetic room and
resuscitation room has also been raised recently. Some argue that

CHAPTER 128 ■ Consent, Research, and Withdrawing Treatment 2113
a parent has a right to be present during the resuscitation of his or
her child, if they so wish. Others argue that the experience of
seeing one’s child in such a desperate situation (particularly during
resuscitation) is likely to cause serious emotional trauma, immediately
and in later life. Whenever possible, the wishes of the
parents should be respected, however, the anesthesiologist or
resuscitation coordinator should have the final veto. This situation
has not, as yet, been challenged in the courts.
Transplantation
The first kidney transplants were undertaken between identical
minors. Couples are now having children for the express purpose
of providing genetically compatible sibling donors of, at present,
regenerative tissue. Whether these practices are ethically and
legally acceptable is debatable, but it appears that they are likely
to increase. Different legal jurisdictions have come to different
conclusions about their acceptability. In Canada, the Ontario
Human Tissue Gift Act (C.C.S.M. c. H180. June 16, 2005) provides
statutory prohibition of donation by minors. In Australia it is not
lawful to remove nonregenerative material from a living child for
the purpose of transplantation. There are also certain qualifica -
tions relating to the donation of regenerative tissue. The law in
France appears to provide a slightly different solution. There, a
living minor may donate, but only to a sibling. Furthermore,
consent must be given by the donor’s legal representative. The
procedure must then be authorized by an “ethics committee”
comprised of at least three experts, two of whom must be doctors,
one of whom must have at least 20 years of experience.
The U.K. situation is, once again, unclear. The Human Tissue
Act 2004 simply states that, regarding child donors, “appropriate
consent” must be obtained, defined as the child’s own consent or,
if incompetent, consent of a person who has parental responsibility.
36 It would appear, from the arguments discussed earlier, that
the “Gillick” competent minor would be able to consent, subject to
the restrictions of the minor’s understanding the risks and benefits
involved. Clearly, donation of nonregenerative organs involves
greater risks than removal of those that can be replaced. Similarly,
the risks inherent in the surgery to obtain the organs are relevant.
Thus, it is far riskier to obtain a part of a liver than to obtain bone
marrow, despite both being capable of regeneration. However,
Lord Donaldson stated that:
“It is inconceivable that [the doctor] should proceed in reliance
solely upon the consent of an under-age patient, however ‘Gillick
competent’ in the absence of supporting parental consent
and equally inconceivable that he should proceed in the absence
of the patient’s consent. In any event he will need the opinion of
other doctors and may well be advised to apply to the court for
guidance …”
The situation regarding incompetent minors is even more
unclear. The debate hinges around whether parents have the right
to consent on behalf of their child to something that will not
benefit, and may indeed harm, the child. Once again, the separation
into regenerative and nonregenerative tissue may help to
assess what would be an acceptable risk. The Council of Europe
Protocol on Transplant of Organs states that removal of regenerative
tissue from a person who does not have the capacity to
consent may be authorized provided no other capable donor is
available, the recipient is a sibling, the donation has life saving
potential for the recipient, authorization has been given by
the donor’s representative or body empowered by law, and the
potential donor does not object. 37
Assessment of what benefit would accrue to the child, such as
survival of a sibling or parent, will also need to be undertaken. It
is suggested that application to the courts would be needed in
virtually all cases in the United Kingdom.
INFORMED CONSENT IN CHILDREN
The Concept of Informed Consent
All medical codes of ethics hold that physicians have a duty to
obtain the informed consent of patients before undertaking
procedures. Thus, there is an obligation to disclose information,
ensure the patient understands the information and, to the best of
their ability, ensure consent is given voluntarily. In particular,
patients have a right to be informed of risks. Thus, patients may
claim that, although consent was given, it was obtained negligently.
Significant case law has arisen as a result of doctors failing to
communicate adequately with their patients, either because there
had been no proper consultation before treatment or because the
doctor failed to disclose the risks inherent in the proposed
treatment.
The concept of informed consent is based on the moral principle
of respect for autonomy, which leads to the patient having the
right to know. 38 It is recognized throughout most Western legal
systems. In the United Kingdom, Lord Templeman stated:
“In order to make a balanced judgment, if he chooses to do so, the
patient needs to be aware of the general dangers and of any special
dangers in each case without exaggeration or concealment.” 39
Similarly, in Germany it has been held that:
“… as a principle the patient must know what he is consenting to.
For him to acquire this position more is necessary than the
disclosure that he needs an operation.” 40
From an ethical point of view, informed consent has criteria
which must be met before consent can be claimed to be truly
“informed.” First of all, the patient must be of sound, competent
mind. He or she must be undergoing the procedure voluntarily
and not under coercion. They must be informed about what the
procedure involves and any risks inherent therein. The more
serious the risk or potential harm, the greater the degree of
information required. Most importantly, they must be able to
understand the explanation given to them by the doctor and
finally, when all the above conditions are satisfied, the patient gives
the doctor authority to proceed with treatment. 41
Informed Consent in the
Practice of Pediatrics
The concept of informed consent is equally applicable to the
practice of pediatrics. As discussed above, most courts throughout
the world are prepared to accept that children of sufficient maturity
and understanding—the so-called “mature” or “emancipated”
minor—can consent to treatment. On the other hand, informed
consent must be obtained from the parents or legal guardian of a
child who is considered too immature to give his or her own
consent. In such cases, based on the moral principle of respect for
autonomy, the parents or legal guardian must be aware of the
general risks of a procedure about to be undertaken. In either case,

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

CHAPTER 128 ■ Consent, Research, and Withdrawing Treatment 2115
very useful in benefiting future patients. It serves as a learning
mechanism for future patients.
Therapeutic Research
The question of minors being involved in therapeutic research is
not too controversial and many of the ethical conditions applicable
to adult research apply. Thus, the research doctor has a duty to act
in the best interests of his research patient and not to harm him.
It has been held in the United States 50 and in Germany 51 that it is
legally wrong for a doctor to withhold information about experimental
therapy for fear that the patient may refuse that therapy,
even though the doctor believes it is in the patient’s best interest to
receive it.
The issue has been clarified somewhat in the European
Community by the 2001 EC Directive, 52 now also part of U.K.
Law, 53 where four fundamental principles are outlined regarding
research in relation to a minor. These are: the requirement of
informed consent by a person with parental responsibility or a
legal representative; the clinical trial has been designed to
minimize pain, discomfort, fear, and any other foreseeable risk;
the risks and degree of distress have been specifically defined; and
that the interests of the patient always prevail over those of science
and society.
The mature minor concept discussed earlier confuses the issue
slightly. It would appear from the previous discussion that a child
who is old enough to understand the risks and implications of an
experimental therapy should be ethically and legally entitled to
consent. It must be pointed out, however, that this application
within the context of research has never been tested in a U.K. court
of law. In France, minors who have been emancipated, either by
marriage or, when they are older than 16 years, by decision of their
parents, should be regarded as adults. The role of parent or
guardian should in such cases be essentially a confirmatory one. It
might be reasonable for a parent or guardian to override a child’s
willingness to take part in research which the adult believes to be
against the child’s interests. There should be no corresponding
opportunity for the parent or guardian to override the capable
child’s refusal. 54
Concerning immature minors, parents must give voluntary
consent, fully understanding the risks and benefits of the research
proposed. After assessing this risk benefit ratio, they must believe
that it is in the minor’s best interest to be involved in that study.
They can then consent on behalf of the minor. The Declaration of
Helsinki 55 states that the consent of the legal guardian should be
procured on behalf of the “legally incompetent.” In U.K. law, the
Medicines for Human Use (Clinical Trials) Regulations 2004
requires a similar approach: “Informed consent given by a person
with parental responsibility or a legal representative … shall
represent the minor’s presumed will.” 56
However, who is actually entitled to consent varies between
jurisdictions.
In France, under article L209-9 of the Public Health Code,
participation requires the consent of the persons legally
responsible for the child. The persons responsible in turn are
regulated by article 371-2 of the Civil Code, parental authority
belonging to both mother and father of the child. However, the
implementation of this is complicated by considerations of
whether the family is united or not. Further complications arise if
the parents disagree.
In the United Kingdom, consent by one parent is sufficient as
parents may act independently, unless a court order has been
made restricting his or her right to consent. 57 However, as Lord
Donaldson stated,
“If the parents disagree, one consenting and the other refusing, the
doctor will be presented with a professional and ethical, but not
with a legal problem because, if he has the consent of one
authorized person, treatment will not without more constitute a
trespass or criminal assault.” 58
Nontherapeutic Research
The question of nontherapeutic research (i.e., research that will
not directly treat the patient, although the results may benefit
other patients), is much more controversial, and issues relating to
consent are pivotal. The primary concern must be with the welfare
of the child, and, although parents are given legal authority to
consent on behalf of their children, this power cannot be used to
place the child at risk of harm. By definition, a child does not gain
directly by being involved in nontherapeutic research and indeed
may be harmed. This implies that parents cannot consent to their
children being involved in nontherapeutic research. In the United
Kingdom, the Medical Research Council stated that:
“in the strict view of the law, parents and guardians of minors
cannot give consent on their behalf to any procedures which are of
no particular benefit to them and which might carry some risk of
harm.” 59
Thus, it has been suggested that it appears to be extremely
doubtful whether valid consent in nontherapeutic research can be
given on behalf of their children, because it cannot be in the child’s
best interests. 60
There are counterarguments to all of this. Firstly, there are no
specific legal rules or rulings on which to base this view. 61 From an
ethical point of view, it is claimed that in everyday life society
allows parents a certain amount of discretion when subjecting
their offspring to risks. 62 Thus, the “reasonable parent test”
employed by Lord Reid in S v. S (1970) 63 could be used to support
the view that reasonable parents may be allowed to subject their
children to certain types of nontherapeutic research, especially
where the risk–benefit ratio is highly in favor of large potential
benefits to others. Furthermore, many believe that the test should
be whether the parents are “clearly not acting against the best
interests of the child.”
The extreme arguments either advocating no research at all or
justifying it as a duty to society are not acceptable. The middleof-the-road
attitude of balancing the risks to the child with the
many advantages to society as a whole should prevail. If risks are
significant, research should not be allowed, because this would be
clearly acting against the best interests of the child.
The Royal College of Pediatrics and Child Health has stated
that it would be unethical to submit a child to more than minimal
risk when the procedure offers no benefit to them. They define
“minimal” as procedures such as questioning, observing, and
measuring children, provided that procedures are carried out in a
sensitive way, and that consent has been given. Procedures with
minimal risk include collecting a single urine sample (but not by
aspiration), or using blood from a sample that has been taken as
part of treatment. 64 The Institute of Medical Ethics, in turn,
defined “minimal” as a risk of death lower than 1:1,000,000, a risk

2116 PART 6 ■ Specific Considerations
of major complications less than 1:100,000 and a risk of minor
complications of less than 1:1,000. 65 It is to be noted that taking a
sample of blood from a vein purely for research purposes is
considered to be low risk rather than a minimal risk. It should also
be noted that in all cases, when parental consent is obtained, the
agreement of school-age children should also be requested by the
researchers. Regardless of age, a child’s refusal to participate in
nontherapeutic research should always be respected, and indeed
where a child becomes upset by a procedure, this should be
accepted as a valid refusal. 66
The concept of the mature minor giving valid consent for
diagnostic or therapeutic interventions has been discussed above
and is widely accepted. It is, however, not certain that this would
apply to nontherapeutic research or experimentation. A practical
approach to this issue would be to obtain parental consent for all
minors, regardless of maturity.
Mature minors, by definition, should be allowed to decide for
themselves in the same way that adults are allowed, with one
limitation: that the greater the risk to the child, the older he or she
must be before a doctor decides he or she is “mature.”
LETTING CHILDREN DIE
It would be impossible to give a full account of the ethics regarding
controversies about withholding and withdrawing treatment in
the limited space available. The Royal College of Pediatrics and
Child Health in the United Kingdom, 67 however, has issued guidelines
on how to approach such decisions and a summary is
provided here.
There are five situations where withholding or withdrawing of
curative medical treatment might be considered:
1. The brain dead child. In the older child, where criteria of brainstem
death are agreed by two practitioners in the usual way, it
may still be technically feasible to provide basic cardiorespiratory
support by means of ventilation and intensive care. It is
agreed within the profession that treatment in such circumstances
is futile and withdrawal of current medical treatment is
appropriate. It is interesting to note that brain-stem death
criteria have no legal basis. In other words, the concept is
accepted by the medical profession and, in turn, the law accepts
the profession’s view that the patient is legally dead.
2. The permanent vegetative state. The child who develops a
permanent vegetative state following insults such as trauma or
hypoxia is reliant on others for all care and does not react or
relate with the outside world. It may be appropriate both to
withdraw current therapy and to withhold further curative
treatment. It must be noted that in these cases the law in most
countries wishes to be involved in the decision-making process
of withdrawing treatment.
3. The “no chance” situation. The child has such severe disease
that life-sustaining treatment simply delays death without any
significant alleviation of suffering. Medical treatment in this
situation may thus be deemed inappropriate.
4. The “no purpose” situation. Although the patient may be able
to survive with treatment, the degree of physical or mental
impairment will be so great that it is unreasonable to expect
them to bear it. The child in this situation will never be capable
of taking part in decisions regarding treatment or its
withdrawal.
5. The “unbearable” situation. The child and/or family feel that in
the face of progressive and irreversible illness further treatment
is more than can be borne. They wish to have a particular
treatment withdrawn or to refuse further treatment irrespective
of the medical opinion on its potential benefit. Oncology
patients who are offered further aggressive treatment might be
included in this category. The assessment of competence of the
child referred to above would once again apply.
In situations that do not fit any of these five categories, or where
there is dissent or uncertainty about the degree of future
impairment, the child’s life should always be safeguarded by all in
the health care team in the best possible way. Clearly, the
recognition that the management of any patient is undertaken not
by medical staff acting on their own, but by a health care team that
also involves nurses, physiotherapists, social workers, and so on
means that a team approach that fully integrates the wishes of the
child and family is essential.
Decisions must never be rushed and must always be made by
the team with all evidence available. In emergencies, it is often
doctors in training who are called to resuscitate. Rigid rules, even
for conditions which seem hopeless, should be avoided; lifesustaining
treatment should be administered and continued until
a senior and more experienced doctor arrives.
The decision to withhold or withdraw curative therapy should
always be followed by consideration of the child’s palliative or
terminal care needs. These may be related to symptom alleviation
(e.g., analgesia or anticonvulsant therapy) or may be related to
dignified and comforting nursing care.
FETAL RIGHTS
This chapter would not be complete without mentioning briefly
the rights of the fetus. It must be pointed out that the law in many
respects is either poorly developed or contradictory. Furthermore,
recognition of fetal rights may result in conflict with those of the
mother. In particular, support or failure to recognise fetal rights is
usually dependant on one’s views on abortion.
Much opposition to legal abortion in the West is claimed to be
based on a concern for fetal rights. Some laws attempt to establish
the right to life of the fetus from the moment of fertilization and
regard the fetus as a person with equal legal status to that of any
other human. The 1978 American Convention on Human Rights
Article 4.1 states that “Every person has the right to have his life
respected. This right shall be protected by law and, in general,
from the moment of conception.” Similarly, the Eighth Amendment
of the Constitution of Ireland recognizes “the right to life of
the unborn” whereas the Federal Constitutional Court of Germany
in 1993 held that the constitution guaranteed the right to life from
conception.
On the other hand, many prochoice groups oppose fetal rights
even when they do not impinge directly on the abortion issue,
because they perceive this as a slippery slope strategy to restricting
abortions. 68 Such groups work to protect and advance reproductive
liberty, including the rights of all women to decide whether
and when to have children, to use contraception, and to safeguard
their own health. In their view, the woman’s health is paramount
and any decision concerning her medical care—including any
decision to continue or terminate her pregnancy—is based solely
on her best interests.

CHAPTER 128 ■ Consent, Research, and Withdrawing Treatment 2117
A number of countries have enacted laws to enable the
protection or even simple recognition of the fetus. Recognition
may be granted under specific conditions, such as being a victim
of crime, a beneficiary of insurance, or as an inheritor of property.
For example, the Unborn Victims of Violence Act is a United
States law passed in 2004 that defines violent assault committed
against pregnant women as being a crime against two persons: the
woman and the fetus she is carrying. 69
There have also been a number of initiatives which discourage
women from engaging in certain behaviors deemed to be detrimental
to the health or development of the fetus. The most
obvious of these are the misuse of alcohol or tobacco. For example,
there is evidence that the use of tobacco products or exposure to
secondhand smoke during pregnancy is linked to low birthweight,
70 whereas many countries encourage those who are pregnant
to avoid alcohol. However, it is still unclear whether society
has a moral right to police and control the behavior of pregnant
women. If it is felt that it does, what will limit those controls? More
worryingly, such a course of action may lead to pregnant women
either avoiding prenatal care or withholding information, both of
which may actually lead to even more harm befalling the fetus.
On the other hand, society has a duty to protect the future child
and this right to be born healthy needs to be balanced against
a pregnant woman’s right to freedom of choice and control over
her own life.
Although no U.S. state has enacted laws which criminalize
specific behavior during pregnancy, many women have been
criminally prosecuted or arrested under existing child abuse
statutes for allegedly bringing about harm in utero through their
conduct during pregnancy. 71 It must be stressed that many of these
convictions have been overturned on appeal.
A different form of fetal rights protection has arisen because of
cultural preferences for male children. Some countries have passed
laws restricting the practice of abortion based upon the gender of
the fetus. India banned the practice of abortion for reasons of fetal
sex in 2002 and China in 2003.
On the other hand, some governments have enacted laws stating
that fetuses are not legally recognized persons. The Canadian
Criminal Code, section 223, states that a fetus is a “human being …
when it has completely proceeded, in a living state, from the body
of its mother whether or not it has completely breathed, it has an
independent circulation or the navel string is severed.”
Similarly, in the case of Vo v. France (European Court of Human
Rights/France) it was argued that the European Convention for the
Protection of Human Rights and Fundamental Freedoms did not
protect the rights of an unborn fetus and that recognizing an
unborn fetus’s right to life would threaten women’s human rights by
permitting a government to privilege the rights of a fetus over those
of a pregnant woman. Furthermore, if upheld, it would have
rendered the abortion laws of most member countries invalid
under Article 2. The European Court of Human Rights agreed and
in July 2004 issued a decision in which it declined to recognize a
fetus as a person under the European Convention.
CONCLUSION
Ethical and legal issues pertaining to pediatrics are complicated
by the special vulnerability of the subjects. The competence of
children and the legality of their consent also create uncertainty.
Religious beliefs and social demands merely serve to confuse
further. It remains very difficult to give precise answers to many of
the questions that pediatric anesthesiologists would like answered.
Frequently, the introductory statement in many arguments is “the
legal position seems to be …” The uncertainties of the law, compounded
by the fact that different countries have unique legal
systems and interpret ethical issues differently, does not help. Also,
ethical beliefs change with time. What is currently thought ethical
was not necessarily so a few years ago, and vice versa. The law
tends to change even more slowly and takes time to catch up with
current ethical thinking. The answers to many issues are therefore
constantly changing. It is hoped that, in the future, the European
Community may analyze the various issues involved and issue
guidelines to ensure the safety and protection that children deserve.
REFERENCES
1. British Medical Association. Medical Ethics Today: The BMA’s Handbook
of Ethics and Law. 2nd ed. London: BMJ Books; 2004. p. 72.
2. Skegg PDG. Law, Ethics and Medicine. Oxford: Clarendon Press; 1984.
3. Schloendorff ME. Appellant v. The Society of the New York Hospital,
Respondent. Court of Appeals of New York 211 N.Y. 1914; 125; 105 N.E. 92.
4. Mason JK, Laurie GT. Biomedical human research and experimentation.
In: Mason JK, McCall-Smith RA, editors. Law and Medical Ethics. 7th ed.
New York: Oxford University Press; 2006. p. 353–354.
5. United Nations Convention on the Rights of the Child, Article 12.
November 20, 1989.
6. Johnston v. Wellesley Hospital (1971). 2 OR 103, (1970) 17. Dominion
Legal Rep (DLR 3d) 139 (Ont. H.C.).
7. Catholic Children’s Aid Society of Metropolitan Toronto v. K. (Ontario
District Court). Rep Fam Law (RFL 2d). 1985;47:361.
8. Gillick v. West Norfolk AHA (1984). 1 All England Rev 365 (1985); 3 All
England Rev 402, HL.
9. Lord Browne-Wilkinson (1997). 4 All England Rev 771 at 779. Butterworth’s
Med Law Rev (BMLR). 1998;39:1–10.
10. Giesen D. International Medical Malpractice Law: A Comparative Study
of Civil Responsibility Arising From Medical Care. Tübingen: JCB Mohr
Siebeck Verlag; 1988. p. 940.
11. British Medical Association. Medical Ethics Today: The BMA’s Handbook
of Ethics and Law. 2nd ed. London: BMJ Books; 2004. p. 135.
12. General Medical Council. 0–18 years: guidance for all doctors. In:
Regulating Doctors and Ensuring Good Medical Practice. General Medical
Council; 2007. p. 52. Available at: http://www.gmc-uk.org/guidance/
children_and_young_people.asp. Accessed September 22, 2010.
13. Hoggett B. Parents, children and medical treatment: the legal issues. In:
Rights and Wrongs in Medicine. Byrne P, editor. London: King’s Fund; 1986.
pp. 163–175.
14. Douglas G. The retreat from Gillick. Modern Law Rev. 1992;55:569–573.
15. Re R (a minor) (wardship: medical treatment) Fam11. Butterworth’s Med
Law Rev (BMLR) Canada. 1992;7:147.
16. Re W (a minor) (medical treatment) (4 All England Rev 627). Butterworth’s
Med Law Rev (BMLR). 1992;9:22.
17. Re M (child: refusal of medical treatment) Federal Legal Reports (2 FLR
1097). Butterworth’s Med Law Rev (BMLR). 2000;52:124.
18. Mason JK, Laurie GT. Consent to treatment. In: Mason JK, McCall-Smith
RA, editors. Law and Medical Ethics. 7th ed. New York: Oxford University
Press; 2006. p. 372.
19. Montgomery J. Health Care Law. New York: Oxford University Press;
1997. p. 286.
20. Northern Ireland. Houston (applicant). Butterworth’s Med Law Rev (32
BMLR 93) 1996. Children (Scotland) Act 1995 s15(5)(b). Summarized in:
British Medical Association, Ethics Department. Medical Ethics Today:
The BMA’s Handbook of Ethics and Law. 2nd ed. London: BMJ Books;
2004. p. 143.
21. Mason JK, Laurie GT. In: Mason and McCall-Smith’s Law and Medical
Ethics. 7th ed. New York: Oxford University Press; 2006. p. 223.
22. Association of Anaesthetists of Great Britain and Ireland. Management of
Anaesthesia for Jehovah’s Witnesses. 2nd ed. London: AAGBI; 2005. p. 9.
Available at: http://www.aagbi.org/publications/guidelines/docs/jehovah.
pdf. Accessed September 22, 2010.
23. Re: T. All England Law Rep. 1992;4:647–670.
24. Couture-Jacquet v. Montreal Children’s Hospital. Dominion Legal Rep
(DLR 4th) (Quebec). 1986;28:22.

2118 PART 6 ■ Specific Considerations
25. The Female Genital Mutilation Act 2003 (England). Local Authority
Social Services Letter (LASSL) 2004. 4. Available at: http://www.
dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Localauthorit
ysocialservicesletters/AllLASSLs/DH_4074779. Accessed September 22,
2010.
26. Brazier M. The practice of medicine today. In: Brazier M, Cave E, editors.
Medicine, Patients and the Law. Harmondsworth: Penguin Books; 1992:
10:73–93.
27. Williams N, Kapila L. Complications of circumcision. Brit J Surg. 1993;80:
1231–1236.
28. Management of Foreskin Conditions and Male Circumcision. Statement
from the British Association of Paediatric Urologists, the Royal College of
Nursing, the Royal College of Paediatrics and Child Health, the Royal
College of Surgeons of England and the Royal College of Anaesthetists.
2007. Available at: http://www.rcseng.ac.uk/media/medianews/statement
onmalecircumcision. Accessed September 22, 2010.
29. Wheeler R. Gillick or Fraser? A plea for consistency over competence in
children. Brit Med J. 2006;8:807–812.
30. Dwyer JG. Parents’ religion and children’s welfare: debunking the doctrine
of parents’ rights. Calif Law Rev. 1994;82:1371–1447.
31. Re J (a minor) (prohibited steps order: circumcision), sub nom Re J
(child’s religious upbringing and circumcision) and Re J (specific issue
orders, Muslim upbringing and circumcision). Federal Legal Rep (1 FLR
571) 2000 and Federal Court Rep (1 FCR 307) 2000. Butterworth’s Med
Law Rev (BMLR). 2000;52:82–96.
32. Re S (children) (specific issue: circumcision). Federal Legal Rep (FLR).
2005;1:236.
33. Simms v Simms. Weekly Law Rep (WLR). 2003;2:1465 and All England
Law Rep (All ER). 2003;1:669.
34. Convention for the Protection of Human Rights and Fundamental
Freedoms (CETS 005). The European Convention on Human Rights.
Strasbourg, France: Council of Europe. Rome (4.IX.1950, TS 71; Cmnd
8969). Human Rights Act 1988. Available at: http://conventions.coe.
int/treaty/Commun/QueVoulezVous.asp?NT=005&CL=ENG. Accessed
September 22, 2010.
35. The law and ethics of male circumcision—guidance for doctors. British
Medical Association. Available at: http://www.cirp.org/library/statements/
bma2003/. Accessed September 22, 2010.
36. Human Tissue Act 2004. Her Majesty’s Stationery Office. Available at:
http://www.opsi.gov.uk/acts/acts2004/pdf/ukpga_20040030_en.pdf.
Accessed: April 21, 2010.
37. Council of Europe. The European Convention on Human Rights and
Biomedicine. Additional Protocol to the Convention on Human Rights
and Biomedicine. On Transplantation of Organs and Tissues of Human
Origin. 2002; Article 14. 2008. Strasbourg, France: European Union.
Available at: http://conventions.coe.int/Treaty/EN/Treaties/Html/186.
htm. Accessed: April 21, 2010.
38. McLean SAM. A patient’s right to know. In: Legal Issues in Medicine.
Aldershot: Gower/Darmouth Publishing; 1989. pp. 93–113.
39. Sidaway v. Bethlem Royal Hospital Governors. All England Law Rep (All
ER). 1985;1:643 HL.
40. Bovine Growth Hormone. 21 September 1982 (VI ZR 302/80) VersR 1982
(1193–1194).
41. Beauchamp TL, Childress JF. Principles of Bioethics. 4th ed. New York:
Oxford University Press; 1994. p. 270.
42. Bolam v Friern. Hospital Management Committee. All England Law Rep
(2 All ER 118) 1957 and Weekly Law Rep (1 WLR 582) 1957.
43. Mason K. Consent to treatment and research in the ICU. In: Ethics and the
Law in Intensive Care. Pace NA, McLean SAM, editors. New York: Oxford
University Press; 1997. p. 38.
44. Maynard v. West Midlands Regional Health Authority. All England Law
Rep (1 All ER 635). 1985.
45. Scarman L. Law and medical practice. In: Byrne P, editor. Medicine in
Contemporary Society. London: King Edward’s Hospital Fund for London;
1987. p. 134.
46. Bolitho v. City and Hackney Health Authority. All England Law Rep
(4 All ER 771). 1997.
47. Giesen D. The patient’s right to know—a comparative law perspective.
Med Law. 1993;12:553–565.
48. Canterbury v. Spence (1972). 464 F2d 772 (DC Cir 1972).
49. Rogers v. Whittaker (HC Australia). Med Law Rev (4 Med LR 79) 1993
50. Edgars J, Morton NS, Pace NA. Review of ethics in paediatric anaesthesia:
consent issues. Paed Anaesth. 2001;11;355–71.
51. Bovine Growth Hormone. (1984) 7 Feb 1984 (VI ZR 174/82) BGHZ 90,
103 (107–108, 111).
52. European Parliament and of the Council of Europe. Directive 2001/20/EC
on the approximation of the laws, regulations and administrative
provisions of the Member States relating to the implementation of good
clinical practice in the conduct of clinical trials on medicinal products
for human use. J Eur Communities. 2001;April 4:L121–134.
53. The Medicines for Human Use (Clinical Trials) Amendment (No. 2)
Regulations. Queen’s Printer of Acts of Parliament. United Kingdom. The
Stationery Office Limited; 2006. Schedule 1, Part 4.
54. Evans D, Evans M. A Decent Proposal: Ethical Review of Clinical Research.
Chichester: J Wiley & Sons; 1996. p. 99.
55. Human D, Fluss SS. World Medical Association’s Declaration of
Helsinki: Ethical Principles for Medical Research Involving Human
Subjects. 52nd World Medical Association General Assembly, Edinburgh,
Scotland, October 2000.
56. The Medicines for Human Use (Clinical Trials) Amendment (No. 2)
Regulations. Queen’s Printer of Acts of Parliament. United Kingdom. The
Stationery Office Limited; 2004. Schedule 1, Part 4.
57. Children’s Act 2004. Amendment of Section 67 of the Children’s Act 1989,
s.2 (7). England: Office of Public Sector Information. 2004.
58. Re R (a minor) (wardship: medical treatment). All England Law Rep (All
ER). 1991;4:184.
59. Alderson P. Competent children? Minors’ consent to health care
treatment and research. Soc Sci Med. 2007;65:2272–2283.
60. Redmon RB. How children can be respected as “ends” yet still be used as
subjects in non-therapeutic research. J Med Ethics. 1986;12:77–82.
61. Dworkin G. Legality of consent to non-therapeutic medical research on
infants and young children. Arch Dis Child. 1978;53:443–446.
62. Somerville MA. Therapeutic and non-therapeutic medical procedures—
what are the distinctions? Health Law Can. 1981;2:85–90.
63. S v. S. All England Law Rep (All ER). 1970;3:107, HL.
64. Hull D. Guidelines for the ethical conduct of medical research involving
children. Royal College of Paediatrics and Child Health: Ethics Advisory
Committee. Arch Dis Child. 2000;82:177–182.
65. Institute of Medical Ethics. Medical research with children: ethics, law
and practice. Bull Med Ethics. 1986;14:8.
66. Medical Research Council Ethics Guide. Medical Research Involving
Children. London: Medical Research Council; 2004.
67. Withholding or withdrawing life sustaining treatment in children—a
framework for practice. 2nd ed. London: Royal College of Paediatrics and
Child Health; 2004.
68. Farmer R. “Fetal rights” initiatives concern abortion rights supporters.
National Organization for Women. 2001. Available at: http://www.now.
org/nnt/fall-2001/fetalrights.html. Accessed September 22, 2010.
69. Congress of the United States of America. The Unborn Victims of
Violence Act of 2004. H.R. 1997. Public Law 108–212. March 25, 2004.
70. Rosenburg J. Low birth weight is linked to timing of prenatal care and
other maternal factors. Int Fam Plan Perspect. 2006; July 31.
71. Center for Reproductive Rights. Punishing women for their behavior during
pregnancy: an approach that undermines women’s health and children’s
interests. New York, NY: Center for Reproductive Rights; 2000;1:71.