JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES

Informed Consent in Pediatric Dentistry: Ethics

Viswanath D, Sarma A.
and Pitfalls-A Review. J Pharm Biomed Sci 2014;04(10):834-838.

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Review article
Informed Consent in Pediatric Dentistry:
Ethics and Pitfalls- A Review
Deepak Viswanath1,*, Anindita Sarma2
Affiliation:-
1*
Professor and Head,2Postgraduate Student,
Department of Pedodontics and Preventive Dentistry,
Krishnadevaraya College of Dental Sciences, Int.
Airport Road, Hunasamaranahalli, Bangalore, India-
562 157
The name of the department(s) and institution(s) to
which the work should be attributed:
Department of Pedodontics and Preventive Dentistry,
Krishnadevaraya College of Dental Sciences, Int.
Airport Road, Hunasamaranahalli, Bangalore, India-
562 157.
Address reprint requests to
Dr.Deepak Viswanath,
Department of Pedodontics and Preventive Dentistry,
Krishnadevaraya College of Dental Sciences ,Int.
Airport Road, Hunasamaranahalli, Bangalore, India-
562 157 or at pedodons@gmail.com
Article citation: Viswanath D, Sarma A. Informed Consent
in Pediatric Dentistry: Ethics and Pitfalls- A Review.
INTRODUCTION
HISTORICAL BACKGROUND
E very phenomenon is followed by some or
the other historical background but the
interest to know the origin and the history of
anything emerges only when the phenomenon
becomes significant to mankind. Informed consent
took a long span of time to come into practice
through many endeavours.
In 18th century, United States physician named
Benjamin Rush, who was influenced by the Age of
Enlightenment cultural movement had advised
that doctors should share as much information as
possible with patients. He suggested that doctors
should educate the public and respect a patient's
informed decision to accept therapy1.
In Nuremberg, Germany, on December 19, 1946, a
trial was conducted of Nazi doctors and a code was
defined in which Americans judges, clearly
emphasized a view of medical research and
technology: science should never transform or
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Pharm Biomed Sci. 2014;04(10):834-838.
Available at www.jpbms.info
ABSTRACT
Informed consent is a leading topic of interest in
health care field. This paper aims at all the pros and
cons of informed consent in dentistry with special
attention to the pediatric sector. The communication
by medical and dental practitioners has to be
legitimate as the patient’s right to know constitutes
the basis of modern medical ethics. It is important
for every dentist to know and learn about informed
consent not only on medico-legal grounds but also to
build trust with the patients.
KEYWORDS: Battery; Behaviour management;
Bolam Test; Informed Consent; Pediatric informed
consent.
J Source of support: None
consider human beings as an instrument to be
employed for scientific purposes2.
The Nuremberg Code, established in 1947,
mandates that ‘there should be made known’ to
each research subject: ‘the nature, duration and
purpose’ of the intervention; the method and
means by which it is to be conducted; all
conveniences and hazards reasonably to be
expected; the effects upon his health or person
which may possibly come’; and the ‘liberty’ to
withdraw if he has reached the physical or mental
state where continuation of the experiment seems
to him to be impossible’3. Patients have complete
rights to know and to take decision and it is based
on the ethical concept of patient autonomy. The
‘basis of consent’ to medical or dental treatment
was expressed by an American judge, Cardozo, in
the case of Schloendorff vs Society of New York
Hospital (1914), as:
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 his patient’s consent commits
an assault4.
The standard of medical care to disclose risks has
been laid down by the Bolam test in 1957 by the
famous English case of Bolam vs Frien Hospital
Management Committee (1957) 5.
The Bolam test give rise to the three essential
elements:
•The practicing methods of the doctors must be
proper;
•This practice should be ‘accepted’ as proper by a
‘responsible body of skilled dental professionals.’
• Factually, if a contrary view is given for the
accepted method of the doctor’s practice, it does
not make the doctor negligent.
The responsible body of medical professionals is
subjected to the scrutiny of court to ensure that it
can withstand logical analysis6.
As the human subject or volunteer may not receive
any direct benefit from the clinical research trial,
Informed consent is much stricter in clinical
studies.
In the present scenario, informed consent is of
prodigious importance to the dental and medical
professions because of modern ethical issues and
medico-legal consequences. This paper reviews the
importance of exchange of information between
the pediatric dental practitioners and the patients
as the patient’s right to know constitutes the basis
of modern medical ethics.6 Law and ethics limits
the conduct of the doctor so as to ensure that the
patient is not harmed at any cost. The pediatric
dentist "should view informed consent as a means
of helping the patient, not merely as a legal
obligation, and conversely, should not use the
consent form as a shortcut to patient discussion
and communication."3. "Consent is willingness in
fact for conduct to occur. It can be manifested by
action or inaction. Consent refers to a patient’s
authorization to be treated by a physician or other
health care provider.
Consent may be either expressed (spoken or
written) or implied by inference from a patient’s
conduct.
"Informed consent is most clearly defined in
guidelines on consent to medical research, not to
treatment.’’ The American Academy of Pediatric
Dentistry (AAPD) recognizes informed consent as
essential in the delivery of health care7. The
informed consent process allows the patient or the
custodial parent/ legal guardian, in case of minors,
to participate in and retain autonomy over the
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health care received. Informed consent also may
decrease the practitioner’s liability from claims
associated with miscommunication. This guideline
reflects that informed consent is governed by the
law and order of individual states and those oral
health care providers should review applicable
state law and regulations8. The informed consent
doctrine serves primarily to protect a patient’s
right of self-determination, and to allow a patient
the freedom to determine what should be done
with one’s body. Professor Alexander Capron,
however, insists that "The doctrine can serve six
salutary functions. It can:
1. Protection of individual autonomy
2. Protection of the patient’s status as a human
being
3. Avoidance of fraud or duress
4. Encouragement of doctors to carefully consider
their decisions
5. Rational decision-making by the patient and
6. Involvement of the public generally in medicine4.
CONCEPTS OF INFORMED CONSENT
The concept of informed consent is guided by
elements of consent1.
 Disclosure: the subject should receive a
thorough disclosure of information about an
intervention.
 Comprehension: The subject should fully
understand the intervention
 Voluntariness: The subject acts “voluntarily” in
giving consent.
 Competent: The subject should be fully
competent to give consent.
 Consent: The subject should provide consent
either oral or written.
ETHICS IN INFORMED CONSENT
Informed consent is an ethical concept that has
become integral to modern medical and dental
profession. The present scenario of dental practice
reveals that informed consent has still not been
able to anchor itself in dental practice.
BATTERY VERSUS NEGLIGENCE
A failure to obtain informed consent may result in
litigation based on the legal concepts of negligence
and / or battery. However negligence differs from
battery. Negligence occurs when health care
standard is not up to the mark and incurs injury to
the patient instead of improvement in health.
Battery, on the contrary, occurs because of an
injury to one’s dignity8.

PROFESSIONAL VERSUS LAY STANDARD
Requirement of the informed consent is to
determine the disclosure standards or the judicial
treatment of the adequacy of the disclosure. The
two major standards existing today are the
professional medical standard (traditional
standard) and the lay standard (material risk or
prudent patient standard). The professional
standard needs the doctor to reveal all risks that
another medical practitioner would reveal under
the same circumstances. The lay standard needs
the disclosure to be determined by the patient’s
need for information (e.g. material which is to be
used) to make a decision of accepting or declining
the treatment3.
AGE SPECIFICATIONS
As per Indian penal code (IPC) 87 and 88, persons
above 18 years of age can give valid consent either
implied or expressed. In case of children under 12
years of age and in persons of unsound mind, IPC
89 prescribes that consent should be obtained
from the guardian or other person having lawful
charge of that person for any act done in good faith
for the person involved9.
PAEDIATRIC INFORMED CONSENT
It is understood that the patient granting consent
is an adult. Patients who are not adults or are with
less mental ability should have treatment consent
obtained from a parent or legal guardian. The adult
accompanying the pediatric patient must be
his/her legal guardian which means the adult has
been allowed by law to give consent on the
patients’ behalf for performing any medical
procedures. This means that a grandparent,
stepparent, noncustodial parent in instances of
divorce, babysitter, or friend of the family cannot
provide consent for a child unless confirmed as
legal guardian by court. An orphan or any child in
ward can be accompanied by a caregiver but the
caregiver will be subjected to legal confirmation of
guardianship for providing consent to medical
procedures. It is recommended that the oral
health care provider should obtain a copy of
authorization document to consent for medical
treatment for the patient7. As a thumb rule,
according to various courts; informed consent for
the medical/dental treatment of a child is to be
provided by the parents which is called proxy.
Proxy consent is at its peak of effectiveness when
the child understands and agrees with the parent
for the medical/dental treatment procedures. But
interestingly, if the child is "capable of appreciating
the nature, extent and probable consequences of
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the conduct consented to, although the consent of a
parent, guardian or other person responsible is not
obtained or is expressly refused, the child’s
consent will be taken into consideration3.
CONSENT FOR DENTAL TREATMENT
Consent for dental as well as medical treatment
may be established by interpretation of a patient’s
responses. Earlier, usually dental litigation cases,
with respect to informed consent, were reported
mostly because of insufficient disclosure of the
possible complications associated with dental
extractions3. One of the potential problems in
dentistry associated with the lack of informed
consent is the debatable safety of some of the
materials and/or medicaments used in the
treatment. Materials like mercury-containing
amalgam filling material, composite filling
material, formocresol, fluoride, and many more
have always been viewed as potential reasons for
health hazards3. However, application of these
substances cannot be diminished in the dental
procedures as they have many positive aspects
also. Therefore, it is important to obtain informed
consent before any treatment to avoid any legal
complication arising due to materials used in the
procedures.
CONSENT FOR PEDIATRIC DENTAL
TREATMENT
A licensed dental practitioner is allowed to provide
any kind of dental treatment to children but a
pediatric dental specialist will always be more
competent in meeting the unique dental health
care requirements of the pediatric population.’’ It
is usually seen that minor procedures like oral
prophylaxis, restorations are done without proxy
consent considering them to be low risk operations
but it is not advisable to do that. Thus, proxy
consent should cover each and every treatment
procedure without confining only to the major
ones. The pediatric dentist is responsible for
obtaining informed consent and should not be
delegated to an auxiliary. Medical terminologies
should be avoided during the conversation for
better comprehension of the procedures and the
risks involved. It is clearly understood that
although verbal consent may be sufficient for legal
needs, written consent is always safe and
important for more adequate documentation. It is
well recognized, that "a written consent isn’t worth
the paper it is printed on if, after reading it, the
patient hasn’t been informed! If oral consent is
obtained, it should be witnessed and documented
in the patient’s chart. This documentation is

essential as parents "may not recall or recognize
information given to them as part of the informed
consent process."This is particularly true after a
considerable period of time has elapsed or during
emergency situations. Since dental treatment often
is ongoing, it may not be necessary to obtain
specific informed consent for every procedure3.
CONSENT FOR BEHAVIORAL MANAGEMENT
Pediatric dentistry always revolves around
behaviour management of the children as
uncooperative children are encountered every
now and then in the clinics. Both the
pharmacological and non pharmacological
behaviour management techniques can be
subjected to jurisdiction if informed consent is not
obtained prior to the practice. Pediatric patients
who refuses or is incapable (mentally or physically
handicapped) of accepting the treatment are most
challenging to the dentists3. In such situation,
refusal or discontinuation of treatment to the child
is negligence and so dental treatment must be
provided to the child with the help of behaviour
management techniques. This has to be explained
clearly to the parents by the dentist and the
specific consent for it must be obtained. Of late it is
seen that many pediatric dentists are now
concerned with legal and ethical concerns
regarding these techniques and try to avoid them.
Although traditional management techniques such
as physical restraint, voice control, the hand-over-
mouth procedure, conscious sedation are widely
used and endorsed, yet some amount of hesitation
always accompanies these techniques10. The main
goal of the pediatric dentist is "to treat the child in
the most efficient manner with the least amount of
trauma to the child’’3. Recent studies indicate that
informed parents show a higher level of approval
of behavior management techniques than do
uninformed parents3.
In a study done by Keith D. Allen et al.11, four
methods were compared for informing parents to
gain their consent for eight pediatric dentistry
behavior management techniques. Descriptions of
each eight traditional child behavior management
techniques in pediatric dentistry were provided for
parental consent:
1. Tell-show-do (TSD)
2. Nitrous oxide (NO)
3. Passive restraint (PR)
4. Voice control (VC)
5. Hand-over-mouth (HOM)
6. Oral premedication (OP)
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7. Active/physical restraint (AR)
8. General anaesthesia (GA).
Methods were video/oral/ written presentation.
This research was designed to determine
1. Which way is best to inform the reasonable
patient (in this case, parents) about the eight
traditional management procedures?
2. According to parents which procedures should
require informed consent prior to intervention?
3. Out of all the traditional child behavior
management procedures, which are the ones that
parents are willing to consent for their children?
4. What are the variables that can influence
parents to give consent?
It was seen that handing parents a written form to
read independently and sign, or having them
watch videos depicting the techniques do not
appear to be adequate. Ensuring that the parents
have understood the procedure which will be done
and then acquiring consent is substantial.
CONTROVERSY FOR ADOLESCENTS’
INFORMED CONSENT
It is widely accepted that proxy informed consent
is obtained for minors which includes individuals
less than 18 years of age in India according to THE
INDIAN MAJORITY ACT, 1875. But many studies
reveal that decision making capacity of adolescents
is equivalent to that of adults. In a study done by
Weithorn LA, Campbell SB., it was seen that 14
year olds do not differ from that of adults in case of
competency while the 9 year olds executed less
competency than the adults12. Mini–Mental State
Examination (MMSE) and the MacArthur test are
however some tools used to find out about
competency of decision making for medical
consent in case of presumed incompetent
patient13. However, even the 9 year olds
conclusions did not differ from older subjects in
their expression of reasonable preferences
regarding treatment. It was concluded that the
denial of the right of self-determination to
adolescents in health-care situations cannot be
supported on the basis of a presumption of
incapacity. Children as young as 9 years appeared
able to participate meaningfully in personal health-
care decision making process14. Hence it is still a
controversy on the moral grounds whether an
adolescent should be given the rights to provide an
informed consent.
RECOMMENDATIONS (AAPD)7: Consent forms
should be specifically mention about the

procedure, make use of simple terminologies, and
avoid unnecessary statements.
When a practitioner utilizes an “informed consent”
form, the following points should be kept in mind:
1. Name and date of birth of pediatric patient;
2. Name and relationship to the pediatric
patient/legal basis on which the person is
consenting on behalf of the patient;
3. Description of the procedure in simple terms;
4. Disclosure of known adverse risk(s) of the
proposed treatment specific to that procedure;
5. Professionally-recognized or evidence-based
alternative treatment(s) to recommended therapy
and risk(s);
6. Place for custodial parent or legal guardian to
indicate that all questions have been asked and
adequately answered; and
7. Places for signatures of the custodial parent or
legal guardian, dentist, and an office staff member
as a witness.
CONCLUSION
Informed consent is an effective tool for providing
information to the patient and also to enhance the
trust between the patient and the dentist. It is the
moral duty of every dental health care giver to
provide each and every patient with adequate
information about all the treatment aspects so that
they can take an informed and rational decision. It
should not be only for medico-legal considerations
but also for the overall welfare of the entire dentist
as well as patient community that an informed
consent is obtained at the very outset to keep
mishaps at bay.
Competing interest / Conflict of interest
The author(s) have no competing interests for financial support, publication of this research, patents and royalties
through this collaborative research. All authors were equally involved in discussed research work. There is no
financial conflict with the subject matter discussed in the manuscript.
Copyright © 2014 Viswanath D, Sarma A. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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