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Journal of Pharmaceutical and Biomedical Sciences (J Pharm Biomed Sci.), Member journal.
Committee of Publication ethics (COPE) and Journal donation project (JDP).
ISSN NO- 2230 – 7885
CODEN JPBSCT
NLM Title: J Pharm Biomed Sci.
Review article
Affiliation:-
1*
Pharm Biomed Sci. 2014;04(10):834-838.
Professor and Head,2Postgraduate Student, Available at www.jpbms.info
Department of Pedodontics and Preventive Dentistry,
Krishnadevaraya College of Dental Sciences, Int. ABSTRACT
Airport Road, Hunasamaranahalli, Bangalore, India- Informed consent is a leading topic of interest in
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health care field. This paper aims at all the pros and
The name of the department(s) and institution(s) to cons of informed consent in dentistry with special
which the work should be attributed: attention to the pediatric sector. The communication
Department of Pedodontics and Preventive Dentistry, by medical and dental practitioners has to be
Krishnadevaraya College of Dental Sciences, Int. legitimate as the patient’s right to know constitutes
Airport Road, Hunasamaranahalli, Bangalore, India-
the basis of modern medical ethics. It is important
562 157.
for every dentist to know and learn about informed
Address reprint requests to consent not only on medico-legal grounds but also to
Dr.Deepak Viswanath, build trust with the patients.
Department of Pedodontics and Preventive Dentistry,
Krishnadevaraya College of Dental Sciences ,Int.
Airport Road, Hunasamaranahalli, Bangalore, India-
KEYWORDS: Battery; Behaviour management;
562 157 or at pedodons@gmail.com Bolam Test; Informed Consent; Pediatric informed
consent.
Article citation: Viswanath D, Sarma A. Informed Consent
in Pediatric Dentistry: Ethics and Pitfalls- A Review. J Source of support: None
INTRODUCTION
HISTORICAL BACKGROUND consider human beings as an instrument to be
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his own body; and a surgeon who performs an health care received. Informed consent also may
operation without his patient’s consent commits decrease the practitioner’s liability from claims
an assault4. associated with miscommunication. This guideline
The standard of medical care to disclose risks has reflects that informed consent is governed by the
been laid down by the Bolam test in 1957 by the law and order of individual states and those oral
famous English case of Bolam vs Frien Hospital health care providers should review applicable
Management Committee (1957) 5. state law and regulations8. The informed consent
The Bolam test give rise to the three essential doctrine serves primarily to protect a patient’s
elements: right of self-determination, and to allow a patient
•The practicing methods of the doctors must be the freedom to determine what should be done
proper; with one’s body. Professor Alexander Capron,
•This practice should be ‘accepted’ as proper by a however, insists that "The doctrine can serve six
‘responsible body of skilled dental professionals.’ salutary functions. It can:
• Factually, if a contrary view is given for the 1. Protection of individual autonomy
accepted method of the doctor’s practice, it does 2. Protection of the patient’s status as a human
not make the doctor negligent. being
The responsible body of medical professionals is 3. Avoidance of fraud or duress
subjected to the scrutiny of court to ensure that it 4. Encouragement of doctors to carefully consider
can withstand logical analysis6. their decisions
As the human subject or volunteer may not receive 5. Rational decision-making by the patient and
any direct benefit from the clinical research trial, 6. Involvement of the public generally in medicine4.
Informed consent is much stricter in clinical
studies. CONCEPTS OF INFORMED CONSENT
The concept of informed consent is guided by
In the present scenario, informed consent is of elements of consent1.
prodigious importance to the dental and medical Disclosure: the subject should receive a
professions because of modern ethical issues and thorough disclosure of information about an
medico-legal consequences. This paper reviews the intervention.
importance of exchange of information between Comprehension: The subject should fully
the pediatric dental practitioners and the patients understand the intervention
as the patient’s right to know constitutes the basis Voluntariness: The subject acts “voluntarily” in
of modern medical ethics.6 Law and ethics limits giving consent.
the conduct of the doctor so as to ensure that the Competent: The subject should be fully
patient is not harmed at any cost. The pediatric competent to give consent.
dentist "should view informed consent as a means Consent: The subject should provide consent
of helping the patient, not merely as a legal either oral or written.
obligation, and conversely, should not use the
consent form as a shortcut to patient discussion ETHICS IN INFORMED CONSENT
and communication."3. "Consent is willingness in Informed consent is an ethical concept that has
fact for conduct to occur. It can be manifested by become integral to modern medical and dental
action or inaction. Consent refers to a patient’s profession. The present scenario of dental practice
authorization to be treated by a physician or other reveals that informed consent has still not been
health care provider. able to anchor itself in dental practice.
Consent may be either expressed (spoken or
written) or implied by inference from a patient’s BATTERY VERSUS NEGLIGENCE
conduct. A failure to obtain informed consent may result in
"Informed consent is most clearly defined in litigation based on the legal concepts of negligence
guidelines on consent to medical research, not to and / or battery. However negligence differs from
treatment.’’ The American Academy of Pediatric battery. Negligence occurs when health care
Dentistry (AAPD) recognizes informed consent as standard is not up to the mark and incurs injury to
essential in the delivery of health care7. The the patient instead of improvement in health.
informed consent process allows the patient or the Battery, on the contrary, occurs because of an
custodial parent/ legal guardian, in case of minors, injury to one’s dignity8.
to participate in and retain autonomy over the
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PROFESSIONAL VERSUS LAY STANDARD the conduct consented to, although the consent of a
Requirement of the informed consent is to parent, guardian or other person responsible is not
determine the disclosure standards or the judicial obtained or is expressly refused, the child’s
treatment of the adequacy of the disclosure. The consent will be taken into consideration3.
two major standards existing today are the
professional medical standard (traditional CONSENT FOR DENTAL TREATMENT
standard) and the lay standard (material risk or Consent for dental as well as medical treatment
prudent patient standard). The professional may be established by interpretation of a patient’s
standard needs the doctor to reveal all risks that responses. Earlier, usually dental litigation cases,
another medical practitioner would reveal under with respect to informed consent, were reported
the same circumstances. The lay standard needs mostly because of insufficient disclosure of the
the disclosure to be determined by the patient’s possible complications associated with dental
need for information (e.g. material which is to be extractions3. One of the potential problems in
used) to make a decision of accepting or declining dentistry associated with the lack of informed
the treatment3. consent is the debatable safety of some of the
materials and/or medicaments used in the
AGE SPECIFICATIONS treatment. Materials like mercury-containing
As per Indian penal code (IPC) 87 and 88, persons amalgam filling material, composite filling
above 18 years of age can give valid consent either material, formocresol, fluoride, and many more
implied or expressed. In case of children under 12 have always been viewed as potential reasons for
years of age and in persons of unsound mind, IPC health hazards3. However, application of these
89 prescribes that consent should be obtained substances cannot be diminished in the dental
from the guardian or other person having lawful procedures as they have many positive aspects
charge of that person for any act done in good faith also. Therefore, it is important to obtain informed
for the person involved9. consent before any treatment to avoid any legal
complication arising due to materials used in the
PAEDIATRIC INFORMED CONSENT procedures.
It is understood that the patient granting consent
is an adult. Patients who are not adults or are with CONSENT FOR PEDIATRIC DENTAL
less mental ability should have treatment consent TREATMENT
obtained from a parent or legal guardian. The adult A licensed dental practitioner is allowed to provide
accompanying the pediatric patient must be any kind of dental treatment to children but a
his/her legal guardian which means the adult has pediatric dental specialist will always be more
been allowed by law to give consent on the competent in meeting the unique dental health
patients’ behalf for performing any medical care requirements of the pediatric population.’’ It
procedures. This means that a grandparent, is usually seen that minor procedures like oral
stepparent, noncustodial parent in instances of prophylaxis, restorations are done without proxy
divorce, babysitter, or friend of the family cannot consent considering them to be low risk operations
provide consent for a child unless confirmed as but it is not advisable to do that. Thus, proxy
legal guardian by court. An orphan or any child in consent should cover each and every treatment
ward can be accompanied by a caregiver but the procedure without confining only to the major
caregiver will be subjected to legal confirmation of ones. The pediatric dentist is responsible for
guardianship for providing consent to medical obtaining informed consent and should not be
procedures. It is recommended that the oral delegated to an auxiliary. Medical terminologies
health care provider should obtain a copy of should be avoided during the conversation for
authorization document to consent for medical better comprehension of the procedures and the
treatment for the patient7. As a thumb rule, risks involved. It is clearly understood that
according to various courts; informed consent for although verbal consent may be sufficient for legal
the medical/dental treatment of a child is to be needs, written consent is always safe and
provided by the parents which is called proxy. important for more adequate documentation. It is
Proxy consent is at its peak of effectiveness when well recognized, that "a written consent isn’t worth
the child understands and agrees with the parent the paper it is printed on if, after reading it, the
for the medical/dental treatment procedures. But patient hasn’t been informed! If oral consent is
interestingly, if the child is "capable of appreciating obtained, it should be witnessed and documented
the nature, extent and probable consequences of in the patient’s chart. This documentation is
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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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