Review Article

Sahana Shiva
Understanding the Importance of Informed
Kumar1, Shiva Kumar Consent in Dentistry
GC2, Gargi Saran3,
Adit Srivastava4 Abstract
1
Reader, Department of
Public Health Dentistry, Patients today are better aware of dental treatment options. It is hence important to
2
Professor, Department of have proper documentation of the prescribed treatment to prevent any legal suit.
Oral Medicine and Informed consent is the acceptance given by the patient for a particular treatment
3
Radiology, Sr. Lecturer, based on the information provided by the dental practitioner.
Department of Oral
Medicine and Radiology,
Babu Banarasi Das College
Keywords: Informed consent, Dentistry, Dental treatment, Patient.
of Dental Sciences,
Lucknow, Uttar Pradesh, Introduction
India.
4 Obtaining informed consent has become an important part of practice management
Associate Professor,
Department of Oral
today. The process of obtaining informed consent as a part of legal documentation
Medicine and Radiology, started in the mid-1980s when the number of malpractice claims increased. As dentists
Faculty of Dental did not have enough knowledge regarding the moral, legal and ethical issues of the
Sciences, IMS, BHU, profession, plaintiffs walked away with an inordinate level of success. In this backdrop,
Varanasi. Uttar Pradesh, arose the process and documentation of informed consent to defend themselves if
India. subjected to litigation.1
Correspondence to:
Dr. Sahana Shiva Kumar, It is the right to be informed as the fundamental human right to life and freedom of
Reader, Department of every individual. The autonomous right to exercise freedom requires knowledge, truth,
Public Health Dentistry, reality and the right to ownership of one’s health. The doctor on the other hand is
Babu Banarasi Das College
obliged to provide the information to the patient in order to self-determine the right to
of Dental Sciences,
Lucknow, Uttar Pradesh,
freedom. The doctor or physician has to inform the patient before providing any
India. treatment along with the reason for the treatment. The moral principle underlying
informed consent was first attested by the Nuremberg Code in 1948. This led to the
E-mail Id: sahana_shiv@
yahoo.com
origin of Decalogue of moral principles in medical practice and research on human
beings, voluntarily participating in research.2

Informed consent is defined as “the process of presentation/information/acceptance of

all aspects of the assumed treatment plan and its implementation relevant to the
person who voluntarily confirms his desire to accept or not3 OR a patient’s knowing
choice about a medical or dental treatment or procedure, made after a physician or a
dentist discloses whatever information a reasonably prudent provider in the medical
community would give to a patient regarding the risk involved in the proposed
treatment or procedure.”4 As a rule, the discipline of medicine implies that any
competent patient should not be treated without prior information about the diagnosis,
How to cite this article: disease progression with or without treatment, the complications, therapeutic
Kumar SS, Kumar SGC,
alternatives, prognosis and his consent. Informed consent evolved on the basis of bio-
Saran G et al.
Understanding the ethical principle of autonomy and beneficence, which gives the patient freedom to
Importance of Informed actively participate and make decisions about their treatment instead of relying on the
Consent in Dentistry. . J health professional’s decision.5
Adv Res Dent Oral Health
2016; 1(3&4): 26-28. Types of Informed Consent

ISSN: 2456-141X Three types of consent exist in dentistry. They are:6

1. Implied consent: This is a type of consent when a patient passively cooperates in a

dental treatment process without discussion or formal consent. There is no

© ADR Journals 2016. All Rights Reserved.

J. Adv. Res. Dent. Oral Health 2016; 1(3&4)
documentation in the clinical record, but the dentist
provides adequate and accurate information
regarding the how and why of the procedure being
performed.
2. Verbal consent: This is a type of consent given
verbally by the patient but a signed written form is
not obtained. This is taken for diagnostic
procedures and prophylaxis.
3. Written consent: This is a type of consent which is
taken in case of extensive intervention like surgical
procedures or when anesthesia or sedation is
required. In any of the intervention involving risks, a
written documentation is obtained.
Factors to be Considered in Obtaining Informed
Consent
1. Diagnosis of the problem/dental condition: The
dental practitioner must present the information
obtained after examination and arriving at a
diagnosis to the patient in a simple, yet
comprehensive manner.
2. Recommended treatment plan: After establishing a
diagnosis, the dentist then decides a treatment
plan. This plan should be discussed with the patient
describing the nature of the treatment and the
entire procedure which will be performed. It is the
duty of the dentist to even let the patient know as
to why was this approach favored.
3. Alternative treatment plans: The dentist must
always keep alternative treatment strategies, if the
primary treatment plan is not acceptable to the
patients for any reason. If the alternative procedure
cannot be performed by the primary dentist, then
the patient should be referred to an appropriate
practitioner who can do it.
4. Potential risks of all treatment alternatives: It is the
responsibility of the dentist to brief the patient
regarding potential and reasonable risks arising out
of the procedures which are planned. Rare,
undesirable risks need not be presented. For
example, the possibility of paresthesia resulting
from extraction of mandibular third molar must
always be briefed to the patient. This is not the case
with the administration of inferior alveolar nerve
block injection. As a matter of law, briefing on these
rare side effects will result in resistance to
treatment from a reasonable person.
5. Potential risks of no treatment: The dentist also
bears the responsibility of any possible risks
associated with not proceeding with the proposed
treatment plan. This is referred to as “informed
refusal”. For example, a patient who refuses to
undergo endodontic treatment must be explained
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Kumar SS et al.
the potential for infection, pain, loss of tooth and
concomitant restorative consequences.
Dental Treatment and Informed Consent
Obtaining informed consent is a must to the dental
profession. But do all procedures require written,
informed consent? It is only those procedures which are
either “invasive or irreversible” that require informed
consent. Patient going to the dentist for an examination
of some problem gives an implied consent to get
himself/herself examined by the dentist. Most dentists
take for granted that this implied consent cannot be
applied for surgical purposes.
The oral cavity harbors a dynamic environment due to
forces of the tongue, lips, cheeks and teeth, which gets
affected even with minor changes in the dentition,
masticatory function or TMJ function. Any procedure
performed like a minor buccal pit restoration or a major
removal of impacted third molar, will result in
irreversible change to body tissues risking some
unwanted side effect or complication.
An extension of the implied consent holds good for
clinical examinations, periodontal probing and
radiograph taking. This ensures that the dentist can
obtain all information necessary to make an accurate
diagnosis of the oral condition. But, if a patient does not
want to undergo a radiographic examination, it should
be treated as “informed refusal” and the consequences
of inaccurate assessment must be explained along with
a written documentation for the refusal.7
Exceptions for Informed Consent
An informed consent is not deemed necessary in a few
situations like:
• Cases of emergency, wherein providing treatment is
a necessity and of first importance and there is no
written advance directive by the patient to the
contrary.
• In case of mental health patients, medical
treatments or interventions authorized by statute
such as compulsory drug screening and certain
procedures.
• As per the direction of the court, if any medical
treatment or intervention is to be carried out or
ceased.
• Proxy consent: This is consent obtained from other
individuals on behalf of children or minors. Consent
for children or young persons is generally given by
their parents. Patients who are under age or minors
and adults with diminished mental capacity should
ISSN: 2456-141X
Kumar SS et al.
be treated only after consented by a parent or legal
guardian. It is not necessary that the adult
accompanying the pediatric patient has to be the
legal guardian. It could be any individual who is
allowed by the law to consent to medical or dental
procedures. They can be grandparents, stepparents,
non-custodial parent or a family friend.8
Elements of an Informed Consent
The dental practitioners must have separate “informed
consent” and “informed refusal” forms. The consent
forms must be framed in an easily comprehensive
manner, use simple terms and be specific. The informed
consent form must include:
• Legal name of the patient
• Relationship of the person consenting on behalf of
the patient, if it is a pediatric patient
• Diagnosis of the present condition
• Treatment plan – as to why it is the recommended
strategy
• Benefits and risks of the proposed treatment
• Alternative treatments
• Signatures of the patient, legal guardian or parent,
dentist and a witness (generally an office member)
Informed Consent and Legal Issues
The signed informed consent is not a civil contract
between the doctor and the patient. It is only a moral
responsibility. This does not represent a legal
framework at all and hence does not cancel the civil
rights of the patient or his fundamental rights. It only
represents the proof that the patient has understood
the information provided to make a decision. Similarly,
the consent obtained does not include any legal liability
of the doctor in case of treatment failure. It only has a
liability for negligence or recklessness in the process of
diagnosis, therapeutic decision, curative or medical
care.
ISSN: 2456-141X
J. Adv. Res. Dent. Oral Health 2016; 1(3&4)
Conclusion
To conclude, when any invasive or irreversible
procedures are performed, it is mandatory to obtain
“informed consent”. If a patient refuses any diagnostic
test or procedure which is necessary to determine the
diagnosis, then an “informed refusal” must be obtained.
This practice will save the dental profession from any
legal conflict, if a mishap arises.
Conflict of Interest: Nil
References
1. Caraiane A, Bartok FF, Nicolae C. The importance of
Informed consent in the accusations of malpractice
in dentistry. Ovidius Dentistry Journal 2014; 1(1): 1-
3.
2. U.S. National Institutes of Health, Office of Human
Subjects Research. “Nuremberg Code”. Reprinted
from Trials of war criminals before the Nuremberg
Military Tribunals under Control Council Law No.
10. 1949; 2: 181-82.
3. Gerson JC, Gralnick JA, Borgeest K et al. The
importance of written consent forms in dental
malpractice litigation: Not just for surgeons
anymore. Dental Dateline Fall 2009; 1-3.
4. Black’s Law Dictionary 2001; 2nd pocket edition:
130.
5. Wu WC, Pearlman RA. Consent in medical decision
making. JGIM 1998; 1(3): 9-14.
6. Mirza AM. Importance of informed consent in
dentistry. International Dental Journal of Student’s
research 2012; 1(2): 13-16.
7. Kakar H, Gambhir RS, Singh S et al. Informed
Consent: Corner stone in ethical medical and dental
practice. J Family Med Prim Care 2014; 3(1): 68-71.
8. American Academy of Pediatric Dentistry-
Guidelines of Informed consent. Reference Manual
2005; 37(6): 315-17.
Date of Submission: 08th Dec. 2016
Date of Acceptance: 20th Dec. 2016
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