Informed Consent
Dr. Natnael Habtamu (MD)
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Introduction
Science of dentistry Autonomy
• It’s necessarily generic/universal • Concerned with only individual
(holds true for large categories of patient
patients) • E.g.
• E.g. • An individual patient may not
agree that white teeth are
• Pain of toothache is unbearable desirable or may not submit
• Maintenance of functional teeth is themselves to the presumed norm
a benefit that teeth should be aligned.
• Aligned and white teeth are
desirable
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Introduction
• Providing care to individual patients → adjust the generic benefits &
needs and interests of individual patients.
• Prior to the 20th century, healthcare providers had been in the habit
of determining patients’ individual needs and interests independently
from actual patients. (Also known as paternalism approach)
• The Hippocratic Oath can be interpreted to justify such action: “I will apply
dietetic measures for the benefit of the sick according to my ability and
judgment.”
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Introduction
• Paternalism
• Soft Paternalism → making decisions for patients without involving them
• Hard Paternalism → making decisions against patients’ objections
• Autonomous individuals are free and able to determine the course of
their own lives, rather than being paternalistically directed by others
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Informed Consent
• The ethical principle of respect for patient autonomy has been
operationalized most clearly in the patient’s right to informed
consent.
• Misnomers regarding informed consent:
• Often expressed as a legal requirement prior to the treatment of patients.
• On this understanding the provision of information may be seen as nothing more than a
requirement to satisfy institutional or (perceived) legal rules
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Informed Consent
• Misnomers regarding informed consent:
• The phrase itself is a misnomer, or at least misleading, implying perhaps that
there is a deference between ‘consent’ and ‘informed consent’.
• For consent to be ethical or legally valid, it must always be an informed one.
• The difference only lies in the cause of action upon which to base claim.
• i.e. Claim for lack of consent → Trespass (battery); Claim for lack of ‘informed consent →
Negligence
• Implies that the provision of information is simply to obtain the patient’s
agreement to go ahead with the proposed treatment
• It’s not limited to merely agreeing to treatment; rather it’s about enabling choices in
recognition of a patient’s right to self determination.
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Informed Consent
• Elements
1. Competence
2. Disclosure
3. Understanding
4. Acceptance
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Informed Consent: Competence
1. Being legally of age
2. Ability to communicate choices
3. Understand relevant information
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Informed Consent: Competence
1. Being legally of age
• Treating children is different from treating adults primarily in the fact that
children are not autonomous
• Therefore their parents are required to make health-care decisions for them
• As children grow older and mature, they develop the capacity to be involved
in making decisions regarding their own health care
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Informed Consent: Competence
1. Being legally of age
• Children as young as 7 years old may be able to be involved in medical
decision making (After assessing their ability to understand and consent)
• However, they are said to provide informed decision via ascent (i.e. through their
parents) until they are of legal age (according to Ethiopia’s context 14 yrs olds??? But no
official legal statement)
• Exceptions where children are considered fully autonomous
• Young people who live separately from their parents, manage their own finances,
• Those who are married or have children of their own,
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Informed Consent: Competence
1. Being legally of age
• Difficulties when obtaining informed consent in minors:
• If an interested party believes the parent is not motivated by acting in the best interest
of the child, (e.g. refusal of immunization)
• Seek a court order that the requested medical care be provided to the child.
• Disclosure of information to children should always be truthful and should encompass
relevant information but what if the parents don’t wish certain info to be disclosed to
the child (e.g. HIV infection to the child)
• Adolescent or child requests the doctor not to inform parents about contraception or
pregnancy
• Consider disclosing to the parents, perhaps assisted by the doctor or social worker.
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Informed Consent: Competence i.e. apart from minors
such as
1. Being legally of age • Non-responsive
patients, or
2. Ability to communicate choices
• Legally
3. Understand relevant information incompetent
person/doesn’t
have decision
making capacity
• Under influence
(by alcohol, fear,
fraud)
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Informed Consent: Competence
• Legally incompetent/Non-responsive Cases
• First confirm the incompetency → Once confirmed consent must be obtained
through proxy→ Beyond this the court should be involved (in no next of kin to
give substituted consent)
• Presumed consent:
• When patients are unconscious or otherwise unable to make their wishes known and
authorize the dentist to initiate treatment.
• For example, a patient may suffer a cardiac arrest while in the dental chair.
• Thus performing emergency treatment is considered as presumed consent.
• Once patient is stabilized and regains consciousness, the consent can no longer be
presumed
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Informed Consent: Competence
• Legally incompetent/Non-responsive Cases
• Note: If a patient has become incompetent to make decisions, that does not
mean the patient has lost all rights.
• In fact, the patient has lost only one right: the right to consent to treatment.
• The patient retains other important patient rights, such as the right to information and
the right to confidentiality.
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Informed Consent: Disclosure
• What things to disclose:
❖Diagnosis
❖Purpose of proposed treatment / procedure
❖Possible risks and benefits of proposed treatment / procedure
❖Possible alternatives to proposed treatment / procedure
❖Possible risks of not receiving treatment / procedure
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Informed Consent: Disclosure
• How to disclose:
• Information should given to the patients in a way they can easily understand.
• It may involve using written material, visual or other aids (e.g. sign interpreter friend of
those who are hearing impaired)
• It should be part of an ongoing discussion between you and the patient.
• Don’t forget to disclose the necessary preparations for each treatment
protocol (especially financial preparations)
• Respond honestly and fully to any questions the patient has
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Informed Consent: Disclosure
• How to disclose:
• Involve other members of the dental team in discussion with the patient,
where appropriate.
• They may have valuable knowledge about the patient’s background and particular
concerns.
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Informed Consent: Understanding
• Grasping the central fact is enough in most cases:
• At least the purpose of the intervention, the risk , alternative
• Exceptions: e.g. interventions which have significant consequences.
• Assess patient understanding by stating,
• “If I have not explained the proposed dentistry clearly or if you have difficulty
understanding, please tell me so we can discuss anything you do not
understand.”
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Informed Consent: Consent
• Right to consent means that s/he can be treated if, and only if, the
patient agrees to proposed interventions.
• It should not be interpreted as
• A state sanctioned right to self-destruction
• Rather it reflects the belief that life-extension and health shouldn’t be justified by
paternalistic coercion of the healthcare provider.
• Patients demanding any treatment from their dentist.
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Informed Consent: Consent
• Explicit versus Implied consent
• E.g. 1: A patient comes to a dentist’s office for the dentist to take a basic
history and oral examination.
• E.g. 2: The above patient requires more drastic diagnostic examination
• E.g. 3: For the patient now a therapeutic plan is proposed
• E.g. 4: The patient has explicitly consented to a particular therapeutic plan
then the subsequent various actions that must be undertaken in realization of
that plan. (e.g. for a patient that consents to an operation, the consent to
suture the wound)
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Informed Consent: Consent
• Process of voluntary decision-making:
o The patient must make the decision
o Don’t pressure the patient to accept your advice
o Patients have a right to refuse to given consent for an investigation or
treatment (Respect their decision)
o Once a patient has given consent, they may withdraw it at any time, including
during the procedure
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Informed Consent: Consent
• Process of voluntary decision-making:
o Make sure that once the patient has given consent, they know how to review
the decision with the person providing the treatment
o Make sure that you are clear how much authority they have given you. For
example, whether the patient agrees to all or only part of a proposed
treatment plan.
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Informed Consent: Consent
• Explicit versus Implied consent
• E.g. 1: A patient comes to a dentist’s office for the dentist to take a basic
history and oral examination.
• IMPLIED CONSENT
• E.g. 2: The above patient requires more drastic diagnostic examination
• EXPLICIT CONSENT required
• E.g. 3: For the patient now a therapeutic plan is proposed
• EXPLICIT CONSENT required
• E.g. 4: The patient has explicitly consented to a particular therapeutic plan
then the subsequent various actions that must be undertaken in realization of
that plan. (e.g. for a patient that consents to an operation, the consent to
suture the wound)
• IMPLIED CONSENT
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Limitations of Informed Consent
• It is important to understand that a properly executed informed
consent does not necessarily protect against claims of malpractice.
• However if h/she has been treated negligently, they still must provide
the four elements of malpractice which are;
1. The duty of the health-care provider to provide competent care.
2. There was a breach of the duty to provide competent care.
3. An injury occurred.
4. The injury was a direct result of breach of the standard of care (called
proximate cause).
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Informed refusal
• A person’s right to refuse all or a portion of the proposed treatment
after the recommended treatment, alternate treatment options, and
the likely consequences of declining treatment have been explained
in language the patient understands.
• A patient who refuses to follow the recommendations of the dental
provider must be advised of the consequences of the refusal
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Informed refusal
• Approach:
• If a patient is referred to see a specialist and refuses the referral, the clinician
should document the refusal thoroughly in the patient chart and have the
patient sign the chart or a separate form.
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How long is consent valid
• Though there is no legally defined time period for consent to be valid,
it can be considered valid until the patient withdraws it or there is a
change in the patient’s circumstances, which may include:
• Improvement/deterioration in the patient’s condition
• Availability of new treatment options since consent was given.
• Due to disease progression the treatment choice has changed from cure to
palliation.
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Final Notes…
• Consent is valid when
• Patient is competent to give consent
• Full information of risks, benefits, alternatives and costs has been provided
• Consent is freely given, and
• Consent is specific to the procedure
• Consent is invalid when
• Consent given under fear, fraud or misrepresentation of facts,
• Persons under the influence of alcohol,
• Person who is ignorant of the connotations of the consent,
• Person who is under 12/14 (Depends with the country) years of age
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Final Notes…
• Situations where consent (doctor-patient r/ship) may not be obtained
• In the event of Medical Emergencies.
• In case of a person suffering from a notifiable diseases
• Immigrants.
• Members of Armed Forces.
• Handlers of food and dairymen.
• New admission to Prisons.
• In case of a court order or request of the police
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Informed Consent: Case
• A patient with a broken anterior central incisor tooth. The diagnosis
of tooth fracture was made, and the doctor recommends restoration
with a porcelain crown. After discussing the cost, the patient asks for
other less costly options. So the dentist decided to go for An
alternative and less costly treatment which was a large composite
restoration as a short term option. The patient made an a verbal
consent decision for the treatment proposed by the dentist. Two
months later, the composite restoration fails.
• Discuss the case from ethical point of view.
• Do you think that the dentist is liable for malpractice?
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References
• Introduction to Medical Ethics,Medical Ethics in the ‘Global Village’ A
course in Medical Ethics at ASRAM, Andhra Pradesh, India December
2007 © Ray Noble 2007
• Principles of Medical Ethics - American Medical Association Adopted
June 1957; revised June 1980; revised June 2001.
• WMA ethics manual 2nd edition 2009
• Ingrid Miletej / Dawit Desalegne Ethical lecture notes AAU CHS
School of medicine (Addis Ababa Ethiopia)
• Basic Ethics in Dentistry by Academy of dentral learning & osha
training, feb 2020
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