INFORMED CONSENT

INFORMED CONSENT How Do I Gain A Patient’s Valid Consent to Benefit Their Oral Health?

“Curiosity is the most insatiable of lusts.” Michel Foucault French Philosopher 1926-1984

Two Moral Principles Provide the Ethical Foundation for Informed Consent: • Principle of Beneficience: Do Good for the Patient by Promoting Their Well-Being. • Principle of Respect for Autonomy: Each Person Should be Self-Determining, the Author of His/Her Own Life.

Instrumental Value of Self-Determination In most cases, the individual’s well-being is best served by his/her own subjective judgement.

Intrinsic Value of Self-Determination “...Unless the patient has requested this course of conduct, the individual will not have been shown proper respect as a person nor provided with adequate protection against arbitrary, albeit well-meaning domination by others.” Even if it could be shown that another could do a better job of determining what is in the individual’s interest, there is still a reason for recognizing self-determination as an individual’s right

Quote from John Stuart Mill “The human faculties of perception, judgement, discriminative feeling, mental activity, and even moral preference, are exercised only in making a choice. He who does anything because it is the custom makes no choice. He gains no practice either in discerning or desiring what is best. The mental and moral, like the muscular powers, are improved by being used...

He who lets the world, or his own portion of it, choose his plan of life for him, has no need of any other faculty than the ape-like one of imitation. He who chooses his plan for himself employs all his faculties. He must use observation to see, activity to gather materials for decision, discrimination to decide, and when he has decided, firmness and self-control to hold his deliberative decision...

Where, not the person’s own character, but the traditions and customs of other people are the rules of conduct, there is wanting one of the principle ingredients of human happiness.” John Stuart Mill English Philosopher Formulator of Utilitarianism

Beneficence:Autonomy • The definition of health is imprecise and indefinite. It depends to some extent upon the goals and values of the individual. • Even when the definition is agreed upon there is often no definitive criterion to determine how to achieve it. • In recommending therapy, health professionals tend to reflect their own values and preferences, which may differ from their patients. • Determining what constitutes health and how it is best promoted requires knowledge of the patient’s goals, values, and preferences.

For the reasons just given, determining whether a treatment plan will, if successful, promote a patient’s well-being is a matter of individual judgement. • In each case the goals and interests of particular patients incline them in different directions not only as to how, but even as to whether, treatment should be provided.

It is important to note that the ethical (and legal) imperative of informed consent does not give patient the right to insist upon anything they might want: • Health professionals are also bound by the concept of non-maleficence, not causing harm. • The choices available to patients must be limited to medically accepted options, all of which scientific evidence indicates will have some possibility of promoting the patient’s welfare.

Opinion inJohn Canterbury versus William Spence “every human being of adult years and sound mind has a right to determine what shall be done with his body… True consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each.”

Major Components of Informed Consent • Disclosure of Adequate Information with Associated Patient Understanding • Lack of Coercion • Competence/Decisional Capacity

Four Standards Considered For Adequate Information • Full Disclosure • Customary Disclosure • Disclosure of all Risks • Reasonable Person Standard

Full Disclosure Disclose every benefit and risk, no matter how small or remote. Rejected: Too prohibitive and unrealistic. If taken literally, full disclosure is impossible. If taken, as probably intended, to reveal adequate information, the standard provides no guidance.

Customary Disclosure Disclose all information that other practitioners would be likely to disclose under similar circumstances. (Also called “community or professional standard.”) Rejected: Customary practice does not necessarily ensure that the patient’s right to self-determination is respected; does not ensure that adequate information will be provided.

Disclose All Risks Disclose every risk that a patient would deem significant to his decision. Rejected: Places an undue burden on the practitioner in that it requires the practitioner to second guess the patient’s subjective view of what would count as significant information.

Reasonable Person Standard Disclose the benefits and risks that a reasonable person, in what the practitioner knows to be the patient’s position, would be likely to deem relevant in deciding whether to forego a proposed therapy. Accepted, on the grounds that “ the scope of the standard is not subjective as to the practitioner or the patient; it remains objective with due regard for the patient’s informational needs and with suitable leeway for the practitioner’s situation.”

Two Exceptions to the Rule of Disclosure • Emergency situations where the patient is incapable of giving consent, and harm from failure to treat is imminent and outweighs any harm threatened by the proposed treatment. • When disclosure of risks itself poses a threat of harm to the patient. However, this “privilege does not accept the paternalistic notion that the practitioner may remain silent simply because divulgence might prompt the patient to forego therapy the practitioner feels the patient really needs.”

Under the Reasonable Person Standard, Adequate Information Generally Includes: • Benefits • Risks • Complications • Alternatives • Prognosis • Non-Treatment • Costs

Lack of Coercion • Coercion is defined as a threat, either psychological or physical, of sufficient force that no rational person would be able to resist it. • Education and persuasion are not coercive. • Manipulation/deception and psychological or physical inducements of benefit or threats of harm are coercive. • Key idea is that the consent is fully voluntary.

Decisional Capacity In much of the ethics literature, the term competency is used to designate decisional capacity. However, the term has taken on legal connotations with the decision regarding a person’s competency determined by the courts. Thus, increasingly the term decisional capacity is employed to designate the third ingredient necessary for a consent to be informed/valid.

Decisional Making Capacity Requires: • Possession of a set of values and goals. • The ability to communicate and to understand information, and • the ability to reason and deliberate about one’s choices. From: The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

Surrogate Decision Making Examples of individuals who cannot rationally deliberate in the process of informed consent are: • minors • persons with dementia • psychotics • persons with extreme anxiety or fear • the mentally retarded • persons under the influences of abused substances

Misconceptions About Informed Consent • Informed consent is merely a legal doctrine and has little to do with a good and ethical practice. • Informed consent is a single event. • Informed consent merely involves the listing of risks and benefits the dentist believes would best serve the patients interests.

Because of their special education and training, practitioners are the best judges of what would serve their patients best interests. • The primary obligation of the dentist is to act in the best interest of the patient’s health, as the dentist understands it. • It is permissible to forego informed consent so long as you are acting in the patient’s best interest.

Patients do not want to be informed of bad news and are always better served by practitioners remaining positive, even if it involves deception. • Any individual who would make a decision that is obvious to the practitioner as contrary to their health and well being is irrational. • The practitioner’s obligations do not extend beyond the legal requirements concerning informed consent.

INFORMED CONSENT