Clinton Fuller MD Texas Childrens Hospital Updated 102019 Disclosures No relevant financial relationships Learning Objectives Describe basic ethical theories and principles List the elements of informed consent in adults ID: 915035
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Consent and Assent for Anesthesia in Infants and Children
Clinton Fuller, MDTexas Children’s Hospital
Updated 10/2019
Slide2Disclosures
No relevant financial relationships
Slide3Learning Objectives:Describe basic ethical theories and principles
List the elements of informed consent in adultsRecognize differences of informed consent and assent in pediatricsApply ethical principles to clinical scenarios
Slide4Case Scenario
14 year old female with no known medical history presents to preoperative area prior to scheduled dental restorations under general anesthesia.She failed dental procedure in clinic due to anxiety and lack of cooperation.
Slide5Case Scenario
Upon entering the exam room, you note the patient sitting on a stretcher with both parents present.Patient begins to yell about not wanting procedure performed, stating she will fight anyone that touches her. She will not take any oral premedication.
Slide6Case Scenario
How would you proceed?A: Premedication with IM KetamineB: Call for help for forced inhalational induction
C: Cancel the caseWhy did you choose that option?Are there any guiding principles to assist in this decision?
Slide7What are Ethics?
The discipline dealing with what is good and bad, and with moral duty and obligation1The
study of actions taken by moral agents to determine if they are good or bad
2
Slide8Who are moral agents?One who is
capable of knowing and understanding good and badHas the capacity
of choosing one over the other
Slide9What is capacity?Ability to make moral distinctions and act on them
Moral agents are expected to act within the boundaries of ethical behaviorWe assume human adults
have capacityBut what about children?
Slide10What are Clinical Ethics?Application of ethical theories, principles, rules, and guidelines to clinical situations
Allow for resolution to ethical issues or dilemmasSuch as consent and assent
Slide11How to best act?
ConsequentialismCorrectness of one’s actions based on the consequencesDeontology
Correctness of one’s actions based on fulfilling the duties of the actor
Virtue ethics
If one acts
virtuously
, they will necessarily do the right thing
Slide12Principlism
4 principles of equal weight:AutonomyBeneficenceNon-maleficenceJustice
Slide13Autonomy
Patients have the right to make decisions about things that will effect their own livesFundamental concept in the western traditionOther cultures may hold other moral domains (ex: community, sanctity) at an equal or higher level3
Underlies the right to informed consent
Slide14BeneficenceDuty to act in the best interest of the patient
Parents and Physician may disagree here
Slide15Non-maleficenceRequirement to avoid harming patients
Expressed in the Hippocratic aphorism“First do no harm.”
Slide16JusticeEquitability:
2 patients with same diagnosis should be treated similarly regardless of social standing or wealthDistributive justice: Distribute limited healthcare resources fairly among patients
Slide17Bias in “Traditional Ethics”Male and Western bias
Historic male domination of academics and medicineDifferent ethical theories may better account for non-western cultural valuesEthics of Caring
Slide18Ethics of Caring
Perspective based on relationships and caring for othersPrimacy of relationships is emphasizedIncorporates the complex web of relationships in which the patient is embedded and considers the perspectives of all those who truly care for the patient
Slide19Informed Consent
Process of dialog with a patient about a planned course of action
45 parts:Disclosure of informationAssess understanding
Determine capacity
Obtain legal authorization
Ensure consent is voluntary
Slide20Disclosure of Information
Nature of illness
Proposed procedure or treatmentProbability of successRisks and benefits involvedAlternative actions
Including refusal of all actions
Slide21Informed Consent for Peds
Explain information in an age-appropriate manner
Patients should participate in decision-making appropriate to their developmentAssent
Slide22Parental Duty
Obligation to protect and promote both the health-related and non-health-related interestsProvide “informed permission” with assent of the child as developmentally appropriate
Slide23Duties
Physician
Beneficence: to act in the best interest, promote health-related interests
Parent
Parallel interests to Physician
Promote non-health-related interests
Family unit autonomy
Government
Societal interest in protecting the child from harm
Slide24Model for consent by others
Adults:
Living will
Substituted Judgement
Children:
Best interest standard
Constrained Parental Autonomy
Shared family-centered decision making
Katz, A.L. and Webb, S.A. “Informed consent in decision-making in pediatric practice.” Pediatrics. 2016; 138(2): e20161485.
Slide25Decision Making Models
Best-interest standard
Maximize benefitsMinimize harmsConstrained parental autonomyPrevent harm
Shared, family-centered decision-making
Collaborative communication and exchange of information between medical team and family
Family shares their goals and values
Katz, A.L. and Webb, S.A. “Informed consent in decision-making in pediatric practice.” Pediatrics. 2016; 138(2): e20161485.
Slide26Assent
To express approval or agreement
Must include:Developmentally appropriate awareness of the nature of the conditionExpectations of tests and treatments
Assess understanding
Assure no undue influence
Solicit expression of approval or agreement
Assent should only be solicited if some element of refusal will be respected
Slide27Rule of 7’s for assent
Younger than age 7
No capacityAge 7-14Assume no capacity, but may be refutedGreater than age 14
Assume capacity, but may be refuted
This is a simplified understanding of assent
Slide28Some minors may consent
In United States, for care related to sexual activity:
Treatment for sexually transmitted diseasesContraceptionPrenatal care
Mature minor doctrine
Legally emancipated minors
Living separately from parents and financially independent
Married
Active military duty
These are general standards in the
United States
, and vary slightly state to state
Slide29Age of minor consent may vary
South Africa:Children’s Act 38 (2005)
“…over the age of 12 years and is of sufficient maturity and decisional capacity to understand the various implications of the treatment including risks and benefits thereof.”
Ganya
W, Kling S, Moodley K. ”Autonomy of the child in the South African context: is a 12 year old sufficient maturity to consent to medical treatment?” BMC Medical Ethics. 2016; 17:66.
Slide30Age of minor consent may vary
Europe
https://
fra.europa.eu
/
en
/publication/2017/mapping-minimum-age-requirements/consent-medical-treatments
Slide31Mature minor doctrine
Some adolescents have the maturity and capacity to understand the elements necessary for consent
This is a judicial determination stating a minor is sufficiently mature to provide own consent
Slide32Special situations
Patients with chronic illness often have enhanced capacity
Reasonable to respect refusal of nonurgent careShould make efforts to understand reason and clarify any misconceptions
May limit short-term autonomy in some instances to preserve long-term autonomous choice
Slide33Guidelines
Slide34Guidelines
Other local cultural or ethical considerations may impact the consent processDifferent ethical constructs may better account for these views
Ethics of caring emphasizes relationships between patient and caregivers or community
Slide35Case 1
14 year old healthy female who does not want to undergo dental restoration under anesthesia
What to do?Cancel the case as the patient does not assent and care is electiveWork to understand why patient objects to treatment, address any misunderstandings
Continued care by dentist
Slide36Case 2
14 year old female with diagnosis of acute lymphoblastic leukemia presents for retrieval of oocytes for fertility preservation prior to chemotherapy
Documented previous assent, but not assenting todayWhat do you do?
Slide37Conclusions:
Ethics provides a framework for decision makingInformed consent involves 5 stepsAssent should be sought from pediatric patients if refusal will be respectedPediatric patients may consent in special situations
Slide38References:
Ethics. Retreived from https://www.merriam-webster.com/dictionary/ethics
Taylor RM. “Ethical principles and concepts in medicine.” Handbook of Clinical Neurology, Vol. 118 (3rd series) Ethical and Legal Issues in Neurology, Elsevier B.V. 2013.
Minkoff H. “Teaching ethics: when respect for autonomy and cultural sensitivity collide.” Am J
Obstet
Gynecol. 2014; 210(4): 298-301.
Katz AL and Webb SA. “Informed consent in decision-making in pediatric practice.” Pediatrics. 2016; 138(2): e20161485.
Ganya
W, Kling S, Moodley K. ”Autonomy of the child in the South African context: is a 12 year old sufficient maturity to consent to medical treatment?” BMC Medical Ethics. 2016; 17:66.
Consenting to medical treatment without parental consent.
Retreived
from
https://fra.europa.eu/en/publication/2017/mapping-minimum-age-requirements/consent-medical-treatments
.
WMA Declaration of Lisbon on the rights of the patient.
Retrieved from https://
www.wma.net
/policies-post/
wma
-declaration-of-
lisbon
-on-the-rights-of-the-patient/.