Ethics in Clinical Practice & Research

I. Core Definitions

II. The Belmont Report (1979)

A foundational NIH document outlining ethical principles for research involving human subjects and clinical care.

Four Cornerstone Principles

• Autonomy – Respecting individuals’ right to make their own decisions.
• Beneficence – Acting to benefit others.
• Nonmaleficence – Avoiding harm.
• Justice – Ensuring fairness in the distribution of resources and care.

III. Expanded Ethical Principles

A. Autonomy

• Liberty: Freedom from coercion or manipulation.
• Agency: Capacity to act intentionally.
• Self-determination: Right to control one’s own body and decisions.

Capacity & Competence: Assessed using criteria:

1. Can’t express a preference
2. Can’t understand situation/consequences
3. Can’t understand relevant information
4. Can’t give a rational reason
5. Can’t weigh risks/benefits
6. Can’t make a reasonable decision

B. Beneficence

• Rescuing those in danger
• Preventing or removing harm
• Defending rights
• Promoting welfare

Paternalism: Overriding someone’s choices to protect or benefit them.

• More justified when autonomy is low and benefit is high
• Common in pediatrics: parents act in child’s best interest

Utility: Beneficence applied to populations

• Maximize overall benefit while minimizing harm and cost
• Tools: cost-effectiveness, QALYs

C. Nonmaleficence

“First, do no harm” – Stronger duty than beneficence

• Negligence
• Killing vs. Letting Die
• Intent vs. Foreseeable Harm
• Futile treatments: No obligation to offer
• Contraindicated treatments: Must not be offered
• Withholding vs. Withdrawing care: Ethically equivalent

D. Justice

• Fair allocation of scarce resources
• Based on need, not race, culture, or ability to pay
• Physicians should focus on individual care, not societal priorities

IV. Summary Table

Informed Consent and Decision Making

A. Patient Self-Determination Act of 1990

At the time of admission or treatment, patients must be informed of their right to refuse care or create an advance directive.

B. Principles of Adequate Informed Consent (Beauchamp and Childress, 2009)

1. Threshold Elements

• Decisional Capacity: Ability to understand, evaluate, and choose realistic options.
  • Does not require full independence in all life functions.
  • Different from legal competence, which must be determined by a judge.
• Voluntariness: Right to refuse care or treatment.
  • Applies to adults and, in some states, teenagers under specific criteria.
  • Parental refusal must not endanger the child; physicians may need to report to CPS.
• Absence of Duress: Patients and families must not be pressured unless in emergencies.
  • Must have time to consider options, ask questions, and change their minds without penalty.
• Informed Consent Process:
  1. Required Informational Elements:
     • Explanation of indication for proposed treatment or procedure
     • Disclosure of nature of the procedure
     • Disclosure of potential benefits
     • Disclosure of risks (frequent and rare but serious)
     • Presentation of all alternatives, including doing nothing
     • Opportunity to ask questions and receive answers
  2. Decision to choose a plan
  3. Authorization by patient, parent, or guardian

C. Consent for Children & Special Populations

Children under 18 require surrogate decision makers, typically parents or guardians.

1. Role of Surrogates

• Must act in the child’s best interest.
• Guardians use substituted judgment for incapacitated former adults.
• Parents are default decision makers unless:
  • Deemed unfit (e.g., abuse, mental illness)
  • Medically negligent (refusal of essential care)
  • Child is a mature minor (≥14 years, varies by state)
  • Child is emancipated (e.g., married, parent, military)
  • Specific medical conditions (e.g., reproductive health, mental health, substance use)

2. Emergent Conditions Without Guardian

• Emergency Exception Rule: Implied consent applies if:
  • Child has a life-threatening condition
  • Guardian is unavailable
  • Treatment cannot be delayed
  • Only emergent care is provided
• Physician must document urgency and efforts to contact guardian.
• Always act in the patient’s best interest.
• Be aware of state and federal laws.

3. Assent by Children

• Not legally required but ethically recommended.
• Parents can override child’s decision; ethics consults may help in disputes.

Confidentiality, Disclosure, and Research Ethics

I. Principles of Confidentiality and Disclosure

A. General Confidentiality

• Applies to both clinical care and research settings.
• Can only be breached under legally defined circumstances.

B. NIH Policy on Research Confidentiality

• Researchers must protect participant identity and personal data.
• They cannot be legally compelled to reveal participant identities in any legal or administrative setting.

C. Confidentiality in Clinical Care

• Physicians must maintain strict confidentiality of patient information.
• Exceptions include:
  • Duty to warn others of potential harm.
  • Preventing greater harm to society by disclosing necessary information.

D. Disclosure

Refers to the information that must be shared to allow patients or participants to make informed decisions.

E. Adverse Events

Healthcare providers must inform patients and families of unexpected adverse outcomes.

II. Ethical Considerations in Human Subjects Research

A. Institutional Review Board (IRB) Responsibilities

• Ensure research protocols are scientifically and ethically sound.
• Review includes:
  • Clear objectives and sound study design
  • Qualified investigators
  • Appropriate data analysis and dissemination plans

B. Risk-Benefit Balance

• Risks must be justified by potential benefits or knowledge gained.
• Safety must be prioritized (nonmaleficence).

C. Justice in Subject Selection

Participants must be chosen fairly and equitably.

D. Informed Consent

Must be obtained and documented from parents or guardians.

E. Assent from Children

• Children ≥7 years may be asked to agree to participate, depending on maturity and institutional policy.
• Children should be involved in decisions to the extent of their abilities.

F. Privacy and Conflicts of Interest

• Participant privacy must be protected.
• Researchers must disclose and manage conflicts of interest.

G. Pediatric Risk Categories (45 CFR 46 Subpart D)

• Risk: Likelihood and severity of harm.
• Benefit: Health or welfare improvements.
• Acceptable risk levels:
  1. Minimal risk
  2. Minor increase over minimal risk with direct benefit
  3. Greater than minimal risk with no direct benefit but valuable knowledge
  4. Otherwise unapprovable research addressing serious child health issues

III. Ethical Dilemmas in Pediatric Gastroenterology

A. Nutritional Support and G-Tubes

• Balance between child’s best interest and family preferences.
• Key considerations:
  • Temporary vs. permanent tube placement
  • Impact on life expectancy and quality of life
  • Family motivations vs. child’s needs
  • Improvement in care or comfort
  • Risks and benefits:
    • Percutaneous vs. surgical placement
    • Medical vs. surgical outcomes
    • Complications (e.g., infection, leakage)
    • Alternatives like prolonged nasogastric tube use

Transplant and Genetic Testing Ethics

I. Liver Transplant Considerations

A. Ethical and Clinical Factors

• Justice: Fair allocation of scarce organs.
• Living Donor:
  • Risk to donor
  • Benefit to recipient
• Cadaveric Donor:
  • Matched risk: organ matches recipient’s needs
  • Unmatched risk: may be used at end-of-life
    • Could benefit another recipient with better match
    • May save a life but require additional organs
  • United Network for Organ Sharing (UNOS): uses exception points to guide allocation
• Immunosuppressive Therapy: Weigh risks of medication vs. stopping treatment.
• Best Interest of the Child:
  • Metabolic disorders
  • Drug-induced liver damage
  • Cancer-related indications
  • Neurological or developmental delays
• Family Capability:
  • Availability of resources
  • Need for medical foster care
  • Transplant refusal due to social factors
  • Concerns about treatment compliance
  • Family refusal of transplant
• Surgical Outcomes:
  • Success rates by surgeon
  • Success rates by transplant center
  • Outcomes based on underlying condition

II. Small-Bowel vs. Multivisceral Transplant

• Standard treatment vs. experimental approaches
• Surgical outcomes similar to liver transplant considerations
• Assessing child’s best interest and quality of life
• Balancing risk of death, medical complications, and potential for recovery
• Evaluating medical morbidity and long-term impact
• Determining ideal candidates and required resources for family and care center

III. Genetic Testing Ethics

A. Types of Genetic Testing

1. Targeted Testing

• Provides specific answers but may lack prognosis
• Used for familial disease screening (e.g., Wilson disease, polyposis syndromes)
• May affect insurance coverage and life expectancy estimates
• Can guide early treatment and avoid invasive procedures

2. Microarray Testing

• Faster results
• Can uncover hidden diagnoses
• May have social or personal consequences
• Insurance implications
• May not provide prognosis or treatment options

3. Whole-Exome Sequencing (WES)

• Clinical benefit is unclear for many patients
• May lead to experimental treatments with uncertain outcomes
• High cost and limited availability (up to $50,000)
• Used in both research and clinical settings
• May become more useful in future
• Often lacks prognosis or actionable treatment options