CLE: 2009: An Introduction and Overview of the History of American Bioethics

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Title

CLE: 2009: An Introduction and Overview of the History of American Bioethics

Creator

Bernard D. Reams

Publisher

St. Mary's University School of Law San Antonio Texas Alumni Homecoming, St. Mary's University School of Law Alumni Homecoming

Date

2009-03-27

Relation

St. Mary's University School of Law Alumni Homecoming

Format

RFC3778

Language

English, en-US

Type

Text

Identifier

STMU_HomecomingCLE2009Reams

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Text

Bernard D. Reams, Jr., J.D., Ph.D.
Professor of Law

AN INTRODUCTION AND OVERVIEW
OF THE HISTORY OF AMERICAN BIOETHICS

I.

Bioethics Defined: The Doctrine of Eugenics

II. American Case Law

Buck v. Bell, 274 U .S. 200 (1926)
Skinner v. Oklahoma, 316 U. S. 535 (1942)
III. Patent Rights and Consent to Treatment
Tuskegee Syphilis Experiment, 1932-1972
Human Radiation Experiments, 1994

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IV . The Regulatory Response
The Belmont Report, 44 F. Reg. 23192 (April 18, 1979)
Basic HHS Policy for Protection of Human Research
Subjects, 45 C.F.R. § 46 .101, etc.
V. Current Trends

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The University of Texas

Health Science Center
at San Antonio

"\·v; w .u thscs ?.. eci t:

Deborah Baruch-Bienen, MD, FACP
Associate Professor of Medicine
Board Certified Internal Medicine
Ethics Consultant, UHS

(210} 617-5120 • Cell: (210} 478-0681
FAX: (210} 567-4856 • baruchbienen@uthscsa.edu
Mail Code 7871 • 7703 F Curl Drive • San Antonio, Texas 78229-3900
loyd

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Introduction to
Clinical Ethics:
The Medical Prospective
Deborah Baruch-Bienen, MD, FACP
Deputy Chief, Medical Service, ALMVAH
Associate Prof Medicine, LJmSCSA
St Mary's School of Law
March 27, 2009

Introduction
• Ethical dilemmas are commonly
encountered in our health care system
• Beauchamp & Childress's 4 principles
of medical ethics and Jansen's "4 box
method" are common tools used by
Western bioethicists
• It is important for the legal community
to understand the bioethical approach
that guides the health care choices

Goals & Objectives
• I ntroduce participants to the concept and
principles of bioethics
• Review a popular approach to ethical dilemmas;
Jansen's 4 box method
• Open discussion of the application of bioethics to
current common medical conflicts
NAil Resulting InN
• Gained insight into the Clinical Ethics Approach

1

Definitions

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• Ethics - study of philosophical right & wrong; a
system of moral values; the rules or standard s
governing the conduct of a person or members
of a profession
• Morals- of or concerned with the judgment of
the goodness or badness of action and character
• Values- a principle, standard, or quality
considered worthwhile or desirable

4 Principles of Bioethics
• Beneficence
• Nonmaleficence
• Respect for Autonomy

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• Justice
Tom Beauchii mp and James OllldreSS. Ptlnc!pl;:s of 61omed!cal Ethlc:i ("'l.h edUon)
(New York: Oxfofd University Press, 1994)

Approach to Clinical Ethics
• Analysis of ethical issues using four main
categories:
• Medical indications
• Patient preference
• Quality of life
• Contextual features

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Medical Indications
• Appropriateness of evaluation & treatment
• What is the patient's medical problem, history,
diagnosis, prognosis?
• Is the condition acute or chronic?
• What are the goals of treatment?
• What are the probabilities of success?
• What are the contingency plans in case of therapeutic
failure?
• How can this patient be benefit ed by medical care,
while harm Is avoided?

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Medical Indications
• Goals of medicine: Basic principles
• Beneficence - the duty to assist persons in need
• Nonmaleficence - the duty to refrain from causing
hanm

• Goals of medicine: Action outcomes
• Promotion of health & prevention of disease
• Relief of symptoms, pain, & suffering
• Cure
• Improvement or maintenance of functional status
• Patient education & counseling
• Avoiding harm

Medical Intervention
• Goals of medicine: Obstacles
• Diagnostic or therapeutic uncertainty
• Conflict between diverse goals
• Actions that cause harm as well as good

• Goals of medicine: Variables

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• Disease: acute/chronic, critical/noncritical,
reversible/Irreversible
• Treatment: curative/supportive, burdensome/nonburdensome

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Patient Preferences
• The patient's preferences are always
relevant in any ethical discussion
• What preferences has the patient expressed?
• Has the patient been informed, comprehend, & given
consent?
• Does the patient have mental capacity & legal
competency?





Presence of prior preferences (advanced directives)
Who is the surrogate?
Patient cooperation
Is the patient 's right to choose being respected?

Patient Preferences
• Clinical significance

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• Shared health care decisions lead to greater trust &
loyalty in the doctor-patient relationship & better
d inical outcomes

• Legal significance: Self-Determination
• Fundamental right to control ones own body

• Psychological significa nce
• Sense of self worth & control

Patient Preferences
• Autonomy
• The moral right to choose & follow one's own plan of
life & action

• Paternalism
• The practice of overriding or Ignoring preferences of
patients in order to benefit them or enhance their
welfare.

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• Medicine has moved from a paternalistic
to an autonomous point of view

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Patient Preference
• Autonomy: Informed consent
• Practical app lication of the practice of autonomy
• A dialogue between doctor & patient leading to a
medical plan
• Legally, it should encompass what reasonable
patients need to know to make rational decisions
• I deally, it should be tailored to the need of the
particular patient

Patient Preference
• Autonomy: I nformed consent
• Disclosure should include current medical status, risks
& benefits of all possible treatment options, an
opinion on alternative treatments, and a
recommendation based on best clinical judgment
• Disclosure must be truthful & complete

Patient Preference
• Decisional capacity
• Competence refers to the ability of a person to
understand & make choices. Judges alone rule on
whether a patient is legally competent
• Medical capacity refers to the patient's ability to
understand relevant Information, communicate a
choice, & deliberate treatment options
• Patients do not need capacity to revoke a directive

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Patient Preference
• Competent refusal of treatment

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• Refusal of care by a competent & informed adult
should be respected, even if that refusal leads to
serious harm to the individual
• Refusal may be based on the grounds of unfamiliar
beliefs
• Enigmatic refusal can be ignored, but should be
discussed, and if ignored, should be done so with the
approval of the court
• Patients have the right to refuse information about
their condition

Patient Preference
• Advanced planning





Directives to physicians
Uving wills
Durable power of attorney
Often, these documents are vague
• "terminal Illness•
• "no reasonable expectation of recovery"
• "forgo artificial means & heroic measures"

Patient Preference
• Advance Directives Act

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• Changes in TEXAS law
• Inpatients - the attending physician can declare a
patient irreversible or terminal (no more 2 MD
documentation).
• Directives - can be written or verbal
• 2 witnesses, both competent adults
• 1 must not be an agent, relative, provider, or
any other person who can be seen to have any
gain from patient's decisions.

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Patient Preference
• Directives

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• Effective until revoked - either written or verbal
• Physicians are not responsible for revoking directives
until they have been informed of the decision.
• If multiple written directives available for a patient,
but are in conflict, the most recent document will
prevail.
• TEXAS - out of state Directives can be honored if they
meet Tx standards -signed, 2 witnesses, ect.
• TEXAS - All hospitalized patients must be informed on
hospital directives policies, and offered the
opportunity to obtain directives.

Patient Preference
• Surrogate decision makers
• Usually a next of kin, or proxy
• DedSions must promote the patient's wishes & welfare.
• Implied consent - in emergency situations when there
Is no one available to consent for a life saVing
procedure
• TEXAS - Directives prior to Sept 99; if surrogate was
subsequently divorced, they were still the agent After
Sept 99; divorce of agent to patient will nullify
document
• If the patient Is wto capacity, no directives, and no
surrogate, then the court must choose a surrogate

Patient Preference
• DNR

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• The purpose of CPR Is prevention of sudden,
unexpected death. It Is not indicated in certain
situations, such as cases in terminal, irreversible
illness where death Is not unexpected (JAMA, 1980)
• It is the phySidan's responsibility to discuss DNR with
terminal patients
• Documentation ~ be clear & regularly reassessed
• DNR should never mean " DO NOT RESPOND"
• Partial Codes are unethical
• TEXAS - can be applied to pat ients with irreversible or
terminal conditions

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Patient Preference
• Decisions to forgo inefficacious or futile
interventions
• The irreversible condition
• a condition that can be treated but never cured,
which leaves the patient unable to care for self or
make decisions, and is fatal without life support
(i.e. -the moribund patient).
• The terminal patient
• Medicare definition: Incurable condition with 6
months or less life expectancy
• TEXAS- all hospice patients considered terminal

Patient Preference
• Out of Hospital DNR- Texas
• Any patient can have an out of hospital DNR
• Patient must have on the bracelet or have the DNR
paperwork on their person for it to be valid
• Providers who try to resuscitate a patient with a
valid OH DNR can be charged with battery
• Providers advised to discuss issue with patients
before signing. Most healthy patients really want a
directive, not a DNR
• Ex. I f a patient has an OH DNR, they would not
be resuscitated for bee sting anaphylaxis. Ask
your patient if they realize this.

Patient Preference
• Limitations of Autonomy
• Patients have no right to demand medical care that is
not indicated, contraindicated, or unorthodox
• Health care providers may refuse to cooperate in
actions they judge immoral on grounds of conscience
• Noncompliance, when extreme and voluntary, a
physician can ethically withdraw from the case, after
advising the patient how to obtain care from other
sources

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Patient Preference
• Termination of a doctor patient relationship

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• Patients have the right to refuse treatment from a
specific provider
• Patients have the ri9ht to leave medical institutions
a9ainst medical adv1ce. They cannot be forced to
SJgn AMA paperwork
• Noncompliance, when extreme and voluntary, a
physician can ethically withdraw from the case, after
advising the patient how to obtain care from other
sources
• Abandonment can be charged when the physldan,
without 9iving timely notice, ceases t o provide care
for a pat1ent who is still in need of medical attention
or when the physician Is dilatory & careless

Quality of Life
• The object of all medical intervention is to
restore, maintain, or improve quality of life
• Prospects w/ or w/o treatment, for a r eturn to normal
life?
• Are there biases the might prejudice an evaluation of
quality of life?
• What defiCits might patient experience if treatment
succeeds?
• Patient's opinion of quality of life.
• Any plan to forgo treatment?
• Plans for comfort & palliative care?

Quality of Life
• Quality of life issues raise ethical questions
in several ways
• When there Is notable divergence between physician
& patient assessment of quality of life
• When patients are unable to express their evaluation
of the quality of life they wish t o have
• When quality of life is used as a standard for
rationing care

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Quality of Life
• Objective criteria for quality of life

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• Restricted quality of life desaibes when a per.;on suffers from
severe deficits (physical or mental) resuiUng in functional
abilities that depart from the normal range
• Minimal quaUty of life describes a cOflditlon in which the patient
has greatly deteriorated, cannot communicate with others, and
who suffers discomfort &. pain
• Quality of life below minimal refers to extreme physical
debilitaUon as well as complete&. irreversible loss of sensory &.
Intellectual activity, i.e. the vegetative state

• Euthanasia & Assisted Suicide

Contextual Features
• Ethical issues must be interpreted in the
larger context of persons, institutions,
finandal & social arrangements

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• Family/soclal issues influencing decisions
• Provider issues influencing treatment
• Financial factors, allocation of resources-JUSTICE PRINCIPLE
• Religious & cultural factors
• Justifications of breach of confidentiality
• Legal implications
• Oinical research or teaching
• Conflicts of interest

Frequent Conflicts
End of Life Care
• Withdrawal of Care
• DNR and Advance Directives
• Futility of Care
• Defining Comfort Care
• Example: What is artificial nutrition & fluids?

• Assisted Suicide
• Defining Death

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Frequent Conflicts
Decision Making

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• Capacity
• Examples: Vacillating capacity,
lack of ascent when a pat ient lacks capacity

• Surrogacy
• Examples: Claims disputes, lack of surrogate

• Quality of the I nformed Consent Process

Frequent Conflicts
Relationship Issues
• Treatment Plan Disputes
• Values and Cultural Conflicts
• Breakdown of Com munication
• Mediator role
• Delivery of care Process Oversight
• Ombudsman role
• Confidentiality
• Training and research issues

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Conclusion
• Clinical ethics can be approached in a structured,
comprehensive way using both the 4 Principles of
Bioethics, in conjunction with a categorical
approach such as the " 4 Box Method"
• Health care systems use these approaches t o
determined what are "ethically acceptable"
choices
• Legal professionals who handle cases involving
healthcare need to be f amiliar with the medical
professional et hos

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Discussion

Thank You for Your Attention
Deborah.Baruch-Bienen@va.gov

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12

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Mental Retardation and the Criminal Defendant
Dorie Klein, Assistant Professor of Law
This session presents a brief overview of how mental retardation is diagnosed, and also examines several
issues that become important when a criminal defendant is mentally retarded, including questions about
the defendant's competence to stand trial and the defendant's eligibility for certain types of sentences.

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I.
A.
1.
2.
3.

Diagnosing Mental Retardation Generally
DSM definition::
Significantly sub-average intellectual functioning
Concurrent deficits or impairments in present adaptive functioning in at least two areas
Onset before age 18

B . Specifying severity. Based on IQ score. An IQ score of 100 is the estimated mean for the
population. An IQ score of70 is two standard deviations below the mean.
1. Mild - from between 50 and 55 to 75
2. Moderate- from between 35 and 40 to between 50 and 55
3. Severe- from between 20 and 25 to between 35 and 40
4. Profound - from <20 to 25
C. AAMR definition:
"Mental retardation is a disability characterized by significant limitations both in intellectual functioning
and in adaptive behavior as expressed in conceptual, social, and practical adaptive skills . This disability
originates before age 18."
II. Particular Problems Diagnosing Mental Retardation in Adult Criminal Defendants
l1l . Issues for Sentencing

A. Atkins v. Virginia
B. Beyond Atkins
Sources:
Am. Ass'n of Mental Retardation, Mental Retardation: Definition, Classification, and Systems of
Suppmts 8 (lOth ed. 2002).
Am. Psychiatric Ass'n, Diagnostic and Statistical Manual of Mental Disorders 49 (4th ed. text rev. 2000).

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Citation

Bernard D. Reams, “CLE: 2009: An Introduction and Overview of the History of American Bioethics,” St. Mary's Law Digital Repository, accessed June 28, 2017, http://lawspace.stmarytx.edu/item/STMU_HomecomingCLE2009Reams.

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