Transcript Ethics Principles

Ethics Principles
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Respect for Autonomy
Nonmaleficence
Beneficence
Justice
Miscellaneous Ethics Terms
• Veracity – honesty, truth-telling
• Privacy – a basic right (see HIPAA)
• Confidentiality – protecting
information you disclose
• Fidelity – keeping promises/
agreements, maintaining relationships
Ethics vs. Morals
• Ethics
– the study of moral beliefs and behavior
– branch of philosophy concerned with the nature of
morals and moral evaluation (what is right and wrong,
virtuous or vicious, and beneficial or harmful (to
others))
– We “study” ethics
• Morals
– What one considers “right” and “wrong” for self
– We “have” moral beliefs
• Sometimes used interchangeably!
http://www.onlineethics.org/glossary.html
Ethics vs. Morals
• Morality - refers to the first-order beliefs and
practices about good and evil by means of which
we guide our behavior.
• Ethics - The explicit, philosophical reflection on
moral beliefs and practices. The difference
between ethics and morality is similar to the
difference between musicology and music. Ethics
is a conscious stepping back and reflecting on
morality, just as musicology is a conscious
reflection on music.
http://ethics.acusd.edu/Glossary.html
Morality
• Developed by “social consensus”
• We are taught moral norms as we
grow up
– Don’t lie, steal, or cheat…
– Often religion-based
• “general” vs. “professional” morality
– Be “of good moral character”!
• “universal” vs. “community-specific”
Moral Dilemmas
• Conflict between moral requirement
and self-interest
– e.g. Andrew Fastow, ENRON CFO
• Confidentiality vs. protection of life
– Therapist whose patient makes a threat
• Larger Examples:
– Bombing of Hiroshima, Invasion of Iraq
Respect for Autonomy
• Autonomy = “self-rule” or “selfgovernance”
• Freedom from controlling influence
• Freedom from inadequate
understanding
• Lack of autonomy:
– Prisoners, mentally incapable, children…
Respect for Autonomy
• patient autonomy refers to the
capability and right of patients to
control the course of their own
medical treatment and participate in
the treatment decision-making
process.
Respect for Autonomy
• Every human being of adult years and
sound mind has a right to determine
what shall be done with his own body;
and a surgeon who performs an
operation without his patient’s
consent commits assault, for which he
is liable in damages
• [Schloendorff vs. Society of New
York Hospital, 105 N.W. 92 (1914)].
Limitations of Autonomy
• Competence
– Psychologically or legally capable of
decision-making
– Determined by health professionals and
the courts
– A relative term that may vary over time
Nonmaleficence
• Primum non nocere
– Above all [or first] do no harm.
• Often considered to be a corollary to the
principle of beneficence.
• Sometimes interpreted as “do no evil”
• Harm is sometimes necessary for greater
benefit
• The principle of “double-effect” allows
harm to achieve greater benefit.
Nonmaleficence
• Treatment vs. nontreatment
– Withholding (not starting) or withdrawing
(stopping) life-sustaining treatment
– Extraordinary (or heroic) and ordinary
treatment
– Artificial feeding and life-sustaining
medical technologies
– Intended effects vs. foreseen effects
Beneficence
• the “first principle” of morality is the
dictum “do good and avoid evil”
• not a specific moral rule
• cannot by itself tell us what concrete
actions constitute doing good and
avoiding evil
Combined
• Nonmaleficence
– One ought not to inflict evil or harm
• Beneficence
– One ought to prevent evil or harm
– One ought to remove evil or harm
– One ought to do or promote good
Justice
• refers to what is owed or due to the
individual members of society.
• varies according to philosophical and
methodological presuppositions from
which one approaches the issue.
Specification
• The process of making abstract
principles specific to a situation
• Ethical principles do not by
themselves guide specific action
• They only make sense when applied to
a specific set of circumstances
• The possibilities are infinite!
Diversity and Disagreement
• People have different moral reasoning
• Not always easy to see own “blind
spots”
• Religious-based differences in
medical ethics
• There is usually no single solution to a
moral problem
Moral Character
• Virtues
– Socially approved set of traits
– Empathy, the “Golden Rule”
• Difficult to “learn” as an adult
• William Bennett “Book of Virtues”
• More apparent in stable and prosperous
societies
Biomedical Research
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Managing potential harm to patients
Nuremberg Code
Declaration of Helsinki
Belmont Report
Institutional Review Boards
Nuremberg Code
• Directives for Human Experimentation - 1949
• Established after war crimes trials of the Nazis
• The voluntary consent of the human subject is
absolutely essential
• The experiment should be such as to yield fruitful
results for the good of society
• The experiment should be so designed and based on
the results of animal experimentation and a knowledge
of the natural history of the disease or other problem
under study that the anticipated results will justify
the performance of the experiment.
Nuremberg Code
• The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury.
• No experiment should be conducted where there is an
a priori reason to believe that death or disabling injury
will occur; except, perhaps, in those experiments
where the experimental physicians also serve as
subjects.
• The degree of risk to be taken should never exceed
that determined by the humanitarian importance of
the problem to be solved by the experiment.
Nuremberg Code
• Proper preparations should be made and adequate
facilities provided to protect the experimental
subject against even remote possibilities of injury,
disability, or death
• The experiment should be conducted only by
scientifically qualified persons. The highest
degree of skill and care should be required
through all stages of the experiment of those who
conduct or engage in the experiment.
Nuremberg Code
• During the course of the experiment the human
subject should be at liberty to bring the experiment
to an end if he has reached the physical or mental
state where continuation of the experiment seems to
him to be impossible.
• During the course of the experiment the scientist in
charge must be prepared to terminate the experiment
at any stage, if he has probable cause to believe, in
the exercise of the good faith, superior skill and
careful judgment required of him that a continuation
of the experiment is likely to result in injury,
disability, or death to the experimental subject.
Nuremberg Code
• Reprinted from Trials of War Criminals before the
Nuremberg Military Tribunals under Control
Council Law No. 10, Vol. 2, pp. 181-182..
Washington, D.C.: U.S. Government Printing
Office, 1949.
• Link to full document
Declaration of Helsinki
WORLD MEDICAL ASSOCIATION
DECLARATION OF HELSINKI
Ethical Principles for Medical Research
Involving Human Subjects
• Adopted in 1964
• Last updated in 2000
• Link to full document
Belmont Report
• In 1975, The National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research, the
first national commission on bioethics,
outlined three basic ethical principles to be
used in research involving human subjects
• Link to Full Report
Belmont Report
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(1) Respect for persons;
(2) Beneficence; and
(3) Justice.
Application of these general principles to the
conduct of research leads to requirements of
informed consent, burden/benefit assessment, and
the equitable selection of research subjects.
• The Belmont Report became the basis for
Institutional Review Boards (IRBs).
Institutional Review Boards
• An interdisciplinary institutional
committee responsible for reviewing
proposed and ongoing research
projects to ensure that they are
ethically sound and adhere to federal
regulations regarding research
experiments involving human subjects
Institutional Review Boards
• Seven criteria that need to be satisfied in
order for an IRB to approve a research
proposal:
• 1) risks to subjects must be minimized;
• 2) risks to subjects must be reasonable in
relation to anticipated benefits;
• 3) selection of subjects must be equitable;
– See checklist for research proposals
Institutional Review Boards
• 4) enough information must be disclosed in
order for participants to be able to give
informed consent;
• 5) informed consent must be documented;
• 6) the research proposal must include
provisions for monitoring safety of the
participants;
• 7) privacy and confidentiality of participant
information must be maintained appropriately.
Informed Consent
• Elements of Informed Consent:
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Competence
Disclosure
Understanding
Voluntariness
Consent
Medical Ethics Controversies
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Medically administered nutrition and hydration
Artificial ventilation
Abortion/stem cell research
Assisted suicide/euthanasia
Rule of double effect
Rationing of healthcare
Emergency contraception
… and many, many more!
Tampering, Adulterating, and Misbranding Drugs
Robert R. Courtney, 49, of Kansas City, Missouri, and his corporation,
Courtney Pharmacy Inc., pleaded guilty on February 26 to 20 felony
criminal charges related to the incorrect preparation and dispensing
of cancer drugs.
Courtney and his corporation have admitted to the following crimes:
On eight occasions between May 17 and June 19, 2001, he committed
"consumer product tampering" by preparing i.v. solutions that did not
contain the amount of paclitaxel or gemcitabine ordered by the
treating physician. This tampering resulted in serious bodily injury
and involved a substantial risk of death to the affected patients.
On six occasions—three times each on August 7 and 13, 2001—he
committed "adulteration of a drug" by preparing i.v. solutions that
did not contain the amount of paclitaxel or gemcitabine ordered by
the treating physician. He did this knowing that the drug solutions’
strength and potency were less than that represented on the
labels.
Tampering, Adulterating, and Misbranding Drugs
On six occasions—three times each on August 7 and 13, 2001—he
committed "misbranding of a drug" by labeling containers of
paclitaxel or gemcitabine to misrepresent the actual strength and
potency of the drug in the corresponding i.v. solution.
Through his plea agreement, Courtney has admitted that he also
diluted and tampered with paclitaxel and gemcitabine solutions
administered to 26 additional patients, for a total of 34 persons.
He also admitted that he diluted and tampered with cisplatin and
carboplatin on an unspecified number of occasions. In addition, he
admitted that he conspired to traffic in stolen drugs and that, by
tampering and diluting drugs but not informing the treating
physician, he caused that physician to file false Medicare claims.
An ongoing investigation into the Courtney case has resulted in at
least four other people confessing to dealing in stolen
prescription drug products.
Tampering, Adulterating, and Misbranding Drugs
Two of those cases involved retired pharmaceutical salesmen who
admitted to buying stolen drugs from a man who worked in the
pharmacy storeroom of the University of Colorado Hospital in
Denver. The former hospital worker confessed in April to stealing
drugs from the facility and selling them.
The investigation also netted a Kansas City pharmacist who,
through a plea agreement, surrendered his pharmacy license to
state authorities in Kansas and Missouri.
Gary S. Ravis, 58, pleaded guilty to knowingly buying stolen drugs
from one of the salesmen. Ravis was sentenced in April to five
years of probation, 2500 hours of community service, and a
$250,000 fine. He must spend the first six months of his
probation under electronic monitoring in his home.
Source: Office of the United States Attorney for the Western
District of Missouri.