health law, policy, and ethics (part 1a)
TRANSCRIPT
8/13/2019 Health Law, Policy, And Ethics (Part 1a)
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Health Law, Policy, and Ethics
Richard Taylor, PhD, MPH
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Learning Objectives
• Explain the scope of health law, policy, and ethics.
• Identify key legal principles that form the basis forpublic health law.
• Identify four types of law.
• Explain the differences between market and social justice.
• Illustrate the potential tensions between individualrights and the needs for society using public health
examples.• Discuss key principles that underlie the ethics of
human research.
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Principles that underlie public health
and healthcare law in the U.S.
1. The U.S. Constitution is a fundamental
document that governs the issues of public
health and healthcare law.
2. Interstate Commerce Clause of the U.S.
Constitution is the major source of federal
authority in public health and health care.
3. US. Constitution grants individual rights
(explicit and inferred)
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Four Sources of Law
• Constitutional law
• Legislative statutes
•
Administrative regulations• Judicial, case, common law
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Characteristics of Market and
Social Justice
Market Justice
• Views health care as an economicgood
• Assumes free market conditions forhealth services delivery
• Assumes that markets are moreefficient in allocating resourcesequitably
• Production and distribution ofhealth care determined by market-based demand
• Medical care distribution based onpeople’s ability to pay
• Access to medical care viewed asan economic reward for personaleffort and achievement
Social Justice
• Views health care as a socialresource
• Requires active government
involvement in health servicesdelivery
• Assumes that the government ismore efficient in allocating healthresources equitably
• Medical resources allocation
determined by central planning• Ability to pay inconsequential for
receiving medical care
• Equal access to medical servicesviewed as a basic right
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Implications of Market and
Social Justice
Market Justice
• Individual responsibility forhealth
• Benefits based on individual
purchasing power• Limited obligation to the
collective good
• Emphasis on individual well-being
•
Private solutions to socialproblems
• Rationing based on ability topay
Social Justice
• Collective responsibility forhealth
• Everyone is entitled to a basic
package of services• Strong obligation to the
collective good
• Community well-beingsupersedes that of the
individual• Public solutions to social
problems
• Planned rationing of healthcare
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Principles of the Nuremberg Code
1. The voluntary consent of the human subject is
absolutely essential…
2. The experiment should be such as to yield
fruitful results for the good of society,
unprocurable by other methods or means ofstudy, and not random and unnecessary in
nature.
3. 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.
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Principles of the Nuremberg Code
4. The experiment should be so conducted as to avoid all unnecessary
physical and mental suffering and injury.
5. No experiment should be conducted where there is a prior reasonto believe that death or disabling injury will occur; except, perhaps, in
those experiments where the experimental physicians also serve as
subjects.
6. 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.
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Principles of the Nuremberg Code
7. Proper preparations should be made and adequate facilities provided to protect theexperimental subject against even remote possibilities of injury, disability, or death.
8. 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.
9. 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.
10. 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.
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Willowbrook Hepatitis Study
• From 1963 through 1966,
• Willowbrook State School for “mentally defective persons.”
• Studies to understand the natural history of infectious hepatitis and to test
the effects of gamma globulin in preventing or ameliorating the disease.
• Children were deliberately infected with the hepatitis virus• Investigators defended the deliberate injection of these children
• During the course of these studies, Willowbrook closed its doors to new
inmates, parents found that they were unable to admit their child to
Willowbrook unless they agreed to his or her participation in the studies.
• This case caused a public outcry because of the perception that parents and
their children were given little choice about whether or not to participate in
research
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Declaration of Helsinki
• June 1964 in Helsinki,Finland
• First significant effort of themedical community to
regulate research itself• Developed the ten
principles first stated in theNuremberg Code
• More specifically addressedclinical research
• Relaxation of the conditionsof consent
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Tuskegee Syphilis Study
• 1932-1972
• Tuskegee, Alabama
• USPHS
•
Enrolled 399 poorAfrican-American menwith syphilis from MaconCounty, Alabama
• Followed naturalprogression of diseasedespite treatmentavailability in 1940s.
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Belmont Report—1979
• Led to the development of Institutional
Review Boards (IRBs)
• Defines the rights of research subjects
incorporating basic ethical principles:
– Respect for Persons
– Beneficence
– Justice