health law, policy, and ethics (part 1a)

8/13/2019 Health Law, Policy, And Ethics (Part 1a)

http://slidepdf.com/reader/full/health-law-policy-and-ethics-part-1a 1/13

Health Law, Policy, and Ethics

Richard Taylor, PhD, MPH



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.



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)



Four Sources of Law

• Constitutional law

• Legislative statutes

•

Administrative regulations• Judicial, case, common law



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



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



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.




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.




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.



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



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



Tuskegee Syphilis Study

• 1932-1972

• Tuskegee, Alabama

• USPHS

•

Enrolled 399 poorAfrican-American menwith syphilis from MaconCounty, Alabama

• Followed naturalprogression of diseasedespite treatmentavailability in 1940s.



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

health law, policy, and ethics (part 1a)

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