Week 3 Research Ethics Overview: – Tuskegee Experiment – Ethnic Issues in Healthcare Settings

Research Ethics

Why is this so important?

Many questions to answer

Need a framework to answer

those questions.

Two types of ethical decision-making

Deductive or principle based

reasoning

Inductive or case based

reasoning

Deductive or principle based reasoning

• Start with an ethical theory

• Continue with a specific principle

• Develop rules

• Make judgments

Case Based Reasoning

Decisions we have made - precedent

Look back at those decisions and combine

them in order to make a judgment

Judgments reflect back on rules

Rules reflect on our principles

Principles reflect back to the ethical theory

What does this have to do with Ethics?

Ethics is about creating a mutually respectful relationship with the research population

Ethics is about creating a mutually respectful relationship with the research population

Subjects are pleased to participate

Community regards the conclusions

as constructive

Failure to treat subjects with respect can result in data that is:

Misleading

Inconclusive

Biased

The problems encountered in research by included:

Lack of informed consent

Disregard for risks encountered by the patient

Deception

Invasion of Privacy

A problem encountered in research examples:

Beecher - 1966 article was published inNew England Journal of Medicine

Tuskegee - untreated syphilis in black males

Beecher

• 1966 article was published in New England Journal of Medicine

was instrumental in the implementation of federal rules on human experimentation and informed consent.

Tuskegee Syphilis Study

Research study conducted by a branch of the U.S. government, lasting for roughly 50 years (ending in the 1970s), in which a sample of African American men diagnosed with syphilis were deliberately left untreated, without their knowledge, to learn about the lifetime course of the disease.

True or False: The federal government brought numerous violations and issues to the forefront and in 1974 mandated the establishment of Institutional Review Boards (National Research Act)

True

The role of the Institutional ReviewBoard (IRB)

to determine whetherthe rights and welfare of the subjectsare adequately protected andwhether the study adheres to soundethical and scientific principles

The Act also created the

National Commission for the Protection of Human Subjects of Biomedical andBehavioral Research (wrote the Belmont Report in 1979)

Belmont Report - 1979

Respect - treat others as autonomous

agents, allow people choice

Beneficence - acts of kindness that go

beyond charity and duty…various

obligations (i.e., do no harm, promote

good)

Justice - treat people fairly

Six Norms of Scientific Research: Valid research design

• takes into

account relevant theory, methods,

and prior findings

Six Norms of Scientific Research: Competence of researcher

capable to carry out the procedures

Six Norms of Scientific Research: Identification of consequences -

assessment of risks and benefits(maximizing benefit and minimizing risk)

Six Norms of Scientific Research: Selection of subjects

appropriate to the purposes of the study, representative of the population that will benefit from the research and appropriate in number

Six Norms of Scientific Research: Voluntary informed consent -

obtained before study begins, without undue threat or inducement, with enough information, and agree ment to participate

Six Norms of Scientific Research: Compensation for injury -

responsibility for what happens to the subject (federal law requires that subjects be informed about compensation, but does not require compensation)

Racial and Ethnic Issues in Health care Settings

Why examine local reports of

discrimination in healthcare

settings?

What does discrimination in health

care settings look like?

What is being done to address

issues of discrimination in

healthcare settings?

Key Findings from the Institute of Medicine

Many sources - including health systems,

healthcare providers, patients, and

utilization managers - may contribute to

these disparities

Bias, stereotyping, prejudice, and clinical

uncertainty on the part of healthcare

providers may contribute….

Studies suggest that racial and ethnic

minority patients are more likely than

white patients to refuse treatment.

What is being done to address issues of discrimination in healthcare settings?

• Train health all care providers and support

staff in cultural competency.

• Incorporate cultural competency measures in

individual performance evaluations.

• Periodically evaluate training to improve

effectiveness.

• Providers should be able to respectfully obtain cultural and ethnic heritage

information of clients when this information

is a necessary component of quality service.

• Change Institutional Policies