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Weekly Overview

Week 4

Overview

Week Four will focus on ethics in research such as human and animal testing, disclosure, consent, etc. This week we will highlight specific cases in history and how ethical implications affect the research being conducted, and apply these historical lessons to present day scenarios. We will discuss the basic principles of medical ethics, such as the role of the Internal Review Board (IRB) and the Belmont Report.

Consider your own personal ethics and how they might influence the outcome of a project. Though laws, regulations, and protocols have been created to clarify appropriate ethical behavior and safeguard against unethical practices, the discussion has not been settled, and there are ongoing efforts to redefine and adjust the boundaries of ethical practice.

What you will cover

1. Ethics in Health Care Research

a. Explain the ethical implications of health care research.

1) Ethics defines what is good for the individual and society and the nature of obligations that one owes to society and their self

2) Human experimentation:

a) Belmont Report (1979)

1) Written by the National Commission for the Protection of Human Services of Biomedical and Behavioral Research

2) In 1981, the Belmont Report was updated to Title 45, Code of Federal Regulations, Part 46, Protection of Human Subjects

3) Details fundamental ethical principles for using human subjects:

a) Respect for persons

b) Beneficence

c) Justice

b) Declaration of Helsinki (1964):

1) Developed by the World Medical Association.

2) A set of ethical principles in relation to human experimentation:

a) Protection of the life

b) Health dignity

c) Integrity

d) Self-determination

e) Privacy

f) Confidentiality

c) Institutional Review Board (IRB)

1) Committee established to review and approve research involving human subjects

2) Ensures that all human research is conducted in accordance with ethical, institutional, and federal guidelines

3) Animal testing

a) Typically used to determine the safety and effects of substances, medication, and food

1) Vulnerable target populations:

a) Children

b) Elderly

c) The poor

d) Prisoners

e) Native populations

a. Summarize how ethics can lead to bias that influence health care research.

1) Three key cases that illustrate how ethics lead to bias in health care research:

a) Henrietta Lacks

1) Henrietta Lacks (HeLa cells) and Johns Hopkins Hospital in the 1940s

2) Henrietta Lacks was a Black tobacco farmer from southern Virginia who got cervical cancer when she was 30

3) A physician at Johns Hopkins took a piece of her tumor without telling her and sent it to the hospital lab to grow tissues in culture

4) No one knows why, but these cells have the capacity to multiply and never die

5) HeLa (from the name Henrietta Lacks) cells were used to develop the polio vaccine by Dr. Jones Salk

6) For years many hospitals and pharmaceutical companies conducted research on HeLa cells without ever compensating the heirs of Henrietta Lacks

7) Deception along with lack of disclosure and consent

b) Tuskegee Syphilis Study

1) Conducted from 1929 to 1972 in Alabama

2) The U.S. Public Health Service (PHS) conducted this experiment on 399 men

3) The purpose of the experiment was to see the effect of syphilis in its tertiary or final form

4) Alexander Fleming had discovered penicillin in 1928, and this drug was effective at treating syphilis

5) PHS did not provide this treatment to the 399 men

6) Deception along with lack of disclosure and consent

c) Project MK Ultra

1) Began in the 1950's

2) A covert research mission that experimented on humans

3) Attempted to alter brain functions by giving the prisoners chemicals, drugs, practicing sensory deprivation, and even verbal abuse.

4) There were numerous participants, including universities, pharmaceutical companies, and hospitals

5) In the 1970's, the Freedom of Information Act uncovered over 15,000 documents about this project, which propelled Senate hearings

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