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Flashcards in Ethical Considerations Vaccines Deck (19)
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1
Q

How many Nazi doctors were involved in criminal proceedings against them following the Second World War due to their involvement in the human experiments in concentration camps?

A

23

2
Q

The ____________ was an experiment conducted from 1932 to 1972 that enrolled African American men from Alabama who had syphilis. The men were not informed that they had syphilis nor were they given proper treatment with penicillin.

A

Tuskegee Syphilis Experiment

3
Q

The ____________ is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association. It is widely regarded as the cornerstone of human research ethics and includes the important idea of informed consent.

A

The Declaration of Helsinki

4
Q

Which document included the concept of informed consent?

A

The Declaration of Helsinki (1964)

5
Q

True or False: the Declaration of Helsinki has been edited and revised many times, last in 2000.

A

True

6
Q

This set of ethical rules mandates the independent review of the design and performance of each experimental procedure that should be clearly formulated in a specific protocol.

A

The Declaration of Helsinki

7
Q

True or False: Research not in accordance with Helsinki principles should not be accepted for publication.

A

True

8
Q

True or False: according to the declaration of Helsinki, in any medical study, every patient– including those of the control group, if any–should be assured of the best proven diagnostic and therapeutic method. This excludes the use of inert placebo in studies where no proven diagnostic or therapeutic method exists.

A

False. It does NOT exclude

9
Q

___________ is a set of research ethics principles for human experimentation set as a result of the subsequent Nuremberg trials at the end of the Second World War.

A

The Nuremberg Code (1947)

10
Q

If you are doing a clinical trial in multiple countries or even one country, there are international guidelines on how to properly implement the study. These guidelines are known as __________.

A

International Conference on Harmonisation (ICH)

11
Q

The Belmont report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: __________, __________, and ________.

A

Respect for persons, Beneficence, and Justice

12
Q

Which report discusses the boundaries between research and practice.

A

The Belmont Report

13
Q

When doing trials, the guiding ethical principles include autonomy, non-malfeasance, beneficence, and justice. What does autonomy mean?

A

Free will

14
Q

When doing trials, the guiding ethical principles include autonomy, non-malfeasance, beneficence, and justice. What does non-malfeasance mean?

A

Do no harm

Maximize possible benefits and minimize possible harms

15
Q

When doing trials, the guiding ethical principles include autonomy, non-malfeasance, beneficence, and justice. What does beneficence mean?

A

Participants gain something

16
Q

Respect for persons is listed as a key element in the Belmont Report. A specific use of this is in the implementation of ______.

A

Informed Consent

17
Q

A specific use if beneficence in the Belmont report is _________.

A

Risk/benefit assessment

18
Q

An application of justice (listed as a principle of research in the Belmont Report) is ___________.

A

Fair procedures and outcomes in the selection of subjects.

Protection of vulnerable subjects.

19
Q

Who is Jean Baptista van Helmont?

A

He was a physician and chemist who first created the idea of having a control/placebo group. (He challenged the idea that an imbalance of blood, phlegm, yellow bile, and black bile causes disease).