History and Principles

Question 1

are moral principles that govern a person’s behavior or the conducting of an activity

Answer 1

Ethics

Question 2

Inoculated 8-year-old James Phipps with cowpox, then smallpox 3 months later

Answer 2

Edward Jenner &
the smallpox
vaccine

Question 3

Later led to the discovery of the smallpox vaccine

Answer 3

Edward Jenner &
the smallpox
vaccine

Question 4

Represented the first scientific attempt to control an infectious disease by vaccination

Answer 4

Edward Jenner &
the smallpox
vaccine

Question 5

US Army surgeon, Chairman of the Reed Commission

Answer 5

Major Walter Reed
& yellow fever

Question 6

Utilized Spanish immigrant volunteers; paid more those who contracted the disease

Answer 6

Major Walter Reed
& yellow fever

Question 7

Tested side effects of a popular cholera vaccine on 24 inmates in Bilibid Prison

Answer 7

Dr. Richard Strong
& a cholera vaccine

Question 8

Eventually proved that yellow fever was spread by female Aedes Aegypti mosquitoes

Answer 8

Major Walter Reed
& yellow fever

Question 9

Killed 13 people

Answer 9

Dr. Richard Strong
& a cholera vaccine

Question 10

The Angel of Death

Answer 10

Josef Mengele

Question 11

Notorious for selecting prisoners for execution and conducting human experiments on camp inmates, including sterilization experiments, unnecessary amputations, and intentional infections, including children

Answer 11

Dr. Josef Mengele

Question 12

Established The Nuremberg Code

Answer 12

The Nuremberg Trials

Question 13

23 leading German physicians and administrators tried for war crimes and crimes against humanity, among others

Answer 13

The Nuremberg Trials

Question 14

Formed the World Medical Association (WMA) in 1947

Answer 14

The Nuremberg Trials

Question 15

10 principles of ethical experiments involving humans

Answer 15

The Nuremberg Code

Question 16

Formed the basis of almost all future guidelines

Answer 16

The Nuremberg Code

Question 16

The first international document that advocated for voluntary participation and informed consent

Answer 16

The Nuremberg Code

Question 17

aka Ethical Principles for Medical Research Involving Human Subjects

Answer 17

Declaration of Helsinki

Question 18

Governs international research ethics and defines rules for research for clinical care and non-therapeutic research

Answer 18

Declaration of Helsinki

Question 19

Formed the basis for the Good Clinical Practices guidelines used today

Answer 19

Declaration of Helsinki

Question 20

Most recent revision was from October 2013

Answer 20

Declaration of Helsinki

Question 21

defines human research and its necessity and emphasizes on the responsibility of the physician to prioritize participant health. This section stresses that special populations involved in research must be closely monitored

Answer 21

Section A

Question 22

discusses basic principles for medical research and reiterates the points of the Nuremberg Code

Answer 22

Section B

Question 23

discusses research combined with medical care and states that research can only be combined with clinical care if it has the potential to prevent, diagnose, or treat

Answer 23

Section C

Question 24

Only 74 of 400 subjects remained alive

Answer 24

Tuskegee Syphilis Study (1932-1972)

Question 25

Led to the first revision of the Declaration of Helsinki

Answer 25

Tuskegee Syphilis Study (1932-1972)

Question 26

Led to the passing of the National Research Act of 1974

Answer 26

Tuskegee Syphilis Study (1932-1972)

Question 27

A statement of basic ethical principles and guidelines addressing ethical problems in research with human participants

Answer 27

Belmont Report

Question 28

3 BASIC PRINCIPLES OF CLINICAL RESEARCH ETHICS

Answer 28

1. Respect for person 2. Beneficence 3. Justice

Question 29

Individuals must be treated according to a shared and voluntary informed consent to participation, and persons with diminished autonomy must be protected

Answer 29

Respect for person

Question 30

Human rights and safety should prevail over scientific and social benefit.

Answer 30

Beneficence and non-maleficence

Question 31

All patients must be treated fairly and not exploited while procedures should be properly performed and managed.

Answer 31

Justice

Question 32

Government-mandated board of experts established at each institution that is engaged in the research process

Answer 32

Institutional Review Board (IRB)

Question 33

Charged with monitoring the ethical conduct of research as outlined by the Belmont Report

Answer 33

Institutional Review Board (IRB)

Question 34

A formal examination of a research protocol by a board composed of 5 to 20 individuals

Answer 34

Full

Question 35

Only a selected subcommittee reviews the research protocol

Answer 35

Expedited

Question 36

A study protocol is exempt from formal review from either the full board or its subcommittee; the IRB is still to approve but without future or annual review necessary

Answer 36

Exempt

Question 37

It is just a standard not a law

Answer 37

Nuremburg Code

Question 38

This was done because of the atrocities in Aushwitz, Germany

Answer 38

The Nuremberg Trial

Question 39

GCP was formed by the

Answer 39

Declaration of Helsinki

Question 40

Written by National Institutes of Health (NIH)

Answer 40

7 Guiding Principles of Ethical Research

Question 41

Universal framework from research whether a research is ethical or not

Answer 41

7 Guiding Principles of Ethical Research

Question 42

Evaluation of a diagnostic or therapeutic intervention leading to health improvement while increasing knowledge

Answer 42

Social or scientific value

Question 43

The study should present with a scientifically sound design, ensuring research outcomes with accurate and reproducible end points

Answer 43

Scientific validity

Question 44

Research subjects should be selected through fair inclusion and exclusion criteria

Answer 44

Fair subject selection

Question 45

Risks to participants should be minimized while benefits should be maximized

Answer 45

Favorable risk/benefit ratio

Question 46

Evaluation of adherence to ethical standards by a full committee of unaffiliated individuals with expertise

Answer 46

Independent review

Question 47

Subjects must be accurately informed of benefits, harms, and alternatives to the proposed research

Answer 47

Informed consent

Question 48

Individuals must be respectfully treated throughout the study

Answer 48

Respect for enrolled participants