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RES 102 > History and Principles > Flashcards

History and Principles Flashcards

1
Q

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

A

Ethics

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2
Q

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

A

Edward Jenner &
the smallpox
vaccine

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3
Q

Later led to the discovery of the smallpox vaccine

A

Edward Jenner &
the smallpox
vaccine

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4
Q

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

A

Edward Jenner &
the smallpox
vaccine

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5
Q

US Army surgeon, Chairman of the Reed Commission

A

Major Walter Reed
& yellow fever

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6
Q

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

A

Major Walter Reed
& yellow fever

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7
Q

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

A

Dr. Richard Strong
& a cholera vaccine

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8
Q

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

A

Major Walter Reed
& yellow fever

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9
Q

Killed 13 people

A

Dr. Richard Strong
& a cholera vaccine

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10
Q

The Angel of Death

A

Josef Mengele

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11
Q

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

A

Dr. Josef Mengele

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12
Q

Established The Nuremberg Code

A

The Nuremberg Trials

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13
Q

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

A

The Nuremberg Trials

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14
Q

Formed the World Medical Association (WMA) in 1947

A

The Nuremberg Trials

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15
Q

10 principles of ethical experiments involving humans

A

The Nuremberg Code

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16
Q

Formed the basis of almost all future guidelines

A

The Nuremberg Code

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16
Q

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

A

The Nuremberg Code

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17
Q

aka Ethical Principles for Medical Research Involving Human Subjects

A

Declaration of Helsinki

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18
Q

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

A

Declaration of Helsinki

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19
Q

Formed the basis for the Good Clinical Practices guidelines used today

A

Declaration of Helsinki

20
Q

Most recent revision was from October 2013

A

Declaration of Helsinki

21
Q

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

A

Section A

22
Q

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

A

Section B

23
Q

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

A

Section C

24
Q

Only 74 of 400 subjects remained alive

A

Tuskegee Syphilis Study (1932-1972)

25
Q

Led to the first revision of the Declaration of Helsinki

A

Tuskegee Syphilis
Study (1932-1972)

26
Q

Led to the passing of the National Research Act of 1974

A

Tuskegee Syphilis
Study (1932-1972)

27
Q

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

A

Belmont Report

28
Q

3 BASIC PRINCIPLES OF CLINICAL RESEARCH ETHICS

A
  1. Respect for person
  2. Beneficence
  3. Justice
29
Q

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

A

Respect for person

30
Q

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

A

Beneficence
and non-maleficence

31
Q

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

A

Justice

32
Q

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

A

Institutional Review Board (IRB)

33
Q

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

A

Institutional Review Board (IRB)

34
Q

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

A

Full

35
Q

Only a selected subcommittee reviews the research protocol

A

Expedited

36
Q

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

A

Exempt

37
Q

It is just a standard not a law

A

Nuremburg Code

38
Q

This was done because of the atrocities in Aushwitz, Germany

A

The Nuremberg Trial

39
Q

GCP was formed by the

A

Declaration of Helsinki

40
Q

Written by National Institutes of Health (NIH)

A

7 Guiding Principles of Ethical Research

41
Q

Universal framework from research whether a research is ethical or not

A

7 Guiding Principles of Ethical Research

42
Q

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

A

Social or scientific value

43
Q

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

A

Scientific validity

44
Q

Research subjects should be selected through fair inclusion and exclusion criteria

A

Fair subject selection

45
Q

Risks to participants should be minimized while benefits should be maximized

A

Favorable risk/benefit ratio

46
Q

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

A

Independent review

47
Q

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

A

Informed consent

48
Q

Individuals must be respectfully treated throughout the study

A

Respect for enrolled participants

RES 102 (11 decks)

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