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146 LE 3 > Ethics in Research > Flashcards

Ethics in Research Flashcards

1
Q

Examples of Unethical Practices in Research

A
  • Nazi experiments during WWII
  • Tuskegee Syphilis Study
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2
Q

History of Ethical guidelines

A
  • Nuremberg code (1947)
  • Helsinki Declaration (1964)
  • Belmont Report (1979)
  • Good Clinical practice guidelines
  • CIOMS Guidelines
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3
Q

This historical landmark established the importance of voluntary consent in research

A

Nuremberg code

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4
Q

Statement of ethical principles for medical
research involving human subjects

A

Helsinki Declaration

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5
Q

Developed by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research

A

Belmont Report

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6
Q

Developed by the International Council for
Harmonization of Technical Requirements for
Pharmaceuticals for Human Use

A

Good Clinical Practice Guidelines

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7
Q

International Ethical Guidelines for Health related Research Involving Humans

A

CIOMS Guidelines

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8
Q

Emphasis of Transitional Epidemiology

A

Application of population health research
findings to efforts addressing disparities and public health issues

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9
Q

Components of Transitional Epidemiology

A

○ Developing interventions based on research results
○ Turning data into actionable health information that can be readily used by healthcare providers, legislators, policymakers, and the general public

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10
Q

Basic Ethical Principles in Research

A
  • Respect for Persons
  • Beneficence
  • Non-maleficence
  • Justice
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11
Q

“Protect those with impaired or diminished autonomy from harm” falls under what basic ethical principle?

A

Respect for persons

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12
Q

A status in which some people may struggle to protect their interests or beat greater risk of being exploited.

A

Vulnerability

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13
Q

Obligation to secure the well-being of research
participants

A

Beneficence

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14
Q

The moral duty not to cause harm to others through interventions

A

Non-maleficence

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15
Q

Related to the concept of equity in health research

A

Justice

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16
Q

Elements of Research Ethics

A
  • Informed Consent
  • Social Value
  • Vulnerability of Research Participants
  • Benefits, risks, and safety
  • Privacy and Confidentiality
  • Transparency
  • Justice
17
Q

Refers to the contribution of the study to an existing social or health problems

A

Social Value

18
Q

Individuals make an explicit choice to participate (or receive intervention) in a study after having been fully informed about the study and one’s rights (risk, potential benefits, etc.)

A

Informed Consent

19
Q

Children are asked for their _____ to participate; parents asked for their ____

A

Assent
Consent

20
Q

Inclusion of vulnerable is only justified when:

A
  • It is necessary to promote the welfare of the
    population represented
  • If research cannot be performed on non-vulnerable persons
21
Q

Probability of physical, psychological, social, or economic harm as a result of participation in a research

A

Risk

22
Q

Interim analysis is performed _______ of the study

A

Before the end

23
Q

Interim analyses is done to assess _____

A

Preliminary outcomes

24
Q

Protecting one’s space, decisions, and personal life from intrusion

A

Privacy

25
Q

The obligation of researchers to protect personal information from being disclosed to unauthorized parties

A

Confidentiality

26
Q

TRUE OR FALSE: Confidentiality must ALWAYS be observed

A

False, Where there is likelihood or opportunity for the researcher to observe the occurrence of illegal or harmful behaviors, explicitly indicate limits to confidentiality

27
Q

Equitable distribution of both benefits and burdens of research participation

A

Justice

28
Q

Data Privacy Act of _____

A

2012

29
Q

Elements of Informed Consent

A
  • Information to be provided to potential participant
  • Documentation of Consent
  • Waiver of informed consent
  • Renewing consent
30
Q

Ethical guidelines for epidemiologic research

A
  • Scientific validity
  • Informed consent
  • Risks and benefits
  • Privacy and confidentiality
  • Sharing of study result with participants
  • Compensation for participants
  • Managing of conflict of interest of researcher

146 LE 3 (6 decks)

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