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Medical Ethics > Exam 2 > Flashcards

Exam 2 Flashcards

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USMLE® Step 1 flashcards
1
Q

Clinical Trials

A

Scientific study that is designed to test medical treatments in humans

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2
Q

Goal of Clinical Trials

A

Knowledge (May result in more health)

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3
Q

Examples of Clinical Trials that were studied

A
  • Polio vaccine trials on children
  • WWII experiments
  • Tuskegee syphilis
  • Willowbrook hepatitis testing
  • Vanderbilt testing radiation on pregnant women
  • MIT oatmeal
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4
Q

4 phases of research for clinical trials

A
  • Pre-trial
  • Phase I
  • Phase II
  • Phase III
    FDA APPROVAL
  • Phase IV
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5
Q

Pre-trial clinical trials

A

Animal trials

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6
Q

Phase I clinical trials

A
  • Testing side effects and safe dosage
  • 20 to 100 people
  • Several months long
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7
Q

Phase II clinical trials

A
  • Testing if it is safe and effective
  • 100 to 300 people
  • Several months to 2 years
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8
Q

Phase III clinical trials

A
  • Tests effectiveness and side effects again
  • 300 to 3000 people
  • 1 to 4 years
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9
Q

If passed the first 3 phases for clinical trials

A

FDA approval

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10
Q

Phase IV

A
  • Long term follow up
  • less than 10% of trials get here and move on
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11
Q

Problems with clinical trials

A
  • Sponsors
  • Researchers
  • Participants
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12
Q

Problem 1 with clinical trials: Sponsors

A
  • Conflict of interest
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13
Q

Problem 2 with clinical trials: Researchers

A
  • Healer vs Researcher
  • Are you doing harm?
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14
Q

Problem 3 with clinical trials: Participants

A
  • Individual vs. Communal good
  • Is it okay to let an individual suffer to benefit many
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15
Q

Proposed solutions to Conflicts of interest in clinical trials

A
  • Double-blind experiments
  • disclosing conflicts of interest
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16
Q

Proposed solutions to Healer vs Researcher

A
  • In the control group, you give them the currently accepted most effective treatment
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17
Q

DDE and Experimentation

A

Intention: Cannot deliberately infect patients
Means to end: Always has to be met
Proportionality: Side effects cannot be worse than the cure
Intrinsic wrong: Have to have informed consent and privacy has to be preserved

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18
Q

How to stay true to Proportionality (experimentation)

A
  • Well-designed experiments
  • Minimize risks to patients
  • Permanent records
  • Public records
19
Q

How to stay true to Informed consent (experimentation)

A
  • No huge incentives
  • No Authority pressures
  • Identify sponsors (known, unknown, disclosed)
20
Q

Paternalism

A

Overriding someones decision making for there own good

21
Q

Strong Paternalism

A

Overriding a persons actions or choices even though they are substantially autonomous

22
Q

Weak Paternalism

A

Overriding someones decision who cannot act autonomously or whose autonomy is greatly diminished

23
Q

Limitations of paternalism

A
  • Cognitive: mental disabilities
  • Social: parental pressures, authority pressures
  • Psychological: denial, depression, and fear
24
Q

Reasons to be paternalistic

A
  • Patients are not sound of mind
  • Autonomy is enabled when patients make the best choices
  • Patients are happier when choices are made for them
25
Q

Autonomy

A

Rational capacity for self-government

26
Q

Against Paternalism

A
  • Physicians make bad decisions
  • People have a right to their own bodies/ a right to freedom
27
Q

Standard for intervention

A

1) Harm principle
2) Best interest principle

28
Q

Harm principle

A
  • Do whatever results in the least harm to the patients
29
Q

Best Interest principle

A
  • Do whatever results in the best interest of the patient in all health fields
30
Q

Conflict of the best interest principle

A

How do you weigh the values?
- physicians have to be pretty sure to overrule parents

31
Q

3 parts of truth-telling

A
  • Informing
  • Lying
  • Whole truth
32
Q

Truth-telling: Informing

A
  • Tell the patient what they want to hear
  • Tell the patient what the hospital wants them to hear
  • Tell the patient what is best for them
33
Q

Truth-telling: Lying

A

Never lie to the patient because they have a right to the truth and because they need to trust you

34
Q

Informed consent

A

Affirmation of permission

35
Q

Privacy

A

Right to have information protected that has not been made public and which the person would reasonably not want to be disclosed

36
Q

Why is privacy important

A
  • Allows you to establish relationships
37
Q

Privacy right

A

The right to be left alone with respect to the information and is not all information it needs to meet two conditions

38
Q

Two conditions to the privacy right

A
  • Would reasonably not want info disclosed
  • If they were entirely reasonable would they want this information disclosed?
39
Q

Defendants: Therapists

A
  • Right to privacy
  • Frustrate treatment
  • If privacy not maintained violence increases
40
Q

Plaintiffs: Tarasoffs

A
  • physicians have a duty to warn
  • protective privilege ends where public peril begins
41
Q

Standard intervention

A

when you

42
Q

Conditions for Informed consent

A
  • Patient is competent to decide
  • Physician discloses info adequately
  • Patient understands the situation
  • Patient has to decide voluntarily
  • Explicitly assents to treatment
43
Q

What are rights issues raised for the patients in clinical trials?

A

Issues of informed consent or confidentiality

44
Q

Best interest principle

A

Value based

Medical Ethics (1 decks)

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