Lecture 5- Research Ethics Flashcards

1
Q

What is scientific misconduct?

A
  • Fraudulent or false data
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2
Q

What are the consequences of scientific misconduct?

A
  • Retraction of published papers
  • Ban on government grants for years
  • End of career
  • Legal (felony) charges
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3
Q

What are correct attribution of ideas?

A
  • Cite the ideas of others appropriately

- Whenever possible, paraphrase, don’t quote

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4
Q

What is authorship?

A
  • Establishes credit and accountability

- Avoid honorary authors

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5
Q

What are conflicts of interest?

A

Roles
- Balancing your roles as a clinician and researchers

Financial

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6
Q

What is the Federal Policy for Protection of Human Subjects?

A
  • Participation must be voluntary, not coerced
  • Participants must be safeguarded from harm (physical and psychological
  • Participants must provided informed consent
  • Must maintain participants confidentiality and privacy
  • Must understand participation ban be discontinued at any time
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7
Q

What does the Belmont Report include?

A
  • Respect of Persons
  • Beneficence
  • Justice
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8
Q

What does respect of persons mean?

A
  • Acknowledge of autonomy

- Protect those with diminished autonomy

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9
Q

What is informed consent?

A
  • Investigator ensures the participant understands
  • Informed consent is a process, not a signature on a piece of paper
  • Participant needs to know the treatment and the alternatives
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10
Q

What about concealment or deception?

A

The investigator must:

  • Determine whether there are any alternatives
  • Determine whether the risk is justified
  • Ensure participants know they are allowed to withdraw at any time
  • Takes full responsibility for detecting and removing stressful after-effects of the experience
  • Ensure that participants are provided with an explanation as soon as possible
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11
Q

What is beneficience?

A
  • Protect the well-being of the person (psychological and physical)
  • Maximize benefits, minimize potential harms
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12
Q

What about beneficial treatments?

A

If there are beneficial treatments, control groups must be provided access to them

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13
Q

What is justice?

A

Fair decisions about who participates (protected classes)

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14
Q

What are some special populations?

A
  • Prisoners
  • Children
  • Pregnant women and their fetuses
  • Persons with impaired capacity to provide consent
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15
Q

What about coercion?

A
  • It is unacceptable to coerce a person to participate

- Can participants feel like they can opt out?

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16
Q

What is the role of the IRB?

A

Protect the rights and welfare of human research participants

17
Q

What are the types of research determined by the IRB?

A

Full Board Review
- More than minimal risk

Expedited
- No more than minimal risk

Exempt
- Less than minimal risk

18
Q

What are the components of the initial IRB application?

A
  • Basic study information
  • Application Part 1: who are the investigators, what type of research
  • Application Part 2: detailed study protocol
  • Supporting documents
  • Linked training records (CITI training)