Class 15 General Methodological Concepts of Research Flashcards

1
Q

Study design selection is based on the following (6):

A

Perspective of research question (hypothesis)
Ability/Desire to force group allocation (randomization)
Ethics of methodology
Efficiency and Practicality (time/resource commitment)
Costs
Validity of acquired information (internal & external)

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2
Q

Define Null Hypothesis

A

A research perspective which states there will be no (true) difference between the groups being compared
Research either accept or reject

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3
Q

Define Alternative Hypothesis

A

A research perspective which states there will be a (true) difference between the groups being compared

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4
Q

What type of Study Design is Described Below?

Researchers observe subject elements occurring naturally or selected by individuals (naturally or freely)

A

Observational

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5
Q

True or False:

Most observational study designs are NOT able to prove causeation

A

TRUE

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6
Q

True or False:

In observational study designs, there is researcher-forced group allocation

A

FALSE

There is NO researcher-forced group allocation in an observational study design

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7
Q

What type of study design is considered experimental?

A

Interventional study design

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8
Q

Does researcher-forced group allocation occur in observational or interventional study design?

A

Interventional study design

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9
Q

Define Population in terms of study subjects

A

All individuals making up a common group, from which a sample (smaller set) can be obtained if desired
Not to be confused with “study population”

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10
Q

Define Sample in terms of study subjects

A

A subset or portion of the full, complete population (“representatives”)

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11
Q

Study population selection is based on:

A

Research Hypothesis/Question
Inclusion & exclusion selection criteria (interventional studies)
Case/Control or Exposed/Non-exposed group selection criteria (obs. studies)
Ethics
Equipoise

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12
Q

Define Equipoise

A

Genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use it in human

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13
Q

What are the four key principles of bioethics?

A

Autonomy
Beneficence
Justice
Nonmaleficence

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14
Q

Define Autonomy

A

Self-rule/Self-determination. Participants must..
full and complete understanding of risks/benefits
decide for one-self, w/o outside influence

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15
Q

Define Beneficence

A

To benefit, or do good for, the patient (not society)

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16
Q

Define Justice

A

Equal and Fair treatment regardless of patient characteristics

17
Q

Nonmaleficence

A

Do no harm. Researchers must not…
withhold info
provide false info
exhibit profesional incompetence

18
Q

What three guiding principles does the Belmont Report contain?

A

Respect for persons
Beneficence
Justice

19
Q

What is the difference between Consent and Assent?

A

Consent - Agreement to participate by mentally-capable individuals of legal consenting age
Assent - Agreement to participate given by mentally-capable individuals NOT able to give legal consent

20
Q

Who is responsible for ethical determination?

A

Institutional Review Board (IRB)

aka “Ethics Committee”

21
Q

What is the IRB’s role?

A

To Protect Human Subjects from undue risk

22
Q

True or False:

Only studies regarding those under the age of 18 must be reviewed by an IRB prior to study initiation

A

FALSE

All human subject studies must be reviewed by an IRB prior to study initiation

23
Q

Who regulates and develops IRBs

A

Regulated by Federal statutes developed by the Department of Health and Human Services

24
Q

What is the name of the agency that administers and enforces the Common Federal Rules?

A

The Office of Human Research Protections (OHRP)

25
Q

What are the levels of IRB review?

A

Full Board
Expedited
Exempt

26
Q

When is Full Board review used?

A

Used for ALL interventional trials with more than minimal/no risk to patients (all medication-related studies)

27
Q

When is Expedited review used?

A

Minimal risk and/or no patient identifiers

28
Q

When is Exempt review used?

A

No patient identifiers, low/no risk, deidentified dataset analysis, environmental studies, use of existing data/specimens (de-identified)

29
Q

What semi-independent committee is charged with reviewing study data as a study progresses, but is not involved with the conduct of the study?

A

Data Safety & Monitoring Board

30
Q

What are the two methodologies of study in human studies?

A

Outcomes

Internal Validity