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N3 EBP > Lecture 3: chapter 4 > Flashcards

Lecture 3: chapter 4 Flashcards

1
Q

what are the elements of ethical research?

A

1) protecting human rights
2) understanding informed consent
3) understanding institutional review of research
4) balancing benefits/ risks in a study

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2
Q

what are the unethical researches mentioned?

A

1) Nazi Medical Experiments
2) Tuskegee Syphilis Study
3) Willowbrook Study
4) Jewish Chronic Disease Hospital Study

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3
Q

what are two documents associated with the Nazi Medical experiments?

A

Nuremberg Code and Declaration of Helsinki

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4
Q

what are the critiquing guidelines for problems and purposes?

what are things to consider when critiquing guidelines of research (problems and purposes)?

A
  • is it clear and concise?
  • limited in scope?
  • is it narrowed to the focus of the study?
  • does it identify variables, population, and setting?
  • does this allow for generation of knowledge?
  • feasible?
  • ethical?
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5
Q

what were the ethical violations of the Nazi Medical Experiments?

A

subjects were given poison, surgery w/o anasthesia, involuntary participation, freezing temperatures, and permanent damage

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6
Q

who were the subjects of the Nazi Medical Experiments?

A

Jewish prisoners of war

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7
Q

what was the goal of Tuskegee Syphilis Study (TSS)?

A

to examine the natural course of syphilis in adult black men w/o treatment

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8
Q

what made TSS unethical?

A

withheld information of effective treatment (Penicillin)

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9
Q

what roles did the CDC play in TSS?

A

they reviewed it and determined it should be continued for the next 40 years

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10
Q

what are the long-term implications of unethical research in the past?

A

severe mistrust by subjects of the researchers

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11
Q

what was the purpose of the Willowbrook Study (WS)?

A

examined the course of hepatitis in the body using mentally impaired children

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12
Q

on what grounds was WS defended at that time?

A

cleaner environment, better supervision, higher nurse-patient ratio

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13
Q

what was the purpose of the Jewish Chronic Disease Study (JCDS)?

A

determine the patient’s rejection response to live cancer cells

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14
Q

who were the subject of JCDS?

A

patients with dementia

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15
Q

what made JCDS unethical?

A

researchers did not inform subjects they were taking part in a study (no informed consent)

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16
Q

doctors who were caring for the patients with dementia did not know about the study

A

true

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17
Q

what is the focus of the Declaration of Helsinki?

A

clarifies the difference between therapeutic and nontherapeutic research

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18
Q

therapeutic research

A

gives patients an opportunity to receive experimental treatment

19
Q

nontherapeutic research

A

is conducted to generate knowledge for science and the benefit of future patients

20
Q

3 ethical principles (Belmont Report)

A

1) respect of persons (autonomy)
2) beneficence (promote good)
3) justice (fairness)

21
Q

what are the ways autonomy is applied in research?

A

informed consent
ability to withdraw
confidentiality

22
Q

what are the ways beneficence is applied in research?

A

minimize risks
assure benefits
maintain integrity of the study

23
Q

how do you maintain the integrity of the study?

A

report true results and finish the study

24
Q

what are the ways fairness is applied in research?

A

establishing inclusion and exclusion criteria

translated consent and surveys

25
Q

5 human rights considered for research

A

1) self-determination
2) privacy
3) anonymity
4) protection from harm and discomfort
5) fair selection and treatment

26
Q

right to self-determination

A

humans are autonomous agents with freedom to conduct their lives as they choose

27
Q

how do you violate the right to self-determination?

A

coercion
covert data collection
deception

28
Q

coercion

A

intentional threat of harm to subject to obtain compliance

29
Q

covert data collection

A

subjects are unaware of the research data being collected

30
Q

deception

A

actual misinforming of subject for research purposes

31
Q

example of deception

A

Milgram Study

administering electric shocks to another person (who was actually an actor)

32
Q

when is deception acceptable?

A

it is not expected to cause any long-lasting harm

33
Q

benefit-risk ratio

A

expected benefits balances high risks

34
Q

who are persons with diminished autonomy?

A

legally and mentally incompetent subjects

neonates and children

terminally ill

people confined to an institution

pregnant women and fetuses

35
Q

right to privacy

A

the freedom people have to determine the time, extent and general circumstances under which private information will be kept or shared

36
Q

what is considered discomfort and harm?

A

no anticipated effects

temporary discomfort

unusual levels of temporary discomfort

risk of permanent damage

certainty of permanent damage

37
Q

which right prevents coercion of subjects?

A

right to fair selection and treatment

38
Q

elements of informed consent

A

disclosure (essential information for consent)

comprehension

competence to give consent

voluntary agreement

39
Q

functions of the Institutional Review Board

A

protection of rights and welfare

voluntary informed consent

benefits exceeds risks

40
Q

what is the focus of the IRB?

A

the safety of the subjects

note they have nothing to do with the study itself (if it was valid)

41
Q

levels of reviews by the IRB

A

1) exempt
2) expedited
3) full/ complete

42
Q

studies that are exempt from review

A

they pose no apparent risks to the research subjects

43
Q

studies that will receive expedited review

A

they have minimal risks

44
Q

studies that will receive a full review

A

carries greater than minimal risks

(but it needs to present how they will actively minimize risks, ensure equitable selection of subjects, protect the privacy, make accommodations)

N3 EBP (14 decks)

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