ch 4 examining ethics in nursing research Flashcards

1
Q

things included nazi medical experiments

A

-high altitudes
-freezing temps
-malaria
-poisons
-typhus
-untested drugs
-surgery w/o anesthetic

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2
Q

type research: Provides patients with an opportunity to receive and experimental
treatment that might have beneficial results

A

therapeutic research

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3
Q

type research: conducted to generate knowledge for a discipline; the
results of the study might benefit future patients but probably will not benefit those acting
as research subjects

A

nontherapeutic research

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4
Q

developed from the nuremberg code that defined two types of research

A

declaration of helsinki

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5
Q

what provided the basis for the declaration of helsinki

A

nuremberg code (trial of nazi experiments for mistreatment of humans)

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6
Q

intentional infection with hepatitis of mentally handicapped children from 1950-1970

A

willowbrook study

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7
Q

intentional lack of treatment of syphilis for african american men from 1932-1972

A

tuskegee syphilis study

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8
Q

injection of 22 patients with live cancer cells by dr chester southam

A

jewish chronic disease hospital study

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9
Q

report that is a statement of basic ethical principles and guidelines that should assist in
resolving the ethical problems that surround the conduct of research with human
subjects
-identified by commission for the protection of human subjects of biomedical and behavioral research

A

belmont report

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10
Q

3 ethical principles included in protection of human subjects (included in belmont report)

A
  1. principle of respect for persons
  2. principle of beneficence
  3. principle of justice
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11
Q

principle of belmont report: People should be treated as autonomous agents with the right to self determination. They have the right to choose to participate or not participate in research

A

principle of respect for persons

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12
Q

principle of belmont report: Do good, and above all, do no harm. Minimize risks and maximize benefits

A

principle of beneficence

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13
Q

principle of belmont report: Human subjects should be treated fairly in terms of the benefits and risks of research

A

principle of justice

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14
Q

5 human rights

A

-self determination
-privacy
-anonymity and confidentiality
-fair treatment
-protection from discomfort and harm

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15
Q

human right: Humans are autonomous agents who can choose to participate in research.

A

self determination

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16
Q

occurs when a person intentionally presents an overt threat of harm or
excessive reward to obtain compliance

17
Q

occurs when subjects are unaware that
research data are being collected.

A

covert data collection

18
Q

actual misinforming of subjects for research purposes that can
violate a subject’s right to self-determination.

19
Q

people with diminished autonomy

A

-minors
-pregnant women and fetuses
-mentally impaired individuals
-unconscious people

20
Q

the freedom people have to determine the time, extent, and general circumstances under which their private information will be shared with or withheld from others

21
Q

occurs when private information is shared without a person’s knowledge or consent, or against their will

A

invasion of privacy

22
Q

covered entities that can use/disclose pt information

A

-health care providers
-health care plans
-employees
-health care clearinghouses

23
Q

researcher must refrain from sharing
information without the authorization of the research subject

A

confidentiality

24
Q

occurs when
there is unauthorized access to raw data

A

breach of confidentiality

25
No one, not even the researcher, knows the identity of the subjects
anonymity
26
4 highly publicized projects that are known for their unethical treatment of human subjects
-nazi medical experiments -tuskegee syphilis study -willowbrook study -jewish chronic disease hospital study
27
when someone changes their behavior because they know they are being observed
hawthorne effect
28
12 critical components of informed consent
-introduction of research activities -statement of research purpose -selection of research subjects -explanation of procedures -description of risks and discomforts -description of benefits -disclosure of alternatives -assurance of anonymity and confidentiality -offer to answer questions -voluntary participation -option to withdraw -consent to incomplete disclosure
29
purpose of institutional review board (IRB) (with informed consent)
have a committee examine the study for ethical concerns -must have no less than 5 members of various backgrounds to promote complete, scholarly and fair reviews of research for the institution
30
3 levels of review for institutional review board
-exempt from review -expedited review -complete review
31
level of review for IRB: study poses no apparent risk for research subject
exempt from review
32
level of review for IRB: study poses minimal risk to subject
expedited review
33
level of review for IRB: anything outside of exempt or expedited reviews; criteria must be met to obtain approval
complete review
34
criteria that must be met for complete review from IRB (6)
-Risk to the subject minimized -Risks to the subject are reasonable in relation to the anticipated benefits -Informed consent will be sought -Informed consent will be appropriately documented -There is adequate provision for monitoring the data collection -There is adequate provision for protection of the privacy and confidentiality of the data under HIPAA