ch 4 examining ethics in nursing research

Question 1

things included nazi medical experiments

Answer 1

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

Question 2

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

Answer 2

therapeutic research

Question 3

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

Answer 3

nontherapeutic research

Question 4

developed from the nuremberg code that defined two types of research

Answer 4

declaration of helsinki

Question 5

what provided the basis for the declaration of helsinki

Answer 5

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

Question 6

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

Answer 6

willowbrook study

Question 7

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

Answer 7

tuskegee syphilis study

Question 8

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

Answer 8

jewish chronic disease hospital study

Question 9

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

Answer 9

belmont report

Question 10

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

Answer 10

1. principle of respect for persons
2. principle of beneficence
3. principle of justice

Question 11

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

Answer 11

principle of respect for persons

Question 12

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

Answer 12

principle of beneficence

Question 13

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

Answer 13

principle of justice

Question 14

5 human rights

Answer 14

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

Question 15

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

Answer 15

self determination

Question 16

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

Answer 16

coercion

Question 17

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

Answer 17

covert data collection

Question 18

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

Answer 18

deception

Question 19

people with diminished autonomy

Answer 19

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

Question 20

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

Answer 20

privacy

Question 21

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

Answer 21

invasion of privacy

Question 22

covered entities that can use/disclose pt information

Answer 22

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

Question 23

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

Answer 23

confidentiality

Question 24

occurs when
there is unauthorized access to raw data

Answer 24

breach of confidentiality

Question 25

No one, not even the researcher, knows the
identity of the subjects

Answer 25

anonymity

Question 26

4 highly publicized projects that are known for their unethical treatment of human subjects

Answer 26

-nazi medical experiments
-tuskegee syphilis study
-willowbrook study
-jewish chronic disease hospital study

Question 27

when someone changes their behavior because they know they are being observed

Answer 27

hawthorne effect

Question 28

12 critical components of informed consent

Answer 28

-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

Question 29

purpose of institutional review board (IRB) (with informed consent)

Answer 29

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

Question 30

3 levels of review for institutional review board

Answer 30

-exempt from review
-expedited review
-complete review

Question 31

level of review for IRB: study poses no apparent risk for research subject

Answer 31

exempt from review

Question 32

level of review for IRB: study poses minimal risk to subject

Answer 32

expedited review

Question 33

level of review for IRB: anything outside of exempt or expedited reviews; criteria must be met to obtain approval

Answer 33

complete review

Question 34

criteria that must be met for complete review from IRB (6)

Answer 34

-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