exam i: ch4

Question 1

tuskegee syphilis study

Answer 1

unethical study that gave poor african american men syphilis to study, did not treat

Question 2

willowbrook study

Answer 2

unethical study where mentally ill children were given hepatitis

Question 3

jewish chronic disease hospital study

Answer 3

unethical study in which cancerous cells were injected into pts who did not have cancer without their consent

Question 4

belmont report

Answer 4

law made after unethical research that made clear the guidelines of how to maintain ethical standards

Question 5

3 principles of the belmont report

Answer 5

1. beneficence (should be good, promote good)
2. respect of persons (autonomy)
3. justice (whatever comes out should benefit the community and all)

Question 6

nuremberg code 1949

Answer 6

brought informed voluntary consent; made sure studies were credible with qualified researchers

Question 7

declaration of helsinki 1964

Answer 7

brought therapeutic and nontherapeutic research

Question 8

national commission for the protection of human subject of biomedical and behavioral research 1978

Answer 8

belmont report was created

Question 9

scientific/research misconduct

Answer 9

the fabrication, falsification, or plagiarism in processing, performing, or reviewing research or in reporting results
- ex - lack of disclosure of data

Question 10

therapeutic research

Answer 10

came from declaration of helsinki; results may benefit participants and the whole community

Question 11

non-therapeutic research

Answer 11

came from declaration of helsinki; generates knowledge for science; no expected benefit for the participants

Question 12

what are the goals of common rule/code of federal regulation

Answer 12

enhance protection of participants and decrease admin burden of regulating research

Question 13

common rule/code of federal regulations

Answer 13

purpose is to protect the rights and welfare of human participants involved in research

Question 14

health insurance portability and accountability act (HIPAA)

Answer 14

implemented to protect private health info

Question 15

what are the 5 human rights

Answer 15

1. right to self determination (make own decision)
2. right to privacy (hipaa)
3. right to anonymity and confidentiality (pt stays anonymous)
4. right to fair treatment (prevents coercion)
5. right to protection from discomfort or harm

Question 16

self determination

Answer 16

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

Question 17

3 ways to violate self-determination

Answer 17

coercion, covert data collection, deception

Question 18

coercion

Answer 18

way of violating self determination; forcing someone to be in the study

Question 19

covert data collection

Answer 19

way of violating self determination; subjects unaware that study is taking place

Question 20

deception

Answer 20

way of violating self determination; misinforming subjects about the study

Question 21

vulnerable population

Answer 21

people with diminished autonomy

Question 22

what are examples of vulnerable populations

Answer 22

Legally and mentally incompetent ppl
Neonates, children
Terminally ill
Ppl confined to institution
Pregnant women + fetus

Question 23

breach of confidentiality

Answer 23

unauthorized access to raw data

Question 24

disclose

Answer 24

provide all details necessary for subjects to know

Question 25

comprehend

Answer 25

understanding of subject

Question 26

competence

Answer 26

ability of subject to understand AND make necessary decisions

Question 27

institutional review board (IRB)

Answer 27

"gatekeepers" of research; board has to look at your study and give you permission to do it or not

Question 28

3 functions of the IRB

Answer 28

1. protection of rights and welfare 2. voluntary informed consent 3. benefits exceed risks

Question 29

3 levels if IRB review of research

Answer 29

exempt, expedited, full

Question 30

exempt

Answer 30

research on regular educational strategies, data does not ID subject, public benefit programs, taste/food quality eval

Question 31

expedited

Answer 31

collection of bodily items and ID data, moderate exercise by healthy volunteers, behavior without stress

Question 32

full

Answer 32

reviewing studies using vulnerable populations, have greater than minimal risk

Question 33

what is the nurse's role in ethical research

Answer 33

critical appraisal of ethical aspects of published studies and research conducted in clinical agencies

Question 34

what type of sampling is good for outcomes research

Answer 34

heterogenous samples

Question 35

what are the parts of informed conset

Answer 35

disclose, comprehend, competence, voluntary agreement

Question 36

protected health research

Answer 36

data generated and collected for research that can be linked to an individual person

Question 37

plagiarism

Answer 37

using the words or ideas of another person without citing the reference or otherwise giving that person credit