chapter 4

Question 1

Identify the historical events influencing the development of ethical codes and regulations for nursing and biomedical research.

Answer 1

1933-1945: Nazi Medical Experiments
1949: Nuremberg Code
1964: Declaration on of Helsinki —> must have a strong hypothesis
Therapeutic research: results might benefit participants
Non-therapeutic research: results are not of benefit to participants but might be in the future
1973: Department of Health, Education and Welfare (DHEW) regulations
1979: Belmont Report
1996: HIPPA

Question 2

What are the 3 Ethical Principles?

Answer 2

Principle of respect for persons —> autonomy

Principle of beneficence —> promote good

Principle of justice —> fairness

Question 3

Principle of respect for persons —> autonomy

Answer 3

informed consent, can withdraw, confidentiality
Self determination (participation and withdrawing)
No coercion (Coercion example: If the instructor ask you to participate in a study and you fear it may affect your grade within the class. Studies that involve deception do happen, but it must be discussed)
Full disclosure, no deception
Voluntary consent
Persons with diminished autonomy have special protections

Question 4

Principle of beneficence —> promote good

Answer 4

minimize risks, assure benefits, maintain integrity of the study
Freedom from harm
Freedom from exploitation
Benefit-risk ratios (high anticipated benefit may balance high risks)

Question 5

Principle of justice —> fairness

Answer 5

inclusion and exclusion criteria, consent and surveys translated
Fair treatment (even if the person chooses not to participate)
Right to privacy (anonymity, confidentiality)

Question 6

What are the 5 human rights?

Answer 6

self-determination
privacy
anonymity/confidentiality
protects from discomfort/harm
fair selection/treatment

Question 7

right to determine your own destiny
Humans are autonomous agents with freedom to conduct their lives as they choose. The principle would be violated by coercion and deception.

Answer 7

self-determination

Question 8

forcing someone to be in study
Convert data collection: subjects are unaware study is taking place

Answer 8

coercion

Question 9

misinforming subjects about the study

Answer 9

deception

Question 10

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

Answer 10

privacy

Question 11

researcher refrains from sharing info with others

Answer 11

confidentiality

Question 12

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

Answer 12

anonymity

Question 13

discomfort and harm can be physical, emotional, social, or economic or any combination of these four. Even a survey study can have emotional harm.

-No anticipated effects
-Temporary discomfort
-Unusual levels of temporary discomfort
-Risk of permanent damage
-Certainty of permanent damage

Answer 13

protect from discomfort and harm

Question 14

Based on the principle of justice
Selection of subjects and their treatment during the study are fair for all
Prevents coercion of subjects (ex: paying subjects large sums of money to participate)

Answer 14

fair selection and treatment

Question 15

Institutional Review Board (IRB):

Answer 15

1974 national research act requires research study review. Who serves on the board? At least 5 members. Functions: protection of rights and welfare, voluntary informed consent, and benefits exceed risks.

-Exempt from review procedures: no risk
-Expedited review procedures: minimal risk
-Full/complete institutional review procedures (reviewing studies using vulnerable populations, have greater than minimal risk)

Question 16

Research misconduct:

Answer 16

Fabrication in research
falsification in research
plagiarism

Question 17

if the making up of results and recording and reporting them

Answer 17

fabrication in research

Question 18

is manipulating research materials, equipment, or processes or changing or omitting data of results such that the research is not accurately represented in the research record. (ex: I don’t like this value… I like this value, willful, intention trying to support your hypothesis)

Answer 18

falsification of research

Question 19

is the appropriation of another person’s idea, processes, results, or words without giving appropriate credit. (can happen on accident but use software to detect it)

Answer 19

plagiarism