Lecture 3: chapter 4

Question 1

what are the elements of ethical research?

Answer 1

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

Question 2

what are the unethical researches mentioned?

Answer 2

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

Question 3

what are two documents associated with the Nazi Medical experiments?

Answer 3

Nuremberg Code and Declaration of Helsinki

Question 4

what are the critiquing guidelines for problems and purposes?

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

Answer 4

• 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?

Question 5

what were the ethical violations of the Nazi Medical Experiments?

Answer 5

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

Question 6

who were the subjects of the Nazi Medical Experiments?

Answer 6

Jewish prisoners of war

Question 7

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

Answer 7

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

Question 8

what made TSS unethical?

Answer 8

withheld information of effective treatment (Penicillin)

Question 9

what roles did the CDC play in TSS?

Answer 9

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

Question 10

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

Answer 10

severe mistrust by subjects of the researchers

Question 11

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

Answer 11

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

Question 12

on what grounds was WS defended at that time?

Answer 12

cleaner environment, better supervision, higher nurse-patient ratio

Question 13

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

Answer 13

determine the patient’s rejection response to live cancer cells

Question 14

who were the subject of JCDS?

Answer 14

patients with dementia

Question 15

what made JCDS unethical?

Answer 15

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

Question 16

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

Answer 16

true

Question 17

what is the focus of the Declaration of Helsinki?

Answer 17

clarifies the difference between therapeutic and nontherapeutic research

Question 18

therapeutic research

Answer 18

gives patients an opportunity to receive experimental treatment

Question 19

nontherapeutic research

Answer 19

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

Question 20

3 ethical principles (Belmont Report)

Answer 20

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

Question 21

what are the ways autonomy is applied in research?

Answer 21

informed consent
ability to withdraw
confidentiality

Question 22

what are the ways beneficence is applied in research?

Answer 22

minimize risks
assure benefits
maintain integrity of the study

Question 23

how do you maintain the integrity of the study?

Answer 23

report true results and finish the study

Question 24

what are the ways fairness is applied in research?

Answer 24

establishing inclusion and exclusion criteria

translated consent and surveys

Question 25

5 human rights considered for research

Answer 25

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

Question 26

right to self-determination

Answer 26

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

Question 27

how do you violate the right to self-determination?

Answer 27

coercion covert data collection deception

Question 28

coercion

Answer 28

intentional threat of harm to subject to obtain compliance

Question 29

covert data collection

Answer 29

subjects are unaware of the research data being collected

Question 30

deception

Answer 30

actual misinforming of subject for research purposes

Question 31

example of deception

Answer 31

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

Question 32

when is deception acceptable?

Answer 32

it is not expected to cause any long-lasting harm

Question 33

benefit-risk ratio

Answer 33

expected benefits balances high risks

Question 34

who are persons with diminished autonomy?

Answer 34

legally and mentally incompetent subjects neonates and children terminally ill people confined to an institution pregnant women and fetuses

Question 35

right to privacy

Answer 35

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

Question 36

what is considered *discomfort and harm*?

Answer 36

no anticipated effects temporary discomfort unusual levels of temporary discomfort risk of permanent damage certainty of permanent damage

Question 37

which right prevents coercion of subjects?

Answer 37

right to fair selection and treatment

Question 38

elements of informed consent

Answer 38

disclosure (essential information for consent) comprehension competence to give consent voluntary agreement

Question 39

functions of the Institutional Review Board

Answer 39

protection of rights and welfare voluntary informed consent benefits exceeds risks

Question 40

what is the focus of the IRB?

Answer 40

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

Question 41

levels of reviews by the IRB

Answer 41

1) exempt 2) expedited 3) full/ complete

Question 42

studies that are ****exempt**** from review

Answer 42

they pose no apparent risks to the research subjects

Question 43

studies that will receive ****expedited review****

Answer 43

they have minimal risks

Question 44

studies that will receive a ****full review****

Answer 44

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)