Deck 2: Ethics Foundations of Ethics in Research

Question 1

What did the 1980s activist poster that read "Stop Protecting Us to Death" refer to?​

A)The HIPAA's requirements to obtain patient data
B)The IRB's monitoring of compliance with research protocols
C)The FDA's cautious approach to approving new drugs
D)The NIH's lack of funding due to conflict of interest

Answer 1

C

Question 2

Current standards do not require that participants in clinical trials be told that they might receive a placebo​

Answer 2

False

Question 3

At smaller universities,Institutional Review Boards typically review research using both humans and animals.

Answer 3

False

Question 4

The ____,passed in 1974,represents one of the first serious attempts to build a comprehensive system of research ethics in the United States.

A)National Research Act
B)Declaration of Helsinki
C)Tuskegee Code
D)Kefauver-Harris Amendments

Question 5

Milgram's famous study was inspired by the Nazi defense,"orders are orders."​

Question 6

FDA inspector Frances Kelsey refused to approve an application with what she viewed as insufficient safety data,even under pressure from her superiors,and thus,prevented the Thalidomide tragedy from occurring in the United States.

Question 7

The principle of "respect for persons" means that people are to be treated as independent and autonomous individuals

Question 8

In a Phase III study,a drug or treatment is given to large groups of people to confirm its effectiveness,monitor side effects,compare it to commonly used treatments,and collect information that will allow the drug or treatment to be used safely​

Question 9

The principle of ____ means that researchers should attempt to maximize the benefits of participation and take steps to identify and limit the potential for harm.

A)respect for persons
B)beneficence
C)justice
D)non-maleficence

Question 10

The classic "obedience study" is believed to have been the first study in which the term ____ was used.

A)debriefing
B)placebo
C)control group
D)confederate

Question 11

Assent means that a child has not stated any objections to participating in a research study.

Question 12

The modern history of human-subject protections began at ____.

A)Nuremberg
B)Stanford
C)Belmont 
D)Tuskegee

Question 13

Which researcher conducted studies of obedience that suggested ordinary people would do things they knew would cause harm to others simply because they were told to do so?​

A)Zajonc
B)Milgram
C)Kohlberg
D)Zimbardo

Question 14

After the Thalidomide tragedy,the ____ Amendments were passed,which requires drug manufacturers to prove the safety of their drugs before marketing them.

A)Milgram
B)Belmont
C)Tuskegee
D)Kefauver-Harris 

Question 15

Fundamentally,research ethics are about doing the right thing for all involved.

Question 16

Even an accidental error in recording or analyzing data is considered misconduct.

Question 17

The 10 principles that were developed as a frame of reference for judging the conduct of Nazi physicians accused of atrocities became the ____.

A)Nuremberg Code
B)Milgram Code
C)Belmont Report
D)Tuskegee Report

Question 18

The principle of ____ means that people are to be treated as independent and autonomous individuals.

A)respect for persons
B)beneficence
C)justice
D)non-maleficence

Question 19

In the United States,the Department of Health and Human Services has placed responsibility for managing conflicts of interest on investigators,IRBs,and institutions​

Question 20

The principle of ____ means that participation should be based on fairness and not on circumstances that give researchers access to or control of a population based on status.

A)respect for persons
B)beneficence
C)justice
D)non-maleficence

Question 21

When ____ is used,either misleading or incomplete information is given to participants in the informed consent process.

A)deception
B)debriefing
C)de-identification​
D)duplicity

Question 22

Narrative 2-1
The Homeless Shelter
Carlos,a psychologist at a local shelter for homeless individuals,makes determinations about who should get special privileges.He is working on his doctorate at the same time,and naturally considers dissertation topics that would involve people who are homeless.​
Carlos wants to make sure that any information from participant surveys is not shared with the shelter's administration to avoid potential consequences.This issue relates most strongly to ____.

A)deception
B)beneficence
C)justice
D)confidentiality

Question 23

Narrative 2-1
The Homeless Shelter
Carlos,a psychologist at a local shelter for homeless individuals,makes determinations about who should get special privileges.He is working on his doctorate at the same time,and naturally considers dissertation topics that would involve people who are homeless.​
Should Carlos decide to recruit participants from the shelter at which he works,his institutional review board is likely to be concerned about ____.

A)respect for persons
B)beneficence
C)justice
D)non-maleficence

Question 24

Narrative 2-1
The Homeless Shelter
Carlos,a psychologist at a local shelter for homeless individuals,makes determinations about who should get special privileges.He is working on his doctorate at the same time,and naturally considers dissertation topics that would involve people who are homeless.​
Carlos is well aware that even a small amount of money can be a powerful incentive.He is struggling with how much he can pay participants without being coercive.This issue relates most strongly to ____.

A)respect for persons
B)beneficence
C)justice
D)assent

Question 25

In a ____ study,the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

A)pilot
B)Phase I
C)Phase II
D)Phase III

Question 26

During the study,participants will stay at a research hospital and be unable to work at their usual jobs,will be aware from friends and families,and have other restrictions on their activities.As a result,Katherine is going to pay her participants.In terms of the principles in the Belmont Report,Katherine's decision about how much to pay participants is most related to ____.

A)comprehension
B)beneficence
C)justice
D)non-maleficence

Question 27

What term refers to an assurance made to study participants that personal information about participants will be protected?​

A)privacy
B)anonymity
C)confidentiality
D)de-identification

Question 28

After recent research showed that the caregivers of family members with developmental disabilities showed significant stress reduction when taught simple mindfulness techniques during everyday activities,Liese wonders whether the same might be true of the caregivers of family members with Alzheimer's disease.Liese will recruit participants from a local peer support program for caregivers but,knowing how stressful caregiving can be,worries about how she will create an ethically sound control group.Liese is most concerned with ____.

A)right to service
B)external validity
C)deception
D)non-maleficence

Question 29

What term refers to an assurance made to study participants that identifying information about them acquired through the study will not be released to anyone outside of the study?​

A)privacy
B)anonymity
C)confidentiality
D)de-identification

Question 30

​Narrative 2-2
Brain Imaging
Katherine is a researcher studying the neurophysiology of schizophrenia.In order to do so,she compares fMRI imaging when individuals are on effective medication and when they have been off their medication long enough that it is no longer detectible in their blood.
Katherine recognizes that this may create more than minimal risk.In terms of the principles in the Belmont Report,she is concerned about ____.

A)respect for persons​
B)beneficence
C)justice
D)voluntariness

Question 31

Human subjects are to the Institutional Review Board as animal subjects are to the ____.

A)Board for the Ethical Treatment of Animals
B)Institutional Animal Care and Use Committee
C)Animal Protection Committee
D)Committee for Animals

Question 32

Narrative 2-1
The Homeless Shelter
Carlos,a psychologist at a local shelter for homeless individuals,makes determinations about who should get special privileges.He is working on his doctorate at the same time,and naturally considers dissertation topics that would involve people who are homeless.​
Carlos decides to focus on individuals who are at high risk of becoming homeless,specifically,individuals with severe,persistent mental illness who are being released from state hospitals.He is extremely careful,in his consent materials,to be clear that people do not have to participate,that their decision to participate or not participate will in no way impact their treatment at the hospital or thereafter,and that,even if they agree to participate,they can withdraw their consent without penalty.In terms of the Belmont Report's conceptualization of informed consent,Carlos is addressing ____.

A)assent
B)comprehension
C)information
D)voluntariness

Question 33

From the standpoint of an Institutional Review Board,research would include ____.

A)program evaluation required by a funding agency
B)patient satisfaction surveys
C)surveys conducted in order to improve clinic services
D)an examination of which of two treatments are most effective

Question 34

​Narrative 2-2
Brain Imaging
Katherine is a researcher studying the neurophysiology of schizophrenia.In order to do so,she compares fMRI imaging when individuals are on effective medication and when they have been off their medication long enough that it is no longer detectible in their blood.
Katherine is aware that some potential participants may have cognitive impairments and she considers excluding them solely on that basis.At the same time,she is aware that participants may,themselves,benefit from participating in the study,since they will live in at research hospital during the study and will have access to numerous resources while hospitalized.If Katherine decides to exclude persons with cognitive impairments,she is also denying these individuals access to other services,and this bothers her.In terms of the principles in the Belmont Report,she is struggling with issues related to ____.

A)respect for persons​
B)beneficence
C)justice
D)voluntariness

Question 35

What term refers to an assurance made to study participants that no one,including the researchers,will be able to link data to a specific individual?

A)privacy
B)anonymity
C)confidentiality
D)de-identification

Question 36

Narrative 2-1
The Homeless Shelter
Carlos,a psychologist at a local shelter for homeless individuals,makes determinations about who should get special privileges.He is working on his doctorate at the same time,and naturally considers dissertation topics that would involve people who are homeless.​
Carlos is thinking about including children in his study.Although the children cannot enter into a legal agreement to participate,he feels it is important that they still agree to participate.By doing so,Carlos is seeking the children's ____.

A)assent
B)confidence
C)willing participation
D)consent

Question 37

Sondra has just finished participating in an experiment that involved deception and is now being told the whole truth about what was done and why.Sondra is undergoing ____.

A)deception​
B)debriefing
C)post-hoc consenting
D)post-hoc analysis

Question 38

A ____ study is designed to test a new drug or treatment in a small group of people to evaluate its safety,determine a safe dosage range,and identify potential side effects.

A)pilot
B)Phase I
C)Phase II
D)Phase III

Question 39

Narrative 2-1
The Homeless Shelter
Carlos,a psychologist at a local shelter for homeless individuals,makes determinations about who should get special privileges.He is working on his doctorate at the same time,and naturally considers dissertation topics that would involve people who are homeless.​
Carlos decides to focus on individuals who are at high risk of becoming homeless,specifically,individuals with severe,persistent mental illness who are being released from state hospitals.He is aware that many of his potential research participants have low literacy levels and takes this into consideration when preparing his informed consent materials.In terms of the Belmont Report's conceptualization of informed consent,Carlos is addressing ____.

A)assent​
B)comprehension
C)information
D)voluntariness

Question 40

The process of removing identifying information from data sets is known as ____.

A)privacy
B)anonymity
C)confidentiality
D)de-identification

Question 41

Rhonda,a stem cell researcher,is found to have mislabeled graphs and photomicrographs.This can most accurately be described as ____.

A)plagiarism
B)falsification
C)fabrication
D)deception

Question 42

In research ethics,groups who may not be fully in control of their decision making are referred to as _______________.

Question 43

Physicist ____ was found to have completely made up some of the data on which his astounding discoveries were made.

A)Jan Hendrik Schön​
B)William Fals-Stewart
C)Haruko Obokata
D)Bodo-Eckehard Strauer

Question 44

The phrase "_______________" means that the risk of harm is not greater than that experienced in everyday life situations such as typical academic or medical examinations.

Question 45

Although the rules surrounding the testing and approval of new drugs were indented to protect the public,these rules can also limit the access to drugs by people who are desperately ill.As a result of demands by ____ activists,the FDA eventually developed an expedited review process as well as a program to expand access to promising drugs.

A)AIDS
B)cancer
C)autism spectrum disorder
D)Alzheimer's disease

Question 46

Ralph,a clinical researcher,is found to have omitted data that are inconsistent with his hypothesis about the causes of autism spectrum disorders.He has engaged in ____.

A)plagiarism
B)falsification
C)fabrication
D)deception

Question 47

In a ____ study,the drug or treatment is given to large groups of people to confirm its effectiveness,monitor side effects,compare it to commonly used treatments,and collect information that will allow the drug or treatment to be used safely.

A)pilot​
B)Phase I
C)Phase II
D)Phase III

Question 48

Research misconduct involving manipulating research materials,equipment,or processes,or changing or omitting data or results such that the research is not accurately represented in the research record is classified as ____.

A)plagiarism
B)falsification
C)fabrication
D)deception

Question 49

The _______________ requires manufacturers to present evidence on the safety and effectiveness of their products to the FDA before marketing them​

Question 50

The _______________ involved poor African American sharecroppers with a potentially fatal sexually transmitted infection who were not treated for the infection even after a cure was available.

Question 51

Sergey is lagging behind his proposed research schedule.Desperate to demonstrate that he is making good use of federal grant money,he makes up data to present in a progress report.What behavior is Sergey demonstrating?​

A)plagiarism
B)falsification
C)fabrication
D)deception

Question 52

Researcher and couples' therapist ____ hired actors to falsely testify about their involvement with data collection activities related to his research studies and deceived those actors about what they were actually doing.

A)Jan Hendrik Schön
B)William Fals-Stewart
C)Haruko Obokata
D)Bodo-Eckehard Strauer

Question 53

When a researcher pre-test assessment that identifies those in greatest need and then provides the intervention to them,the researcher is using a _______________ design.

Question 54

The _______________ includes basic standards that should underlie the conduct of any biomedical and behavioral research involving human participants.

Question 55

Research misconduct involving making up data or results and recording or reporting them is classified as ____.

A)plagiarism​
B)falsification
C)fabrication
D)deception

Question 56

The _______________ was adopted by the World Medical Association in 1964 in order to provide a set of principles to guide the practice of medical research.

Question 57

Research misconduct involving the appropriation of another person's ideas,processes,results,or words without giving appropriate credit is classified as ____.

A)plagiarism​
B)falsification
C)fabrication
D)deception

Question 58

The term _______________ means that participation should be based on fairness and not on circumstances that give researchers access to or control of a population based on status.

Question 59

A detailed document summarizing the purpose and procedures of a study is referred to as a(n)_______________.

Question 60

A(n)_______________ study is designed to test a new drug or treatment in a small group of people for the first time to evaluate its safety,determine a safe dosage range,and identify potential side effects.

Question 61

According to the Office of Research Integrity,_______________  is manipulating research materials,equipment,or processes,or changing or omitting data or results such that the research is not accurately represented in the research record.

Question 62

The role of a local _______________ is to review all proposed research involving human subjects to ensure that subjects are going to be treated ethically and that their rights and welfare will be adequately protected.

Question 63

Explain beneficence and how it relates to research ethics​.

Question 64

Describe the goals and methods of the Tuskegee Study and the consequences for the participants involved.

Question 65

How does the office of research integrity define research misconduct?​

Question 66

Discuss privacy as it relates to research ethics.

Question 67

According to the Office of Research Integrity,_______________ involves making up data or results and recording or reporting them.

Question 68

In research,_______________ means protection of personal information about participants.

Question 69

What is a conflict of interest and why is it considered to be an ethical issue?

Question 70

An assurance of _______________ made to study participants specifies that identifying information about them acquired through the study will not be released to anyone outside of the study.