Deck 4: Examining Ethics in Nursing Research
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Deck 4: Examining Ethics in Nursing Research
1
When obtaining informed consent from study subjects,the researcher will ensure that subjects freely choose whether or not to participate and will provide subjects
A) general knowledge and overview of the study.
B) information about the study methods and design.
C) reports about the study results and conclusions.
D) the right to choose whether to be in the control versus the study group.
A) general knowledge and overview of the study.
B) information about the study methods and design.
C) reports about the study results and conclusions.
D) the right to choose whether to be in the control versus the study group.
general knowledge and overview of the study.
2
A special concern when conducting research using terminally ill cancer patients as subjects is
A) an inability to randomly assign subjects to study groups.
B) an increased risk of harm with decreased benefits.
C) difficulty enlisting subjects for participation in the study.
D) poor control of extraneous variables.
A) an inability to randomly assign subjects to study groups.
B) an increased risk of harm with decreased benefits.
C) difficulty enlisting subjects for participation in the study.
D) poor control of extraneous variables.
an increased risk of harm with decreased benefits.
3
The Tuskegee Syphilis Study violated several ethical principles in which way?
A) Coercion of subjects to participate in the study in exchange for treatment
B) Failing to inform subjects about the purpose and procedures in the study
C) Failing to inform the Centers for Disease Control about the results of the study
D) Not informing the subjects' physicians that they were in the study
A) Coercion of subjects to participate in the study in exchange for treatment
B) Failing to inform subjects about the purpose and procedures in the study
C) Failing to inform the Centers for Disease Control about the results of the study
D) Not informing the subjects' physicians that they were in the study
Failing to inform subjects about the purpose and procedures in the study
4
To safeguard the right to self-determination among research subjects,the researcher will ensure that subjects
A) are afforded anonymity to the researcher and the reader.
B) are allowed to choose whether to be in a control or a study group.
C) may choose whether or not to participate in a study.
D) receive a large monetary reward for participating in the study.
A) are afforded anonymity to the researcher and the reader.
B) are allowed to choose whether to be in a control or a study group.
C) may choose whether or not to participate in a study.
D) receive a large monetary reward for participating in the study.
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5
A researcher will have greater success gaining approval for a research study involving pregnant women if which provision is put into place?
A) Care is taken to maintain strict confidentiality of subjects.
B) Consent is given by the pregnant women's significant others.
C) Subjects may experience therapeutic effects from the intervention.
D) Subjects receive financial rewards for participation in the study.
A) Care is taken to maintain strict confidentiality of subjects.
B) Consent is given by the pregnant women's significant others.
C) Subjects may experience therapeutic effects from the intervention.
D) Subjects receive financial rewards for participation in the study.
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6
The purpose of an institutional review board (IRB)in a university or clinical agency is to
A) approve funding for studies based on ethical standards.
B) critically appraise ethical aspects of published studies.
C) define ethical standards for the institution.
D) protect the human rights of subjects in proposed studies.
A) approve funding for studies based on ethical standards.
B) critically appraise ethical aspects of published studies.
C) define ethical standards for the institution.
D) protect the human rights of subjects in proposed studies.
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7
A researcher wishes to study the effects of anti-seizure medications on adult subjects who have severe cognitive impairments.Which statement is true about using these subjects in research?
A) Assent must be gained from the subjects and is sufficient for participation.
B) A legally authorized guardian must give informed consent.
C) These adults cannot be used as subjects for this study.
D) The subjects' physicians must give consent for participation in the study.
A) Assent must be gained from the subjects and is sufficient for participation.
B) A legally authorized guardian must give informed consent.
C) These adults cannot be used as subjects for this study.
D) The subjects' physicians must give consent for participation in the study.
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8
Which ethical principle protects human subjects from harm?
A) Beneficence
B) Ethics
C) Justice
D) Respect for persons
A) Beneficence
B) Ethics
C) Justice
D) Respect for persons
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9
The ethical principles of respect for persons,beneficence,and justice are considered essential elements in research involving human subjects.In which document are these principles identified?
A) Declaration of Helsinki
B) Department of Health,Education,and Welfare regulations (DHEW)
C) National Commission for the Protection of Human Subjects in the Belmont Report
D) Nuremberg Code
A) Declaration of Helsinki
B) Department of Health,Education,and Welfare regulations (DHEW)
C) National Commission for the Protection of Human Subjects in the Belmont Report
D) Nuremberg Code
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10
An important initial focus of the Declaration of Helsinki,developed in 1964,was to
A) differentiate therapeutic from nontherapeutic research.
B) define the concept of informed consent of research subjects.
C) prevent the use of placebos during clinical drug trials.
D) prohibit nontherapeutic research to protect subjects from harm.
A) differentiate therapeutic from nontherapeutic research.
B) define the concept of informed consent of research subjects.
C) prevent the use of placebos during clinical drug trials.
D) prohibit nontherapeutic research to protect subjects from harm.
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11
The greatest risk to a person confined to an institution who is a research subject is
A) diminished autonomy.
B) discomfort.
C) lack of information.
D) lack of privacy.
A) diminished autonomy.
B) discomfort.
C) lack of information.
D) lack of privacy.
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12
Which subject groups may feel especially coerced to participate in research studies?
A) Children
B) Institutionalized patients
C) Pregnant women
D) Terminally ill patients
A) Children
B) Institutionalized patients
C) Pregnant women
D) Terminally ill patients
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13
After the Department of Health,Education,and Welfare (DHEW)regulations were published in 1973,all research using human subjects was required to
A) avoid using subjects who were ill,mentally impaired,or dying.
B) obtain informed consent from all subjects prior to enrollment in a study.
C) review only studies in which risk of harm to subjects is especially high.
D) undergo full institutional review to examine risks and benefits to subjects.
A) avoid using subjects who were ill,mentally impaired,or dying.
B) obtain informed consent from all subjects prior to enrollment in a study.
C) review only studies in which risk of harm to subjects is especially high.
D) undergo full institutional review to examine risks and benefits to subjects.
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14
If a healthcare provider discloses information about a patient to a researcher for a study,the provider and the researcher must have a(n)
A) agreement about the study's purpose.
B) data use agreement.
C) limited data set.
D) written study proposal.
A) agreement about the study's purpose.
B) data use agreement.
C) limited data set.
D) written study proposal.
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15
When a researcher indicates that assent for participation was gained in a study involving 10-year-old children,this indicates which has occurred?
A) The children gave informed consent to participate in the study.
B) The children have agreed to be subjects in the study.
C) The parents granted approval for their children to participate.
D) The parents do not need to give consent because the children gave consent.
A) The children gave informed consent to participate in the study.
B) The children have agreed to be subjects in the study.
C) The parents granted approval for their children to participate.
D) The parents do not need to give consent because the children gave consent.
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16
When conducting research to study medical devices for human use,the nurse researcher must comply with the Department of Health and Human Services human subjects' regulations as well as regulations put forth by the
A) American Nurses Association (ANA).
B) Code of Federal Regulations (CFR).
C) Food and Drug Administration (FDA).
D) Presidential Commission for the Study of Bioethics.
A) American Nurses Association (ANA).
B) Code of Federal Regulations (CFR).
C) Food and Drug Administration (FDA).
D) Presidential Commission for the Study of Bioethics.
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17
In a study about pregnant women's use of tobacco,the researcher can link individual subjects' identities to their responses on a questionnaire,but does not share this information with others.This is an example of
A) anonymity.
B) breach of confidentiality.
C) confidentiality.
D) privacy.
A) anonymity.
B) breach of confidentiality.
C) confidentiality.
D) privacy.
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18
A clinical research nurse identifies which of the following as a vulnerable population?
A) Women hospitalized for a mastectomy
B) Clients who speak both English and Spanish
C) Men 65 years and older belonging to the Active Seniors Wellness Center
D) Pediatric clients hospitalized for cancer
A) Women hospitalized for a mastectomy
B) Clients who speak both English and Spanish
C) Men 65 years and older belonging to the Active Seniors Wellness Center
D) Pediatric clients hospitalized for cancer
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19
Which ethical principle includes the right to self-determination and the right to full disclosure?
A) Beneficence
B) Ethics
C) Justice
D) Respect for persons
A) Beneficence
B) Ethics
C) Justice
D) Respect for persons
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20
A researcher makes every effort to ensure that subjects may benefit from a research intervention while taking measures to minimize potential harm.This is an example of protecting a research subject's right to
A) anonymity and confidentiality.
B) fair treatment.
C) protection from discomfort and harm.
D) self-determination.
A) anonymity and confidentiality.
B) fair treatment.
C) protection from discomfort and harm.
D) self-determination.
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21
According to the HIPAA privacy rules,which are covered entities that may use and disclose a limited data set to researchers for study? Select all that apply.
A) Health plans
B) Healthcare providers
C) Institutional Review Boards
D) Researchers
A) Health plans
B) Healthcare providers
C) Institutional Review Boards
D) Researchers
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22
Which of the following are true statements about genomic research? Select all that apply.
A) Genomic research is a promising area of science related to human disease and healing.
B) Genomic research involves unethical challenges dues to the potential that the subject can be identified by the data.
C) The Human Genome Project funded by NIH recognized from the onset the ethical and legal dilemmas of genomic research.
D) Broad consent in the revised Common Rule was developed to address some of the unresolved issues in genomics research.
E) De-identification of data and ownership of specimens are two of the unresolved issues in genomics research.
A) Genomic research is a promising area of science related to human disease and healing.
B) Genomic research involves unethical challenges dues to the potential that the subject can be identified by the data.
C) The Human Genome Project funded by NIH recognized from the onset the ethical and legal dilemmas of genomic research.
D) Broad consent in the revised Common Rule was developed to address some of the unresolved issues in genomics research.
E) De-identification of data and ownership of specimens are two of the unresolved issues in genomics research.
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23
Which of the following represent some degree of risk of causing discomfort or harm to subjects in a study? Select all that apply.
A) Asking parents of children in a clinic waiting room to complete a patient satisfaction questionnaire
B) Assessing the number of males and females enrolled in nursing schools using enrollment data
C) Interviewing nursing home residents about their memories of the Great Depression
D) Using pathology reports from a hospital lab to gain data about the percentage of new patients who have anemia
A) Asking parents of children in a clinic waiting room to complete a patient satisfaction questionnaire
B) Assessing the number of males and females enrolled in nursing schools using enrollment data
C) Interviewing nursing home residents about their memories of the Great Depression
D) Using pathology reports from a hospital lab to gain data about the percentage of new patients who have anemia
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24
Which situation may allow waiving the need to obtain written consent for participation in a research study?
A) The researcher is conducting an informal study about heart disease.
B) The researcher is using questionnaires to collect data about suicide risk.
C) The subjects do not want documentation linking them to the study.
D) The subjects desire complete anonymity in the study.
A) The researcher is conducting an informal study about heart disease.
B) The researcher is using questionnaires to collect data about suicide risk.
C) The subjects do not want documentation linking them to the study.
D) The subjects desire complete anonymity in the study.
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25
Which is an example of falsification in research?
A) Citing work by another researcher and claiming it as one's own
B) Making up statistics about the incidence of reactions to an intervention
C) Omitting data about a subject that disproves the researcher's hypothesis
D) Using data gained without the consent of the research subjects
A) Citing work by another researcher and claiming it as one's own
B) Making up statistics about the incidence of reactions to an intervention
C) Omitting data about a subject that disproves the researcher's hypothesis
D) Using data gained without the consent of the research subjects
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26
A researcher gives healthy adult subjects a handout explaining the nature of a study and then obtains written consent from those who choose to participate.Which statement is true about this process?
A) Subjects have given informed consent for participation in the study.
B) Subjects have not given voluntary consent for participation in the study.
C) The researcher has failed to determine comprehension of the study by participants.
D) The researcher has not disclosed information about the study to the participants.
A) Subjects have given informed consent for participation in the study.
B) Subjects have not given voluntary consent for participation in the study.
C) The researcher has failed to determine comprehension of the study by participants.
D) The researcher has not disclosed information about the study to the participants.
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27
A researcher combines data from another researcher's study along with data from the reported study in graphs without noting the source of the data.This is an example of
A) an honest error.
B) fabrication.
C) falsification.
D) plagiarism.
A) an honest error.
B) fabrication.
C) falsification.
D) plagiarism.
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28
Which unethical study in previous history involved withholding a treatment from subjects to study the effects of a disease progression on subjects?
A) The Jewish Chronic Disease Hospital Study
B) The Nazi Medical Experiments
C) The Tuskegee Syphilis Study
D) The Willowbrook Study
A) The Jewish Chronic Disease Hospital Study
B) The Nazi Medical Experiments
C) The Tuskegee Syphilis Study
D) The Willowbrook Study
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29
A researcher has submitted a proposal to an Institutional Review Board (IRB)to evaluate the effects of a new drug on newborn infants.In this case,members of the IRB should include: Select all that apply.
A) an ethicist.
B) a hospital pharmacist.
C) a neonatologist.
D) a pharmaceutical representative.
A) an ethicist.
B) a hospital pharmacist.
C) a neonatologist.
D) a pharmaceutical representative.
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30
When a prospective subject has decided to take part in a research study of his or her own volition,without coercion or any undue influence describes which element of Informed Consent?
A) Disclosure
B) Comprehension
C) Competence
D) Voluntary agreement
A) Disclosure
B) Comprehension
C) Competence
D) Voluntary agreement
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31
Which federal agency was established to manage investigations of misconduct in research?
A) Department of Health,Education,and Welfare (DHEW)
B) Department of Health and Human Services (DHHS)
C) Food and Drug Administration (FDA)
D) Office of Research Integrity (ORI)
A) Department of Health,Education,and Welfare (DHEW)
B) Department of Health and Human Services (DHHS)
C) Food and Drug Administration (FDA)
D) Office of Research Integrity (ORI)
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32
Which of the following are true statements about informed consent? Select all that apply.
A) Informed consent is the process of providing information to a potential subject and the opportunity to participate in the study.
B) The process ends with the subject's signature on a document agreeing to be in a study.
C) A potential subject's decision about whether to participate is the informing part of the process.
D) Informed consent is incomplete or unethical unless all three elements are incorporated.
E) The documentation of informed consent depends on the study's level of risk and the requirement of the IRB who approves the study.
A) Informed consent is the process of providing information to a potential subject and the opportunity to participate in the study.
B) The process ends with the subject's signature on a document agreeing to be in a study.
C) A potential subject's decision about whether to participate is the informing part of the process.
D) Informed consent is incomplete or unethical unless all three elements are incorporated.
E) The documentation of informed consent depends on the study's level of risk and the requirement of the IRB who approves the study.
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33
An institutional review board consists of a committee of peers who examine studies for ethical concerns with three levels of review.A descriptive study with anonymous online data collection using a social support scale and demographic questionnaire is an example of what level of IRB review?
A) Expedited review
B) Exempt from review
C) Partial review
D) Full review
A) Expedited review
B) Exempt from review
C) Partial review
D) Full review
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34
A researcher wants to study whether showing a video about car safety increases the likelihood of car seat use among a group of first-time parents.When obtaining informed consent,the researcher must include: Select all that apply.
A) an assurance of anonymity.
B) a statement of the research purpose.
C) consent to incomplete disclosure.
D) voluntary participation.
A) an assurance of anonymity.
B) a statement of the research purpose.
C) consent to incomplete disclosure.
D) voluntary participation.
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35
A subject's right to fair selection and treatment in a study is related to which ethical principle?
A) Beneficence
B) Justice
C) Privacy
D) Respect for persons
A) Beneficence
B) Justice
C) Privacy
D) Respect for persons
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36
Which patient information requires de-identifying to maintain privacy? Select all that apply.
A) E-mail addresses
B) Full-face photographs
C) State of residence
D) Medical record numbers
A) E-mail addresses
B) Full-face photographs
C) State of residence
D) Medical record numbers
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37
A researcher using a small sample of an easily distinguishable group of subjects wishes to use extensive quotes in the research report.This researcher risks
A) a loss of study validity.
B) breaching confidentiality.
C) losing objectivity.
D) reduction of benefits to subjects.
A) a loss of study validity.
B) breaching confidentiality.
C) losing objectivity.
D) reduction of benefits to subjects.
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38
A descriptive comparative study of blood vessel structures of placentas obtained at delivery from women who had pregnancy-induced hypertension to those of women who were normotensive through pregnancy would be an example of what level of IRB review?
A) Expedited review
B) Exempt from review
C) Full review
D) Final review
A) Expedited review
B) Exempt from review
C) Full review
D) Final review
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39
A researcher makes an honest error when tabulating and analyzing research findings.According to the Office of Research Integrity,this constitutes
A) fabrication.
B) falsification.
C) misrepresentation.
D) no misconduct.
A) fabrication.
B) falsification.
C) misrepresentation.
D) no misconduct.
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40
A researcher conducts a study to evaluate the frequency of intimate partner violence among females treated for sexually transmitted diseases (STDs).When collecting data,which action may be problematic when protecting subjects' rights?
A) Allowing subjects to decline participation in the study
B) Approaching all patients who meet eligibility requirements
C) Identifying subjects with numbers instead of names
D) Instructing subjects to complete every item on the questionnaire
A) Allowing subjects to decline participation in the study
B) Approaching all patients who meet eligibility requirements
C) Identifying subjects with numbers instead of names
D) Instructing subjects to complete every item on the questionnaire
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41
A nurse researcher who wishes to use animals in a research study must include which elements in an animal use protocol? Select all that apply.
A) Animal living conditions and veterinary care
B) Assurances that animals will be kept alive
C) Justification for the use of animals over humans
D) Procedures to minimize pain and distress
A) Animal living conditions and veterinary care
B) Assurances that animals will be kept alive
C) Justification for the use of animals over humans
D) Procedures to minimize pain and distress
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