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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 in the Centers for Disease Control about the results of the study
D) Not informing the subjects' physicians that they were in the study

E) All of the above
F) B) and D)

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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.

E) A) and B)
F) All of the above

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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.

E) All of the above
F) A) and B)

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D

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.

E) B) and C)
F) All of the above

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D

Which subject groups may feel especially coerced to participate in research studies?


A) Children
B) Institutionalized patients
C) Pregnant women
D) Terminally ill patients

E) C) and D)
F) None of the above

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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.

E) None of the above
F) A) and B)

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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.

E) None of the above
F) C) and D)

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A researcher wishes to study the effects of antiseizure 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.

E) None of the above
F) B) and D)

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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
B) Code of Federal Regulations
C) Food and Drug Administration
D) Presidential Commission for the Study of Bioethics

E) A) and B)
F) C) and D)

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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

E) B) and C)
F) C) and D)

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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.

E) None of the above
F) C) and D)

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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.

E) None of the above
F) A) and B)

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If a health care 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.

E) C) and D)
F) B) and D)

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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.

E) None of the above
F) A) and C)

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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

E) All of the above
F) None of the above

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In a study about pregnant women's use of tobacco,the researcher is able to 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.

E) A) and B)
F) A) and C)

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Which patient information requires deidentifying in order to maintain privacy? (Select all that apply)


A) E-mail addresses
B) Full-face photographs
C) State of residence
D) Medical record numbers

E) B) and D)
F) B) and C)

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Which ethical principle protects human subjects from harm?


A) Beneficence
B) Ethics
C) Justice
D) Respect for persons

E) None of the above
F) A) and B)

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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.

E) A) and C)
F) B) and C)

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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.

E) B) and D)
F) A) and B)

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A

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