Chapter 4

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The purpose of an institutional review board (IRB) in a university or clinical agency is to

Question 1 options:

approve funding for studies based on ethical standards.

critically appraise ethical aspects of published studies.

define ethical standards for the institution.

protect the human rights of subjects in proposed studies.

Question 2 (1 point)

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An important initial focus of the Declaration of Helsinki, developed in 1964, was to

Question 2 options:

differentiate therapeutic from nontherapeutic research.

define the concept of informed consent of research subjects.

prevent the use of placebos during clinical drug trials.

prohibit nontherapeutic research to protect subjects from harm.

Question 3 (1 point)

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The Tuskegee Syphilis Study violated several ethical principles in which way?

Question 3 options:

Coercion of subjects to participate in the study in exchange for treatment

Failing to inform subjects about the purpose and procedures in the study
 Failing to inform the Centers for Disease Control about the results of the study

Not informing the subjects' physicians that they were in the study

Question 4 (1 point)

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A clinical research nurse identifies which of the following as a vulnerable population?

Question 4 options:

Women hospitalized for a mastectomy

Clients who speak both English and Spanish

Men 65 years and older belonging to the Active Seniors Wellness Center

Pediatric clients hospitalized for cancer

Question 5 (1 point)

Saved

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?

Question 5 options:

Declaration of Helsinki

The Common Rule

National Commission for the Protection of Human Subjects in the Belmont Report

Nuremberg Code

Question 6 (1 point)

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Which ethical principle protects human subjects from harm?

Question 6 options:

Beneficence

Ethics

Justice

Respect for persons

Question 7 (1 point)

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Which ethical principle includes the right to self-determination and the right to full disclosure?

Question 7 options:

Beneficence

Ethics

Justice

Respect for persons

Question 8 (1 point)

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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

Question 8 options:

American Nurses Association (ANA).

Code of Federal Regulations (CFR).

Food and Drug Administration (FDA).

 Presidential Commission for the Study of Bioethics.

Question 9 (1 point)

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To safeguard the right to self-determination among research subjects, the researcher will ensure that
subjects

Question 9 options:

are afforded anonymity to the researcher and the reader.

are allowed to choose whether to be in a control or a study group.

may choose whether or not to participate in a study.

receive a large monetary reward for participating in the study.

Question 10 (1 point)

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The greatest risk to a person confined to an institution who is a research subject is

Question 10 options:

diminished autonomy.

discomfort.

lack of information.

lack of privacy.

Question 11 (1 point)

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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?
Question 11 options:

The children gave informed consent to participate in the study.

The children have agreed to be subjects in the study.

The parents granted approval for their children to participate.

The parents do not need to give consent because the children gave consent.

Question 12 (1 point)

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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?

Question 12 options:

Assent must be gained from the subjects and is sufficient for participation.

A legally authorized guardian must give informed consent.

These adults cannot be used as subjects for this study.

The subjects' physicians must give consent for participation in the study.

Question 13 (1 point)

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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

Question 13 options:

anonymity and confidentiality.

fair treatment.

protection from discomfort and harm.

 self-determination.

Question 14 (1 point)

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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

Question 14 options:

general knowledge and overview of the study.

information about the study methods and design.

reports about the study results and conclusions.

the right to choose whether to be in the control versus the study group.

Question 15 (1 point)

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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

Question 15 options:

anonymity.

breach of confidentiality.

confidentiality.

privacy.

Question 16 (1 point)

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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

Question 16 options:

a loss of study validity.

breaching confidentiality.

losing objectivity.

reduction of benefits to subjects.

Question 17 (1 point)

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A subject’s right to fair selection and treatment in a study is related to which ethical principle?

Question 17 options:

Beneficence

Justice

Privacy

Respect for persons

Question 18 (1 point)

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Which unethical study in previous history involved withholding a treatment from subjects to study the
effects of a disease progression on subjects?

Question 18 options:

The Jewish Chronic Disease Hospital Study

The Nazi Medical Experiments

The Tuskegee Syphilis Study

 The Willowbrook Study

Question 19 (1 point)

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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?

Question 19 options:

Disclosure

Comprehension

Competence

Voluntary agreement

Question 20 (1 point)

Saved

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?

Question 20 options:

Allowing subjects to decline participation in the study

Approaching all patients who meet eligibility requirements

Identifying subjects with numbers instead of names

Instructing subjects to complete every item on the questionnaire

Question 21 (1 point)

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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?

Question 21 options:

Subjects have given informed consent for participation in the study.

Subjects have not given voluntary consent for participation in the study.

The researcher has failed to determine comprehension of the study by participants.

The researcher has not disclosed information about the study to the participants.

Question 22 (1 point)

Saved

Which situation may allow waiving the need to obtain written consent for participation in a research
study?

Question 22 options:

The researcher is conducting an informal study about heart disease.

The researcher is using questionnaires to collect data about suicide risk.

The subjects do not want documentation linking them to the study.

The subjects desire complete anonymity in the study.

Question 23 (1 point)

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Which federal agency was established to manage investigations of misconduct in research?

Question 23 options:

Department of Health, Education, and Welfare (DHEW)

Department of Health and Human Services (DHHS)

Food and Drug Administration (FDA)

Office of Research Integrity (ORI)

Question 24 (1 point)

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A researcher makes an honest error when tabulating and analyzing research findings. According to the
Office of Research Integrity, this constitutes

Question 24 options:

fabrication.

falsification.

misrepresentation.

no misconduct.

Question 25 (1 point)

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Which is an example of falsification in research?

Question 25 options:

Citing work by another researcher and claiming it as one's own

Making up statistics about the incidence of reactions to an intervention

Omitting data about a subject that disproves the researcher's hypothesis

Using data gained without the consent of the research subjects

Question 26 (1 point)

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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

Question 26 options:
 an honest error.

fabrication.

falsification.

plagiarism.

Question 27 (1 point)

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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?

Question 27 options:

Expedited review

Exempt from review

Partial review

Full review

Question 28 (1 point)

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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?

Question 28 options:

Expedited review

Exempt from review

Full review
 Final review

Question 29 (1 point)

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Which patient information requires de-identifying to maintain privacy? (Select all that apply.)

Question 29 options:

Address

Birthdate

State of residence

Medical diagnoses

Question 30 (1 point)

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Which of the following are true statements about genomic research? (Select all that apply.)

Question 30 options:

Genomic research is a promising area of science related to human disease and healing.

Genomic research involves unethical challenges dues to the potential that the subject can be identified by the
data.

The Human Genome Project funded by NIH recognized from the onset the ethical and legal dilemmas of genomic
research.

Broad consent in the revised Common Rule was developed to address some of the unresolved issues in
genomics research.

De-identification of data and ownership of specimens are two of the unresolved issues in genomics research.

Question 31 (1 point)

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1

Which of the following represent some degree of risk of causing discomfort or harm to subjects in a
study? (Select all that apply.)

Question 31 options:

Asking parents of children in a clinic waiting room to complete a patient satisfaction questionnaire

Assessing the number of males and females enrolled in nursing schools using enrollment data

Interviewing nursing home residents about their memories of the Great Depression

Using pathology reports from a hospital lab to gain data about the percentage of new patients who have anemia

Question 32 (1 point)

Saved

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.)

Question 32 options:

an ethicist.

a hospital pharmacist.

a neonatologist.

a pharmaceutical representative.

Question 33 (1 point)

Saved

Which of the following are true statements about informed consent? (Select all that apply.)

Question 33 options:

Informed consent is the process of providing information to a potential subject and the opportunity to
participate in the study.
 The process ends with the subject's signature on a document agreeing to be in a study.

A potential subject's decision about whether to participate is the informing part of the process.

Informed consent is incomplete or unethical unless all three elements are incorporated.

The documentation of informed consent depends on the study's level of risk and the requirement of the IRB
who approves the study.

Question 34 (1 point)

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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.)

Question 34 options:

Animal living conditions and veterinary care

Assurances that animals will be kept alive

Justification for the use of animals over humans

Procedures to minimize pain and distress

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