Question 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.

Accepted Answer

Informed consent includes disclosure to the subject of essential study information,comprehension of this information by the subject,competence of the subject to give consent,and voluntary consent of the subject to participate in the study.Information on the study design is given only as it applies to what will happen to the subject.It is not necessary to provide reports about the study results and conclusions as part of gaining informed consent.Subjects are generally randomly assigned to control versus study groups and choice of placement is not a part of informed consent.

Question 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.

Accepted Answer

Participating in research may carry increased risks with minimal or no benefits for terminally ill subjects.Subjects may still be randomly assigned to control versus study groups.Terminally ill patients may be more likely to be willing to participate in research.There is no difference when controlling extraneous variables in studies involving terminally ill patients.

Question 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

Accepted Answer

In the Tuskegee Syphilis Study,subjects were not informed about the purpose and procedures of the study; some were not even informed that they were subjects.Subjects were not coerced by the promise of treatment,which was not offered,even when the benefits were known.The Centers for Disease Control was informed about the results and decided the study could continue.In the Jewish Chronic Disease Study,subjects' physicians were not informed.

Question 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.

Accepted Answer

Self-determination refers to individuals' rights to knowingly become a subject in the study or not,and to do so of their own free will.The right to anonymity means that subjects cannot be identified.Subjects are generally randomly assigned to groups.Subjects who are given large rewards for participation may be coerced.

Question 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.

Accepted Answer

Pregnant women are considered to have legal and/or mental diminishment of autonomy.Research involving such subjects is generally more acceptable if the research is therapeutic.Confidentiality and consent must be maintained in all research involving human subjects and do not influence approval for subjects with diminished capacity.Confidentiality and consent must be maintained in all research involving human subjects and do not influence approval for subjects with diminished capacity.Financial rewards may be a form of coercion.

Question 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.

Accepted Answer

Institutional review boards (IRBs)are organized to examine the ethical aspects of studies before they are conducted.IRBs do not approve funding for studies based on ethical standards.IRBs review ethical aspects of studies prior to the conduction of the study,not after they are published.IRBs do not define ethical standards.

Question 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.

Accepted Answer

Persons with mental illness or a cognitive impairment are incapable of giving informed consent.A researcher must gain approval from a legally authorized representative or guardian along with gaining assent from the participant.Assent must be gained if possible,but is not sufficient for participation in a study.Adults with mental impairments may be used in studies if their rights are protected and proper consent is obtained.Physicians are not legally authorized representatives.

Question 8

Which ethical principle protects human subjects from harm?
A) Beneficence
B) Ethics
C) Justice
D) Respect for persons

Accepted Answer

The ethical principle of beneficence encourages the researcher to do good and to "do no harm." Ethics is not a specific ethical principle.The principle of justice addresses the fair treatment of human subjects.The principle of respect for persons indicates that human subjects should be treated as autonomous agents with rights to self-determination.

Question 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

Accepted Answer

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed in the United States in 1978.This commission developed ethical research guidelines based on the ethical principles of respect for persons,beneficence,and justice and made recommendations to the U.S.Department of Health and Human Services (DHHS)in the Belmont Report.A major focus of the Declaration of Helsinki was the differentiation of therapeutic research from nontherapeutic research.The Department of Health,Education,and Welfare (DHEW)regulations were published in 1973 providing for the protection of human research subjects.The development of the Nuremberg Code in 1949 addressed the mistreatment of human subjects.

Question 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.

Accepted Answer

The Declaration of Helsinki was adopted in 1964 and its major focus was to differentiate between therapeutic research and nontherapeutic research.The Nuremberg code helped to define the concept of informed consent of subjects.The Declaration of Helsinki did not prevent the use of placebos,but declared that researchers must provide subjects in the placebo group with access to proven diagnostic and therapeutic procedures after the study.The Declaration of Helsinki did not prohibit nontherapeutic research,but developed guidelines to address issues with this type of research.

Question 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.

Accepted Answer

Persons who are vulnerable because of legal or mental incompetence,terminal illness,or confinement to an institution have diminished autonomy.They are not necessarily at higher risk for discomfort,lack of information,or lack of privacy than are other subjects.They are not necessarily at higher risk for discomfort,lack of information,or lack of privacy than are other subjects.They are not necessarily at higher risk for discomfort,lack of information,or lack of privacy than are other subjects.

Question 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

Accepted Answer

Persons confined to institutions may feel coerced to participate in research because they fear harm or because they feel that they may receive special benefits for participation.Children,pregnant women,and terminally ill patients are allowed to give assent or consent freely for participation in research.

Question 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.

Accepted Answer

The Department of Health,Education,and Welfare (DHEW)regulations were published in 1973,providing for the protection of human research subjects and requiring full institutional review of all studies involving human subjects.The DHEW regulations do not prohibit using subjects who are ill,mentally impaired,or dying,but provided protections for such subjects.The US Code of Federal Regulations requires informed consent of human subjects.DHEW regulations require institutional review of all human subjects,not just those with especially high risk.

Question 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.

Accepted Answer

A data use agreement limits how data may be used and how it will be protected and must be in place for a provider to disclose data to a researcher.Agreement about the study's purpose is not necessary for sharing information.A limited data set describes the type of data that may be disclosed without an individual subject's authorization or an IRB waiver; to disclose this limited data set,a data use agreement must be in place.The written study proposal does not confer the right to disclose patient data to a researcher.

Question 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.

Accepted Answer

Assent is gained from children who are subjects and represents their agreement to participate.Assent is not informed consent,which must be given by a child's parent or legal guardian.Assent does not represent approval by the parents.Assent is given in conjunction with informed consent by the parent or legal guardian and is not sufficient by itself to allow a minor to participate in a study.

Question 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.

Accepted Answer

The FDA and the DHHS regulations govern most of the biomedical and behavioral research conducted in the United States.Drugs,medical devices,biological products,human dietary supplements,and electronic devices are all regulated by these two entities.The ANA,CFR,and the Presidential Commission do not have specific regulations governing research of medical devices.The ANA,CFR,and the Presidential Commission do not have specific regulations governing research of medical devices.The ANA,CFR,and the Presidential Commission do not have specific regulations governing research of medical devices.

Question 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.

Accepted Answer

Confidentiality is the researcher's safe management of information or data shared by a subject to ensure the data are kept private.Anonymity exists when the subject's identity cannot be linked,even by the researcher,with individual responses.A breach of confidentiality occurs when a researcher allows an unauthorized person to gain access to the raw data of a study.Privacy is a larger concept encompassing anonymity and confidentiality.

Question 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

Accepted Answer

Vulnerable populations are defined as persons who are susceptible to undue influence or coercion such as children,prisoners,and persons who are economically or educationally disadvantaged.Persons who have impaired decision-making were also identified as being vulnerable.This might include persons with Alzheimer's disease,traumatic brain injury,or persons born with intellectual limitations.

Question 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

Accepted Answer

The principle of respect for persons indicates that human subjects should be treated as autonomous agents with rights to self-determination and full disclosure.The ethical principle of beneficence encourages the researcher to do good and to "do no harm." Ethics is not a specific ethical principle.The principle of justice addresses the fair treatment of human subjects.

Question 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.

Accepted Answer

The right to protection from discomfort and harm from a study is based on the ethical principle of beneficence,which states that one should do good and,above all,do no harm.Complete anonymity exists if the subject's identity cannot be linked,even by the researcher,with his or her individual responses.Confidentiality is the safe management of private information shared by a subject.The researcher must refrain from sharing that information without the authorization of the subject.Research findings need to be reported so that a subject or group of subjects cannot be identified.The right to fair treatment suggests that people should be treated fairly and should receive what they are due or owed.Self-determination refers to individuals' rights to knowingly become a subject in the study or not and to do so of their own free will.

Quiz 4: Examining Ethics in Nursing Research

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 special concern when conducting research using terminally ill cancer patients as subjects is

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

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

A researcher will have greater success gaining approval for a research study involving pregnant women if which provision is put into place?

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

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?

Which ethical principle protects human subjects from harm?

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?

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

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

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

After the Department of Health,Education,and Welfare (DHEW) regulations were published in 1973,all research using human subjects was required to

If a healthcare provider discloses information about a patient to a researcher for a study,the provider and the researcher must have a(n)

When a researcher indicates that assent for participation was gained in a study involving 10-year-old children,this indicates which has occurred?

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

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

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

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