Question 1

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

The purpose of an institutional review board (IRB) in a university or clinical agency is to protect the human rights of subjects in proposed studies. The IRB reviews research proposals to ensure that they meet ethical standards and that the research does not harm participants. The IRB also monitors ongoing studies to ensure that participants' rights are protected throughout the study. Choices A, B, and C do not fully capture the purpose and scope of an IRB.

Question 2

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 3

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
C) National Commission for the Protection of Human Subjects in the Belmont Report
D) Nuremberg Code

Accepted Answer

The ethical principles of respect for persons, beneficence, and justice are identified in the Belmont Report, which was published by the National Commission for the Protection of Human Subjects in 1979. The other options listed also relate to the ethical conduct of research involving human subjects, but they do not specifically outline these three principles. The Declaration of Helsinki emphasizes the ethical principles for medical research involving human subjects; the Department of Health, Education, and Welfare regulations provide guidelines for conducting research with human subjects in the United States; and the Nuremberg Code outlines ethical principles for research on human subjects in the aftermath of Nazi medical experiments during World War II.

Question 4

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.

Accepted Answer

Since the subjects have severe cognitive impairments, they may not be able to give informed consent. Therefore, a legally authorized guardian must provide informed consent on their behalf. This is in accordance with ethical guidelines for research involving vulnerable populations.

Question 5

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 requires that researchers take steps to protect the well-being of research participants and minimize any potential harms that may result from their participation in the study. This includes not only physical harm, but also emotional or psychological harm.

Question 6

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

Terribly ill cancer patients are already suffering from a severe health condition, and introducing further risk to their health by conducting research may lead to harm. The benefit of the study may not outweigh the potential harm to the patients. Therefore, it is essential to weigh the potential unfavorable outcomes before including terminally ill cancer patients as the participants in research.

Question 7

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

Protecting research subjects from discomfort and harm is a key element of protecting their rights. In this scenario, the researcher is taking steps to minimize potential harm while also working to make sure the subjects may benefit from the intervention. This is an example of protecting a research subject's right to be protected from harm.

Question 8

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.

Accepted Answer

The researcher's act of linking individual subjects' identities to their responses on a questionnaire but not sharing this information with others ensures confidentiality. Confidentiality refers to the researcher's pledge to protect the respondent's personal information from being divulged to anyone outside the study team without their consent. In this situation, the subjects' identities remain confidential, and their responses are only used for research purposes.

Question 9

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

Accepted Answer

Justice is the ethical principle that ensures fair selection and treatment of subjects in a study. It requires researchers to avoid excluding certain groups from studies without a valid reason and to ensure that they are not subject to disproportionate harm or burden.

Question 10

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

Accepted Answer

The Food and Drug Administration (FDA) regulates medical devices and requires compliance with specific regulations for research involving human subjects.

Question 11

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.

Accepted Answer

Breach of confidentiality is of special concern in qualitative studies that have few study participants and involve the reporting of long quotes.Study validity is related to the proper use of study tools and measurements.Objectivity is the ability of the researcher to avoid interpreting results in a biased manner.Benefits to subjects are not necessarily compromised in small studies using quotations.

Question 12

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

Diminished autonomy is the greatest risk to a person confined to an institution who is a research subject because they may lose their ability to make decisions for themselves and may feel coerced into participating in the research. Discomfort, lack of information, and lack of privacy are important considerations and risks, but do not pose as great a threat to the person's overall wellbeing as their loss of autonomy.

Question 13

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

The right to self-determination means that research subjects have the right to choose whether or not to participate in a study. This choice should be respected by the researcher, and subjects should never be coerced or pressured into participating. Anonymity (A) and group choice (B) can be important ethical considerations, but they do not directly relate to the right to self-determination. Offering a large reward (D) could potentially undermine a subject's decision to participate based on their own interests and free will.

Question 14

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

Accepted Answer

The answer of The Tuskegee Syphilis Study violated several ethical...

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

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 17

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 18

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 19

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 20

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.

Accepted Answer

A data use agreement is a legal contract or agreement that outlines how a researcher can access, use, and disclose patient health information (PHI) for research purposes. It ensures that the researcher understands their obligations and responsibilities for protecting patient privacy and confidentiality. An agreement about the study's purpose, limited data set, and a written study proposal are all important components of a research study but do not address the specific issue of data use and disclosure.

Quiz 4: Examining Ethics in Nursing Research

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

When obtaining informed consent from study subjects,the researcher will ensure that subjects freely choose whether or not to participate and will provide subjects:

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 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?

Which ethical principle protects human subjects from harm?

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

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:

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

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 researcher using a small sample of an easily distinguishable group of subjects wishes to use extensive quotes in the research report.This researcher risks:

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

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

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

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

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

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

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

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

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) :