Chapter 04: Examining Ethics in Nursing Research My Nursing Test Banks

Chapter 04: Examining Ethics in Nursing Research

Grove: Understanding Nursing Research, 6th Edition

MULTIPLE CHOICE

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.

ANS: D

Feedback

A

IRBs do not approve funding for studies based on ethical standards.

B

IRBs review ethical aspects of studies prior to the conduction of the study, not after they are published.

C

IRBs do not define ethical standards.

D

Institutional review boards (IRBs) are organized to examine the ethical aspects of studies before they are conducted.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: pp. 94-95

2. 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.

ANS: A

Feedback

A

The Declaration of Helsinki was adopted in 1964 and its major focus was to differentiate between therapeutic research and nontherapeutic research.

B

The Nuremberg code helped to define the concept of informed consent of subjects.

C

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.

D

The Declaration of Helsinki did not prohibit nontherapeutic research, but developed guidelines to address issues with this type of research.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: p. 96

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 in the Centers for Disease Control about the results of the study

d.

Not informing the subjects physicians that they were in the study

ANS: B

Feedback

A

Subjects were not coerced by the promise of treatment, which was not offered, even when the benefits were known.

B

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.

C

The CDC was informed about the results and decided the study could continue.

D

In the Jewish Chronic Disease Study, subjects physicians were not informed.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 97

4. 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.

ANS: D

Feedback

A

The DHEW regulations do not prohibit using subjects who are ill, mentally impaired, or dying, but provided protections for such subjects.

B

The US Code of Federal Regulations requires informed consent of human subjects.

C

DHEW regulations require institutional review of all human subjects, not just those with especially high risk.

D

The Department of Health, Education, and Welfare regulations were published in 1973, providing for the protection of human research subjects and requiring full institutional review of all studies involving human subjects.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 98

5. 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

ANS: C

Feedback

A

A major focus of the Declaration of Helsinki was the differentiation of therapeutic research from nontherapeutic research.

B

The Department of Health, Education, and Welfare regulations were published in 1973 providing for the protection of human research subjects.

C

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.

D

The development of the Nuremberg Code in 1949 addressed the mistreatment of human subjects.

PTS: 1 DIF: Cognitive level: Knowledge REF: pp. 98-99

6. Which ethical principle protects human subjects from harm?

a.

Beneficence

b.

Ethics

c.

Justice

d.

Respect for persons

ANS: A

Feedback

A

The ethical principle of beneficence encourages the researcher to do good and to do no harm.

B

Ethics is not a specific ethical principle.

C

The principle of justice addresses the fair treatment of human subjects.

D

The principle of respect for persons indicates that human subjects should be treated as autonomous agents with rights to self-determination.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: pp. 98-99

7. 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

ANS: C

Feedback

A

The ANA, CFR, and the Presidential Commission do not have specific regulations governing research of medical devices.

B

The ANA, CFR, and the Presidential Commission do not have specific regulations governing research of medical devices.

C

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.

D

The ANA, CFR, and the Presidential Commission do not have specific regulations governing research of medical devices.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: pp. 99-100

8. 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.

ANS: C

Feedback

A

The right to anonymity means that subjects cannot be identified.

B

Subjects are generally randomly assigned to groups.

C

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.

D

Subjects who are given large rewards for participation may be coerced.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p.101

9. 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.

ANS: A

Feedback

A

Persons who are vulnerable because of legal or mental incompetence, terminal illness, or confinement to an institution have diminished autonomy.

B

They are not necessarily at higher risk for discomfort, lack of information, or lack of privacy than are other subjects.

C

They are not necessarily at higher risk for discomfort, lack of information, or lack of privacy than are other subjects.

D

They are not necessarily at higher risk for discomfort, lack of information, or lack of privacy than are other subjects.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: pp. 99-100

10. 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 womens significant others.

c.

Subjects may experience therapeutic effects from the intervention.

d.

Subjects receive financial rewards for participation in the study.

ANS: C

Feedback

A

Confidentiality and consent must be maintained in all research involving human subjects and do not influence approval for subjects with diminished capacity.

B

Confidentiality and consent must be maintained in all research involving human subjects and do not influence approval for subjects with diminished capacity.

C

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.

D

Financial rewards may be a form of coercion.

PTS:1DIF:Cognitive level: Applying (Application)

REF:pp. 101-102 |p. 104

11. 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.

ANS: B

Feedback

A

Assent is not informed consent, which must be given by a childs parent or legal guardian.

B

Assent is gained from children who are subjects and represents their agreement to participate.

C

Assent does not represent approval by the parents.

D

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.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 102

12. 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.

ANS: B

Feedback

A

Assent must be gained if possible, but is not sufficient for participation in a study.

B

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.

C

Adults with mental impairments may be used in studies as long as their rights are protected and proper consent is obtained.

D

Physicians are not legally authorized representatives.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 104

13. 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 subjects right to:

a.

anonymity and confidentiality.

b.

fair treatment.

c.

protection from discomfort and harm.

d.

self-determination.

ANS: C

Feedback

A

Complete anonymity exists if the subjects 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.

B

The right to fair treatment suggests that people should be treated fairly and should receive what they are due or owed.

C

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.

D

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.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: pp. 100-101

14. 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.

ANS: A

Feedback

A

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.

B

Information on the study design is given only as it applies to what will happen to the subject. The correct answer is general knowledge and comprehension of the study. 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.

C

It is not necessary to provide reports about the study results and conclusions as part of gaining informed consent.

D

Subjects are generally randomly assigned to control versus study groups and choice of placement is not a part of informed consent.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: pp. 100-101

15. 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.

ANS: B

Feedback

A

Subjects may still be randomly assigned to control versus study groups.

B

Participating in research may carry increased risks with minimal or no benefits for terminally ill subjects.

C

Terminally ill patients may be more likely to be willing to participate in research.

D

There is no difference when controlling extraneous variables in studies involving terminally ill patients.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 104

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

ANS: B

Feedback

A

Children, pregnant women, and terminally ill patients are allowed to give assent or consent freely for participation in research.

B

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.

C

Children, pregnant women, and terminally ill patients are allowed to give assent or consent freely for participation in research.

D

Children, pregnant women, and terminally ill patients are allowed to give assent or consent freely for participation in research.

PTS:1DIF:Cognitive level: Knowing (Knowledge)

REF: p. 104

17. 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 studys purpose.

b.

data use agreement.

c.

limited data set.

d.

written study proposal.

ANS: B

Feedback

A

Agreement about the studys purpose is not necessary for sharing information.

B

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.

C

A limited data set describes the type of data that may be disclosed without an individual subjects authorization or an IRB waiver; in order to disclose this limited data set, a data use agreement must be in place.

D

The written study proposal does not confer the right to disclose patient data to a researcher.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 106

18. In a study about pregnant womens 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.

ANS: C

Feedback

A

Anonymity exists when the subjects identity cannot be linked, even by the researcher, with individual responses.

B

A breach of confidentiality occurs when a researcher allows an unauthorized person to gain access to the raw data of a study.

C

Confidentiality is the researchers safe management of information or data shared by a subject to ensure the data are kept private.

D

Privacy is a larger concept encompassing anonymity and confidentiality.

PTS:1DIF:Cognitive level: Applying (Application)

REF: pp. 106-107

19. 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.

ANS: B

Feedback

A

Study validity is related to the proper use of study tools and measurements.

B

Breach of confidentiality is of special concern in qualitative studies that have few study participants and involve the reporting of long quotes.

C

Objectivity is the ability of the researcher to avoid interpreting results in a biased manner.

D

Benefits to subjects are not necessarily compromised in small studies using quotations.

PTS:1DIF:Cognitive level: Applying (Application)

REF: pp. 106-107

20. A subjects 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

ANS: B

Feedback

A

The principle of beneficence requires that subjects are protected from harm.

B

The right to fair selection and treatment of subjects is based on the ethical principle of justice, requiring people to be treated fairly and to receive what they are owed.

C

The principle of privacy requires that anonymity and confidentiality are protected.

D

The principle of respect for persons requires that human subjects should be treated as autonomous agents with rights to self-determination.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: pp. 107-108

21. Which unethical study in previous history involved withholding a treatment from subjects in order 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

ANS: C

Feedback

A

In the Jewish Chronic Disease Hospital Study, subjects were injected with a suspension containing live cancer cells and did not know they were taking part in a study or that the injections contained these live cancer cells.

B

In the Nazi Medical Experiments, an array of atrocious unethical medical experiments were conducted on prisoners of war.

C

In the Tuskegee Syphilis Study, penicillin was deliberately withheld from the research subjects and their families, in order to study the effects of the natural progression of syphilis.

D

In the Willowbrook Study, mentally retarded children were infected with the hepatitis virus and new patients were not admitted to this institution unless their parents consented for their children to participate in this study.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 97

22. 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

ANS: D

Feedback

A

Autonomy is protected when subjects are informed that participation is voluntary.

B

Approaching all subjects who meet eligibility requirements removes the possibility of bias.

C

Using numbers instead of names helps to protect privacy.

D

Subjects who are told that they must complete every item on a questionnaire risk losing their right to autonomy.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: p. 101

23. 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.

ANS: C

Feedback

A

Informed consent implies not only that the researcher has imparted information to the subjects, but also that the prospective subjects have comprehended the information. The researcher needs to discuss the information with the subjects and ask them to restate the information to assess their understanding.

B

The subjects have voluntarily consented to participate.

C

These subjects have been given written information, but have not stated their understanding, so informed consent has not been obtained.

D

The researcher disclosed information to the subjects about the study.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: p. 112

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.

ANS: C

Feedback

A

Informal studies and those using questionnaires about potentially harmful subjects do not meet the requirements for waiving of consent.

B

Informal studies and those using questionnaires about potentially harmful subjects do not meet the requirements for waiving of consent.

C

Subjects who do not want documentation linking them to the research who have received information and demonstrated comprehension of the information may have consent waived if they desire.

D

Anonymity can be maintained even with signed consent.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 114

25. 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)

ANS: D

Feedback

A

This is not a correct statement.

B

This is not a correct statement.

C

This is not a correct statement.

D

The Office of Research Integrity was developed by the federal government in 1989 to supervise the implementation of the rules and regulations related to research misconduct and to manage any investigations of misconduct.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 122

26. 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.

ANS: D

Feedback

A

Fabrication refers to making up results and recording or reporting them.

B

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented.

C

Misrepresentation refers to presenting data inaccurately.

D

A researcher making an honest error is not guilty of misconduct.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 122

27. Which is an example of falsification in research?

a.

Citing work by another researcher and claiming it as ones own.

b.

Making up statistics about the incidence of reactions to an intervention.

c.

Omitting data about a subject that disproves the researchers hypothesis.

d.

Using data gained without the consent of the research subjects.

ANS: C

Feedback

A

Plagiarism is citing anothers research and claiming it as ones own.

B

Fabrication involves making up results and reporting them.

C

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented.

D

Lack of informed consent occurs when the researcher fails to gain consent from study subjects.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 122

28. A researcher combines data from another researchers 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.

ANS: D

Feedback

A

An honest error would occur if the researcher was unaware that the data belonged to someone else.

B

Fabrication involves making up results and reporting them.

C

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented.

D

Plagiarism is citing anothers research and claiming it as ones own.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 122

MULTIPLE RESPONSE

1. 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

ANS: A, B, D

Feedback

Correct

E-mail addresses, full-face photographs, and medical record numbers may all be used to identify patients and must be de-identified in study reports to prevent linking study results to individuals.

E-mail addresses, full-face photographs, and medical record numbers may all be used to identify patients and must be de-identified in study reports to prevent linking study results to individuals.

E-mail addresses, full-face photographs, and medical record numbers may all be used to identify patients and must be de-identified in study reports to prevent linking study results to individuals.

Incorrect

The state of residence is not necessarily an identifier, but any geographic division smaller than a state is.

PTS: 1 DIF: Cognitive level: Understanding (Comprehension)

REF: p. 106

2. 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.

Health care providers

c.

Institutional Review Boards

d.

Researchers

ANS: A, B

Feedback

Correct

Health care providers, health plans, and health care clearinghouses are covered entities.

Health care providers, health plans, and health care clearinghouses are covered entities.

Incorrect

This is not a correct statement.

This is not a correct statement.

PTS: 1 DIF: Cognitive level: Remembering (Knowledge)

REF: p. 106

3. 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.

ANS: A, C, D

Feedback

Correct

Asking parents to complete a questionnaire increases the risk of temporary discomfort associated with filling out the form. Interviewing nursing home residents increases the risk of discomfort because it may invoke bad memories.  Using pathology reports does not confer benefits to the subjects and may run the risk of invasion of privacy.

Asking parents to complete a questionnaire increases the risk of temporary discomfort associated with filling out the form. Interviewing nursing home residents increases the risk of discomfort because it may invoke bad memories.  Using pathology reports does not confer benefits to the subjects and may run the risk of invasion of privacy.

Asking parents to complete a questionnaire increases the risk of temporary discomfort associated with filling out the form. Interviewing nursing home residents increases the risk of discomfort because it may invoke bad memories.  Using pathology reports does not confer benefits to the subjects and may run the risk of invasion of privacy.

Incorrect

Assessing the numbers of males and females does not increase risk or cause discomfort.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: p. 108

4. 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.

ANS: A, C, D

Feedback

Correct

Anonymity and voluntary participation must be assured in all research involving human subjects. In this study, parents who know ahead of time that the purpose is to see whether car seat use is increased may increase their use of car seats whether or not they view the video.

Anonymity and voluntary participation must be assured in all research involving human subjects. In this study, parents who know ahead of time that the purpose is to see whether car seat use is increased may increase their use of car seats whether or not they view the video.

Anonymity and voluntary participation must be assured in all research involving human subjects. In this study, parents who know ahead of time that the purpose is to see whether car seat use is increased may increase their use of car seats whether or not they view the video.

Incorrect

In some cases, a statement of the research purpose can influence the results and a consent to incomplete disclosure may be obtained instead.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: p. 111

5. 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.

ANS: A, B, C

Feedback

Correct

When selecting an IRB, there must be at least five members of varying backgrounds to promote a complete, scholarly, and fair review of research. When vulnerable subjects such as newborns are part of a study, at least one member must have knowledge and experience in working with these subjects. A neonatologist and a hospital pharmacist would both be included in this case. All IRBs must have an ethicist, lawyer, or minister whose primary concern is nonscientific.

When selecting an IRB, there must be at least five members of varying backgrounds to promote a complete, scholarly, and fair review of research. When vulnerable subjects such as newborns are part of a study, at least one member must have knowledge and experience in working with these subjects. A neonatologist and a hospital pharmacist would both be included in this case. All IRBs must have an ethicist, lawyer, or minister whose primary concern is nonscientific.

When selecting an IRB, there must be at least five members of varying backgrounds to promote a complete, scholarly, and fair review of research. When vulnerable subjects such as newborns are part of a study, at least one member must have knowledge and experience in working with these subjects. A neonatologist and a hospital pharmacist would both be included in this case. All IRBs must have an ethicist, lawyer, or minister whose primary concern is nonscientific.

Incorrect

A pharmaceutical representative would have a conflict of interest in promoting the drug.

PTS:1DIF:Cognitive level: Applying (Application)

REF: p. 117

6. 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

ANS: A, C, D

Feedback

Correct

Elements of animal use protocols should include descriptions of animal living conditions and veterinary care, justifications for the use of animals, and procedures that will minimize pain and distress.

Researches need to identify methods of euthanasia and do not need assurances that animals will be kept alive.

Incorrect

Elements of animal use protocols should include descriptions of animal living conditions and veterinary care, justifications for the use of animals, and procedures that will minimize pain and distress.

Elements of animal use protocols should include descriptions of animal living conditions and veterinary care, justifications for the use of animals, and procedures that will minimize pain and distress.

PTS:1DIF:Cognitive level: Analyzing (Analysis)

REF: pp. 123-124

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