Question 1

The purpose of an institutional review board (IRB) is to:&#10;A) critique the research methods of a study.&#10;B) design and develop research studies.&#10;C) determine the extent to which human rights will be protected in a study.&#10;D) review the costs associated with an institutional study.

Accepted Answer

The functions of an IRB involve reviewing research to determine whether the rights and welfare of the subjects were protected, the methods used to secure informed consent were appropriate, and the potential benefits of the study were greater than the risks.
The IRB examines studies for ethical concerns. Their job is to protect human subjects, not critique the research methods. The functions of an IRB involve reviewing research to determine whether the rights and welfare of the subjects were protected, the methods used to secure informed consent were appropriate, and the potential benefits of the study were greater than the risks.
The IRB examines studies for ethical concerns. Their job is to protect human subjects, not design and develop studies. The functions of an IRB involve reviewing research to determine whether the rights and welfare of the subjects were protected, the methods used to secure informed consent were appropriate, and the potential benefits of the study were greater than the risks.
The IRB examines studies for ethical concerns. Their job is to protect human subjects, not reviewing cost associated with research. The functions of an IRB involve reviewing research to determine whether the rights and welfare of the subjects were protected, the methods used to secure informed consent were appropriate, and the potential benefits of the study were greater than the risks.

Question 2

Subjects who volunteered to receive an experimental treatment for AIDS are educated about essential study information, assessed for understanding of this information, and asked to willingly participate in the research study. This process is referred to as:

A) contractual agreement.
B) debriefing.
C) informed consent.
D) legal liability.

informed consent.

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.
A contractual agreement is what the researcher and the participant enter into once the subject signs the informed consent.
A debriefing takes place after the study is over and addresses any concerns that the subject has as a result of participation in the study.
Legal liability is the extent to which the researcher might be held accountable for any harm to subjects as a result of participation in the study.

Question 3

One example of a research population with diminished autonomy (vulnerability) would be:&#10;A) college students.&#10;B) members of a senior citizen center.&#10;C) mentally ill patients.&#10;D) middle-aged women.

Accepted Answer

Children, the mentally impaired, and unconscious patients are legally and mentally incompetent to give informed consent.
College students would not be considered a vulnerable population. Children, the mentally impaired, and unconscious patients are legally and mentally incompetent to give informed consent.
The members of a senior citizen center would not be considered a vulnerable population. Children, the mentally impaired, and unconscious patients are legally and mentally incompetent to give informed consent.
Middle-aged women would not be considered a vulnerable population. Children, the mentally impaired, and unconscious patients are legally and mentally incompetent to give informed consent.

Question 4

The safeguard mechanism by which even the researcher cannot link the participant with the information provided is called:&#10;A) anonymity.&#10;B) confidentiality.&#10;C) informed consent.&#10;D) right to privacy.

Accepted Answer

Complete anonymity exists if the subject's identity cannot be linked, even by the researcher, with his or her individual responses.
Confidentiality means that the researcher will not share any individual, identifiable information obtained from the subject.
Informed consent is the individual's permission to use information collected for purposes of the research.
The right to privacy is one of the human rights established by the National Research Act. Privacy ensures that the participant's information will not be shared to anyone by the researcher.

Question 5

The researcher's efforts to maximize benefits and minimize risks refer to the research subject's right to:&#10;A) anonymity and confidentiality.&#10;B) fair treatment.&#10;C) protection from discomfort and harm.&#10;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.
The right to fair treatment suggests that people should be treated fairly and should receive what they are due or owed.
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.
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.

Question 6

Which organization is responsible for ensuring the humane treatment of animals in research?&#10;A) American Association for Accreditation of Laboratory Animal Care&#10;B) American Society for Prevention of Cruelty to Animals&#10;C) Animal Legal Defense Fund&#10;D) Humane Society of the United States

Accepted Answer

The American Association for Accreditation of Laboratory Animal Care (AAALAC) was developed to ensure the humane treatment of animals in research.
The American Society for Prevention of Cruelty to Animals does not approve research or ensure humane treatment, although they do campaign for it. The American Association for Accreditation of Laboratory Animal Care (AAALAC) was developed to ensure the humane treatment of animals in research.
The Animal Legal Defense Fund is a source of money for protection of animals. The American Association for Accreditation of Laboratory Animal Care (AAALAC) was developed to ensure the humane treatment of animals in research.
The Humane Society of the United States is concerned with immediate care of animals and their disposition. The American Association for Accreditation of Laboratory Animal Care (AAALAC) was developed to ensure the humane treatment of animals in research.

Question 7

The provision that research be differentiated to potential subjects as therapeutic or nontherapeutic is a part of the:&#10;A) Declaration of Helsinki.&#10;B) Department of Health, Education, and Welfare regulations.&#10;C) National Commission for the Protection of Human Subjects ordinance.&#10;D) Nuremberg Code.

Accepted Answer

A major focus of the Declaration of Helsinki was the differentiation of therapeutic research from nontherapeutic research.
The Department of Health, Education, and Welfare 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.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed in 1978. It was established by the National Research Act, which passed in 1974.

Question 8

If a researcher unobtrusively observes interactions among patients in a psychiatric hospital for the purposes of data collection, which human right may be violated?&#10;A) Confidentiality&#10;B) Freedom from harm&#10;C) Justice&#10;D) Self-determination

Accepted Answer

Self-determination means the researcher informed subjects about the study, allowed them to choose whether or not to participate, and allowed them to withdraw from the study at any time without penalty.
Confidentiality protects subject's privacy.
Freedom from harm ensures that the subjects will not be hurt in any way (physically, psychologically, etc).
The principle of justice states that human subjects should be treated fairly in terms of the benefits and the risks of research.

Question 9

Which of the following is an example of a study typically exempt from IRB review?&#10;A) Comparison of IV insertion techniques related to incidence of pain&#10;B) Description of levels of spiritual distress in cancer patients&#10;C) Effect of a new antiemetic on nausea in pregnant women&#10;D) Qualitative investigation of drug abusers' experiences in the health care system

Accepted Answer

Studies are usually exempt from review if they involve no apparent risks for the research subjects. Studies involving interventions or treatments usually fall into the nonexempt category as do studies of high-risk patients.
The study described in this option involves an invasive procedure and would require complete review
The study described in this option not only involves an invasive procedure, but is using a vulnerable population, both requiring full review.
This study involves a minimal risk, but a vulnerable population, so it would require an expedited review.

Question 10

A research subject reported to a nurse that he was not receiving as much physical therapy as his friend who was not in the study. Which human right needs to be investigated?&#10;A) Anonymity&#10;B) Fair treatment&#10;C) Privacy&#10;D) Self-determination

Accepted Answer

The right to fair treatment suggests that people should be treated fairly and should receive what they are due or owed.
Complete anonymity exists if the subject's identity cannot be linked, even by the researcher, with his or her individual responses.
Right to privacy is one of the human rights established by the National Research Act.
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 correct answer is "Fair treatment." The right to fair treatment suggests that people should be treated fairly and should receive what they are due or owed.

Question 11

The first internationally recognized effort to establish ethical standards was the:&#10;A) Belmont Report from NIH.&#10;B) Declaration of Helsinki.&#10;C) Institutional review board code.&#10;D) Nuremberg Code.

Accepted Answer

The answer of The first internationally recognized effort to establish...

Question 12

In a study of patients experiencing arthritis, the researcher used real names in the field notes. Which human right was violated?&#10;A) Fair treatment&#10;B) Privacy&#10;C) Protection from discomfort&#10;D) Self-determination

Accepted Answer

The answer of In a study of patients experiencing arthritis,...

Question 13

Informed consent requires that a study subject has free power of choice regarding participation and:&#10;A) general knowledge and comprehension of the study.&#10;B) information on the study design.&#10;C) psychological support from the researcher and staff.&#10;D) the right to direct his or her role in the study.

Accepted Answer

The answer of Informed consent requires that a study subject...

Question 14

Competence of a potential research subject to give informed consent is typically determined by the:&#10;A) closest of kin.&#10;B) patient.&#10;C) primary health care provider.&#10;D) researcher.

Accepted Answer

The answer of Competence of a potential research subject to...

Question 15

Which of the following identified the ethical principles of respect for persons, beneficence, and justice as relevant to the conduct of research using human subjects in the United States?&#10;A) Declaration of Helsinki&#10;B) Department of Health, Education, and Welfare regulations&#10;C) National Commission for the Protection of Human Subjects ordinance&#10;D) Nuremberg Code

Accepted Answer

The answer of Which of the following identified the ethical...

Question 16

Which of the following are true statements regarding ethical research?&#10;A) Because of the development of the IRB process, misconduct is no longer a problem in the scientific community.&#10;B) Ethical research follows the three principles set forth by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.&#10;C) Researchers strive to protect the rights of human subjects, but in some situations, violation of these rights is necessary if valuable information about disease conditions is to be obtained.&#10;D) Since the time of the Nazi experiments in Germany, unethical research has been eliminated through the Nuremberg Code.

Accepted Answer

The answer of Which of the following are true statements...

Question 17

A questionnaire has an ID number in one corner that allows the research team to identify the subject. This is an example of:&#10;A) anonymity.&#10;B) confidentiality.&#10;C) deception.&#10;D) informed consent.

Accepted Answer

The answer of A questionnaire has an ID number in...

Question 18

What international document was developed in 1949 to direct investigators in conducting ethical research?&#10;A) Declaration of Helsinki&#10;B) Department of Health, Education, and Welfare regulations&#10;C) National Commission for the Protection of Human Subjects ordinance&#10;D) Nuremberg Code

Accepted Answer

The answer of What international document was developed in 1949...

Question 19

In a study in which nurses rated weekend versus weekday work schedule preference, the researcher permitted nursing administrators to examine the raw data. Which human right was violated?&#10;A) Confidentiality&#10;B) Fair treatment&#10;C) Protection from harm&#10;D) Self-determination

Accepted Answer

The answer of In a study in which nurses rated...

Question 20

A researcher who does not disclose that a portion of the data from the original study sample was not used in the final data analysis could be accused of:&#10;A) infidelity.&#10;B) lack of scientific objectivity.&#10;C) plagiarism.&#10;D) scientific misconduct.

Accepted Answer

The answer of A researcher who does not disclose that...

Question 21

The current practice with regard to research on neonates is:&#10;A) only nonviable neonates should become research subjects.&#10;B) parents are allowed to give consent on behalf of the neonate.&#10;C) studies with neonates must include a pilot study.&#10;D) they are extremely vulnerable and should not be involved in research.

Accepted Answer

The answer of The current practice with regard to research...

Question 22

What statement is untrue regarding the atrocious medical activities of the Third Reich in Europe during the late 1930s and early 1940s?&#10;A) Although terrible, at least some valuable medical information made up for the misconduct.&#10;B) Researchers did not follow standard methodology for scientific study.&#10;C) Subjects in the experiments would be considered a vulnerable population.&#10;D) The medical experiments were conducted on a biased sample.

Accepted Answer

The answer of What statement is untrue regarding the atrocious...

Question 23

Which situation is the most likely to lead to a breach of confidentiality?&#10;A) A qualitative researcher conducting interviews&#10;B) An English speaking researcher using non-English-speaking subjects&#10;C) An inexperienced researcher analyzing secondary data&#10;D) Researchers who went through an expedited IRB review

Accepted Answer

The answer of Which situation is the most likely to...

Question 24

Which of the following is not necessary to be included in the information provided to potential participants in a study for them to give informed consent? The&#10;A) participation requirements of the subjects&#10;B) research hypothesis&#10;C) research purpose&#10;D) risks and benefits of participating in the study

Accepted Answer

The answer of Which of the following is not necessary...

Question 25

Conducting a study using children as subjects requires all except which of the following?&#10;A) Assent&#10;B) Informed consent&#10;C) Pilot study&#10;D) Permission

Accepted Answer

The answer of Conducting a study using children as subjects...

Question 26

When assessing unusual levels of temporary discomfort, which of the following would be the top concern to a researcher?&#10;A) A potential feeling of sadness when reminiscing about old memories&#10;B) Completion of the tool takes 30 minutes of the subject's time&#10;C) The participant needs to travel across town to the research facility&#10;D) Unrelieved pain caused by the use of a placebo medication in a study looking at chronic pain relief

Accepted Answer

The answer of When assessing unusual levels of temporary discomfort,...

Question 27

Which of the following rights or principles did the Willowbrook Study not violate? The principle or right of/to:&#10;A) beneficence&#10;B) justice&#10;C) privacy&#10;D) self-determination

Accepted Answer

The answer of Which of the following rights or principles...

Question 28

Which of the following statements is true regarding the use of deception in current research studies? The use of deception:&#10;A) in studies is no longer approved by Institutional Review Boards.&#10;B) involves not telling a subject if he or she is in the control or intervention group.&#10;C) is the same thing as using covert methods of data collection.&#10;D) violates the right of self-determination.

Accepted Answer

The answer of Which of the following statements is true...

Question 29

Which of the following is a true statement regarding use of animals in research?&#10;A) Nurses are almost never involved with animal research.&#10;B) Research studies should be conducted on whether animals should be used in research.&#10;C) The Institutional Review Board gives the same scrutiny to animal research as it does to research with human subjects.&#10;D) The main goal of the Public Health Service policy is to ensure the humane treatment of animals used in research.

Accepted Answer

The answer of Which of the following is a true...

Question 30

Which of the following is not among the rights of research subjects that are protected in ethical research?&#10;A) Fair pay for participation&#10;B) Privacy&#10;C) Protection from discomfort and harm&#10;D) Self-determination

Accepted Answer

The answer of Which of the following is not among...

Question 31

A researcher looking over a patient's record for purposes of obtaining research data would be exposing that subject to what degree of harm?&#10;A) No anticipated effects&#10;B) Risk of permanent damage&#10;C) Temporary discomfort&#10;D) Unusual levels of temporary discomfort

Accepted Answer

The answer of A researcher looking over a patient's record...

Question 32

The goal of the Health Insurance Portability and Accountability Act (HIPAA) addresses which of the following? The principle or right of/to:&#10;A) beneficence&#10;B) justice&#10;C) respect&#10;D) self-determination

Accepted Answer

The answer of The goal of the Health Insurance Portability...

Question 33

Which of the following statements is true regarding the Tuskegee Syphilis Study? The&#10;A) proven medical treatment, when available, was withheld from the subjects.&#10;B) purpose of the study outweighed the risks and continued for 40 years.&#10;C) research design was amended so that it could continue regardless of the outcome.&#10;D) subjects did not know they were in a study.

Accepted Answer

The answer of Which of the following statements is true...

Question 34

A compromise from the rigorous standards created by the Department of Health, Education, and Welfare 1973 regulations for the Protection of Human Research Subjects resulted in which of the following?&#10;A) A lot more time being required to get approval and a lower number of studies being conducted&#10;B) Stricter interpretation of the need for review of all studies going before institutional review boards&#10;C) Student participation in several research studies to assist researchers in determining risk&#10;D) The eventual creation of levels of institutional review board reviews

Accepted Answer

The answer of A compromise from the rigorous standards created...

Deck 4: Examining Ethics in Nursing Research