Deck 6: Legal and Ethical Issues
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Deck 6: Legal and Ethical Issues
1
The issue of personal privacy may be more difficult for nurse researchers to protect in qualitative studies than it is in quantitative studies for which reason?
A) Participants may be related to each other.
B) The researcher meets participants face to face in such studies.
C) Participants are not asked to sign an informed consent statement.
D) Verbatim quotations from participants may reveal personal information.
A) Participants may be related to each other.
B) The researcher meets participants face to face in such studies.
C) Participants are not asked to sign an informed consent statement.
D) Verbatim quotations from participants may reveal personal information.
Verbatim quotations from participants may reveal personal information.
2
Which of the following ethical principles is violated when a potential participant refuses to participate in a clinical study and,in response,the physician takes less time to answer this patient's questions than he does with other patients?
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity
Promoting Justice
3
A patient newly diagnosed with breast cancer is asked to participate in a clinical trial for a new chemotherapy agent.This patient's freedom to participate or not participate in the study exercises protection of which of her human rights?
A) Right to fair treatment
B) Right to self-determination
C) Right to privacy and confidentiality
D) Right to anonymity
A) Right to fair treatment
B) Right to self-determination
C) Right to privacy and confidentiality
D) Right to anonymity
Right to self-determination
4
The nurse researcher is planning a research study that will use human participants and their choice to participate in a specific treatment.The ethical principle that describes a prospective participant's freedom to choose whether or not to participate in the research study is what?
A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons
A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons
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5
Which of the following ethical principles was violated in the Hyman versus Jewish Chronic Disease Hospital case,in which doctors injected older adults with cancer cells to study their rejection responses?
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Promoting and Respecting Informed Decision Making
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Promoting and Respecting Informed Decision Making
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6
The Research Ethics Board (REB)is responsible for
A) approval of the research design.
B) protecting participants from undue risk.
C) ensuring that informed consent is obtained.
D) promotion of nursing research in health care institutions.
A) approval of the research design.
B) protecting participants from undue risk.
C) ensuring that informed consent is obtained.
D) promotion of nursing research in health care institutions.
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7
A mother agreed to let her young son participate in a research study because she believed that if she did not agree,her child would be denied drug therapy.What right has been violated in this situation?
A) Voluntary consent
B) Freedom from harm
C) Protection from discomfort
D) Fair and equitable treatment
A) Voluntary consent
B) Freedom from harm
C) Protection from discomfort
D) Fair and equitable treatment
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8
Which of the following ethical guidelines describes a prospective participant's freedom to participate or not participate in a research study?
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Promoting and Respecting Informed Decision Making
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Promoting and Respecting Informed Decision Making
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9
A "captive" population of potential participants for comparing the effectiveness of a pamphlet versus a videotape in teaching young men how to perform testicular self-examination indicates what?
A) Students in a high school health education class
B) Young men undergoing treatment for testicular cancer
C) Men who request screening information from the Canadian Cancer Society
D) People who respond to a newspaper advertisement that requests responses from sons and brothers of men who have had testicular cancer
A) Students in a high school health education class
B) Young men undergoing treatment for testicular cancer
C) Men who request screening information from the Canadian Cancer Society
D) People who respond to a newspaper advertisement that requests responses from sons and brothers of men who have had testicular cancer
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10
In which of the following circumstances is informed consent always necessary?
A) An experimental study
B) A retrospective chart audit
C) A study in which the convenience sample participant voluntarily completes and returns a questionnaire
D) A study with minimal risk in which the participant has been given a verbal explanation of the study
A) An experimental study
B) A retrospective chart audit
C) A study in which the convenience sample participant voluntarily completes and returns a questionnaire
D) A study with minimal risk in which the participant has been given a verbal explanation of the study
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11
In Canada,the ethical standards for nursing practice come from
A) the Criminal Code.
B) the provincial legislation.
C) the Canadian Nurses Association (CNA) professional Code of Ethics.
D) the Regulated Health Professions Act.
A) the Criminal Code.
B) the provincial legislation.
C) the Canadian Nurses Association (CNA) professional Code of Ethics.
D) the Regulated Health Professions Act.
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12
A nurse researcher is developing a study's informed consent form.Which statement violates the Code of Federal Regulations?
A) "I understand that I may experience a small amount of discomfort during the study when blood is taken from one of my veins."
B) "I understand that the investigator will not be responsible for any harm I experience that results from negligence."
C) "I understand that I will not receive any compensation for my participation in this research study."
D) "I understand that this study may not have any immediate benefits to me as a result of my participation."
A) "I understand that I may experience a small amount of discomfort during the study when blood is taken from one of my veins."
B) "I understand that the investigator will not be responsible for any harm I experience that results from negligence."
C) "I understand that I will not receive any compensation for my participation in this research study."
D) "I understand that this study may not have any immediate benefits to me as a result of my participation."
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13
A person gives consent to participate in a study,is assigned to an intervention group,and is expected to remain in the study for 1 year.Which ethical principle is violated if after 6 months the participants in the treatment group have more problems than do the control participants but the researcher does not allow the members of the treatment group to stop the treatment?
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity
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14
What is the ethical principle that is violated if doctors inject aged and senile patients with their cancer cells to study their rejection responses?
A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons
A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons
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15
The nurse researcher is planning a research study that will use human participants and their choice to participate in a specific treatment.The ethical principle that describes a prospective participant's freedom to choose whether or not to participate in the research study is what?
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity
A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity
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16
Which statements,descriptions,or pieces of information are considered an essential element of the informed consent form for a research study?
A) "Patients who were contacted by study personnel and who signed (or whose proxy signed) informed consent were enrolled in the study cohort."
B) "The research has been reviewed and approved by the Human Participants' Review Committee, which include Jane Doe and John Smith."
C) "If you have any concerns about the conduct of this study or your rights as a research participant, please contact Jay Tee, lead investigator for this project at…"
D) "You have been randomly assigned to the intervention group, which will receive a new experimental drug developed to prevent breast cancer."
A) "Patients who were contacted by study personnel and who signed (or whose proxy signed) informed consent were enrolled in the study cohort."
B) "The research has been reviewed and approved by the Human Participants' Review Committee, which include Jane Doe and John Smith."
C) "If you have any concerns about the conduct of this study or your rights as a research participant, please contact Jay Tee, lead investigator for this project at…"
D) "You have been randomly assigned to the intervention group, which will receive a new experimental drug developed to prevent breast cancer."
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17
Women have been excluded as participants in many randomized controlled trials because
A) it is difficult to include both genders.
B) female hormones may interact with the drugs studied.
C) women are generally more difficult to recruit as participants.
D) female participants may not realize they are pregnant, thus putting the fetus at risk.
A) it is difficult to include both genders.
B) female hormones may interact with the drugs studied.
C) women are generally more difficult to recruit as participants.
D) female participants may not realize they are pregnant, thus putting the fetus at risk.
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18
What is the basic human right that is violated when a researcher allows an unauthorized person access to study data containing information about participant identities and responses?
A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons
A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons
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19
Which statement about informed consent is most accurate?
A) Informed consent needs to be sought only if risks outweigh benefits.
B) Informed consent is required if physical risks exist but not psychological risks.
C) Researchers must obtain voluntary participation of participants after informing them of possible risks and benefits.
D) A researcher is not obligated to seek informed consent if the details of the study could upset the participant and potentially affect the study outcome.
A) Informed consent needs to be sought only if risks outweigh benefits.
B) Informed consent is required if physical risks exist but not psychological risks.
C) Researchers must obtain voluntary participation of participants after informing them of possible risks and benefits.
D) A researcher is not obligated to seek informed consent if the details of the study could upset the participant and potentially affect the study outcome.
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20
How should a completed and signed informed consent form be handled?
A) It is turned over to the agency's REB for safekeeping.
B) It is sent to the Canadian Institutes of Health Research as evidence of compliance.
C) It is copied; one copy is given to the participant and the other is filed by the researcher in a secured location.
D) There is not special procedure for handling a consent form.
A) It is turned over to the agency's REB for safekeeping.
B) It is sent to the Canadian Institutes of Health Research as evidence of compliance.
C) It is copied; one copy is given to the participant and the other is filed by the researcher in a secured location.
D) There is not special procedure for handling a consent form.
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21
A representative from a pharmaceutical company presents to the nurses at a long-term care facility a new product,a premedicated wound dressing,for treating pressure ulcers.The representative asks the nurses to try the new product for 1 month and compare its effectiveness with that of their current method of treatment.What type of unethical action does this situation demonstrate?
A) Intent to harm
B) Fraudulent behaviour
C) Scientific misconduct
D) Unauthorized research
A) Intent to harm
B) Fraudulent behaviour
C) Scientific misconduct
D) Unauthorized research
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22
A staff nurse overhears a health care professional use coercion to make a patient agree to participate in a research study.What should the staff nurse do?
A) Confront the researcher with concerns.
B) Document suspicions in the patient's medical record.
C) Contact the hospital's REB.
D) Secretly record the researcher's interaction with a potential participant.
A) Confront the researcher with concerns.
B) Document suspicions in the patient's medical record.
C) Contact the hospital's REB.
D) Secretly record the researcher's interaction with a potential participant.
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23
What basic human right exists when participants have the right to withdraw from a study without penalty?
A) Right to self-determination
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm
A) Right to self-determination
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm
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24
An adult participant receives an informed consent form to participate in a study on breast cancer in women younger than the age of 35.The study's informed consent process should include which elements?
A) The participant's meeting the REB members who approved the study
B) The participant's being informed of risks associated with the study
C) The participant's being informed of the study protocol
D) The participant's being given the right to decline participation at any time
E) The participant's being assured that her confidentiality will be maintained
A) The participant's meeting the REB members who approved the study
B) The participant's being informed of risks associated with the study
C) The participant's being informed of the study protocol
D) The participant's being given the right to decline participation at any time
E) The participant's being assured that her confidentiality will be maintained
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25
What basic human right is considered to be equitable selection of participants and their treatment during the research study?
A) Right to self-determination
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm
A) Right to self-determination
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm
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26
You are a staff nurse,and you observe a health care professional coercing a patient to agree to participate in a research study.What should you do in this situation?
A) Contact the hospital's REB.
B) Confront the researcher with your concerns.
C) Document your suspicions in the patient's medical record.
D) Secretly record the researcher's interaction with the patient.
A) Contact the hospital's REB.
B) Confront the researcher with your concerns.
C) Document your suspicions in the patient's medical record.
D) Secretly record the researcher's interaction with the patient.
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27
Which statements are accurate regarding the assent process for pediatric research?
A) A parental signature is required for a child to participate in a study.
B) The study protocol is reviewed with the parent and not the child.
C) The child should be able to express a preference for participation.
D) A child older than age 16 does not require a parent's signature for consent.
E) The child should understand the purpose of the study.
A) A parental signature is required for a child to participate in a study.
B) The study protocol is reviewed with the parent and not the child.
C) The child should be able to express a preference for participation.
D) A child older than age 16 does not require a parent's signature for consent.
E) The child should understand the purpose of the study.
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28
Which is considered an essential element of the informed consent form for a research study?
A) The witnessing signature of an authorized party
B) The listing of members of the agency's REB
C) Explanation of whom to contact regarding any area of the study
D) List of participant's assignment to intervention group or control group
A) The witnessing signature of an authorized party
B) The listing of members of the agency's REB
C) Explanation of whom to contact regarding any area of the study
D) List of participant's assignment to intervention group or control group
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29
What is the basic human right that exists when the participant's identity cannot be linked,even by the researcher,with his or her individual responses?
A) Right to self-determination
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm
A) Right to self-determination
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm
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30
The five human rights that are outlined in CNA guidelines include which rights?
A) Right to self-determination
B) Right to privacy and dignity
C) Right to legal consultation
D) Right to anonymity and confidentiality
E) Right to fair treatment
F) Right to protection from discomfort and harm
G) Right to comprehensive medical care
A) Right to self-determination
B) Right to privacy and dignity
C) Right to legal consultation
D) Right to anonymity and confidentiality
E) Right to fair treatment
F) Right to protection from discomfort and harm
G) Right to comprehensive medical care
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31
What factors might influence whether it is ethical to require an older adult to participate in a research study?
A) The relevance of the research to issues important to older adults
B) The ethnic background of the potential participant
C) The age of the potential participant
D) The cognitive capacity of the potential participant
E) The degree of risk associated with the study
A) The relevance of the research to issues important to older adults
B) The ethnic background of the potential participant
C) The age of the potential participant
D) The cognitive capacity of the potential participant
E) The degree of risk associated with the study
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32
What are ethical principles that are illustrated by obtaining REB approval?
A) Respect
B) Beneficence
C) Trust
D) Justice
E) Anonymity
F) Confidentiality
A) Respect
B) Beneficence
C) Trust
D) Justice
E) Anonymity
F) Confidentiality
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