Deck 11: Legal and Ethical Issues

Question 1

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 dignity
D) Right to anonymity and confidentiality

Answer 1

Right to self-determination

Question 2

The nurse researcher is planning a research study that will use human subjects and their choice to participate in a specific treatment.Which ethical principle guiding the research study describes the nurse researcher's obligation to benefit others?

A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons

Answer 2

Beneficence

Question 3

Which group represents a captive population of potential subjects for comparing the effectiveness of a pamphlet versus a videotape in teaching young men how to perform testicular self-examination?

A) Students in a high school health education class
B) Young men undergoing treatment for testicular cancer
C) Males who request screening information from the American Cancer Society
D) People who respond to a newspaper advertisement requesting responses by sons and brothers of men who have had testicular cancer

Answer 3

Students in a high school health education class

Question 4

Why is the issue of personal privacy more difficult for nurse researchers to protect in qualitative studies than it is in quantitative studies?

A) Participants may be related to each other.
B) The researcher meets face to face with most participants.
C) Participants are not asked to sign an informed consent statement.
D) Verbatim quotations from participants may reveal personal information.

Question 5

The nurse researcher is planning a research study that will use human subjects and their choice to participate in a specific treatment.Which ethical principle describes a prospective subject's freedom to choose whether or not to participate in the research study?

A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons

Question 6

Which statement regarding the American Nursing Association ( ANA )'s "Human Rights Guidelines for Nursing in Clinical and Other Research" ( 1975 )is most accurate?

A) It is relevant only for nurse researchers.
B) It defines what is and what is not nursing research.
C) It specifies the nurse's role in obtaining informed consent for medical studies.
D) It is used by all nurses to ensure that the patient's human rights are safeguarded.

Question 7

Which basic human right is violated when a nurse researcher allows an unauthorized person access to study data containing information about subject identity and responses?

A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons

Question 8

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.What ethical principle is violated if after 6 months the subjects in the treatment group have more problems than the control subjects,and the nurse researcher does not allow the members of the treatment group to stop treatment?

A) Justice
B) Beneficence
C) Confidentiality
D) Respect for persons

Question 9

Which agency currently provides guidance to federal agencies on the ethical conduct of current and future human biological and behavioral research?

A) Human Genome Project
B) Department of Health and Human Services
C) National Bioethics Advisory Commission
D) NIH Office of Research Integrity

Question 10

When did the United States government mandate that all research studies must be reviewed and approved by an IRB?

A) 1946
B) 1964
C) 1973
D) 1984

Question 11

When can pediatric subjects give joint consent (along with parental consent)rather than assent to participate in a research study?

A) 10 years
B) 12 years
C) 14 years
D) 18 years

Question 12

A staff nurse overhears a health care professional use coercion to make a patient agree to participate in a research study.How should this situation be handled most appropriately?

A) Confront the researcher with concerns.
B) Document your suspicions in the patient's medical record.
C) Contact the hospital's IRB.
D) Secretly tape-record the researcher's interaction with a potential subject.

Question 13

Which factor is considered an essential element of the informed consent form for a research study?

A) The witnessing signature
B) The listing of members of the agency's IRB
C) An explanation about whom to contact concerning any aspect of the research study
D) An indication of whether the subject is assigned to the intervention group or to the control group

Question 14

What criterion must be met to include prisoners as subjects in a research study?

A) The research must have direct relevance to the prison population.
B) The prisoner must receive compensation in some form for his or her participation.
C) At least two witnesses are required to demonstrate that the prisoner was not coerced to participate.
D) Prisoners selected as participants must either have life sentences or death sentences.

Question 15

When should a nurse researcher always need informed consent?

A) With an experimental study
B) With a retrospective chart audit
C) With a study with minimal risk in which the subject has been given a verbal explanation of the study
D) With a study in which the convenience sample voluntarily completes and returns a questionnaire

Question 16

Which ethical principle 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

Question 17

How should a completed and signed informed consent form be handled?

A) It is turned over to the agency's institutional review board ( IRB ) for safekeeping.
B) It is sent to the National Institutes of Health Office of Research Integrity to demonstrate compliance.
C) It is filed in the researcher's office in a locked filing cabinet, separate from any details or data generated by the study.
D) It is copied ( carbon acceptable ), with one copy given to the participant and the other held by the researcher.

Question 18

All the following statements appear in 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 this study may not have any immediate benefits to me as a result of my participation."

Question 19

Which statement regarding informed consent is most accurate?

A) Informed consent needs to be sought only if the risks outweigh the benefits.
B) Informed consent is required if there are physical risks but not if there are psychological risks.
C) Researchers must obtain voluntary participation of subjects 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 subject and potentially affect the study outcome.

Question 20

A mother agrees to let her child participate in a research study because she believes that if she does not agree her child will be denied medical treatment.What right is violated in this situation?

A) Voluntary consent
B) Freedom from harm
C) Protection from discomfort
D) Fair and equitable treatment

Question 21

What factors might influence whether it is ethical to require an elderly person to participate in a research study? (Select all that apply.)

A) The relevance of the research study to issues important to elderly patients
B) The ethnic background of the potential elderly participant
C) The age of the potential elderly participant
D) The cognitive capacity of the potential elderly participant
E) The degree of risk associated with the study

Question 22

Which of the following statements are accurate regarding the assent process for pediatric research? (Select all that apply.)

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.

Question 23

Which ethical principles are illustrated by obtaining IRB approval? (Select all that apply.)

A) Respect
B) Beneficence
C) Trust
D) Justice
E) Anonymity
F) Confidentiality

Question 24

Which basic human right exists when the subject'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

Question 25

What does the role of an IRB include? (Select all that apply.)

A) Assisting researchers in maintaining rigor during the data analysis phase of a study
B) Ensuring that human subjects are protected from undue risks
C) Providing approval for studies to be conducted at an institution
D) Interviewing subjects for the informed consent process
E) Ensuring that Health Insurance Portability and Accountability Act ( HIPAA ) privacy rules will be maintained in a study

Question 26

A representative from a pharmaceutical company presents a new product for healing pressure ulcers to the nurses at a long-term care facility.The product is a wound dressing that is impregnated with a new drug.The representative asks the nurses to try the new product for 1 month and compare its effectiveness with that of the current method of treatment.What type of unethical action does this situation demonstrate?

A) Scientific misconduct
B) Unauthorized research
C) Fraudulent behavior
D) Intent to harm

Question 27

Which basic human right exists when subjects 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

Question 28

Which basic human right is considered to be equitable selection of subjects 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

Question 29

An adult participant receives an informed consent form to participate in a study on breast cancer in women under the age of 35.The study's informed consent process should include: (Select all that apply.)

A) The participant's meeting the IRB 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

Question 30

A nurse researcher critiques a study that examined cardiovascular health in male prison inmates.When reviewing the study for ethical concerns,what does the researcher expect the study to include? (Select all that apply.)

A) A copy of the informed consent form in the Appendix
B) A statement that participants received informed consent information
C) A statement that the study was reviewed and approved by an IRB
D) A paragraph detailing the proceedings of the IRB approval hearing
E) A statement that identifies how this vulnerable population was protected

Question 31

Which basic human right exists when people are treated as autonomous agents who have the freedom to choose without external controls?

A) Right to free speech
B) Right to anonymity and confidentiality
C) Right to fair treatment
D) Right to protection from discomfort and harm

Question 32

What are the five human rights that are outlined in ANA guidelines?

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