Deck 13: Legal and Ethical Issues

Question 1

What 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

Answer 1

Right to fair treatment

Question 2

What is the basic human right that 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

Answer 2

Right to anonymity and confidentiality

Question 3

Which 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.

Answer 3

A parental signature is required for a child to participate in a study.
The child should be able to express a preference for participation.
The child should understand the purpose of the study.

Question 4

What 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 5

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.
C) It is filed in a locked filing cabinet, separate from data generated by the study.
D) It is copied, with one given to the participant and the other held by the researcher.

Question 6

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

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

Question 7

The nurse researcher is planning a research study that will use human subjects and their choice to participate in a specific treatment. The ethical principle that describes a prospective subject'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

Question 8

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

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

Question 9

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 10

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 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 11

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 IRB
C) Explanation of whom to contact regarding any area of the study
D) List of subject's assignment to intervention group or control group

Question 12

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 feel discomfort during the study when blood is drawn."
B) "I understand that the researcher is not responsible for negligence-caused injury."
C) "I understand that I will not be compensated for participating in this study."
D) "I understand that participating in the study will not immediately benefit me."

Question 13

The role of an IRB includes which actions? (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 HIPAA privacy rules are maintained in a study

Question 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

Question 15

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

Question 16

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? (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 17

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 18

What is the basic human right that 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 19

The five human rights that are outlined in ANA guidelines include which rights? (Select all that apply.)

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

Question 20

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 Institutional Review Board.
D) Secretly tape-record the researcher's interaction with a potential subject.

Question 21

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

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