Deck 6: Legal and Ethical Issues

Question 1

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 subject voluntarily completes and returns a questionnaire
D) A study with minimal risk in which the subject has been given a verbal explanation of the study

Answer 1

An experimental study

Question 2

Which of the following ethical guidelines describes a prospective subject'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

Answer 2

Promoting and Respecting Informed Decision Making

Question 3

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 of the following ethical principles is violated if after 6 months the subjects in the treatment group have more problems than do the control subjects 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

Answer 3

Promoting Justice

Question 4

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.

Question 5

Which of the following groups 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 (TSE)?

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

Question 6

Which of the following ethical principles was violated in the Hyman vs.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

Question 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

Question 8

Which of the following statements about informed consent is 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 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 9

Women have been excluded as participants in many randomized controlled trials (RCTs)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.

Question 10

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

Question 11

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 tape-record the researcher's interaction with the patient.

Question 12

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

A) It is turned over to the agency's research ethics board ( REB ) for safekeeping.
B) It is sent to the Canadian Institutes of Health Research ( CIHR ) 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.

Question 13

All of 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 that this study may not have any immediate benefits to me as a result of my participation."

Question 14

Why is personal privacy more difficult to protect in qualitative studies than in quantitative studies?

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.

Question 15

Which of the following basic human rights is violated when a researcher allows an unauthorized person access to study data containing information about subject identities and responses?

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

Question 16

Which of the following statements,descriptions,or pieces of information is 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."

Question 17

Which of the following ethical principles is violated when a potential subject 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

Question 18

Which of the following ethical guidelines describes the researcher's obligation to do no harm?

A) Promoting Justice
B) Promoting Health and Well-Being
C) Maintaining Privacy and Confidentiality
D) Preserving Dignity

Question 19

A woman newly diagnosed with breast cancer is asked to participate in a clinical trial for a new chemotherapy agent.Which of her human rights is protected by her freedom to choose whether nor not to participate in the study?

A) Right to fair treatment
B) Right to self-determination
C) Right to privacy and confidentiality
D) Right to anonymity

Question 20

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.