Question 1

In which of the following circumstances is informed consent always necessary?

Accepted Answer

Informed consent is always necessary in experimental studies because they involve testing a new intervention or procedure on human subjects.

Answer: C 
 Informed consent may not always be necessary for studies with minimal risk, such as a questionnaire study, as long as the subjects are fully informed about the purpose and nature of the study and willingly participate.

Answer: D 
 If a study involves minimal risk, and the subject is provided a verbal explanation of the study, informed consent can be waived by the Institutional Review Board.

Answer: B
 Retrospective chart audits involve the collection of personal health information from medical records, and even if it is not possible to obtain the subjects' consent, informed consent must be sought according to privacy laws in some jurisdictions.

Question 2

Which of the following ethical guidelines describes a prospective subject's freedom to participate or not participate in a research study?

Accepted Answer

Promoting and Respecting Informed Decision Making refers to the ethical guideline that describes a prospective subject's freedom to participate or not participate in a research study. This involves providing the subject with all the necessary information about the study, including its purpose, potential risks and benefits, and alternatives to participation, so that they can make an informed decision about whether or not to participate.

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?

Accepted Answer

A

Question 4

The Research Ethics Board ( REB )is responsible for:

Accepted Answer

The answer of The Research Ethics Board ( REB )is...

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)?

Accepted Answer

Students in a high school health education class represent a captive population because they are already enrolled in a class and can be required to participate in the study. The other options involve individuals who may have self-selected to participate or who are actively seeking information about testicular cancer, which may introduce bias into the study results.

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?

Accepted Answer

The ethical principle violated was "Promoting and Respecting Informed Decision Making" because the patients were not informed about the nature of the experiment or given the opportunity to consent to the injection of cancer cells.

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?

Accepted Answer

The right that has been violated in this situation is voluntary consent. It is important for participants to give their informed and voluntary consent to participate in research, without feeling pressured or coerced in any way. In this case, the mother agreed to let her son participate because she believed that if she didn't, her child would be denied drug therapy, which constitutes coercion.

Question 8

Which of the following statements about informed consent is accurate?

Accepted Answer

The statement is accurate that researchers must obtain voluntary participation of subjects after informing them of potential risks and benefits. This is a standard ethical requirement for any study involving human subjects. Informed consent is a critical aspect of protecting the welfare and autonomy of research participants. It is not sufficient to seek informed consent only if the risks outweigh benefits (choice A), or if physical but not psychological risks exist (choice B). Furthermore, a researcher must make every effort to seek informed consent, even if the details of the study could potentially upset the subject (choice D).

Question 9

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

Accepted Answer

The answer of Women have been excluded as participants in...

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?

Accepted Answer

This situation demonstrates unauthorized research because the pharmaceutical representative is asking the nurses to conduct a comparison study without proper authorization, oversight, or informed consent, which are essential components of ethical research practices.

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?

Accepted Answer

Contacting the hospital's Research Ethics Board (REB) is the appropriate action to take if you observe coercion in a research study. The REB is responsible for reviewing and approving research studies to ensure they meet ethical standards, and they have the authority to investigate and stop any unethical behavior. Confronting the researcher directly may not be effective and could potentially put you in a difficult or unsafe situation. Documenting your suspicions in the patient's medical record is important, but it should not be the only action taken. Secretly recording the interaction is not advisable, as it may be illegal and violates the patient's privacy.

Question 12

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

Accepted Answer

The answer of How should a completed and signed informed...

Question 13

All of the following statements appear in a study's informed consent form.Which statement violates the Code of Federal Regulations?

Accepted Answer

This statement violates the Code of Federal Regulations because it implies that the investigator is not responsible for any harm that may occur due to their own negligence. Researchers have a legal and ethical responsibility to ensure participant safety and cannot waive that responsibility through an informed consent form.

Question 14

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

Accepted Answer

In qualitative studies, verbatim quotations from participants are often used to support findings and conclusions, which can reveal personal information about the participants. Unlike in quantitative studies, where data is often collected through surveys, experiments, or other structured methods that do not necessarily reveal personal information about the participants. Therefore, personal privacy is more difficult to protect in qualitative studies.

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?

Accepted Answer

Confidentiality is the basic human right that is violated when unauthorized persons are given access to study data containing information about subject identities and responses. Researchers have the ethical responsibility to maintain the anonymity of participants and ensure that their personal information is not disclosed to any unauthorized person or organization. Violating confidentiality can lead to the breach of trust between researchers and participants and jeopardize the integrity of the research project.

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?

Accepted Answer

The informed consent form must include contact information for someone who can address concerns about the study or participant rights.

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?

Accepted Answer

The answer of Which of the following ethical principles is...

Question 18

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

Accepted Answer

The ethical guideline that describes the researcher's obligation to do no harm is promoting health and well-being. This guideline encourages researchers to minimize the potential risks or negative consequences their research may have on participants, including physical, psychological, social, and economic harm. By prioritizing the health and well-being of participants, researchers can ensure that their research is ethical and responsible.

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?

Accepted Answer

The right to self-determination, or the right to make decisions about one's own body and health, is protected by the freedom to choose whether or not to participate in the clinical trial. The other options are not directly related to this specific situation.

Question 20

In Canada,the ethical standards for nursing practice come from:

Accepted Answer

The Canadian Nurses Association (CNA) professional Code of Ethics outlines the ethical standards for nursing practice in Canada. While the Criminal Code and provincial legislation may have some impact on these standards, the CNA Code of Ethics is considered the primary source for ethical guidance and decision-making for nurses. The Regulated Health Professions Act may have some influence on the regulation of nursing practice, but it is not directly related to ethical standards.

Quiz 6: Legal and Ethical Issues