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Question 1

What are the key topics covered in Unit 3: Bioethics and Research?

Answer 1

• Principle of Ethics in Research
• Ethical Issues in Evidence-Based Practice
• Nuremberg Code
• Declaration of Helsinki
• National Research Act & Belmont Report
• Ethico-Moral Obligations of the Nurse in Evidence-Based Practices
• Introduction of Good Clinical Practice Guidelines

Question 2

Who inoculated his son with swinepox against smallpox in 1798?

Answer 2

Edward Jenner

Question 3

What ethical issue arises from Edward Jenner’s experiments?

Answer 3

No consent was taken from the subjects

Question 4

What is the significance of Moses Maimonides’ contributions to ethics in research?

Answer 4

He instructed colleagues to treat patients as ends in themselves, not as means for learning new truths

Question 5

What major historical events prompted the development of regulated ethical constraints in research?

Answer 5

Nazi experiments during WWII

Question 6

What does the Nuremberg Code emphasize regarding human subjects in research?

Answer 6

Voluntary consent of the human subject is absolutely essential

Question 7

What is the Belmont Report and its purpose?

Answer 7

It outlines ethical principles and guidelines for the protection of human subjects of research

Question 8

What year was the Declaration of Helsinki adopted?

Answer 8

1964

Question 9

What principle does the Declaration of Helsinki promote?

Answer 9

It provides guidance to physicians and participants in medical research involving human subjects

Question 10

What is the ethical principle of respect for human dignity?

Answer 10

Each person is worthy of honor and respect for who they are, not just for what they can do

Question 11

Fill in the blank: The principle of _______ entails high ethical obligations towards vulnerable persons.

Answer 11

Respect for Vulnerable Persons

Question 12

What does informed consent indicate regarding privacy and confidentiality?

Answer 12

It should indicate how the researcher will protect the confidentiality of participants

Question 13

What is the main focus of the principle of beneficence in research ethics?

Answer 13

To protect subjects from harm and secure their well-being

Question 14

What is evidence-based practice?

Answer 14

An approach to health care using the best available evidence for decision-making

Question 15

What tragic event influenced the Declaration of Helsinki?

Answer 15

The Thalidomide tragedy

Question 16

What does the principle of justice in the Belmont Report emphasize?

Answer 16

Subjects should be treated equally regarding the distribution of burdens and benefits of research

Question 17

What was the outcome of the Tuskegee Syphilis Study?

Answer 17

128 men died, 40 wives contracted the disease, and 19 children were born with congenital syphilis

Question 18

What are the three basic principles outlined in the Belmont Report?

Answer 18

• Respect for persons
• Beneficence
• Justice

Question 19

True or False: The Declaration of Helsinki aims to prevent human subjects from being mistreated.

Answer 19

True

Question 20

What does minimizing harm and maximizing benefit in research ethics focus on?

Answer 20

Promoting positive consequences by balancing harms with benefits

Question 21

What was the main reason for the establishment of the National Research Act of 1974?

Answer 21

To define public regulations for protecting human research participants

Question 22

What does the risk-benefit ratio consider in research ethics?

Answer 22

The comfort level of researchers with having family members participate in the study

Question 23

Fill in the blank: The Nuremberg Code was established in response to _______ human experiments.

Answer 23

Nazi

Question 24

What are the three main ethical principles outlined in the Belmont Report?

Answer 24

• Respect for persons
• Beneficence
• Justice

These principles ensure the protection and fair treatment of research subjects.

Question 25

What is the primary purpose of the Belmont Report?

Answer 25

To protect the rights of all research subjects or participants. ## Footnote It serves as an ethical framework for research.

Question 26

What does the principle of beneficence in the Belmont Report entail?

Answer 26

Subjects should be protected from harm and efforts should be made to secure their well-being.

Question 27

Define the principle of justice as per the Belmont Report.

Answer 27

Subjects should be treated equally in regards to the distribution of the burdens and benefits of the research.

Question 28

What role do ethical norms play in research?

Answer 28

* Promote the aims of research such as knowledge and truth * Ensure trust, accountability, mutual respect, and fairness * Hold researchers accountable to the public * Build public support for research * Promote moral and social values ## Footnote Ethical norms help prevent harm to subjects and maintain the integrity of research.

Question 29

What is the significance of honesty in research ethics?

Answer 29

Strive for honesty in all scientific communications and do not fabricate, falsify, or misrepresent data.

Question 30

What does objectivity in research ethics refer to?

Answer 30

Striving to avoid bias in all aspects of research including experimental design and data analysis.

Question 31

What is meant by integrity in the context of research ethics?

Answer 31

Keeping promises and agreements and acting with sincerity.

Question 32

Fill in the blank: Ethical norms in research help to build _______ for research.

Answer 32

[public support]

Question 33

What are some responsibilities of researchers regarding intellectual property?

Answer 33

* Honor patents and copyrights * Do not use unpublished data without permission * Give proper credit for all contributions * Never plagiarize.

Question 34

What is the International ethical and scientific quality standard for clinical trials involving human subjects called?

Answer 34

Good Clinical Practice (GCP).

Question 35

Why is Good Clinical Practice (GCP) necessary?

Answer 35

To ensure the rights, safety, and well-being of trial subjects are protected.

Question 36

What should be included in a research protocol according to GCP?

Answer 36

The objective(s), design, methodology, statistical considerations, and organization of the trial.

Question 37

What does the principle of risk identification in GCP entail?

Answer 37

Foreseeable risks and discomforts and anticipated benefits for trial subjects must be identified before research begins.

Question 38

What is the purpose of the independent ethics committee/institutional review board (IEC/IRB) in research?

Answer 38

To review research protocols for ethical compliance before the initiation of the study.

Question 39

True or False: Misconduct in research only occurs when there is intent to deceive.

Answer 39

True.

Question 40

What ethical dilemma does Dr. Wexford face regarding sharing her dataset?

Answer 40

Balancing the ethical norm of openness with the potential loss of recognition for her own research.

Question 41

What are the four principal elements of the ICN Code of Ethics for nurses?

Answer 41

* Nurses and people * Nurses and practice * Nurses and the profession * Nurses and co-workers.

Question 42

What is the importance of responsible mentoring in research ethics?

Answer 42

To help educate, mentor, and advise students while promoting their welfare.

Question 43

Fill in the blank: Ethical lapses in research can significantly harm _______.

Answer 43

[human and animal subjects, students, and the public]

Question 44

What is the purpose of an independent committee in research?

Answer 44

To ensure that research is free from undue influence by the investigator, sponsor, or others ## Footnote This is in accordance with the Declaration of Helsinki.

Question 45

What does Principle 5 emphasize in clinical research?

Answer 45

Protocol review by an IEC/IRB in accordance with GCP and applicable laws ## Footnote IEC stands for Independent Ethics Committee and IRB stands for Institutional Review Board.

Question 46

What is required for research involving humans under Principle 6?

Answer 46

Conduct research in compliance with the approved protocol ## Footnote This ensures that the ethical acceptability of the trial remains valid.

Question 47

How is compliance with the protocol ensured according to Principle 6?

Answer 47

Through verifiable investigator adherence, submission of protocol changes, and effective monitoring by the sponsor

Question 48

What is the main requirement of Principle 7?

Answer 48

Obtain freely given informed consent from every subject prior to participation

Question 49

What should be done when a subject cannot give informed consent?

Answer 49

Obtain permission from a legally authorized representative

Question 50

What does Principle 8 focus on in research involving humans?

Answer 50

Continuing review and ongoing benefit-risk assessment

Question 51

What processes are involved in applying Principle 8?

Answer 51

Safety monitoring, reporting adverse events, and reviewing unanticipated risks

Question 52

Who should be responsible for the medical care of trial subjects according to Principle 9?

Answer 52

Qualified and duly licensed medical personnel

Question 53

What does Principle 10 require of individuals conducting a trial?

Answer 53

They should be qualified by education, training, and experience

Question 54

What is the focus of Principle 11 regarding clinical trial information?

Answer 54

Accurate recording, handling, and storage for reporting and verification

Question 55

How is Principle 11 applied in practice?

Answer 55

Through adherence to data quality, study protocol, and preparation of essential documents

Question 56

What does Principle 12 protect?

Answer 56

The confidentiality of records that could identify subjects

Question 57

How is confidentiality ensured according to Principle 12?

Answer 57

Through appropriate procedures and informed consent process

Question 58

What is the focus of Principle 13?

Answer 58

Manufacturing, handling, and storage of investigational products according to GMP

Question 59

What does Principle 14 emphasize for clinical trials?

Answer 59

Implementation of quality systems and procedures

Question 60

Fill in the blank: Principle 8 encompasses safety monitoring, reporting adverse events, and _______.

Answer 60

reviewing unanticipated risks

Question 61

True or False: Principle 10 requires that every individual involved in a trial must be currently licensed.

Answer 61

True