Chapter 15: Ethical Principles in Research

Outline and Review Questions

The _____________ is an ancient and ethical code for medical professionals, traditionally attributed to an ancient Greek physician of the same name.

Hippocratic Oath

_____________ means to do no harm.

Nonmaleficence

__________ means to remove existing harm.

Beneficence

______________ is the ability to govern one’s profession and respect for others (patient has the power to make decisions about issues that may affect their health).

Autonomy

____________ is doing what the provider thinks is right.

Paternalism

___________ means to provide patients with what is owed.

Justice

__________ means being honest.

Veracity

The ___________ was developed after WWII when unethical research had been conducted on individuals held in concentration camps.

Nuremberg Code

Ethical behavior is:

Right, legal, fair

Which organization is in charge of reviewing the ethical implications of a research study? It assures the rights and safety of the research subjects are respected and protected.

Institutional Review Board

The ________________ was created after the Tuskegee study, describes ethical principles and guidelines for research involving human subjects, and has these three principles:

• Respect for persons

• Beneficence

• Justice

Belmont Report

___________ includes plagiarism, copyright or patent infringement, falsifying or fabricating data, misrepresenting data, and conflict of interest.

Research misconduct

What is described:

• Requires educating subjects about the study’s purpose, duration, procedures, risks and benefits

• A process, not just a form

• In a language that participants understand

Informed consent

______________ reviews research conducted in the private sector.

FDA

____________ provides strict controls on which treatments, medicines, and medical devices can be sold and on what health claims may be regarding these products.

Government oversight

The ____________ is where the majority of the national government research is conducted.

NIH

______________ serve as research centers for studies and may be able to tap a minority population of interest to the research.

Local government

_____________ design and carry out the bulk of medical research in the US.

Private institutions

The field of bioethics has its origins with which physician?

Hippocrates

The entity charged with reviewing research proposals for purposes of ethics is called a(n):

Institutional review board

HIPAA helps ensure:

Patient confidentiality

Which government entity has a primary role in oral health research?

Federal

Nonmaleficence is:

A health care provider’s first obligation to the patient is to do no harm

Which of the following are included in the full description of nonmaleficence?

All of the above

______________ requires that existing harm be removed.

Nonmaleficence

___________ is self-determination and the ability to self-govern and self-direct.

Autonomy

The following are true and applied toward autonomy EXCEPT:

The dental care provider should act on the patient’s treatment choice even if it may cause harm.

The principle of __________ is concerned with providing individuals or groups with what is owed, due, or deserved.

Justice

Veracity is entrusted or held in secret, and confidentiality is defined as being honest and telling the truth.

Both statements are false.

Informed consent, first requires that the researcher provide the subject with all relevant information needed to make a decision. Second, it allows the subject to make the decision on the basis of the information provided.

Both statements are true

All of the following apply to informed consent EXCEPT:

The researcher is the one who makes the final decision on treatment for the patient.

_____________ means that the health care professional acts as a parent and makes decisions for the patient on the basis of what the professional believes is in the best interest of the patient.

Paternalism

The Belford War Crimes trials brought to light examples of medical research that had clearly exploited human beings. Crimes had been committed that involved unethical research on humans that were held in concentration camps.

First statement is false, second statement is true

African-American men had agreed to be examined and treated in USPHS study on ___________, but the men were not informed about the real purpose of the study and had been misled.

Syphilis

Ethical behavior in research may be described as what is:

Legal

Ethical misconduct in research may include:

Both falsifying data and conflict of interest

A research proposal may have to pass the scrutiny of more than one IRB. The IRB is involved to ensure ethical standards are being met.

Both statements are true

Which report described ethical principles and guidelines for research involving human subjects?

Belmont