Conceptual models or theories

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Chapter 7

Ethics in Nursing Research

Question

Tell whether the following statement is true or false:

An ethical dilemma occurs when a situation in which the rights of study participants are in direct conflict with requirements for a rigorous study.

Answer

True

An ethical dilemma is situation in which the rights of study participants are in direct conflict with requirements for a rigorous study.

Ethical Dilemma in Conducting Research

A situation in which the rights of study participants are in direct conflict with requirements for a rigorous study

Question

Tell whether the following statement is true or false:

The Nuremberg Code serves as the basis for regulations affecting research sponsored by the U.S. government.

Answer

False

The Belmont Report serves as the basis for regulations affecting research sponsored by the U.S. government. The Nuremberg Code was an international effort to establish ethical standards.

Code of Ethics

Nuremberg Code
Declaration of Helsinki
Belmont Report
Codes for professional disciplines (e.g., by the American Nurses Association, American Psychological Association)

Question

What is nonmaleficence?

Performance of some good

Protection from physical and psychological harm and exploitation

Participants right to self-determination

Freedom to control their own actions

Answer

Beneficence involves the performance of some good, and the protection of participants from physical and psychological harm and exploitation is nonmaleficence. Respect for human dignity involves participants’ right to self-determination, which means they have the freedom to control their own actions.

Question

Tell whether the following statement is true or false:

Justice includes the right to fair treatment and the right to privacy.

Answer

True

Justice includes the right to fair treatment and the right to privacy.

Ethical Principles from the Belmont Report

Principle of Beneficence: Above all,
do no harm.

Freedom from harm

Freedom from exploitation

Maximizing benefits to participants and society

Maintaining an appropriate risk/benefit ratio

Ethical Principles from the Belmont Report (cont.)

Principle of Respect for Human
Dignity

Right to self-determination (absence of coercion)

Right to full disclosure (absence of deception or concealment)

Ethical Principles from the Belmont Report (cont.)

Principle of Justice

Right to fair treatment

Right to privacy (confidentiality, anonymity)

Informed Consent

Informed consent means that participants:

Have adequate information about the research
Can comprehend that information
Have free choice in deciding whether to participate in or withdraw from the study

Content of Informed Consent—What Must Be Communicated?

Status as a study participant
Study goals
Type of data to be collected and procedures to be used
Nature of participant’s commitment

Content of Informed Consent (cont.)

Sponsorship of the study
Participant selection
Potential risks and benefits
Treatment alternatives

Content of Informed Consent (cont.)

Confidentiality pledge
Voluntary nature of participation
Participant’s right to withdraw or withhold information
Information on contacting researcher

Vulnerable Subjects

Children
Mentally or emotionally disabled people
Severely ill or physically disabled people
Terminally ill people
Institutionalized people
Pregnant women