Chapter 7

Designing Ethical Research

Ethical Dilemma in Conducting
Research:

• A situation in which the rights of study

participants are in direct conflict with
requirements for a rigorous study
Codes of Ethics

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

1. 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
Box 7.2 Potential Benefits and Risks
To Study Participants
Ethical Principles from the Belmont
Report (cont.)

2. 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.)

3. 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’d)

• Sponsorship of the study

• Participant selection
• Potential risks and benefits
• Treatment alternatives
Content of Informed Consent (cont’d)

• 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