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Chapter 7
Generating Research Evidence Ethically
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Ethical Dilemma in Conducting Research
•A situation in which the rights of study participants are in direct conflict with requirements for a rigorous study
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Code of Ethics
•Nuremberg Code •Declaration of Helsinki •Belmont Report •Codes for professional disciplines (e.g.,
by the American Nurses’ Association, American Psychological Association)
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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
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Potential Benefits and Risks of Research to Participants
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Ethical Principles from the Belmont Report (cont’d)
2. Principle of Respect for Human Dignity• Right to self-determination (absence of
coercion) • Right to full disclosure (absence of
deception or concealment)
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Ethical Principles from the Belmont Report (cont’d)
3. Principle of Justice • Right to fair treatment • Right to privacy (confidentiality,
anonymity)
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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
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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
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Content of Informed Consent (cont’d)
•Sponsorship of the study •Participant selection •Potential risks and benefits •Treatment alternatives
Copyright © 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins
Content of Informed Consent (cont’d)
•Confidentiality pledge •Voluntary nature of participation •Participant’s right to withdraw or
withhold information •Information on contacting researcher
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Vulnerable Subjects
•Children •Mentally or emotionally disabled people •Severely ill or physically disabled people •Terminally ill people • Institutionalized people •Pregnant women
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