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

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