Chapter 5 Ethical Concerns in Research Basics in

Chapter 5 Ethical Concerns in Research

Basics in Ethics • Examples of unethical conduct in research • Regulation of research and protection of research participants • Scientific misconduct in reporting

Examples of unethical conduct • Nazi Germany experimentation during World War II – freezing experiments – malaria experiments – high-altitude experiments • Tuskegee syphilis study in Alabama

Regulation • Ethics: description of human behavior as right or wrong • Situational ethics: “it depends” • 1947 • Helsinki Declaration • Belmont Report (1979)

Belmont Report • Current federal regulations 1. Respect for persons 2. Beneficence 3. Justice

Code of Federal Regulations (45 CFR 46) • DHHS regulations made into law • Stipulates that protocols must be reviewed by Institutional Review Board (IRB) • Office of Human Research Protections (OHRP) – provides educational materials

Informed consent • Subjects made fully aware of nature and purpose of research project • Consent is voluntarily given • Participant has legal capacity to give consent • Responsibility for obtaining consent rests with researcher

Vulnerable groups • Children • Prisoners • Pregnant women

Privacy and Confidentiality • – capacity of individuals to control when and under what conditions others will have access to their behaviors, beliefs, & values • – ability to link information or data to a person’s identity

Research Involving Animals • Similar institutional review boards to approve protocols • Training courses for all personnel using animals for research

Institutional Review Boards (IRBs) 1. 2. 3. 4. 5. 6. Subject risk minimized Subject risk reasonable to benefits Selection of subjects is equitable Informed consent is obtained Informed consent is documented Research plan provides for monitoring safety of subjects 7. Steps are taken to protect privacy and maintain confidentiality

Disclosure of Research Findings • Published reports must be credible • Misconduct – fabrication, falsification, plagiarism, or other practices in proposing, conducting, or reporting research – retaliation against a person who reports suspected misconduct and who has not acted in bad faith

• Plagiarism – presentation of ideas or works of others as your own without giving credit • Authorship – should be limited to those who have made significant contribution to the research