Chapter 5

1. Chapter 5 Ethical Concerns in Research Conducting & Reading Research Baumgartner et al

2. Basics in Ethics • Examples of unethical conduct in research • Regulation of research and protection of research participants • Scientific misconduct in reporting Conducting & Reading Research Baumgartner et al

3. Examples of unethical conduct • Nazi Germany experimentation during World War II • freezing experiments • malaria experiments • high-altitude experiments • Tuskegee syphilis study in Alabama Conducting & Reading Research Baumgartner et al

4. Regulation • Ethics: description of human behavior as right or wrong • Situational ethics: “it depends” • 1947 • Helsinki Declaration • Belmont Report (1979) Conducting & Reading Research Baumgartner et al

5. Belmont Report • Current federal regulations • Respect for persons • Beneficence • Justice Conducting & Reading Research Baumgartner et al

6. 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 Conducting & Reading Research Baumgartner et al

7. 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 Conducting & Reading Research Baumgartner et al

8. Vulnerable groups • Children • Prisoners • Pregnant women Conducting & Reading Research Baumgartner et al

9. 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 Conducting & Reading Research Baumgartner et al

10. Research Involving Animals • Similar institutional review boards to approve protocols • Training courses for all personnel using animals for research Conducting & Reading Research Baumgartner et al

11. Institutional Review Boards (IRBs) • 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 • Steps are taken to protect privacy and maintain confidentiality Conducting & Reading Research Baumgartner et al

12. 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 Conducting & Reading Research Baumgartner et al

13. 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 Conducting & Reading Research Baumgartner et al