1. Ethics In Research: Duties, Decisions and Dilemmas Colleen M. Gallagher, PhD, FACHE Chief & Executive Director Section of Integrated Ethics Associate Professor, Critical Care

2. Ethics In Research Assumption #1: –Ethical considerations permeate all aspects of scientific research: Design. Conduct. Monitoring. Analysis of Data/Results. Reporting and Publishing. Seeking & Receive Financial Support.

3. Ethics In Research Assumption #2: –There is educational and behavioral benefit from examining others’ … Mistakes. Misconduct. Unethical actions. Illegal behavior.

4. Ethics In Research Examples of 20th Century Scientific Misconduct and Violations: Nazi Physicians Tuskegee Syphilis Study (1930-1972) Brooklyn Jewish Chronic Disease Hospital (1964) Beecher’s Examples (NEJM, 1966)

6. Ethics In Research Examples of 20th Century Scientific Misconduct and Violations: Willowbrook State School (1967) Human Radiation Experiments Gene Transfer at The University of Pennsylvania (Jesse Gelsinger) And...

7. Eric T. Poehlman, PhD (2004) Tenured research professor, University of Vermont Falsified and fabricated numerous federal research grant applications ($2.9 million over 10 years) $180,000 settlement for civil complaint $16,000 for the legal fees of his accuser Faces 5 years imprisonment Debarred for life from federal funds Must retract or correct 10 articles

10. Scientific Misconduct Fabrication, falsification, plagiarism, or other practices that materially deviate from those that are commonly accepted within the academic community for proposing, conducting, or reporting research. Does not include honest errors or honest differences in interpretations or judgments of data.

11. Scientific Misconduct Fabrication: Making up results & recording/reporting them. Falsification: Manipulating research materials, equipment, or processes; or changing or omitting data or results. Plagiarism: Appropriation of another’s ideas, processes, results or words without appropriate credit.

12. OHRP and FDA Investigations and Suspensions UC Irvine Med College of GA Univ of Minnesota Univ of Pennsylvania Rush Presbyterian West LA VA Hosp Duke University Univ of IL at Chicago Univ of Colorado Vir Commonwealth U Univ of AL at Birmin Univ of OK HCS Univ of TX Galv Univ of Miami Univ of Missouri Johns Hopkins Univ

13. Ethical Guidance 1. Codes, Reports & Regulations Nuremberg Code (1947) Declaration of Helsinki (1964, +Revisions) Belmont Report (1979) –Respect for Persons –Beneficence –Justice 45 CFR 46 (1981, +Revisions) MDACC’s Principles for Scientific Research (1995)

14. Ethical Guidance 1. Codes, Reports & Regulations 2. Institutional Committees Clinical Research Committees (CRC) Psychosocial, Behavioral and Health Services Research Committee (PBHSRC) Institutional Review Boards (IRB) Institutional Animal Care and Use Committee (IACUC) Conflict of Interest Committee (COIC)

15. Ethical Guidance 1. Codes, Reports & Regulations 2. Institutional Committees 3. Informed Consent Forms Process

16. Ethical Guidance 1. Codes, Reports & Regulations 2. Institutional Committees 3. Informed Consent 4. Researcher Integrity Professional Commitments Character Traits (e.g., honesty) Management of “Conflicts of Interest” Learning from Mentors

17. MDACC’s Ethical Principles for Scientific Research 1. To accept individual responsibility for the accuracy, authenticity, originality, and completeness of our research and to give proper credit for the contributions of others. 2. To maintain open communication in the course of collaborations concerning conception of hypotheses, experimental design, data analysis, and the preparation of publications.

18. MDACC’s Ethical Principles for Scientific Research 3. To take responsibility for the work of technical staff and junior researchers by providing guidance and evaluation throughout all investigations. 4. To maintain records of procedures and original research data, which should be made available, when appropriate, for others to understand the results and conclusions.

19. MDACC’s Ethical Principles for Scientific Research 5. To include as authors of scientific publications only those who have contributed substantially to the conception, design, execution, or analysis of the research and who accept responsibility for the integrity of the results and the honesty of their presentation.

20. MDACC’s Ethical Principles for Scientific Research 6. To avoid conflicts of interest that may compromise objectivity in research or scientific communications. 7. To conduct peer review with fairness, objectivity, and confidentiality.