Introduction to Ethics and Research Graduate School Orientation 2011

1. Introduction toEthics and ResearchGraduate School Orientation 2011 Joe Giffels Director, Research Integrity Office University of Maryland Baltimore

2. What Is Research? • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Pharmacy Nursing Medicine Dental Social Work

5. Bruce Ivins, PhD

6. What Is Ethics? • Fairness • Equity • Volition • Trust • Responsibility • Good vs Evil (Right vs Wrong) • Values ethical constructs

7. Research Is Big Business • US R&D budget… $200 B • NIH budget… $31 B • UMB annual awards… $517 M • New drug R&D costs… $800 M (industry) • New drug R&D costs… $200 M (watchdog) • Ave R01 (annual)… $400 K • Annual Revenue to universities on inventions… $1 B

8. Scientific misconduct Invalid conclusions Financial conflicts of interest Science is politically, economically, popularly driven Research Is Prone to Corruption? Never try to walk across a river just because it has an average depth of four feet. -- Martin Friedman

9. Responsible Conduct of Research Topics • Research Involving Humans • Research Involving Animals • Scientific Misconduct • Authorship • Data Handling • Intellectual Property • Conflict of Interest • Mentoring • Collaborative Science

10. Research Involving Humans Jesse Gelsinger

11. Johns Hopkins University Agrees to $25,000 Settlement Over Animal Care Allegations Research Involving Animals

12. Animal studies teach us nothing about the health of humans because animals of different species absorb, metabolize, and eliminate substances differently than humans do. The truth is that testing on animals is bad science: It is unreliable and unnecessary. - www.peta.org

13. Firebombed UCSC researcher speaks out Shanna McCord - Sentinel staff writer Article Launched:08/04/2008 01:32:32 AM PDT SANTA CRUZ -- The FBI today is expected to take over the investigation of the Saturday morning firebombings of a car and of a Westside home belonging to two UC Santa Cruz biomedical researchers who conduct experiments on animals. Santa Cruz police officials said Sunday the case will be handed to the FBI to investigate as domestic terrorism while local authorities explore additional security measures for the 13 UCSC researchers listed in a threatening animal-rights pamphlet found in a downtown coffee shop last week.

14. Firebombed UCSC researcher speaks out Shanna McCord - Sentinel staff writer Article Launched:08/04/2008 01:32:32 AM PDT ‘Obviously, I am upset and worried for my family's safety in the future… Once we rebuild our house and move back in, I don't know what more we can do… I don't think the university can do too much to prevent these kind of attacks. I would like to see the citizens of Santa Cruz and our elected officials including the mayor step up and condemn this kind of violence.’

15. Firebombed UCSC researcher speaks out Shanna McCord - Sentinel staff writer Article Launched:08/04/2008 01:32:32 AM PDT Woodland Hills-based Animal Liberation Front called the attacks a "necessary" act, just like those who fought against civil rights injustices. Spokesman Dr. Jerry Vlasak showed no remorse for the family or children who were targeted. ‘If their father is willing to continue risking his livelihood in order to continue chopping up animals in a laboratory than [sic] his children are old enough to recognize the consequences,’ said Vlasak, a former animal researcher who is now a trauma surgeon. ‘This guy knows what he is doing. He knows that every day that he goes into the laboratory and hurts animals that it is unreasonable not to expect consequences.’

16. Research Misconduct • Fabrication • Falsification • Plagiarism

17. Authorship Issues

18. Examples of Ethical Concerns in Data Management • Replicability of results • Analysis of data sets • Data sharing / public use data sets • Fabricated, falsified, plagiarized (ie, stolen) data • Stewardship of data • Ownership of data • Social or political unacceptability

19. Though many have tried, no one has ever yet explained away the decisive fact that science, which can do so much, cannot decide what it ought to do. - Joseph Wood Krutch

20. Intellectual Property

22. Conflict of Interest Jesse Gelsinger

23. Responsible Conduct of ResearchAdditional Topics • Collaborative Science • Security Issues • Research Management • Science and Society

24. Science cannot stop while ethics catches up— and nobody should expect scientists to do all the thinking for the country. - Elvin Stackman

25. Ethical Considerations for the Researcher • The Research Question • How the Research Is Conducted • How the Results of the Research Are Used

26. Schools Should Teach ‘Intelligent Design’ Theory Alongside Evolution, Bush Says

27. Demand for Their data On Climate Chills Scientists Congressman Opens Probe of Researchers Who Have Reported Global Warming

28. U of Minnesota Investigates Stem-Cell Researcher August 7, 2009 Questions raised by the magazine New Scientist about the veracity of images in a scientific paper on the therapeutic use of stem cells have prompted the University of Minnesota to begin an investigation of the author of that paper, Jizhen Lin, a scientist at the university’s Stem Cell Institute. -The Chronicle of Higher Education

29. Just 2 Lines of Embryonic Stem Cells Are Used for Most Research, Raising Worries August 7, 2009 Federally sponsored research conducted with human embryonic stem cells has largely involved only two genetically distinct lines, a Stanford University researcher has found… -The Chronicle of Higher Education

30. Medical Papers by Ghostwriters Pushed Therapy August 5, 2009 Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known… -The New York Times

31. To find out more… • CIPP 907 Research Ethics • CIPP 909 Responsible Conduct of Research • www.ori.dhhs.gov/education

32. Research Integrity Office(Academic Affairs) Joe Giffels JGiff001@umaryland.edu 410-706-1853 5th Floor, 620 W Lexington St

33. Case Study Discussions