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The Fundamental Proposition

The Responsible Conduct of Research: Research Misconduct Prevention & Investigation Daniel R. Vasgird, PhD, CIP Office of Research Responsibility University of Nebraska, Lincoln dvasgird2@unl.edu www.unl.edu/research/orr/. 1. The Fundamental Proposition.

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The Fundamental Proposition

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  1. The Responsible Conduct of Research:Research Misconduct Prevention & InvestigationDaniel R. Vasgird, PhD, CIPOffice of Research ResponsibilityUniversity of Nebraska, Lincolndvasgird2@unl.eduwww.unl.edu/research/orr/ 1

  2. The Fundamental Proposition Rules are just a small part of the picture. The alpha and the omega has to be integrity from which all else will follow, including compliance.

  3. “One is apt to think of moral failure as due to weakness of character: more often it is due to an inadequate ideal.”Richard Livingstone

  4. “Ethics primarily concerns the effects of our actions on others.”Randy Cohen

  5. Robert K. Merton Stated that the disinterested pursuit of truth is the norm of science, expressed as: • Universalism • Communalism • Disinterestedness • Organized skepticism

  6. “Fakery at a Top Research Lab” NY Times, 10/1/02: • J. Hendrik Schön of Bell Labs • Published in Science and Nature (peer review) • Falsified Data • Bell Labs: no Research Misconduct policy (“Can’t happen here”) • Afterword: PhD at U of Konstanz revoked

  7. UNL ORR MissionFoster a culture of integrity and compliance within the University directed at ensuring that participants in the University of Nebraska, Lincoln research enterprise internalize and pursue the goal of self-directed responsible conduct of research.

  8. ORR Core Areas • Human research protections • Animal research protections • Research misconduct • Conflict of interest and commitment • Data acquisition, management, sharing, and ownership • Mentor/trainee relationships • Authorship and publication • Peer review • Collaborative science • Privacy (HIPAA)

  9. UNL RCR Program

  10. UNL RCR Online Training Series

  11. RCR Research Misconduct Resources

  12. FSGO Compliance Elements • Implementing written policies & procedures; • Designating a compliance officer and compliance committee; • Conducting effective training and education; • Developing effective lines of communication; • Conducting internal monitoring and auditing; • Enforcing standards through well-publicized disciplinary guidelines; and • Responding promptly to detected problems.

  13. HHS 8th Element ‘‘Defining roles and responsibilities and assigning oversight responsibility’’

  14. National Academy of Sciences To maintain (public) confidence and trust in this (the scientific) enterprise, researchers must protect the empirical objectivity of research, the unbiased reporting of results and the open sharing of that information for the good of society.

  15. NAS Report Primary Recommendations • Research institutions should offer effective educational programs that enhance RCR. • Research institutions should promote integrity in research through top-down commitment to RCR through strong supervision, communication, socialization, etc. • Research institutions should perform self-assessments to determine areas of need.

  16. HHS Research Misconduct Final Rule (June, 2005) Universities must: • Foster an environment that promotes RCR • Have research misconduct P&P’s • Deal with allegations or possible evidence of research misconduct promptly

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