Sharing responsibility for ethical research takes more than guidelines

1. Sharing responsibility for ethical research takes more than guidelines Dr Giuliana Fuscaldo Dr Sarah Russell Research Matters

2. World firsts in research • Researcher jailed for falsified data • Researcher indicted on embezzlement charges for faking stem cell data • Researcher found guilty of fraud for fabricating patient data

3. Myths about research misconduct • Mavericks and rogues • Rare and surprising • Guidelines protect against misconduct

4. Research misconduct: is there a problem? • Science 1987, “no evidence” • MJA 2006 “tip of the iceberg” • Nature 2007 “rare & serious”

5. Incidence of Research Misconduct • 1.5% falsification or plagiarism. • 7.6% circumvented some requirements • 12.5% overlooked flawed data • 15.5% changed design, method or results Martinson, Nature (June 2005)

6. Further incidences Biostatisticians: • 26% involved fraud and fabrication • 31% directly involved in projects with misconduct • 51% knew about fraud in medical research Ranstam, Control Clinical Trials (2000)

7. More misconduct 305 new medical consultants: • 55.7% observed misconduct • 5.7% committed misconduct in the past • 18% would commit in future • 17% had research ethics training Geggie, J Med Ethics (2001)

8. Some explanations • Heightened pressure to publish • Increased competition for research dollars • Lack of strong surveillance mechanisms • Limited infrastructure to support ethics codes • Absence of education and training

9.  I, the researcher, agree to observe the principles in the National Statement on Ethical Conduct in Research involving Humans published by the National Health and Medical Research Council (June 1999)

10. What is the Australian Code? • Australian soccer • A new Australian values test for immigrants • Dan Brown’s sequel to Da Vinci Code • A code for research conduct • Australia’s anti-terrorism defense code • Dialing code for overseas phone calls • Marketing code for prescription drugs

11. Education in research ethics • Ad hoc • Apprenticeship • Mentorship • ‘Osmosis’ • Intuition

12. Australia Code Recommendations • Institutions to be more active in • providing research ethics education • handling allegations of research misconduct • Greater emphasis on institutional model of ‘research governance’ • Appoint adviser on research integrity

13. Research Governance in practice • Risk management plan • Guidelines • Short courses in research practice • Research project audits • Research governance coordinator

14. We believe that these two draft documents herald a new era in the governance of research. Anderson, Cordner, Breen 2006

15. Conclusion Without education and training, it is unfair to expect current researchers to comply with the key national guidelines

16. The extent to which responsibility for research conduct is shared, or merely divested from one group to another, will depend largely on how research institutions respond to the guidelines. Fuscaldo, Monash Bioethics Review, 2007