1 Why does responsible conduct of research matter? Bernard Lo, M.D. August 21, 2008

BREAD

4 Darsee case  Fellow in premier cardiology department

5 Darsee case  109 papers as a fellow  Fabricated data in view of colleagues  Patients and collaborators did not exist

8 Slutsky case  Faculty member in radiology  Fellow in cardiology  Resident in nuclear medicine

9 Slutsky case  137 papers while a resident and fellow  One paper every ten days  Two studies had same mean and SD for different populations

10 Questions raised  Role of coauthors  Supervision by chief  Investigation by institution

11 Lessons  When self-regulation fails, government will step in  NIH Requirement for ethics training  Conflict of interest disclosures when submit grant

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15 South Korean cloning scandal  Fabricated data  High medical risks in oocyte donors  Recruited staff and trainees as donors  Lied about number of oocytes, payments

16 Lessons  Hard to detect misconduct  Responsibilities on interdisciplinary team  Not see raw data  Implications for Roadmap collaborations

17 Social science research

Scholar Sets Off Gastronomic False Alarm The New York Times

19 NY restaurant study  Response to consumer complaints  Anniversary dinner, nasty GI complaints

20 NY restaurant study  “This could be the kiss of death for a restaurant.”

21 NY restaurant study  “Some people could have gotten in trouble, with screaming and yelling and people with sharp knives.”

22 NY restaurant study  No specifics, no reservations, no credit card records

23 NY restaurant study  Never reviewed by IRB  Researcher had to send personal letters of apology

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25 What would you do?  You are asked to review paper on small prevention trial for cancer.  Accrual extremely rapid.  Point estimate not vary across sites.  Confidence interval very narrow.

26 How you will encounter misconduct?  Review manuscript or grant  Looks too familiar  Cannot replicate or verify previous work

27 How you will encounter misconduct?  Progress faster than expected  Enrollment at site >> other sites  Data are too good to be true  Discrepancy from other sites  Variation too small  Warning signs are not specific

28 How you will encounter misconduct?  Challenges to your work by others  Serve on investigation panel

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30 Federal definition of research misconduct  Fabrication  Falsification  Plagiarism  Must be intentional

31 Why is research misconduct problematic?  Question validity of data  Question conclusions of study  Unmerited rewards  Undermines public trust and support

33 Congressman Dingle  “Every time a researcher takes taxpayer money and publishes fabricated, falsified, or plagiarized findings, the taxpayer has in effect been swindled. Furthermore, given our budget deficit, there is never enough money to go around.”

34 Research misconduct excludes  Unintentional “honest” error  Sloppiness, incompetence, laziness  Differences of opinion or interpretation

35 Research misconduct excludes other ethical problems  Lack of IRB approval  Lack of informed consent  These handled by IRB

36 Research misconduct excludes other bad actions  Financial mismanagement  Discrimination  Poor mentoring

37 Federal definition of misconduct  Legal requirements set a minimum standard  Ethical and professional standards may be higher

38 Institutional response to alleged misconduct  Inquiry  Is a full investigation warranted?  Investigation  Is there misconduct?

39 Responses to allegations  I didn’t know it was wrong  Course precludes this defense  It’s just a personal vendetta  This is just creative science

40 Problems with institutional inquiry  Underestimate problems  Self-interest  Can be unconscious  Assumption of trust

41 Institutional responses to allegations of misconduct  Both whistleblower and accused have rights  No retaliation  Written charges  Accused may respond to charges  Right to have lawyer

42 Consequences of research misconduct  Suspension of federal grant  Debarment from future grants  Institutional penalties  Termination of employment  Civil and criminal liability

43 Take home points  Misconduct a serious offense, with grave consequences  Address allegations of misconduct

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