1. B UILDING A V ISION OFFICE OF RESEARCH RESEARCH AT UC DAVIS Integrity in Research Preventing and Investigating Research/Scientific Misconduct Lynne Chronister Associate Vice Chancellor for Research University of California, Davis Tokyo, Japan February 22, 2007

2. 2 The right to search for truth implies also a duty; one must not conceal any part of what one has recognized to be true. Albert Einstein

3. 3 Standards and Regulations –Code of Federal Regulations (42 CFR 93) –Federal Laws and Notices –Agency specific Requirements (DHHS, NSF) –State Laws –System Policies –Campus Policies

4. 4 Research Misconduct - Definition “…fabrication, falsification or plagiarism in proposing, performing or reviewing research or in reporting research results.” “Research misconduct does not include honest error or differences of opinion.”

5. 5 A Finding of Research Misconduct Requires: –A significant departure from accepted practices of the relevant community; AND –The misconduct be committed: intentionally knowingly recklessly; AND –The allegation be proven by a preponderance of the evidence (51%; more likely than not).

6. 6 What is “Recklessly” An Individual makes a false, fabricated or plagiarized representation with callous disregard as to whether or not it is true or requires attribution to another.

7. 7 “Recklessly” “ The individual had a high degree of awareness of the probable falsity or misleading nature or source of the representation or, in fact, entertained serious doubts as to the truth of the representation. The subjective awareness of the falsity or misleading nature of a representation can be inferred from evidence indicating that there were obvious reasons to doubt the accuracy of the representation and the individual did not act reasonably in dispelling those doubts.”

8. 8 The Conduct of Science – Scientific Integrity – Good Science – Error or Carelessness – Bad Science – Misconduct or Non-Compliance

9. 9 Overview of Process at the University of California, Davis Step 1 Preliminary Assessment by Knowledgeable individual Step 2 Inquiry Phase - Appropriate appointment of members and training and charge to committee helps to avoid bias Step 3 Investigation Phase Step 4 Potential Repercussions, Remediation

10. 10 Expertise 1.Compliance Officer is an Attorney 2.Preliminary assessment - Knowledge of Discipline 3.Inquiry and Investigation - Knowledge of Discipline plus peer representative (e.g., Graduate Studies) - Generally three members - Sign Conflict of Interest statement - Sign Confidentiality agreement - Generally all internal members

11. 11 It is not permitted to the most equitable of men to be a judge in his own cause. Blaise Pascal (1670)

12. 12 Cooperation with Inquiry/Investigation 1.University Employees are compelled to cooperate by virtue of employment. 2.Former Employees cannot be compelled to cooperate. The investigation would continue under most circumstances. 3.Non-university involvement - in some instances there may be a legal mandate to cooperate. 4.Involvement of federal funds is a compelling factor for non- institutional employees 5.In absence of a legal mandate-persuasion may be the only option. 6.Lack of cooperation falls under UC Davis faculty misconduct not scientific misconduct (APM 015)

13. 13 Institutional Authority Committees have little power/authority. Can only recommend. The authority is vested in the institution. Must work in cooperation with external individuals and institutions. If federal funds are involved, anyone in receipt of the funds must comply with Federal regulations. Campus authorities can sequester material/information.

14. 14 Process Issues Frequently an investigation will expand to other individuals including allegations of retaliation and counter allegations by the accused. If additional information is uncovered during the investigation, the investigation would be expanded. Generally the existing committee would handle the expanded allegation. If possible criminal activities were uncovered, the investigation would continue unless the responsible government agency (e.g. police, justice) requested that the inquiry/investigation be put on hold.

15. 15 Process Costs Financial costs are not recorded nor reimbursed by a sponsoring agency. The institutional costs may be incorporated into the negotiated federal indirect cost rate. The human/personal costs are extremely high and include; loss of prestige, personal anxiety, position, scientific standing in the community.

16. 16 Investigation Outcomes: Exoneration Survey of Accused but Exonerated Individuals n Research Misconduct Cases June 30, 1996 Lawrence Rhoades, PhD DHHS, Office of Research Integrity “Sixty percent of the respondents reported experiencing one or more negative consequences of being accused of scientific misconduct even though the allegation was unsupported”

17. 17 UC Davis P&P Manual § 240-01 Sanctions & Administrative Actions Withdrawal or correction of all pending or published papers Removal of person from project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, termination of employment If no misconduct found, institution to undertake reasonable efforts to restore accused’s reputation

18. 18 Exoneration con’t “… It appears important for institutions to consult with those exonerated of research misconduct to develop a plan for restoring their reputations and to take action, unless specifically requested not to by respondents…” Most important action-officially notifying institutional officials.

19. 19 Investigation Outcomes: Finding of Misconduct UC Davis: If the preliminary investigation determines that human health or other serious impact is or reasonably could occur, the research can be temporarily suspended. Process: 1.Investigation Committee makes recommendation of misconduct to Vice Chancellor for Research 2.Vice Chancellor accepts or rejects recommendation 3.If accepted, forwards to Vice Provost for Academic Affairs, Faculty Senate, or Human Resources.

20. 20 Protections No formal provision for graduate students, post doctoral fellows and other employees when funding is terminated or suspended. Generally local institutional policies will apply. Whistleblower protections are in place to guard against retaliation.

21. 21 Prevention –Responsible Conduct of Research Training –Laboratory Management Training –Appropriate Policies and Processes

22. 22 Responsible Conduct of Research Training –Responsible Conduct of Research Conflict of InterestMentor/Mentee Relationships Research MisconductEntrepreneurship/Intellectual Property Research CollaborationsData Acquisition / Animal Welfare Authorship & Publication –Human Subjects Protection –Animal Subjects Protection –Environmental Health and Safety Field safety Boating safety Radiological safety Biosafety Lab Safety

23. 23 Laboratory Leadership and Management John C. Galland, Ph.D. Director, Laboratory Management Institute University of California, Davis Office of Research Laboratory Management Institute Better Science through Better Management SM ™

24. 24 MANAGEMENTMANAGEMENTMANAGEMENTMANAGEMENT COMPLIANCECOMPLIANCECOMPLIANCECOMPLIANCE HEALTH HHEEAALLTTHH&S&SAAFFEETTYYHHEEAALLTTHH&S&SAAFFEETTYYAFETY ETHICSETHICSETHICSETHICS Breakthrough Science Distinguished Career Basic & Scientific Discipline Skills Laboratory Management Skills People Money Time Material Project Quality Informati on LEADERSHIPLEADERSHIP Vision Mission Goal Setting Strategic Planning Innovation Policy & Procedures Regulations Technology Transfer Conflict of Commitment Conflict of Interest Intellectual Property Patents/ Copyrights/ TM Contractual Requirements Health, Safety, & Security Employee Research Subjects Human Subjects Environment Emergency Preparedness Authorship Integrity Academic Freedom Ownership ©JCG 07/2005 Five Pillars of Laboratory Education

25. 25 ProductiveEfficientOrganizedSatisfiedInnovativeCompliantSafeSuccessful Purpose of LMI is to help scientists become more:

26. 26 Lynne Chronister Associate Vice Chancellor for Research Luchronister@ucdavis.edu http://research.ucdavis.edu 530-747-3812 ありがとう