Research Integrity

1. Research Integrity Is it just “adherence” to the regulations?

3. Academia…………… • "Scientists are not a special breed of human being," says Thomas Murray, president of the Hastings Center, a bioethics institute in Garrison, N.Y. "But they function in a special environment.... They are bright people working in a community where the best ideas rise to the top. If you're not in first place, you're no place.“ 1

4. Examples • In October, the Massachusetts Institute of Technology fired a young biologist and promising immunology researcher. MIT officials say Luk Van Parijs was dismissed after he admitted to school investigators that he fabricated and altered evidence in research papers to support grant applications. 1 • In March, a University of Vermont obesity scientist admitted faking data in order to buttress grant applications. (He netted $3 million in government grants.) Under a deal with US prosecutors, Eric Poehlman agreed to plead guilty to criminal fraud and to retract or correct several research papers. 1

5. “Scientists Behaving Badly” 2

6. Federal Mandate • 42 C.F.R. Part 50--Policies of General Applicability Subpart A--Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science

7. What does it Say? • Institution must have misconduct policy if it accepts PHS funds • Institution’s policy must meet the minimum standard outlined in federal regs • Institution must have a Research Integrity Officer who acts as the gatekeeper for this policy and serves as the interface with the federal gov’t for reporting purposes

8. 2.13 09 University Handbook for Appointed Personnel Policy and Procedures for Investigations of Misconduct in Scholarly, Creative, and Research Activities http://www.vpr.arizona.edu/integrity/ResearchIntegrityPolicy-Final1.pdf Approved by Faculty Senate February 3, 2003 and Adopted by President Likins April 4, 2003

9. Key Points in UA Misconduct Policy • Applies to everyone - faculty, staff, students, fellows, visitors, guests, consultants, collaborators • Applies to all scholarship, research and creative endeavors conducted at UA, funded or unfunded (not just PHS funded)

10. Key Points in UA Misconduct Policy (continued) • Misconduct is fabrication, falsification, or plagiarism in proposing, performing or reviewing research or creative endeavors, or in reporting research results or the results of creative endeavors. It does not include honest error or differences in interpretation or judgments in evaluating research methods or results or differences in opinion.

11. Definitions • Fabrication – Making up data or results and recording or reporting them • Falsification – Manipulating research or scholarship materials, equipment, or processes, or changing or omitting data or results such that the scholarship or research is not accurately represented in the record • Plagiarism – The appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

12. Fabrication • creating records of interviews of subjects that were never performed; • making up progress notes for patient visits that never took place and inserting them into the medical record to support published and unpublished research reports; and • preparing records for calls and follow-up contacts to subjects who had already died.

13. Falsification • substituting one subject's record for that of another subject; • falsely reporting to a data coordinating center that certain clinical trial staff, who were certified to perform the procedures on the subjects, had done so, when they had not; • altering the dates and results from subjects' eligibility visits; • altering the dates on patient screening logs and/or submitting the same log with altered dates on multiple occasions;

14. Falsification (cont) • failing to update the patients' status and representing data from prior contacts as being current; • altering the results of particular tests on blood samples to show that the test accurately predicted a disease or relapse; • backdating follow-up interviews to fit the time window determined by the study protocol; and • falsifying the times that blood samples were drawn from human subjects.

15. Plagiarism • The theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes. • The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.

16. What Does Research Integrity Officer Do? • Receives allegation(s) • Conducts Pre-inquiry • Notifies sponsors as appropriate • Notifies respondent • Notifies Chair of UCEC (faculty ethics panel) of need for Inquiry into allegation(s) • Obtains and preserves evidence (paper, electronic, equipment etc.)

17. What Does Research Integrity Officer Do? (cont) • Receives report from Inquiry Panel • Initiates ad hoc Investigative Committee if appropriate • Receives & transmits final investigation report to VPR & Provost • Notifies parties involved of outcome

18. Research Integrity The UA promotes Responsible Conduct of Research by expecting all those involved in research to adhere to all university, state, federal, and other policies relating to the research or creative activity carried out under his/her direction. Sign up for the PRIE Newsletter by emailing Ruth Daniels at rhk@u.arizona.edu Visit the PRIE website to view past issues http://www.vpr.arizona.edu/integrity/index.html

19. More thoughts…………. • In the end, no system is infallible, ethicists note. "If you have someone determined to fabricate evidence, no screening system will catch that," says Alto Charo, a law professor at the University of Wisconsin who specializes in biomedical and research ethics. "You have to rely on the integrity of the individual."

20. Data sharing/ownership Mentor/trainee responsibilities Publication Practices & Responsible Authorship Peer Review Collaborative Science Human Subjects Research Involving Animals Research Misconduct Conflict of Interest & Commitment Responsible Conduct of Research

21. Where do I go for information/help? Dr. Tom Lindell Research Integrity Officer Life Sciences South 254 621-5125 tlindell@u.arizona.edu Ruth Daniels Program Coordinator Program in Research Integrity Education 626-7643 Research Compliance Office 1203 North Mountain rhk@email.arizona.edu Alice Langen Director, Research Compliance Associate Director, Program in Research Integrity Education Office of the VP for Research Administration Bldg 601 621-5196 langena@email.arizona.edu

22. References/Readings • 1 Spotts, Peter N. (December 22, 2005) . Laboratory ethics: What makes some scientists cheat?http://www.csmonitor.com/2005/1222/p02s01-stss.htm (19 February 2006) • 2 Martinson, Brian C., Anderson, Melissa S., de Vries, Raymond (9 June 2005). Scientists behaving badly. http://www.nature.com/nature/journal/v435/n7043/full/435737a.html access via http://www.ahsl.arizona.edu/journals/ejrnl_gateway.cfm?name=Nature&ID=1567 (19 February 2006) • http://onlineethics.org/othersites.html#scienglish