1. Research Misconduct & Policies for Handling Misconduct Shine Chang, PhD UT Distinguished Teaching Professor Department of Epidemiology Director, Cancer Prevention Research Training Program Responsible Conduct of Research Seminar Series

2. 1.Overview & definitions 2.Participatory case study 3.How to report occurrences 4.Summary AGENDA

3. Overview Why me? –Normal faculty (not an expert) –Want to support others –Want to protect myself, our institution, trainees & collaborators –Want RCR to be daily practice, incorporated into best research practices

4. One of these things is not like the others Death Marriage Sex RCR

5. One of these things is not like the others Death Marriage ** Sex RCR

6. Definitions Research Misconduct Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results Does not include honest error or differences of opinion Other definitions - See handout

7. Fabrication - Making up data or results, and - Recording or reporting them Falsification - Manipulating research materials, equipment, or processes, or - Changing or omitting data or results - Such that the research is not accurately represented in the research record Plagiarism - Appropriation of another person’s ideas, processes, results, or words without giving appropriate credit ***Research misconduct does not include honest error or differences of opinion. Definitions 7

8. Significant departure from accepted practices of research community Conduct committed intentionally, knowingly, or recklessly, and Allegation of research misconduct can be proven by a preponderance of evidence Context 8

9. Allegation(s) Assessment Inquiry Investigation Institutional action Research Misconduct Institutional Processes 9

10. It is every Workforce Member’s responsibility to report violation or potential violation Failure to report violation or potential violation may subject you to disciplinary action To report compliance concerns - Call the Institutional Compliance Office (713-745-6636) - Call the Fraud and Abuse Hotline (1-800-789-4448) - Call the Privacy Hotline (1-888-337-7497) IMPORTANT: All discussions and reports treated confidentially and may be made anonymously Suspected fraud, waste and abuse involving state resources State Auditor’s Office Hotline (1-800-892-8348) Compliance Concerns 10

11. Office of Research Integrity http://ori.hhs.gov http://ori.hhs.gov Misconduct case summaries Policies & resources “The Research Clinic” –Interactive training video –Four characters Busy oncologist Clinical research coordinator Research assistant IRB chair Online Learning Tool for Research Integrity & Image Processing http://ori.hhs.gov/education/products/RIandImages/default.html

12. Participatory Case Study “The Lab,” interactive movie about avoiding misconduct http://ori.hhs.gov/thelab Play a role –Kim Park, Grad Student –Hardik Rao, PhD, Postdoc –Dr. Aaron Hutchins, PI –Beth Ridgley, Res Integrity Officer (RIO) Now in Spanish & Chinese!

13. Scenario #1: Boss’ Expectations Being Hardik Rao, PhD, Postdoc http://ori.hhs.gov/TheLab/TheLab.shtml (HP_52)

14. Key Learning Points If unsure of expectations, ask - don’t guess! Don’t fall in love w/hypothesis & discard data b/c of what PI wants Manipulating data can lead to charges of misconduct

15. Difficult Discussions? What makes raising an issue of misconduct difficult? What makes raising such an issue easier?

16. Scenario #2: Reporting Potential Misconduct HP_52 (Hardik Rao) http://ori.hhs.gov/TheLab/TheLab.shtml

17. Good ideas Everybody struggles with work/life “balance” – communicate well Sometimes cannot split the difference & make everyone happy Keep up w/best practices Decisions you make can “box you in” to course of action. Make sure even small decisions are ethical ones. Sometimes may have to help someone else “do the right thing”

18. Key Q’s in Assessing Allegation of Research Misconduct Does allegation fit definition of research misconduct? Is allegation credible & specific? If YES to both, then RIO moves forward with “Assessment & Inquiry”

19. How to report potential research misconduct at MD Anderson? Chief Compliance Officer (via page operator): 713-792-7090 Institutional Compliance Office: 713-745-6636 Fraud & Abuse Hotline: 800-789-4448 Privacy Hotline: 888-337-7497 Report suspected fraud, waste & abuse involving state resources, call State Auditor’s Office Hotline: 1-800-892-8348

20. The Cancer Letter http://www.cancerletter.com/

21. Summary Responsible conduct of research –A daily activity –Involves everyone Misconduct of research –Avoidable –Not just major events or happens to other people Resources & help available – here & EW UT Healthy Science Center at Houston Research Misconduct Training https://www.uth.edu/ctrc/training/investigator-training.htm US HHS Office of Research Integrity http://ori.hhs.gov/general-resources-0

22. NCI R25T Training Program in Cancer Prevention 4 pre-doctoral trainees; 8 post-doctoral fellows NCI R25E Student Research Experiences 25 short-term research experiences in cancer prevention for graduate, health professional & undergraduate students $4000/10 weeks + housing subsidy for out of towners 3 Donor-sponsored postdoctoral fellowships Cancer Prevention Research Training Program @ MD Anderson www.CancerPreventionTraining.org

23. Questions?Comments?