Research Misconduct and Compliance Navigating the Grey Areas

Research Misconduct and Compliance: Navigating the Grey Areas Michelle Stalilonis Senior Compliance Specialist Office for Research Integrity m-stalilonis@northwestern. edu

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Research Compliance Fiscal Administration Use & Care of Animals Responsible Conduct of Research Misconduct Human Subjects Protections Operating Environment Research Safety

Compliance - Why? • Regulatory requirement • It is the right thing to do • To protect: - Your research - Your institution - Your principal investigator - Yourself Grant or Contract Terms University Policies & Procedures Sponsor Specific Policies Federal Policies Policy & Procedure

Who is non-compliant and why? People who believe the rules do not apply to them People under pressure: • Competitive environment • Personal pressures • Pressured by others Untrained, unqualified, unsupervised

Example: Lab sabotage deemed research misconduct Vipul Bhrigu, former postdoctoral fellow at the University of Michigan Hidden camera, then confession, “trying to slow other student down” Fired, taken to court, pleaded guilty to malicious destruction of property, subsequently ordered to pay more than $30, 000 total in fines and restitution. Debarred for three years from involvement in US federally funded research and from serving as an advisor to the US Public Health Service. http: //blogs. nature. com/news/2011/04/lab_sabotage_deemed_research_ m_1. html

Research Misconduct Fabrication & Falsification • Making up data or results and recording or reporting them • 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 42 CFR Part 93 and 45 CFR 689

Research Misconduct Defined A finding of research misconduct requires that: • There be a significant departure from accepted practices of the relevant research community; and • The misconduct be committed intentionally, or knowingly, or recklessly; and • The allegation be proven by a preponderance of evidence 42 CFR Part 93 and 45 CFR 689

Research Misconduct Defined • Does not have to be formally published – Could include proposals, draft manuscripts, nonpublished/shared research records • Does not include: – honest error – differences of opinion – authorship disputes • Mandatory reporting to federal ORI or NSF OIG for federally funded projects

Northwestern’s Procedures for Reviewing Alleged Research Misconduct • Initial assessment of allegation(s) • Inquiry Committee – Does the evidence warrant full investigation? • Investigation Committee – Did research misconduct take place? – Who committed research misconduct? • Institutional decision • Federal reporting and oversight review

Research Misconduct Consequences • Recognition on federal websites and publications http: //ori. dhhs. gov/misconduct/cases/ • Suspension or termination of grants • Debarment • Prohibition from service on PHS advisory committees, peer review committee, or as consultants • Criminal charges, fines, penalties and/or imprisonment

Example of research misconduct: Dong-Pyou Han, Ph. D. Researcher who spiked rabbit blood to fake HIV vaccine results slapped with rare prison sentence Dong Pyou Han, a former Iowa State University researcher charged with falsifying HIV vaccine research, says that his troubles all started as an accident. Quickly, it became a multimillion-dollar research fraud scheme that landed him in prison. On Wednesday, Han, 57, became a rare academic to not just fall from grace but also be punished with time behind bars. A federal judge sentenced him to more than four and half years in prison and ordered him to repay $7. 2 million in grant funds his team received from the federal government using his falsified data. https: //www. federalregister. gov/articles/2013/12/23/2013 -30424/findings-of-research-misconduct https: //www. washingtonpost. com/news/to-your-health/wp/2015/07/01/researcher-who-spiked-rabbit-blood-to-fake-hiv-vaccine-results-slapped-with-rareprison-sentence/

Thorny Issues • Are allegations brought in “good faith? ” • Preventing retaliation • Protecting confidentiality • Restoring respondent’s reputation • Power differentials

Activity!

Compliance http: //www. research. northwestern. edu/ori/misconduct/

To ask a question, receive guidance, or report a violation, contact a representative from the list below. All are trained and ready to help. Falsification of Research Effort Controller’s Office Mike Daniels, Director Call: 847 -491 -4710 Email: m-daniels 2@northwestern. edu ________________________________________________________ Grant Management Office of Sponsored Research Kelly Morrison, Director, Evanston Campus Call: (847) 467 -3283 Email: kellym@northwestern. edu Rex Chisholm, Associate Vice President for Research, Chicago Campus Call: 312 -503 -1780 Email: OSR-Chicago@northwestern. edu Controller’s Office Mike Daniels, Director Call: 847 -491 -4710 Email: m-daniels 2@northwestern. edu ________________________________________________________ Research Misconduct Office for Research Integrity Lauran Qualkenbush, Director Call: 312 -503 -0054 Email: nu-ori@northwestern. edu ________________________________________________________ Research on Animals Institutional Animal Care and Use Committee Mandy Kozlowski, Director of IACUC Call: 312 -503 -0109 Email: m-kozlowski@northwestern. edu ________________________________________________________ Research on Human Subjects Institutional Review Board Eileen Yates, MS, CIP, Assistant Director Call: (312) 503 -6011 Email: eyates@northwestern. edu

www. northwestern. edu/ethics Compliance

Ethics. Point: A Compliance Hotline • Report potential misconduct or violations of policy: – (866)294 -3545 – www. northwestern. edu/ethics • Any suspected problems will be reviewed according to University procedures • Policy prohibits retaliatory action against those reporting • Anonymous Compliance

Uncovered a Potential Compliance Monster? Even a little one, or you just have questions…. .

What should you do if you suspect misconduct is occurring? • It depends somewhat on how sure you are – the really tricky part… • Try to get as clear a picture as you can WITHOUT becoming a CSI • Potentially discuss your concerns with A senior person if that is feasible, or go to NU ORI to discuss your concerns – that is what they are there for

What should you NOT do if you suspect misconduct is occurring? • Talk about your suspicions with a lot of people • Set a trap to try to catch someone or gather more evidence • Call or email NIH, NSF, OIG or the DHHS ORI • Call or email the Chicago Tribune • However, if you believe your concerns are not taken seriously by the institution where you work you do have the right to pursue other options….

How can you ensure compliance? o Everyone involved in research is responsible ØEnsuring compliance ØReporting suspected noncompliance or misconduct o Understand that regulations and compliance are complex o Talk to your PI, department chairs, trusted faculty o Identify resources - ORI o Know when and where to ask for help o When in doubt, ask

In the long run, we shape our lives, and we shape ourselves. The process never ends until we die. And the choices we make are ultimately our own responsibility. -Eleanor Roosevelt