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

University Policies & Procedures Sponsor Specific Policies 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 Policies governing the research administration process can be viewed as a regulatory pyramid with each policy level building upon and more specific than those below. The guidelines also become more restrictive after there are problems. The federal regulations are the floor, the minimum, they set the stage. We are expected to build our policies on top of the federal policies. Therefore, if we just did the bare minimum (followed the federal policies only), we would be seen as non-compliant. Federal Policies: A-21 & A-110 Sponsor Specific Policies: NIH Grants Policy Statement, NSF Grants Policy Manual, Federal Demonstration Partnership University Policies & Procedures: Northwestern University policies Grant or Contract Terms: Award specific NIH/NSF/etc. Grant/Contract terms 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

Fabrication & Falsification Research Misconduct Fabrication & Falsification Plagiarism 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 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, non-published/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 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 http://ori.dhhs.gov/misconduct/cases/ Debarment – ineligible to receive any federal funds, including Medicare and Medicaid

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-rare-prison-sentence/

Thorny Issues Are allegations brought in “good faith?” Preventing retaliation Protecting confidentiality Restoring respondent’s reputation Power differentials Are allegations brought in “good faith”? Is complainant’s belief in the truth of the allegations reasonable? Is allegation made with reckless disregard to information that would negate the allegation? Allegation may lack sufficient credibility and specificity but still not be made in bad faith Preventing Retaliation Retaliation = taking adverse action against complainant, witness or committee member in response to good faith allegation or cooperation Restoring Respondent’s Reputation No finding of misconduct Confidentiality is critical – but how to ensure? Power Differentials Bringing allegations against your PI

Activity!

http://www.research.northwestern.edu/ori/misconduct/ Compliance Contact ORI! You can visit our website, call, or email us. http://www.research.northwestern.edu/ori/misconduct/ Compliance

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-daniels2@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 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

Questions or concerns? www.northwestern.edu/ethics Compliance

EthicsPoint: 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 By phone (866-294-3545) or by web (www.northwestern.edu/ethics), a simple way to report activities that may involve misconduct or violations of University policy. Not a substitute for existing methods or protocols for reporting suspected problems complaints. Any suspected problems reported via EthicsPoint will be reviewed in accordance with current University procedures, including those described in the Faculty, Staff or Student Handbooks. Northwestern policy prohibits the taking of retaliatory action against anyone for reporting or inquiring about potential breaches of University policy or for seeking guidance on how to handle suspected breaches. No personally identifying information is automatically collected from reporters using EthicsPoint 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? Everyone involved in research is responsible Ensuring compliance Reporting suspected noncompliance or misconduct Understand that regulations and compliance are complex Talk to your PI, department chairs, trusted faculty Identify resources - ORI Know when and where to ask for help When in doubt, ask

In the long run, we shape our lives, and we shape ourselves 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