1. Research Misconduct and Compliance: Navigating the Grey Areas
Michelle Stalilonis
Senior Compliance Specialist
Office for Research Integrity

2. PRESSURE
It can turn a lump of coal into a flawless diamond or an average person into a perfect basketcase

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

4. 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

5. 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

6. 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.

7. 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

8. 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

9. 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

10. 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

11. 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
Debarment – ineligible to receive any federal funds, including Medicare and Medicaid

12. 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.

13. 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

14. Activity!

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

16. 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:
________________________________________________________________________________________________________________
Grant Management
Office of Sponsored Research
Kelly Morrison, Director, Evanston Campus
Call: (847)
Rex Chisholm, Associate Vice President for Research, Chicago Campus
Call:
Research Misconduct
Office for Research Integrity
Lauran Qualkenbush, Director
Call:
Research on Animals
Institutional Animal Care and Use Committee
Mandy Kozlowski, Director of IACUC
Call:
Research on Human Subjects 
Institutional Review Board
Eileen Yates, MS, CIP, Assistant Director
Call: (312)

17. Questions or concerns?
Compliance

18. EthicsPoint: A Compliance Hotline
Report potential misconduct or violations of policy:
(866)
Any suspected problems will be reviewed according to University procedures
Policy prohibits retaliatory action against those reporting
Anonymous
By phone ( ) or by web ( 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

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

20. 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

21. 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 NIH, NSF, OIG or the DHHS ORI
Call or 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….

22. 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

23. 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