1. Research Integrity

2. Research Integrity Office
Dr. Sarah Archibald, Research Integrity Officer/Program Director for Research Integrity
Dr. Stephan Vigues, Program Director for Research Accountability and Compliance Monitoring.

3. UMB Policy
Integrity in research is the responsibility of the entire academic community.
All members of the university community (students, staff, faculty, and administrators) share responsibility for developing and maintaining standards to assure honesty, accuracy and objectivity in science.
Misconduct in carrying out academic activities undermines the integrity of the educational system and the scientific enterprise, and erodes the public trust in the university community

4. Why do we need a Research Integrity Office?

5. Why do we need a Research Integrity Office?
Until 19th century, Science was an avocation
Leonardo Da Vinci

6. A Quick History of Sciences
Molecular Biology
Biochemistry
Microbiology
Immunology
Chemistry
Mathematics
Anatomy
Physics
Biology
Mathematics
Astronomy
Optic
Geometry
12th
16th
17th
18th
19th
20th

7. The Industrialization
Need to develop new technologies
Cure/control diseases
Creation of NIH (1887)

8. $8M
$1B
The Golden Years at NIH
The entire NIH budget expanded from $8 million in 1947 to $1 billion in 1966.
Science became a career.

9. Being a Scientist Now
Get funded
Publish Articles

10. 2 Cases that Triggered Federal Changes
1974 William Summerlin case: “The Patchwork Mouse”
Steven Breuning: “The Use of Neuroleptic”

11. What is Research Misconduct?

12. Definition of Research Misconduct
Fabrication, falsification or plagiarism in proposing, performing, reviewing and/or reporting research.
Fabrication/ Falsification of data
Plagiarism
Enhancing digital Images partially
Excluding Data from articles, presentations, grants
Performing statistical analysis in a deliberately dishonest way.
Creating data that was never recorded or performed
Copying paragraph to use in a manuscript (article, thesis, grant, poster)
Republishing your own work (Self-plagiarism)

13. Government Regulations
Congress passed legislation to fix ethical issues
1966 Animal Welfare Act
1974 National Research Act
1985 Health Research Extension Act
In response to Congress the Department of Health and Human Services (DHHS) created the Office of Scientific Integrity (OSI) in 1989 that became Office of Research Integrity in 1992.

14. ORI NIH NSF Role of ORI Institutions
Oversees and directs PHS research integrity activities
Make research misconduct findings and recommend administrative actions to the Assistant Secretary for Health
Provide technical assistance to institutions if needed
Implement activities and programs to train researchers on Responsible Conduct of Research (RCR) topics.

15. Requirements for PHS-funded Institutions
Policies
Revised UMB Policy
Effective
Procedures to investigate and report research misconduct
Provide training
Committees
Reviewing Research
Human
(IRB)
Animal
(IACUC)
Research Integrity
Officer
RCR training
(CITI and in class)

16. Is There Any Research Misconduct Now?
Martinson et al. 2005Nature. Vol.435(7043):737-8.

17. Success Rate/Number of Applicants
Source: NIH

18. Research misconduct represents a low percentage, but…
Fang et al. Proc Natl Acad Sci (2012) Vol 109 p
…consequences could be catastrophic.

19. Estimated grant funding associated with retracted articles
Between 1992 and 2012, 291 articles published in the US were retracted for research misconduct.
The estimated funding totals of all NIH grants that contributed in any way to the retracted papers:
$2,324,906,182
Stern AM et al. Elife Aug 14;3

20. When is the Research Integrity Office involved?
When an allegation reaches our office
From the Hotline: or
From an
From a phone call

21. What are the steps following allegations?
Allegation of
Research Misconduct
Sequestration of evidence
Interviews
Preliminary Review
Does allegation meet the definition of research misconduct?
Is there evidence to support the allegation?

22. What are the steps following allegations?
Allegation of
Research Misconduct
Sequestration of evidence
Interviews
Preliminary Review
Formal Inquiry
Does allegation Meet the definition of research misconduct?
Is there evidence to support the allegation?
Does allegation meet the definition of research misconduct?
Is there enough evidence to start a full investigation?
Do any other issues need to be addressed?

23. What are the steps following allegations?
Inform federal government agencies(NIH: ORI, NSF)
Possibility of settlement with respondent.
Investigation Report to Responsible Official (RO) for
Recommendations (sanctions, retractions) and to Respondent.
Allegation of
Research Misconduct
Sequestration of evidence
Interviews
Preliminary Review
Formal Inquiry
Investigation
The RO (in consultation with the Dean) will make the final decision
Does allegation Meet the definition of research misconduct?
Is there evidence to support the allegation?
Does allegation Meet the definition of research misconduct?
Is there enough evidence to start a full investigation?
Do any other issues need to be addressed?
For each allegation, does the preponderance of the evidence support a misconduct finding?
Was the misconduct done intentionally, knowingly or recklessly?

24. Time line needed for processing allegations
Inform ORI
Possibility of Settlement
RO shares report with the Dean to make final decision
Allegation of
Research Misconduct
Sequestration of evidence
Interviews
Respondent response
Respondent response
Preliminary Review
Formal Inquiry
Investigation
Final decision
120 days
+120 days if requested by committee
30 days
30 days
30 days
+30 days if requested by the President
30 days
30 days
60 days
15 days
15 days
30 days
Report
Report

25. What are the most common ways to falsify/fabricate data?
70% of research misconduct involve Western Blots.
Western Blots are used to show the presence of a specific protein in blood or tissue samples.

26. Tips from complainants, lab members?
How do we prove that published blots are falsified?
Interviews
Tips from complainants, lab members?
Notebooks/Binders
Original western blot?
Hard drives
Original figures?

27. Image Analysis 1/4 X Y A B Photoshop Analysis shows
That same picture was flipped horizontally and vertically

28. Image analysis 2/4

29. Image analysis 3/4

30. Image analysis 4/4

31. Was it done knowingly, intentionally, recklessly?
What do we need to show when misconduct has been found?
Who did it?
Was it done knowingly, intentionally, recklessly?
sequestration, hard drive analysis, lab members/collaborators interviews are critical piece of evidence.

32. Where to Report Allegations
From the Hotline: or
From an
From a phone call
Sarah Archibald:
Stephan Vigues: