Research Integrity Research Integrity Office Dr Sarah Archibald
Research Integrity
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.
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
Why do we need a Research Integrity Office?
Why do we need a Research Integrity Office? Until 19 th century, Science was an avocation Leonardo Da Vinci
my 0 12 th 16 th y 17 th 18 th olo gy Im bio y mu lo M no gy ole lo cu gy lar Bi Bio istry ch M em icr ist o r em Ch olo gy Ph mati ys cs Bi ics at he M om at tic An Op s ma tic he at M ry no tro As om et Ge A Quick History of Sciences 19 th 20 th
The Industrialization • Need to develop new technologies • Cure/control diseases Creation of NIH (1887)
The Golden Years at NIH The entire NIH budget expanded from $8 million in 1947 to $1 billion in 1966. Science became a career. $8 M $1 B
Being a Scientist Now Get funded Publish Articles
2 Cases that Triggered Federal Changes • 1974 William Summerlin case: “The Patchwork Mouse” • 1980 -1983 Steven Breuning: “The Use of Neuroleptic”
What is Research Misconduct?
Definition of Research Misconduct Fabrication, falsification or plagiarism in proposing, performing, reviewing and/or reporting research. • Fabrication/ Falsification of data • • 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 • Plagiarism • • Copying paragraph to use in a manuscript (article, thesis, grant, poster) Republishing your own work (Self-plagiarism)
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.
Role of ORI NIH • 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. NSF Institutions
Requirements for PHS-funded Institutions Policies Procedures to investigate and report research misconduct Revised UMB Policy Effective 08 -01 -15 Research Integrity Officer Provide training RCR training (CITI and in class) Committees Reviewing Research Human (IRB) Animal (IACUC)
Is There Any Research Misconduct Now? Martinson et al. 2005 Nature. Vol. 435(7043): 737 -8.
Success Rate/Number of Applicants Source: NIH
Research misconduct represents a low percentage, but… Fang et al. Proc Natl Acad Sci (2012) Vol 109 p 17028 -33 …consequences could be catastrophic.
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. 2014 Aug 14; 3
When is the Research Integrity Office involved? When an allegation reaches our office From the Hotline: 866 -594 -5220 or http: //www. ethicspoint. com From an email From a phone call
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?
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?
What are the steps following allegations? Allegation of Research Misconduct Inform federal government agencies(NIH: ORI, NSF) Possibility of settlement with respondent. 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? Investigation Report to Responsible Official (RO) for Recommendations (sanctions, retractions) and to Respondent. Investigation • For each allegation, does the preponderance of the evidence support a misconduct finding? • Was the misconduct done intentionally, knowingly or recklessly? The RO (in consultation with the Dean) will make the final decision
Time line needed for processing allegations RO shares report with the Dean to make final decision Inform ORI Possibility of Settlement Allegation of Research Misconduct Sequestration of evidence Interviews Preliminary Review 30 days Respondent response Formal Inquiry 30 days 60 days Final decision Investigation 15 days Report 15 days 30 days 120 days +120 days if requested by committee 30 days Report 30 days +30 days if requested by the President
What are the most common ways to falsify/fabricate data? 70% of research misconduct involve Western Blots are used to show the presence of a specific protein in blood or tissue samples.
How do we prove that published blots are falsified? Interviews Notebooks/Binders Hard drives Tips from complainants, lab members? Original western blot? Original figures?
Image Analysis 1/4 X Y A B Photoshop Analysis shows That same picture was flipped horizontally and vertically
Image analysis 2/4
Image analysis 3/4
Image analysis 4/4
What do we need to show when misconduct has been found? • Who did it? • Was it done knowingly, intentionally, recklessly? Email sequestration, hard drive analysis, lab members/collaborators interviews are critical piece of evidence.
Where to Report Allegations From the Hotline: 866 -594 -5220 or http: //www. ethicspoint. com From an email From a phone call Sarah Archibald: sarchibald@umaryland. edu Stephan Vigues: svigues@umaryland. edu
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