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 19th century, Science was an avocation Leonardo Da Vinci

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

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

$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.

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 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)

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.

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.

Requirements for PHS-funded Institutions Policies Revised UMB Policy Effective 08-01-15 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)

Is There Any Research Misconduct Now? Martinson et al. 2005Nature. 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 p17028-33 …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? 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?

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

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.

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?

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

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? 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