DEFINITIONS AND REGULATORY REQUIREMENTS RELATED TO RESPONSIBLE RESEARCH

DEFINITIONS AND REGULATORY REQUIREMENTS RELATED TO RESPONSIBLE RESEARCH OFFICE OF RESEARCH INTEGRITY Zoë Hammatt, J. D. , M. Phil. Director, Division of Education and Integrity Office of Research Integrity U. S. Department of Health and Human Services Susan Garfinkel, Ph. D. Director, Division of Investigative Oversight Office of Research Integrity U. S. Department of Health and Human Services Promoting the Responsible Conduct of Research for College and University Leaders Marina del Rey, Los Angeles April 14 -15, 2016

WHO WE ARE DIVISION OF INVESTIGATIVE OVERSIGHT DIVISION OF EDUCATION & INTEGRITY OFFICE OF RESEARCH INTEGRITY OFFICE OF THE DIRECTOR PRIM&R AER Promoting Conference, RCR for Boston, College MA, and. November University 14, Leaders 2016

42 CFR PART 93 Promoting RCR for College and University Leaders

WHAT IS RESEARCH MISCONDUCT? fabrication | falsification | plagiarism 42 CFR PART 93. 103 42 CFR PART 93 not honest error or differences in opinion intentionally | knowingly | recklessly preponderance of evidence significant departure from accepted practices 42 CFR PART 93. 104 Promoting RCR for College and University Leaders

Nearly 5, 000 Institutions Worldwide ASSURANCE INVESTIGATION SUPPORT GRANTS PROGRAMS POLICY REVIEW CONFERENCES EDUCATION & COMMUNICATI ON PRIM&R AER Promoting Conference, RCR for Boston, College MA, and. November University 14, Leaders 2016

ORI Assurance Program PROGRAM https: //ori. hhs. gov/arprm/Login. php Promoting RCR for College and University Leaders

TRAINING FOR BIOMEDICAL RESEARCHERS RESEARCH INTEGRITY EDUCATION Promoting RCR for College and University Leaders

TRAINING FOR CLINICAL AND BEHAVIORAL RESEARCHERS RESEARCH INTEGRITY EDUCATION Promoting RCR for College and University Leaders

HANDLING RESEARCH MISCONDUCT ALLEGATIONS Allegation DIO reviews DIO Review at assessment DIO Review at Inquiry Institution conducts an inquiry Institution investigates RRTA ASH Review and Misconduct Findings Published Case Tracking “Sheila” End Administrative Closure End Finding Yes ORI settles ORI issues a charge letter CEC Administrative Closure INVESTIGATIVE PROCESS Allegation Institution assesses allegation Referral Appeal DIO Review at Investigation End Case Closure No Institution Finding-DTP ORI Admin. Law Judge Promoting RCR for College and University Leaders

HANDLING RESEARCH MISCONDUCT ALLEGATIONS https: //www. statnews. com/2016/04/05/universities-research-misconduct/ INVESTIGATIVE PROCESS Promoting RCR for College and University Leaders

HTTP: //ORI. HHS. GOV/THE LAB INTERACTIVE VIDEO Promoting RCR for College and University Leaders

THANK YOU | CONTACT US Zoë Hammatt, J. D. , M. Phil. Director, DEI Zoe. Hammatt@hhs. gov 240 -453 -8400 Susan Garfinkel, Ph. D. Director, DIO Susan. Garfinkel@hhs. gov 240 -453 -8800 Office of Research Integrity U. S. Department of Health and Human Services Promoting the Responsible Conduct of Research for College and University Leaders Marina del Rey, Los Angeles April 14 -15, 2016