Yvonne Lau, MD, PhD, MBHL NIH Extramural Research Integrity Officer OD/OER/OEP National Institutes of Health OER Regional, June 2013

NIH Mission & Goal Mission NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. An Agency Goal: To exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

Research Misconduct PHS Policies & Procedures on Research Misconduct, Final Rule 42 C.F.R. Parts 50 and 93 HHS Office of Research Integrity (ORI) overseas and directs PHS research integrity activities ▫ Reviews and monitors research misconduct (RM) allegations ▫ Provides technical assistance to institutions that respond to allegations of RM ▫ Administer programs for maintaining institutional assurances

OER-RI Structure Agency Extramural Research Integrity Officer (AERIO): oversees and coordinates NIH Extramural activities related to research misconduct and promotion of research integrity Extramural Research Integrity Officer (ERIO) & Extramural Research Integrity Liaison Officer (ERILO) assists the AERIO Primary point of contact for research misconduct allegations. NIH Institutes & Centers (IC) Research Integrity Officers (RIOs)

Office of Extramural Research (OER-RI) Allegations are treated seriously; handled promptly & professionally Protection of Confidentiality Functions NIH point of contact with ORI, other agencies, NIH Offices, the extramural research community, the public Training for NIH staff Program Development

NIH Staff IC RIO OER-RI ORI PEER REVIEWERS _______________ EXTRAMURAL RESEARCH COMMUNITY _______________ PUBLIC PEER REVIEWERS _______________ EXTRAMURAL RESEARCH COMMUNITY _______________ PUBLIC CONTROLLED CORRESPONDENCES ________________ OTHER NIH POLICY & ADMINISTRATIVE OFFICES CONTROLLED CORRESPONDENCES ________________ OTHER NIH POLICY & ADMINISTRATIVE OFFICES Research Misconduct Allegations Receipt & Referral

OER Allegations Statistics

How OER-RI Handles Allegations? Allegations OER-RI Preliminary Review OER-RI Preliminary Review OUTSIDE ORI JURISDICTION OUTSIDE ORI JURISDICTION ORI DETERMINES JUDRISDICTION – ORI performs oversight & review of Institutional inquiry/investigation ORI DETERMINES JUDRISDICTION – ORI performs oversight & review of Institutional inquiry/investigation Legend FFP = Falsification, Fabrication, Plagiarism NON FFP ALLEGATIONS OR COMPLAINTS - INCLUDE HUMAN SUBJECTS /IRB OVERSIGHT ISSUES; MISUSE OF FUNDS; FRAUD - MAY BE REFERRED TO OTHER FEDERAL AGENCIES/NIH OFFICES Institution RIO Institution RIO

Research Misconduct & Penalties 42 CFR § a.Fabrication b.Falsification c.Plagiarism d.does not include honest error or differences of opinion ORI Administrative Actions  Debarment  Prohibition from participating on advisory role  Requirement for supervision  Certification from institution  Retraction Permanent record kept NIH Actions

Role of Pub Med

Notice in the NIH Guide

How OER-RI Handles Allegations? Allegations OER-RI Preliminary Review OER-RI Preliminary Review OUTSIDE ORI JURISDICTION OUTSIDE ORI JURISDICTION ORI DETERMINES JUDRISDICTION – ORI performs oversight & review of Institutional inquiry/investigation ORI DETERMINES JUDRISDICTION – ORI performs oversight & review of Institutional inquiry/investigation Legend FFP = Falsification, Fabrication, Plagiarism NON FFP ALLEGATIONS OR COMPLAINTS - INCLUDE HUMAN SUBJECTS /IRB OVERSIGHT ISSUES; MISUSE OF FUNDS; FRAUD - MAY BE REFERRED TO OTHER FEDERAL AGENCIES/NIH OFFICES Institution RIO

Other Allegations & Issues NIH Office of Policy for Extramural Research Administration (OPERA) – grants management policy and compliance NIH Office of Acquisition and Management Policy (OAMP) – contracts & acquisitions NIH Office of Management Assessment (OMA) – fraud, waste & abuse investigations NIH Office of Laboratory Animal Welfare (OLAW) Others: OHRP, FDA

OER Allegations Statistics

Responsible Conduct of Research RCR: The practice of scientific investigation with integrity ▫ established professional norms; ▫ ethical principles NIH Policy: all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award, research education grant, and dissertation research grant must receive instruction in RCR

Guidance 1.Specifies the format, faculty participation, duration and frequency of instructions. 2.Includes 9 subject matter: Conflict of Interest; Human and animal research; mentor/mentee responsibilities and relationships; collaborations in research; peer review; data handling and management; research misconduct; authorship and publication; scientist as a responsible member of society Plans & progress reports will be reviewed and considered for acceptability

Information OER-RI NIH RCR Requirement html