Research Misconduct Allegations Yvonne Lau MD PhD MBHL NIH Extramural Research Integrity Officer ODOEROEP National Institutes of Health OER Regional June 2013 NIH Mission amp Goal ID: 614274
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How OER Handles Research Misconduct Allegations
Yvonne Lau, MD, PhD, MBHLNIH Extramural Research Integrity OfficerOD/OER/OEPNational Institutes of Health
OER Regional, June 2013Slide2
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.Slide3
Research MisconductPHS 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 RMAdminister programs for maintaining institutional assurancesSlide4
OER-RI StructureAgency 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) Slide5
Office of Extramural Research (OER-RI)
Allegations are treated seriously; handled promptly & professionallyProtection of Confidentiality FunctionsNIH point of contact
with ORI, other agencies, NIH Offices, the extramural research community, the public
Training for NIH staff
Program DevelopmentSlide6
NIH Staff
IC RIO
OER-RI
ORI
PEER REVIEWERS
_______________
EXTRAMURAL RESEARCH COMMUNITY
_______________
PUBLIC
CONTROLLED CORRESPONDENCES
________________
OTHER NIH POLICY & ADMINISTRATIVE OFFICES
Research Misconduct Allegations
Receipt & ReferralSlide7
OER Allegations Statistics Slide8
How OER-RI Handles Allegations
?
Allegations
OER-RI
Preliminary Review
OUTSIDE ORI
JURISDICTION
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
RIOSlide9
Research Misconduct & Penalties
42 CFR §93.103FabricationFalsification
P
lagiarism
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 ActionsSlide10
Role of Pub MedSlide11
Notice in the NIH GuideSlide12
How OER-RI Handles Allegations
?
Allegations
OER-RI
Preliminary Review
OUTSIDE ORI
JURISDICTION
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 RIOSlide13
Other Allegations & IssuesNIH Office of Policy for Extramural Research Administration (OPERA) – grants management policy and compliance
NIH Office of Acquisition and Management Policy (OAMP) – contracts & acquisitionsNIH Office of Management Assessment (OMA) – fraud, waste & abuse investigationsNIH Office of Laboratory Animal Welfare (OLAW)Others: OHRP, FDASlide14
OER Allegations Statistics Slide15
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 Slide16
Guidance
Specifies the format, faculty participation, duration and frequency of instructions. 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 acceptabilitySlide17
Information
Email: NIHResearchIntegrity@mail.nih.gov OER-RIhttp://grants.nih.gov/grants/research_integrity/index.htm NIH RCR Requirement
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html