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Office of Extramural Programs
RESEARCH INTEGRITY AND THE NIH
NOVEMBER 9, 2017
PATRICIA VALDEZ, Ph.D.
NIH EXTRAMURAL RESEARCH INTEGRITY OFFICER
Office of Extramural Programs
Important Goal of the NIH
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To exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in
the conduct of science.
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Office of Extramural Programs
Overview
•What is research misconduct?
•How does NIH handle allegations of RM?
•Institutional and ORI findings of research misconduct
•Assurances and reporting
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HHS ORI oversees allegations of RM involving PHS-funded activities
Public Health Service includes these OpDivs: NIH, CDC, FDA, HRSA, IHS, SAMHSA
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Office of Extramural Programs
What Constitutes Research Misconduct?
42 CFR §93.103
a. Fabrication
b. Falsification
c. Plagiarism- In proposing, performing or reviewing research or in
reporting research results
d. does not include honest error or differences of opinion.
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Office of Extramural Programs
ORI Policy on PlagiarismExcludes:
• The limited use of general phrases that describe methodology or procedures
- Not substantially misleading or of great significance
• Disputes among collaborators (present or former)
- Authorship disputes; IP rights
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http://ori.hhs.gov/ori-policy-plagiarism
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Office of Extramural Programs
Research Misconduct in Clinical Studies
Examples of Fabrication:
• Making up patient visits
• Creating record of interview that never occurred
• Filling in missing vitals
Examples of Falsification:
• Altering prescreening results to meet eligibility
• Substituting one subject’s record or samples for another’s
• Selectively eliminating data
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Reminders:• Most clinical research misconduct picked up
during routine audits.
• Research misconduct can be committed by anyone in the ‘research team’, not just the principal investigators or the scientific staff.
• When human participants are involved, priority is to ensure their safety.
Research Misconduct in Clinical Studies
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Office of Extramural Programs
HOW THE NIH HANDLES ALLEGATIONS OF RESEARCH MISCONDUCT
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Office of Extramural Programs
National Institutes of Health
Extramural RIOsAgency Intramural RIO
Agency Research Integrity Liaison Officer
Agency Extramural RIO
26 Extramural IC RIOs
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Research Misconduct Allegations (OER‐RI)
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Office of Extramural Programs
Process for Handling Allegations
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Allegation IC RIOERIO/ERILO
& AERIO ORIOffice ofResearchIntegrity
Allegation from a reviewer, whistleblower, PI, colleague, etc.
Designatedsenior NIHOfficials in ICs
Dr. Lauerand designatedstaff
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Office of Extramural Programs
Process for Handling Allegations
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Allegation IC RIOERIO/ERILO
& AERIO
OMA
OLAW
OHRP
ORIOffice ofResearchIntegrity
Office ofHumanResearch Protections
Office ofManagementAssessment
Office ofLaboratory Animal Welfare
Allegation from a reviewer, whistleblower, PI, colleague, etc.
Designatedsenior NIHOfficials in ICs
Dr. Lauerand designatedstaff
Office of Extramural Programs
ORI AND INSTITUTIONAL FINDINGS
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Office of Extramural Programs
From Allegation to ORI Oversight
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Allegation Assessment Inquiry InvestigationInvestigation ORIoversight
• Inquiry involves sequestration; prelim fact-finding• Inquiry determines whether investigation is warranted• Investigation based on institution’s rules
Institution• Does allegation meet
definition?• Credible and specific?• Involves PHS funds?
ORI or Institution
60 days 120 days
Office of Extramural Programs
Institution’s Responsibilities During an Investigation
•Protect human subjects, animals, environment
•Protect scientific integrity of the project
•Determine whether project can continue
•Ensure proper expenditure of funds, if appropriate
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NIH GPS 4.1.27
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ORI Requirements for Making a Finding of Research Misconduct
a) Significant departure from accepted practices; and
b) Committed intentionally, knowingly, or recklessly; and
c) Proven by a preponderance of evidence.
Plus, additional considerations
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HHS ORI Findings(2007-2016)
Num
ber
of fi
ndin
gs
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Publication of Research Misconduct Findings
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Office of Extramural Programs
Announce In PubMed
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Office of Extramural Programs
NIH eRA Links to PHS Administrative Action Bulletin Board
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Office of Extramural Programs
Finding of Research Misconduct Involving SBIR Application
ORI found that the Respondent:(1) used research images and descriptions posted on the
Internet to create seven figures in the application and used that material, its associated text, and text from other publications obtained from the Internet without attribution;
(2) misrepresented research results in two of the plagiarized figures as exemplar applications of the company’s proprietary technology; and
(3) misrepresented his research bibliography in that application and to ORI staff during the investigation.
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Finding of Research Misconduct Involving SBIR Application
Respondent entered a Voluntary Exclusion Agreement with ORI:
• Accepted PHS findings and agreed to terms
• Debarred for 3 years
• Not allowed to serve in PHS advisory capacity for 3 years
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ASSURANCES AND REPORTING
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Grantee Responsibilities
• Hold active assurance of compliance with ORI
• Have written policies & procedures for addressing allegations of research misconduct
• Foster environment promoting research integrity
• Ensure confidentiality and protect whistle-blower
• Cooperate with and make reports to ORI
• Submit Annual Report on Possible Research Misconduct to ORI – January each year
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Provision for Small Institutions
• Small institutions (1-10 persons) usually cannot conduct inquiry or investigation themselves
• May file Small Organization Statement
• Agreement to report all allegations of research misconduct to ORI
• Still need to follow other provisions, including submission of Annual Report
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ORI Website: www.ori.hhs.gov/
Office of Extramural Programs
Annual Report System
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Scenario
•A retraction by an NIH-supported PI appears on Retraction Watch.
•Retraction notice indicates an institutional investigation found falsified data in NIH-supported paper.
•What should the NIH do now?
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Office of Extramural Programs
Scenario
•NIH contacts the institution for more information.
•Finds that a current award is based on falsified data.
•NIH compliance oversight required.
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Communication is Key!
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https://grants.nih.gov/policy/research_integrity/
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Interactive Training Videos onResearch Misconduct
Available at
ori.hhs.gov
Office of Extramural Programs
THANK YOU!
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