research integrity and the nih - ctsioffice of extramural programs research integrity and the nih...

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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


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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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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Office of Extramural Programs 4

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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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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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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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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HOW THE NIH HANDLES ALLEGATIONS OF RESEARCH MISCONDUCT

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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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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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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


ORI AND INSTITUTIONAL FINDINGS

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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


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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Announce In PubMed

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NIH eRA Links to PHS Administrative Action Bulletin Board

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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/


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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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


THANK YOU!

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[email protected]

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