Research Integrity at the NIH

Patricia Valdez, Ph.D.NIH Extramural Research Integrity OfficerOD/OER/OEPNational Institutes of Health

NIH OER Regionals, 2015

Overview

•Research Misconduct Allegations – How NIH works with ORI

•You checked the assurances & certifications box – What did you just agree to?

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PHS Policies on Research Misconduct

•42 C.F.R. Part 93

•HHS Office of Research Integrity (ORI) oversees and directs PHS research integrity activities

• Institution Responsibilities (§93 Subpart C)

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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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OER-RI Allegation Statistics

OER-RI Allegation Types by Year

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Allegation

NIH OER-RI

ResolutionResolution Other?

OHRPOPERAOMAOLAW

RM?

ORI

Handling Allegations - NIH

ORI Research Misconduct Findings Involving NIH-Funded Activities

Notice in the NIH Guide

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Role of Pub Med

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NIH Role in Enforcing PHS Actions

• Prohibition from participating on advisory role

• Debarment

• Requirement for supervision

• Certification from institution

• Retraction

• Selecting peer reviewers

• Receiving applications for funding/making awards

• Ensuring conditions are met before releasing funds

• Announcing the retraction in PubMed

PHS Administrative Actions

NIH’s Role in Implementation

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You checked the assurances & certifications box

What did you just agree to?

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Box 17 of SF424 (R&R) Cover form

See also Box 14 of PHS 398

…I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are true, complete and accurate to best of my knowledge. I also provide the required assurances* and agree to comply with any resulting terms if I accept the award. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001)

Application Certifications and Assurances

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* The list of certifications and assurances, or an internet site where you may obtain this list, is contained in the announcement or agency specific instructions.

Box 17 of SF424 (R&R) Cover form

Public Health Service Supplemental Instructions Part III, Policies,

Assurances, Definitions, and Other Information.

What are you agreeing to?

2.7 Research Misconduct

Checking the “I agree” box on line 17 of the SF424 (R&R) Cover Form serves as certification that:

1) Institution will comply with the requirements for dealing with reporting possible research misconduct under 42 CFR part 93;

2) Institution has established policies and procedures incorporating provisions set forth in 42 CFR part 93;

3) Institution will provide its policies and procedures to the Office of Research Integrity upon request; and

4) The institution will submit an Annual Report on Possible Research Misconduct (Form 6349).

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2.14 Program Director/Principal Investigator, Fellow & Sponsor Assurance …[O]rganizations must retain a unique signature and date for each submitted application…[A]ssurance must include at least the following certifications:

1) that the information submitted within the application is true, complete and accurate to the best of the PD/PI’s knowledge;

2) that any false, fictitious, or fraudulent statements or claims may subject the PD/PI to criminal, civil, or administrative penalties; and

3) that the PD/PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application.

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1.16 Policy on Instruction in the Responsible Conduct of Research

NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research.

• Requirements:• At least 8 contact hours• Minimum of once every four years, • Need training at each career stage (T, F, K)

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NOT-OD-10-019

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http://grants.nih.gov/grants/research_integrity/

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