1. Research Integrity at the NIH
NIH OER Regionals, 2015
Patricia Valdez, Ph.D.
NIH Extramural Research Integrity Officer
OD/OER/OEP
National Institutes of Health

2. Overview Research Misconduct Allegations – How NIH works with ORI
You checked the assurances & certifications box – What did you just agree to? 2

3. 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) 3

4. What Constitutes Research Misconduct?
42 CFR §93.103
Fabrication
Falsification
Plagiarism
- In proposing, performing or reviewing research or in reporting research results
d. does not include honest error or differences of opinion.*
Research Misconduct is defined by the Public Health Service as “fabrication, falsification or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”
(a) Fabrication is making up data or results and recording or reporting them.
(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
(d) Research misconduct does not include honest error or differences of opinion.

5. OER-RI Allegation Statistics

6. OER-RI Allegation Types by Year

7. Handling Allegations - NIH
NIH OER-RI
Resolution
Other?
OHRP
OPERA
OMA
OLAW
RM?
ORI
NIH OER-Research Integrity does an initial review of allegation
Refers all allegations of RM to ORI
NIH Office of Policy for Extramural Research Administration (OPERA) – grants management policy and compliance
NIH Office of Management Assessment (OMA) – fraud, waste & abuse investigations
NIH Office of Laboratory Animal Welfare (OLAW)
Other Federal Agencies: OHRP, FDA

8. ORI Research Misconduct Findings Involving NIH-Funded Activities

9. Notice in the NIH Guide

10. Role of Pub Med

11. NIH Role in Enforcing PHS Actions
PHS Administrative Actions
NIH’s Role in Implementation
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

12. You checked the assurances & certifications box What did you just agree to?

14. Application Certifications and Assurances
Box 17 of SF424 (R&R) Cover form
…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)
See also Box 14 of PHS 398

15. What are you agreeing to?
Box 17 of SF424 (R&R) Cover form
* 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.
Public Health Service
Supplemental Instructions Part III, Policies, Assurances, Definitions, and Other Information.

16. 2.7 Research Misconduct
Checking the “I agree” box on line 17 of the SF424 (R&R) Cover Form serves as certification that:
Institution will comply with the requirements for dealing with reporting possible research misconduct under 42 CFR part 93;
Institution has established policies and procedures incorporating provisions set forth in 42 CFR part 93;
Institution will provide its policies and procedures to the Office of Research Integrity upon request; and
The institution will submit an Annual Report on Possible Research Misconduct (Form 6349).

17. 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:
that the information submitted within the application is true, complete and accurate to the best of the PD/PI’s knowledge;
that any false, fictitious, or fraudulent statements or claims may subject the PD/PI to criminal, civil, or administrative penalties; and
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.

18. 1.16 Policy on Instruction in the Responsible Conduct of Research
NOT-OD
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)

20. NIH… WE VALUE YOUR INPUT! 2015 NIH REGIONAL SEMINAR
Session Evaluations: Overall Evaluations:
NIH…
Turning Discovery Into Health