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

NIH OER Regionals, 2015
Patricia Valdez, Ph.D.
NIH Extramural Research Integrity Officer
OD/OER/OEP
National Institutes of Health
Overview
• Research Misconduct Allegations –
How NIH works with ORI
• You checked the assurances & certifications box –
What did you just agree to?
2
2
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
3
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.*
4
OER-RI Allegation Statistics
5
OER-RI Allegation Types by Year
Handling Allegations - NIH
Allegation
NIH OER-RI
Resolution
Other?
OHRP
OPERA
OMA
OLAW
7
RM?
ORI
Resolution
ORI Research Misconduct Findings
Involving NIH-Funded Activities
Notice in the NIH Guide
9
Role of Pub Med
10
NIH Role in Enforcing PHS Actions
PHS Administrative
Actions
• Prohibition from participating
on advisory role
• Debarment
• Requirement for supervision
• Certification from institution
• Retraction
11
NIH’s Role in
Implementation
• Selecting peer reviewers
• Receiving applications for
funding/making awards
• Ensuring conditions are met
before releasing funds
• Announcing the retraction in
PubMed
You checked the assurances &
certifications box
What did you just agree to?
12
13
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
14
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.
15
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).
16
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.
17
1.16 Policy on Instruction in the
Responsible Conduct of Research
NOT-OD-10-019
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)
18
http://grants.nih.gov/grants/research_integrity/
19
WE VALUE YOUR INPUT!
2015 NIH REGIONAL SEMINAR
Session Evaluations: http://surveymonkey.com/s/nihsessions
Overall Evaluations: http://surveymonkey.com/s/nihoverall
NIH
…
Turning Discovery Into Health
20