WHAT IS THIS?
The U.S. Department of Health and Human Services (HHS) has issued a final rule in
the Federal Register that amends the Public Health Service (PHS) regulations on
Responsibility of Applicants for Promoting Objectivity in Research for which PHS
Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective
Contractors (45 C.F.R. Part 94).
An Institution applying for or receiving NIH funding from a grant or cooperative
agreement must be in compliance with all of the revised regulatory requirements no
later than 365 days after publication of the regulation in the Federal Register, i.e.,
August 24, 2012.
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MAJOR CHANGES TO THE 1995 REGULATIONS
Topic
1995 Regulations
2011 Final Rule
Significant Financial
Interests (SFI)
threshold
De minimis threshold of $10,000
De minimis threshold of $5,000. Includes any equity
interest in non-publicly traded entities.
Which SFIs need to be
disclosed (once the
threshold is met)
Only those SFI the Investigator deems
related to the PHS-funded research.
All SFI related to the Investigator’s institutional
responsibilities.
Travel reimbursements
and sponsored travel
Travel reimbursement is not mentioned
explicitly in the regulations but is not
excluded from the SFI definition.
Disclose the occurrence of any reimbursed travel or
sponsored travel related to Institutional responsibilities.
NOT required to disclose travel that is reimbursed or
sponsored by a federal, state, or local government agency,
an Institution of higher education.
Public Accessibility
No requirement
Make certain information available concerning
identified FCOIs held by senior/key personnel via a
publicly accessible Web site or by a written response to
any requestor within five business days of a request.
FCOI training
No requirement
Each Investigator must complete training prior to
engaging in research related to any PHS-funded grant
or contract and at least every four years.
Not mentioned
Institution is required to conduct a retrospective review
in those cases of non-compliance with the regulation
but is not required to report the review to the PHS
Awarding Component.
Retrospective Review
(“Mitigation plan”)
TRAINING REQUIREMENT
Institutions must require that each “Investigator” complete
FCOI training:
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Prior to engaging in research related to any NIH funded project;
At least every four years, and
Immediately when any of the following circumstances apply:
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Institution revises its policy in a manner that affects the investigator;
When an investigator is new to the institution; or
When the institution finds an Investigator is not in compliance with the
Institution’s policy or management plan.
TRAINING REQUIREMENT
Step #1
NIH’s 2011 Web-based Tutorial:
http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
Step #2
Once complete, e-mail a copy of the
“Certificate of Completion” to
vprfcoi@ou.edu
DISCLOSURE OF SIGNIFICANT FINANCIAL INTEREST (SFI)
At time of Application: Requires that each Investigator, including subrecipient
Investigators (i.e., on subcontracts), planning to participate in PHS/NIH-funded
research disclose SFIs to their designated official(s) at time of application.
Should it be determined that additional disclosures are required those should be submitted at
the time of the award.
Annually: Requires that each Investigator, including subrecipient Investigators, to submit
an updated disclosure of SFI at least annually, in accordance with the specific time
period prescribed by the Institution, during the period of the award.
Within 30 days: Requires that each Investigator, including subrecipient Investigators,
who is participating in the NIH-funded research to submit an updated disclosure of
SFI within thirty days of discovering or acquiring (e.g., through purchase, marriage, or
inheritance) a new SFI.
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DISCLOSURE FORMS
All PHS funded Investigators are required to submit a disclosure form. This can be
submitted electronically here: http://ors.ou.edu/fcoi/fcoireport.asp. (link will be
activated on 8/24)
Investigator Discloses known SFI(s) to the Institution:
At time of Application (link available on Infosheet)
Within 30 days of acquiring or discovering SFI
Annually after the Notice of Award
Investigator
DEFINITIONS
The project director or principal Investigator and any other person, regardless of title or position, who is
responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding.
Public Health Service (PHS)
Means the Public Health Service of the U.S. Department of Health and Human Services, and any components of
the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not
limited to:
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The Administration for Children and Families
Administration on Aging
Agency for Healthcare Research and Quality
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Federal Occupational Health
Food and Drug Administration
Health Resources and Services Administration
Indian Health Service
National Institutes of Health
Substance Abuse and Mental Health Services Administration
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SIGNIFICANT FINANCIAL INTEREST (SFI)
Significant Financial Interest means a Financial Interest that reasonably appears to be related to
the Investigator’s Institutional Responsibilities, and:
• if with a publicly traded entity, the aggregate value of any salary or other payments for
services received during the 12 month period preceding the disclosure, and the value of
any equity interest during the 12 month period preceding or as of the date of disclosure,
exceeds $5,000; or
• if with a non-publicly traded entity, the aggregate value of any salary or other payments for
services received during the 12 month period preceding the disclosure exceeds $5,000;
or
• if with a non-publicly-traded company, is an equity interest of any value during the 12
month period preceding or as of the date of disclosure; or
• is income related to intellectual property rights and interests not reimbursed through the
Institution.
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MANAGEMENT OF FCOIS
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Institutions must take necessary actions to manage FCOIs of its Investigators
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Develop a management plan(s) and monitor compliance
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If an Institution identifies an SFI that was not disclosed or reviewed in a timely
manner, the designated official shall within sixty (60) days review the SFI,
determine if an FCOI exists and implement an interim management plan, if
needed.
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In cases of non compliance, complete a retrospective review and submit a
Mitigation Report if bias is found.
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RETROSPECTIVE REVIEW
Whenever an FCOI is not identified or managed in a timely manner,
including:
 failure by the Investigator to disclose a SFI
 failure by the Institution to review or manage a FCOI, or
 failure to comply with the management plan
the institution shall within 120 days of the determination of
noncompliance, complete a retrospective review of the Investigator’s
activities and the project to determine bias in the design, conduct or
reporting of such research.
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MITIGATION REPORT
If bias is found through retrospective review, notify the NIH Awarding
Component promptly (through the eRA Commons) and submit a Mitigation
Report.
Mitigation Report
• Key elements documented in retrospective review
• Description of the impact of the bias on the research project
• Plan of action(s) to eliminate or mitigate the effect of the bias
Thereafter, submit FCOI reports annually.
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WHAT’S THE DEAL W/ TRAVEL?
 The regulation requires Investigators to disclose the occurrence of any reimbursed or sponsored travel
(i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the
exact monetary value may not be readily available), related to the Investigator’s institutional
responsibilities. However, the disclosure requirement does not apply to travel that is reimbursed or
sponsored by the following:
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a federal, state, or local government agency,
an Institution of higher education as defined at 20 U.S.C. 1001(a),
an academic teaching hospital,
a medical center, or
a research institute that is affiliated with an Institution of higher education.
DOES THIS REGULATION APPLY TO ALL AWARDS FROM THE NIH?
No. This regulation does not apply to Phase I Small Business Innovation Research
(SBIR) or Small Business Technology Transfer (STTR) program applications or awards.
The regulation also does not apply to training and fellowship awards funded under the
“T” and “F” award mechanisms and to Research Construction Programs funded under
C06 and UC6 award mechanisms.
SO, WHAT DO I REALLY NEED TO DO?
#1 START EARLY!
#2 Complete the NIH FCOI training and e-mail the certificate to VPRFCOI@ou.edu
You will not have to do this again for 4 years!
Encourage all your colleagues to get it done now.
#3 On your next NIH proposal submit the disclosure form
Even if there is no SFI
There is a link available through the Infosheet
This is for every proposal
A disclosure form is needed for every “Investigator” (PI identifies at proposal stage)
#4 If awarded, you will be reminded to submit the disclosure form annually
This will be similar to the reminders for your annual or patent reports.
#5 Submit a disclosure form within 30 days of acquiring or discovering a new SFI
KEEP IN MIND
A disclosure should only be triggered by a financial interest that reasonably appears
to be related to the Investigator’s Institutional Responsibilities
A disclosure will not automatically trigger a management plan – in fact, most will not
If in doubt, go ahead and disclose and let us help you figure out the question
Carefully consider the actual contributions that those listed as “Key Personnel” on
your proposal or project make to the originality of the science
INFORMATION & RESOURCES
• OU’s NIH FCOI Website: http://ors.ou.edu/fcoi
(will be available 8/24)
• Institutional policy
• Link to Required Training
• Summary of Requirements
• List of Investigator responsibilities
• NIH FCOI Website: http://grants.nih.gov/grants/policy/coi/
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Tutorial
FAQs
Case Studies
Federal Register Notice
QUESTIONS?
Inquiries about the NIH FCOI regulation for grants and cooperative agreements
may be directed to:
VPRFCOI@ou.edu
Dr. Morris Foster
Andrea Deaton
Amanda Pai
Associate Vice President for
Research
Associate Vice President for Research
and Executive Director, ORS
Research Information Services
Coordinator
mwf@ou.edu
adeaton@ou.edu
amandahale@ou.edu