FINANCIA

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WHAT IS THIS?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, 2012August 24, 2012..

MAJOR CHANGES TO THE 1995 MAJOR CHANGES TO THE 1995 REGULATIONSREGULATIONS

Topic 1995 Regulations 2011 Final RuleSignificant 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.

Retrospective Review

(“Mitigation plan”)

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.

TRAINING REQUIREMENTTRAINING REQUIREMENT

TRAINING TRAINING REQUIREMENTREQUIREMENT

NIH’s 2011 Web-based Tutorial: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

Once complete, e-mail a copy of the “Certificate of Completion” to

vprfcoi@ou.edu

Step #1

Step #2

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 OF SIGNIFICANT FINANCIAL DISCLOSURE OF SIGNIFICANT FINANCIAL INTEREST (SFI)INTEREST (SFI)

DISCLOSURE FORMSDISCLOSURE 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)

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DEFINITIONSDEFINITIONSInvestigator

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:

• 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 (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.

• Institutions must take necessary actions to manage FCOIs of its Investigators

• Develop a management plan(s) and monitor compliance

• 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.

• In cases of non compliance, complete a retrospective review and submit a Mitigation Report if bias is found.

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MANAGEMENT OF FCOISMANAGEMENT OF FCOIS

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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RETROSPECTIVE REVIEW RETROSPECTIVE REVIEW

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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MITIGATION REPORT MITIGATION REPORT

WHAT’S THE DEAL W/ TRAVEL?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:

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 DOES THIS REGULATION APPLY TO ALL AWARDS FROM THE NIH? 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?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 InfosheetThis is for every proposalA disclosure form is needed for every “Investigator” (PI identifies at proposal

stage)

#4 If awarded, you will be reminded to submit the disclosure form annuallyThis 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 MINDKEEP 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 & RESOURCESINFORMATION & 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/

• Tutorial• FAQs• Case Studies• Federal Register Notice

QUESTIONS?QUESTIONS?

Inquiries about the NIH FCOI regulation for grants and cooperative agreements may be directed to:

VPRFCOI@ou.edu

Dr. Morris Foster

Associate Vice President for Research

mwf@ou.edu

Andrea DeatonAssociate Vice President for

Research and Executive Director, ORS

adeaton@ou.edu

Amanda PaiResearch Information Services

Coordinator

amandahale@ou.edu