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t3    ?@ABCDEFHIJKLMNPQRSTUVWXYZ[\]^`abcdefghijklmnopq 0AA0 f@8amS ʚ;>$ʚ;g4.d.d$ 0Dppp@ <4dddd@k 0tPu <4!d!d@l 0t<4BdBd@l 0t0___PPT10 ___PPT9x$*%&*(+&,.;,01D2~345*6? ,O  =M3"Financial Conflict of Interest4rSue Kauble Assistant Grants Compliance Officer Division of Grants Compliance and Oversight, OPERA, OER, NIH, DHHS &sZ h4#*What is a Financial Conflict of Interest?++( A significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS funded research. This determination will be made by a Designated Official (DO) at your institution.   ?5$FCOI Regulations ,(& 42 CFR Part 50 Subpart F (grants and cooperative agreements) http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr50_04.html 45 CFR Part 94 (contracts) http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr94_04.html These regulations became effective October 1, 1995 =dP?dPddP>PP3P =@?3 0=z 06%=Intent of the Regulations To Promote Objectivity in Research>>(&#$ Institutions must establish standards to ensure there is no reasonable expectation that the design, conduct, or reporting of PHS funded research is biased by a conflicting financial interest of an Investigator " K Z 7&Objectivity in Research(Protects research subjects Preserves public trust in research Protects reputation of institution and researcher Protects integrity of scientific data (#222&s&U:+Applicability of Financial COI Regulations ,,(To be applicable, three elements must exist: 1) A grant or cooperative agreement funded by the Public Health Service (PHS) 2) Research - A systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research (includes basic, applied research, and product development) 3) Investigator (Note: The regulations do not apply to Phase I SBIR or STTR projects) }PP(P2GPP` E 9(.Important Definitions 45 CFR Part 50, Sec 603,/($ Investigator  Principal Investigator (PI) and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding The term  Investigator includes the Investigator s spouse and dependent children Z2Z RT9Definition of Investigator(Let s Clarify: An investigator is not just the Principal Investigator conducting the PHS sponsored research. It can be& Anyone (i.e., key personnel, lab technicians, etc.) that is involved in the design, conduct, or reporting of the PHS sponsored research Remember these regulations also apply to an investigator s spouse and dependent childrenj2Z \F  Z:)$Significant Financial Interest (SFI)%%$b  Anything of Monetary Value Exclusions: Salary at the applicant institution Ownership interests in the institution, if the institution is an applicant under the SBIR program Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities Income from service on advisory committees for public or non-profits entities An equity interest under $10,000 in value AND represents less than 5% ownership in a single entity Salary, royalties, or other payments that over the next twelve months are expected to be less than $10,000zP  PP   v;*&Significant Financial Interest Matrix''(<+Key Excerpts 42 CFR Part 50,($Sec. 50.604 (a) Maintain an appropriate written and enforced policy Inform each investigator of the policy, reporting responsibilities, and the regulations (i.e., 42 CFR Part 50)adad4 o=, Key Excerpts 42 CFR Part 50.604,!($(b): Designate an official (DO) to solicit and review financial disclosure statements from each investigator planning to participate in PHS-funded research (c) (1): Require that at the time an application is submitted to PHS that the Investigator has submitted to the DO a listing of known SFIs (c) (2): Financial disclosures must be updated during the period of award, either annually or as new reportable SFIs are obtaineddZd ddZd ddZIh R>-*What is a Financial Disclosure Statement?++(v A listing of Investigators SFIs (and those of his/her spouse and dependent children): (i) that would reasonably appear to be affected by the research for which PHS finding is sought; and (ii) in entities whose financial interests would reasonably appear to be affected by the research (e.g., stocks) X!P! i!P!!w!PtS8SFI Versus FCOI(Remember& A SFI is not always a FCOI. A FCOI exists when the DO reasonably determines that a SFI could directly and significantly affect the design, conduct, or reporting of the PHS funded research>      ?. Key Excerpts 42 CFR Part 50.604,!($ (g) (2): Prior to the Institution s expenditure of any funds under the award, the Institution will report to the PHS Awarding Component the existence of a conflicting interest (but not the nature of the interest) found by the institution and assure that the interest has been managed, reduced, or eliminated& (for any interest identified after the initial report, report its existence and assure that the interest will be managed, reduced, or eliminated, at least on an interim basis, within 60 days of that identification) 6dPd<dP"V;!Summary of Reporting Requirements""(DAt the time of application, the Investigator must submit a listing of SFIs Prior to the expenditure of any funds the Institution must report a FCOI to the NIH and assure that it was managed reduced or eliminated Any other FCOI identified after an initial report should be reported and managed, reduced, or eliminated within 60 days (Institution must maintain records of all financial disclosures and all actions taken regarding each conflict of interest for at least three years from the date of submission of the final expenditure report& ) LpdZpdpdZpdxpdZpd mdZpdZ,%L"? A0.Ways to Manage, Reduce or Eliminate Conflicts :/-( 42 CFR Part 50.605 (a) (1)  (6) Public disclosure of SFIs Monitor of research by independent reviewers Modification of research plan Divestiture of SFIs Severance of relationships that create actual or potential conflicts!-222E"  '     +B1Some Things to Consider(Do you have an effective FCOI program? Do you have a written policy? Is it enforced? Do you have guidelines for determining if a FCOI exists? Do you have procedures for managing, reducing, or elimination a FCOI? Are they applied consistently to all cases? *'ddd9s((ks  C2Some Things to Consider(oHow are investigators informed of the need to comply with the FCOI regulations? Do you have an effective training program? Who is responsible for: Managing the reporting process and maintaining records? Determining if a FCOI exists? Reporting a FCOI to the NIH? Developing a plan to manage, reduce, or eliminate a FCOI? Ensuring compliance with a management plan? ZPdPd(+P(dPdsP:Z,PdPP+  ,  D3Areas of Concern(_FCOIs not reported to NIH Subgrantee/subcontractor noncompliance Policies are not specific to the PHS regulation Compliance program ineffective Lack of attention by administration Program not adequately designed Lack of effective training Poorly designed financial disclosure forms Lack of adequate oversight Inconsistent handling of FCOI cases 4dPd'dPd 0dPd dPd P(PPE47Suggestions for Improving Your Institutional Policy 88(]Provide a link to the PHS regulations Identify a contact point for FCOI issues Define roles/responsibilities Define terms used in the PHS regulations Establish guidelines for Institutional Officials to use in determining the existence of a FCOI State requirement for reporting a FCOI to NIH Include examples of when a FCOI may or may not exist*&Z )Z Z )Z _Z .Z 5Z^F5Compliance in Action(:Centralized database: Provides FCOI policies, forms (with instructions), and training resources Electronically solicits financial disclosures Electronically receives and tracks submission of disclosure forms Stores copies of disclosure forms for review Tracks management plans (audits to monitor compliance) J / C - 7$G6Compliance in Action(Mandatory centralized training Involve Investigators in developing management plans Establishment of a FCOI committee Distribute case studies or sample management plans (templates) to ensure consistency and promote fairness and efficiency Management setting a positive example5"y&H7 Questions?  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(2 !Financial Conflict of .-@Arial-. 2 /9Interest.-@Arial-. 2 Q Sue Kauble.-@Arial-. <2 Y #Assistant Grants Compliance Officer.-@Arial-. :2 a "Division of Grants Compliance and .-@Arial-. 92 g !Oversight, OPERA, OER, NIH, DHHS .-՜.+,0P    On-screen ShowNIH\OD.  Arial GaramondTimes New RomanVerdana Wingdings Wingdings 2SymbolLevelFinancial Conflict of Interest+What is a Financial Conflict of Interest?FCOI Regulations >Intent of the Regulations To Promote Objectivity in ResearchObjectivity in Research,Applicability of Financial COI Regulations /Important Definitions 45 CFR Part 50, Sec 603Definition of Investigator%Significant Financial Interest (SFI)'Significant Financial Interest MatrixKey Excerpts 42 CFR Part 50!Key Excerpts 42 CFR Part 50.604+What is a Financial Disclosure Statement?SFI Versus FCOI!Key Excerpts 42 CFR Part 50.604"Summary of Reporting Requirements/Ways to Manage, Reduce or Eliminate Conflicts Some Things to ConsiderSome Things to ConsiderAreas of Concern8Suggestions for Improving Your Institutional Policy Compliance in ActionCompliance in Action Questions?  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