Financial Conflict of Interest 2010 NIH Regional Seminar

2 Financial Conflict of Interest (FCOI) Regulations 42 CFR Part 50 Subpart F (grants and cooperative agreements) 42 CFR Part 50 Subpart F (grants and cooperative agreements) 45 CFR Part 94 (contracts) 45 CFR Part 94 (contracts) These regulations went into effect on October 1, 1995

3 What is the Purpose of the Regulation? This regulation is aimed at ensuring that the design, conduct, or reporting of research funded under NIH grants and cooperative agreements will not be biased by any conflicting financial interest of the Investigators responsible for the research. This regulation is aimed at ensuring that the design, conduct, or reporting of research funded under NIH grants and cooperative agreements will not be biased by any conflicting financial interest of the Investigators responsible for the research.

4 Objectivity in Research Maintaining objectivity in researchMaintaining objectivity in research Preserves the public trustPreserves the public trust IntegrityIntegrity Institution Institution Investigator Investigator Data Data NIH NIH TransparencyTransparency

The Regulation Compliance (including accurate & timely reporting) Institutional Policy ImplementationManagementOversight Institution DisclosureCompliance Investigator Oversight Education & Outreach NIH

6 Who is Covered? Each Institution that applies for NIH grants or cooperative agreements for research Each Institution that applies for NIH grants or cooperative agreements for research Domestic, foreign, public, private (not Federal)Domestic, foreign, public, private (not Federal) Any Investigator, as defined by the regulation, participating in the research Any Investigator, as defined by the regulation, participating in the research SBIR/STTR Phase I applications are exempt SBIR/STTR Phase I applications are exempt

7 What is an FCOI? A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH funded research

Institutional Responsibilities Institutions must establish standards to ensure there is no reasonable expectation that the design, conduct, or reporting of NIH funded research is biased by a conflicting financial interest of an Investigator

9 Institutional Responsibilities Maintain a written, enforced policy that complies with the regulation andMaintain a written, enforced policy that complies with the regulation and inform Investigators of the policy, the regulation, and their reporting responsibilities inform Investigators of the policy, the regulation, and their reporting responsibilities Establish enforcement mechanisms and provide for sanctions where appropriateEstablish enforcement mechanisms and provide for sanctions where appropriate Maintain records for at least three years from date of submission of final expenditures reportMaintain records for at least three years from date of submission of final expenditures report

10 Institutional Responsibilities Designate an Institutional Official to solicit & review disclosure statement from each Investigator planning to participate in NIH-funded research Provide guidelines to identify conflicting interests Take action to ensure they are managed, reduced, or eliminated By the time an application is submitted, assure that the Institutional Official has received a financial disclosure statement from each Investigator who is planning to participate in the NIH-funded research.

11 Institutional Responsibilities If NIH-funded research is performed through “subgrantees, contractors, or collaborators,” [aka subrecipients] the grantee Institution must take reasonable steps to ensure compliance by either requiring: If NIH-funded research is performed through “subgrantees, contractors, or collaborators,” [aka subrecipients] the grantee Institution must take reasonable steps to ensure compliance by either requiring: Subrecipient Investigators to comply with the Institution’s policy ORSubrecipient Investigators to comply with the Institution’s policy OR Subrecipient Institutions to provide assurances to the grantee Institution that will enable it to complySubrecipient Institutions to provide assurances to the grantee Institution that will enable it to comply Subrecipients should report identified FCOIs to the grantee Institution. Grantee Institution reports to NIH.

12 Institutional Responsibilities Certify in each application for funding: Certify in each application for funding: There is in effect a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interestsThere is in effect a written and enforced administrative process to identify and manage, reduce or eliminate conflicting interests Report existence of an FCOI prior to expenditure of funds under an award and within 60 days of identification of a new conflicting interestReport existence of an FCOI prior to expenditure of funds under an award and within 60 days of identification of a new conflicting interest Agree to make information available upon request regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated.Agree to make information available upon request regarding all conflicting interests identified by the Institution and how those interests have been managed, reduced, or eliminated.

13 Institutional Responsibilities Reports of an identified Financial Conflict of Interest include: grant and/or contract number, PD/PI or contact PD/PI, name of Investigator with the FCOI, and an indication whether the conflict has been managed, reduced or eliminated. For grants, all FCOI reports must be submitted through the eRA Commons FCOI Module. For contracts, reports should be sent to the appropriate Director, Office of Acquisitions.Director, Office of Acquisitions

14 Institutional Responsibilities eRA Commons – FCOI Module eRA Commons – FCOI Module Enables grantees to report identified FCOIs to NIH through the eRA CommonsEnables grantees to report identified FCOIs to NIH through the eRA Commons Mandatory use began 7/1/09Mandatory use began 7/1/09 NIH Guide Notice: NOT-OD files/NOT-OD html NIH Guide Notice: NOT-OD files/NOT-OD html files/NOT-OD html files/NOT-OD html

15 eRA Commons FCOI Module/reporting tool System allows institutions to: System allows institutions to: Initiate and send a new FCOI report electronically through the eRA CommonsInitiate and send a new FCOI report electronically through the eRA Commons Search previously created recordsSearch previously created records Edit a previously submitted recordEdit a previously submitted record Respond to a request for additional informationRespond to a request for additional information Rescind a previously submitted recordRescind a previously submitted record View history of actionsView history of actions To prepare, institutional Signing Officials must assign FCOI roles to users in eRA Commons. To prepare, institutional Signing Officials must assign FCOI roles to users in eRA Commons. More information on the FCOI Module can be found at More information on the FCOI Module can be found at

Summary of FCOI Reporting Requirements At the time of application: Investigators must submit known significant financial interests to the Institution Prior to the expenditure of funds: The Institution must report an identified financial conflict of interest to the NIH and assure that it has been managed, reduced, or eliminated FCOI identified after the initial report: The Institution must report to the NIH within 60 days of identification and assure that it has been managed, reduced, or eliminated.

17 Definition of Investigator The Principal Investigator (PI) AND any other person who is responsible for the design, conduct, or reporting of NIH-funded research, or proposed for such funding The Principal Investigator (PI) AND any other person who is responsible for the design, conduct, or reporting of NIH-funded research, or proposed for such funding Includes Investigator’s spouse and dependent children Includes Investigator’s spouse and dependent children

18 Investigator Responsibilities Submit financial disclosure statements which is a listing of Significant Financial Interests that would reasonably appear to be affected by the research for which you are seeking funding, and in entities whose financial interests would reasonably appear to be affected by the research Comply with all Institutional requirements

19 Significant Financial Interest Anything of monetary value, including but not limited to: Anything of monetary value, including but not limited to: Salary or other payments for services (e.g., consulting fees or honoraria)Salary or other payments for services (e.g., consulting fees or honoraria) Equity interests (e.g., stocks, stock options or other ownership interests)Equity interests (e.g., stocks, stock options or other ownership interests) Intellectual property rights (e.g., patents, copyrights and royalties from such rights)Intellectual property rights (e.g., patents, copyrights and royalties from such rights)

Salary, royalties, or other remuneration from 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 or review panels for public or non-profits entities Salary, royalties, or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next 12 months are not expected to exceed $10,000 Significant Financial Interest Exclusions

21 Significant Financial Interest Exclusions An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children meets both of the following tests: An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value ANDDoes not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value AND Does not represent more than a 5% ownership interest in any single entityDoes not represent more than a 5% ownership interest in any single entity

22 SFI vs. FCOI A Significant Financial Interest (SFI) is not always an FCOI An FCOI exists when a designated Institutional official reasonably determines that an SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research

23 NIH Responsibilities NIH may request information regarding all conflicting interests identified by the Institutions and how those interests have been managed, reduced, or eliminated to protect research from bias. If the failure of an Investigator to comply with the Institution’s conflict of interest policy has biased the design, conduct, or reporting of the NIH-funded research, the Institution must promptly notify NIH of the corrective action taken or to be taken. NIH will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project.

24 NIH Responsibilities NIH may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in NIH-funded research, including a requirement for submission of, or review on site, all records pertinent to compliance. NIH may decide that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict in accordance with requirements. If necessary, NIH may suspend funding until the matter is resolved.

25 NIH Responsibilities In any case in which an NIH-funded clinical research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed in accordance with the regulation, the Institution must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research

NIH continues to Promote Compliance Published an Advanced Notice of Proposed Rule Making Published an Advanced Notice of Proposed Rule Making eRA Commons FCOI module/reporting tool for grantees (Pilot began 10/08. Mandatory use began 7/1/09) eRA Commons FCOI module/reporting tool for grantees (Pilot began 10/08. Mandatory use began 7/1/09) Updated FAQs and an online tutorial Updated FAQs and an online tutorial For grants, cooperative agreements, and research contractsFor grants, cooperative agreements, and research contracts Articles in NIH Extramural Nexus Articles in NIH Extramural Nexus

27 NIH continues to Promote Compliance FCOI mailbox FCOI mailbox NIH Guide Notices NIH Guide Notices Web postings and resource documents Web postings and resource documents ( /coi/index.htm) /coi/index.htmhttp://grants/nih.gov/grants/policy /coi/index.htm Review of institutional FCOI policies and procedures Review of institutional FCOI policies and procedures

28 Advanced Notice of Proposed Rulemaking (ANPRM) NIH Requests Comments on Proposed Amendment of Regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors” – NIH Requests Comments on Proposed Amendment of Regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors” – Published May 8, 2009 in the NIH Guide to Grants and Contracts: NOT-OD Published May 8, 2009 in the NIH Guide to Grants and Contracts: NOT-OD Federal Register (Vol. 74, No. 88) May 8, 2009 Federal Register (Vol. 74, No. 88) May 8, day comment period – closed July 7, day comment period – closed July 7, comments received and considered78 comments received and considered All comments are posted at: tDetail?R=NIH All comments are posted at: tDetail?R=NIH tDetail?R=NIH tDetail?R=NIH

29 Advanced Notice of Proposed Rulemaking (ANPRM) Asked for comment on various topics including: Asked for comment on various topics including: Expanding the scope of regulation and disclosure of interests;Expanding the scope of regulation and disclosure of interests; Definition of “Significant Financial Interest”;Definition of “Significant Financial Interest”; Identification and management of conflicting interests by institutions;Identification and management of conflicting interests by institutions; Assuring institutional compliance;Assuring institutional compliance; Requiring institutions to provide additional information;Requiring institutions to provide additional information; Broadening the regulations to address institutional conflict of interestBroadening the regulations to address institutional conflict of interest

30 ANPRM response Several professional societies (e.g. AAU/AAMC) and institutions that conduct research provided comments. All the questions raised in the ANPRM were addressed in the comments. Many of the comments addressed the definition of Significant Financial Interest and what information should be provided to the funding agency.

31 Notice of Proposed Rulemaking (NPRM) NIH has carefully considered and analyzed comments submitted in response to the ANPRM and on behalf of the Department of Health and Human Services and the Public Health Service has prepared an NPRM which proposes changes to the regulation NIH has carefully considered and analyzed comments submitted in response to the ANPRM and on behalf of the Department of Health and Human Services and the Public Health Service has prepared an NPRM which proposes changes to the regulation The NPRM is under review and clearance The NPRM is under review and clearance NPRM will be published in the Federal Register for public comment NPRM will be published in the Federal Register for public comment A Final Rule is expected to be published this year A Final Rule is expected to be published this year

32 NIH Compliance Program Financial Conflict of Interest Assess Institutional compliance with the regulatory requirements of the Federal financial conflict of interest (FCOI) in research pertaining to NIH grants and cooperative agreements Assess Institutional compliance with the regulatory requirements of the Federal financial conflict of interest (FCOI) in research pertaining to NIH grants and cooperative agreements An outgrowth of NIH site visit initiatives: Proactive Compliance Site Visits, Targeted Site Reviews, and Pilot Compliance Program An outgrowth of NIH site visit initiatives: Proactive Compliance Site Visits, Targeted Site Reviews, and Pilot Compliance Program Desk reviews, not site visits Desk reviews, not site visits

NIH Compliance Program Financial Conflict of Interest If areas of noncompliance are noted, Institutions will be expected to address and resolve the issues If areas of noncompliance are noted, Institutions will be expected to address and resolve the issues Results of NIH compliance initiatives are shared with the grantee community for educational purposes to enhance and improve FCOI compliance. Results of NIH compliance initiatives are shared with the grantee community for educational purposes to enhance and improve FCOI compliance.

OIG Report - NIH: Conflict of Interest in Extramural Research Recommendations to NIH in January 2008 report: Increase oversight of grantee Institutions to ensure their compliance with Federal FCOI regulations.Increase oversight of grantee Institutions to ensure their compliance with Federal FCOI regulations. Require grantee Institutions to routinely provide details regarding the nature of FCOI and how they are managed, reduced or eliminated.Require grantee Institutions to routinely provide details regarding the nature of FCOI and how they are managed, reduced or eliminated. Require NIH Institutes to forward to the Office of Extramural Research (OER), NIH, all FCOI reports received from grantee Institutions and ensure OER’s database includes all FCOI reports provided by grantee Institutions.Require NIH Institutes to forward to the Office of Extramural Research (OER), NIH, all FCOI reports received from grantee Institutions and ensure OER’s database includes all FCOI reports provided by grantee Institutions. Full report available at:

35 OIG Report – Grantee Management of FCOI in Research Funded by NIH Recommendations to NIH in November 2009 Report Recommendations to NIH in November 2009 Report Request grantee institutions to provide details to NIH regarding the nature of all reported financial conflicts of interest and how they are managed, reduced, or eliminated.Request grantee institutions to provide details to NIH regarding the nature of all reported financial conflicts of interest and how they are managed, reduced, or eliminated. Require grantee institutions to collect information on all significant financial interests held by researchers and not just those deemed by researchers to be reasonably affected by the research.Require grantee institutions to collect information on all significant financial interests held by researchers and not just those deemed by researchers to be reasonably affected by the research. Require grantee institutions to collect information on specific amounts of equity and compensation from researchers.Require grantee institutions to collect information on specific amounts of equity and compensation from researchers. Develop and disseminate guidance on methods to verify researchers’ financial interests.Develop and disseminate guidance on methods to verify researchers’ financial interests. Full report is available at:

36 OIG Report – Grantee: Grantee Management of FCOI in Research Funded by NIH (cont’d) Ensure that grantee institutions are providing adequate oversight of subgrantee compliance with Federal financial conflict-of-interest regulations.Ensure that grantee institutions are providing adequate oversight of subgrantee compliance with Federal financial conflict-of-interest regulations. Ensure that grantee institutions are maintaining proper documentation as outlined in the Federal financial conflict-of-interest regulations.Ensure that grantee institutions are maintaining proper documentation as outlined in the Federal financial conflict-of-interest regulations. Ensure that grantee institutions take appropriate actions against researchers who do not follow grantee institutions’ financial conflict-of-interest policies and procedures.Ensure that grantee institutions take appropriate actions against researchers who do not follow grantee institutions’ financial conflict-of-interest policies and procedures. Increase oversight of grantee institutions to ensure that financial conflicts of interest are reported and managed appropriately.Increase oversight of grantee institutions to ensure that financial conflicts of interest are reported and managed appropriately. Develop regulations that address institutional financial conflicts of interest.Develop regulations that address institutional financial conflicts of interest.

37 OIG: Financial Interests Held by Institutions Receiving NIH Research Grants Current review to determine: Current review to determine: If and to what extent grantee institutions receiving NIH grants have financial interests that could be affected by the researchIf and to what extent grantee institutions receiving NIH grants have financial interests that could be affected by the research There are no Federal regulationsThere are no Federal regulations Previous work identified instances where grantee institutions were receiving financial payments from the same companies that they believed created a conflict for the researchers.Previous work identified instances where grantee institutions were receiving financial payments from the same companies that they believed created a conflict for the researchers. Outcome is to identify and quantify financial interests that grantee institutions have that are related to research conducted at these institutions Outcome is to identify and quantify financial interests that grantee institutions have that are related to research conducted at these institutions See FY2010 HHS/OIG Work Plan at See FY2010 HHS/OIG Work Plan at

38 Policy Tips Ensure that your Institution’s FCOI policy is compliant with all aspects of the FCOI regulation Ensure that your Institution’s FCOI policy is compliant with all aspects of the FCOI regulation Clearly state to whom the policy applies Clearly state to whom the policy applies Include definition of terms Include definition of terms Delineate roles and assign responsibilities Delineate roles and assign responsibilities InvestigatorsInvestigators Designated Official(s)Designated Official(s) OversightOversight ReportingReporting

39 Policy Tips Ensure that the definition of Investigator is consistent with the FCOI regulation Ensure that the definition of Investigator is consistent with the FCOI regulation Broad definitionBroad definition Consider roles rather than titlesConsider roles rather than titles Consider degree of independence with which individuals workConsider degree of independence with which individuals work

40 Policy Tips Develop a process to identify all Investigators Develop a process to identify all Investigators The PI and any other person who is responsible for the design, conduct, or reporting of NIH-funded researchThe PI and any other person who is responsible for the design, conduct, or reporting of NIH-funded research Ensure that Investigators understand their responsibility to disclose Ensure that Investigators understand their responsibility to disclose Conduct a meaningful and consistent review of financial disclosures Conduct a meaningful and consistent review of financial disclosures Develop and execute appropriate management plans and ensure compliance with them Develop and execute appropriate management plans and ensure compliance with them

41 Policy Tips Comply with all reporting requirements Comply with all reporting requirements Prior to the expenditure of funds under a grant awardPrior to the expenditure of funds under a grant award Within 60 days of identifying new FCOIWithin 60 days of identifying new FCOI Ensure that all identified FCOIs are reported to the NIH for each award Ensure that all identified FCOIs are reported to the NIH for each award

42 Policy Tips Ensure that subrecipients are in compliance by Ensure that subrecipients are in compliance by Complying with your Institution’s policy ORComplying with your Institution’s policy OR Providing assurances to your Institution to enable it to complyProviding assurances to your Institution to enable it to comply Are subrecipients reporting identified FCOIs to your Institution? Are subrecipients reporting identified FCOIs to your Institution? Are you reporting them to NIH? Are you reporting them to NIH?

43 Policy Tips Maintain proper documentation Maintain proper documentation All Financial disclosuresAll Financial disclosures All actions taken by the institution with respect to each conflicting interestAll actions taken by the institution with respect to each conflicting interest Retain records for at least 3 years following submission of final Financial Status report or, where applicable, from other dates specified in 45 CFR 74.53(b) for different situations. Retain records for at least 3 years following submission of final Financial Status report or, where applicable, from other dates specified in 45 CFR 74.53(b) for different situations.

44 Things to Consider How effectively do you communicate FCOI policy requirements to Investigators? How effectively do you communicate FCOI policy requirements to Investigators? Are forms clear and do they collect the correct information? Are forms clear and do they collect the correct information? Are your policies and other documents related to FCOI readily accessible? Are your policies and other documents related to FCOI readily accessible? Do you periodically review your policies and procedures to ensure that they are current and operating as intended? Do you periodically review your policies and procedures to ensure that they are current and operating as intended?

45 Resources OER FCOI Web Site OER FCOI Web Site Frequently Asked Questions Frequently Asked Questions Web-based tutorial Web-based tutorial Mailbox for inquiries Mailbox for inquiries

46 Questions? Diane Dean Director, Division of Grants Compliance and Oversight, OPERA/OER Kathy Hancock Assistant Grants Compliance Officer, Division of Grants Compliance and Oversight, OPERA/OER