Financial Conflict of Interest Financial Conflict of Interest

Financial Conflict of Interest

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

What is the Purpose of the Regulation? n 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. 3

Objectivity in Research • Maintaining objectivity in research • Preserves the public trust • Integrity Institution n Investigator n Data n NIH n • Transparency 4

The Regulation Oversight Education & Outreach NIH Institutional Policy Implementation Management Oversight Compliance (including accurate & timely reporting) Institution Disclosure Compliance Investigator

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

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

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

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

Institutional Responsibilities n 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 n 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. 10

Institutional Responsibilities n 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 OR • Subrecipient 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. 11

Institutional Responsibilities n Certify in each application for funding: • There 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 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. 12

Institutional Responsibilities n n n 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 e. RA Commons FCOI Module. For contracts, reports should be sent to the appropriate Director, Office of Acquisitions. 13

Institutional Responsibilities n e. RA Commons – FCOI Module • Enables grantees to report identified FCOIs to NIH through the e. RA Commons • Mandatory use began 7/1/09 n NIH Guide Notice: NOT-OD-09 -072 http: //grants. nih. gov/grants/guide/noticefiles/NOT-OD-09 -072. html 14

e. RA Commons FCOI Module/reporting tool n System allows institutions to: • Initiate and send a new FCOI report electronically through the e. RA Commons • Search previously created records • Edit a previously submitted record • Respond to a request for additional information • Rescind a previously submitted record • View history of actions n To prepare, institutional Signing Officials must assign FCOI roles to users in e. RA Commons. n More information on the FCOI Module can be found at http: //era. nih. gov/services_for_applicants/other/fcoi. cfm 15

Summary of FCOI Reporting Requirements 1. 2. 3. 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.

Definition of Investigator n n 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 17

Investigator Responsibilities n 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 n Comply with all Institutional requirements 18

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

Significant Financial Interest Exclusions n n n 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 n 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 AND • Does not represent more than a 5% ownership interest in any single entity 21

SFI vs. FCOI n n 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 22

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. 23

NIH Responsibilities n 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. 24

NIH Responsibilities n 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 25

Policy Tips n n Ensure that your Institution’s FCOI policy is compliant with all aspects of the FCOI regulation Clearly state to whom the policy applies Include definition of terms Delineate roles and assign responsibilities • • Investigators Designated Official(s) Oversight Reporting 26

Policy Tips n Ensure that the definition of Investigator is consistent with the FCOI regulation • Broad definition • Consider roles rather than titles • Consider degree of independence with which individuals work 27

Policy Tips n Develop a process to identify all Investigators • The PI and any other person who is responsible for the design, conduct, or reporting of NIHfunded research n n n Ensure that Investigators understand their responsibility to disclose Conduct a meaningful and consistent review of financial disclosures Develop and execute appropriate management plans and ensure compliance with them 28

Policy Tips n Comply with all reporting requirements • Prior to the expenditure of funds under a grant award • Within 60 days of identifying new FCOI n Ensure that all identified FCOIs are reported to the NIH for each award 29

Policy Tips n Ensure that subrecipients are in compliance by • Complying with your Institution’s policy OR • Providing assurances to your Institution to enable it to comply Are subrecipients reporting identified FCOIs to your Institution? n Are you reporting them to NIH? n 30

Policy Tips n Maintain proper documentation • All Financial disclosures • All actions taken by the institution with respect to each conflicting interest n 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. 31

Things to Consider n n How effectively do you communicate FCOI policy requirements to Investigators? Are forms clear and do they collect the correct information? 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? 32

Resources n OER FCOI Web Site • http: //grants. nih. gov/grants/policy/coi/ n Frequently Asked Questions • http: //grants. nih. gov/grants/policy/coifaq. htm n Web-based tutorial • http: //grants. nih. gov/grants/policy/coi/tutorial/fcoi. htm n Mailbox for inquiries • FCOICompliance@mail. nih. gov 33