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Financial Conflict of Interest 2010 NIH Regional Seminar Financial Conflict of Interest 2010 NIH Regional Seminar

Financial Conflict of Interest (FCOI) Regulations n 42 CFR Part 50 Subpart F (grants 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 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

The Regulation Oversight Education & Outreach NIH Institutional Policy Implementation Management Oversight Compliance (including 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 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 (current regulation) 5

What is an FCOI? n A significant financial interest that could directly and significantly What is an FCOI? n A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH funded research 6

Institutional Responsibilities Institutions must establish standards to ensure there is no reasonable expectation that 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 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 8

Institutional Responsibilities n Designate an Institutional Official to • solicit & review disclosure statement 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. 9

Institutional Responsibilities n If NIH-funded research is performed through “subgrantees, contractors, or collaborators, ” 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. 10

Institutional Responsibilities n Certify in each application for funding: • There is in effect 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. 11

Institutional Responsibilities n n n Reports of an identified Financial Conflict of Interest include: 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. http: //oamp. od. nih. gov/Acquisition. Offices/chief_cos 1. asp 12

Institutional Responsibilities n e. RA Commons – FCOI Module • Enables grantees to report 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 13

e. RA Commons FCOI Module/reporting tool n System allows institutions to: • Initiate and 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 14

Summary of FCOI Reporting Requirements 1. 2. 3. At the time of application: Investigators 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 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 16

Investigator Responsibilities n Submit financial disclosure statements which is a listing of Significant Financial 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 17

Significant Financial Interest n Anything of monetary value, including but not limited to: • 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) 18

Significant Financial Interest Exclusions n n n Salary, royalties, or other remuneration from the 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 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 20

SFI vs. FCOI n n A Significant Financial Interest (SFI) is not always an 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 21

NIH Responsibilities • NIH may request information regarding all conflicting interests identified by the 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. 22

NIH Responsibilities n NIH may at any time inquire into the Institutional procedures and 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. 23

NIH Responsibilities n In any case in which an NIH-funded clinical research project whose 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 24

Recent Environment n n Since the existing rules were promulgated in 1995: • biomedical Recent Environment n n Since the existing rules were promulgated in 1995: • biomedical and behavioral research has grown in complexity • interactions among Government, research institutions, and the private sector have increased • public scrutiny has grown All these factors have raised the question whether a more rigorous approach is required 25

Advanced Notice of Proposed Rulemaking (ANPRM) n NIH Requests Comments on Proposed Amendment of Advanced Notice of Proposed Rulemaking (ANPRM) n 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-09 -099. n Federal Register (Vol. 74, No. 88) May 8, 2009 n 60 -day comment period – closed July 7, 2009 • 78 comments received and considered n All comments are posted at: http: //www. regulations. gov/search/Regs/home. html#docke t. Detail? R=NIH-2008 -0002 26

Advanced Notice of Proposed Rulemaking (ANPRM) n Asked for comment on various topics including: Advanced Notice of Proposed Rulemaking (ANPRM) n Asked for comment on various topics including: • Expanding the scope of regulation and disclosure of interests; • Definition of “Significant Financial Interest”; • Identification and management of conflicting interests by institutions; • Assuring institutional compliance; • Requiring institutions to provide additional information; • Broadening the regulations to address institutional conflict of interest 27

ANPRM response n n n Several professional societies (e. g. AAU/AAMC) and institutions that ANPRM response n n n 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. 28

Notice of Proposed Rulemaking (NPRM) n n n NIH carefully considered analyzed comments submitted Notice of Proposed Rulemaking (NPRM) n n n NIH carefully considered analyzed comments submitted in response to the ANPRM and on behalf of the Department of Health and Human Services and the Public Health Service prepared an NPRM which proposes changes to the regulations The NPRM was published in the Federal Register on May 21, 2020 for Public Comment until July 20, 2010 NIH is soliciting comments on all aspects of the NPRM; in addition, preamble highlights certain topics for which comments are specifically solicited, e. g. , definitions (SFI, “institutional responsibilities”), public disclosure requirement; elements of FCOI reports, Institutional conflict of interest policy requirement? ) 29

Notice of Proposed Rulemaking (NPRM) n Submit comments on Regulations. gov [Docket Number: NIH-2010 Notice of Proposed Rulemaking (NPRM) n Submit comments on Regulations. gov [Docket Number: NIH-2010 -0001] or see notice for further submission options and instructions n [email protected] nih. gov for questions about the proposed rule – NO COMMENTS PLEASE n See NIH Guide to Grants and Contracts (NOT-OD 10 -099), at http: //grants. nih. gov/grants/guide/noticefiles/NOT-OD-10 -099. html n NIH will carefully consider comments in drafting the Final Rule 30

Major proposed changes to the regulations n Significant Financial Interest (SFI) definition CURRENT: - Major proposed changes to the regulations n Significant Financial Interest (SFI) definition CURRENT: - De minimis threshold of $10, 000 for disclosure generally applies to payments or equity interests over the next 12 months - Exclusions include income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities PROPOSED: - De minimis threshold of $5, 000 for disclosure generally applies to payments and/or equity interests 12 months preceding the disclosure and the value of any equity interest as of the date of disclosure - Includes any equity interest in non-publicly traded entities - Exclusions include income from seminars, lectures, or teaching, and service on advisory or review panels, for government agencies 31 or institutions of higher education

Major proposed changes to the regulations (cont. ) n Investigator disclosure requirements CURRENT: - Major proposed changes to the regulations (cont. ) n Investigator disclosure requirements CURRENT: - Only SFIs related to PHS-funded research as determined by the Investigator PROPOSED: - SFIs include financial interests that are related to an Investigator’s institutional responsibilities - Institutions responsible for determining whether SFI relates to PHS-funded research and is a FCOI 32

Major proposed changes to the regulations (cont. ) n Public disclosure CURRENT: - No Major proposed changes to the regulations (cont. ) n Public disclosure CURRENT: - No requirement PROPOSED: - Make FCOI policy available via a publically assessable web site - Before spending funds for PHS-supported research, an Institution shall post on a publicly accessible web site information on certain SFIs that the Institution determines are related to the PHS-funded research and are FCOI (< $20 K; <$50 K; , $100 K; <$250 K and >$250 K) 33

Major proposed changes to the regulations (cont. ) • Management of an identified FCOI Major proposed changes to the regulations (cont. ) • Management of an identified FCOI by the Institution CURRENT: - Manner of compliance with regulation not specified (manage, reduce or eliminate are indicated as options) PROPOSED: - For all identified FCOI, Institutions must develop and implement a management plan (may include reduction or elimination of the SFI) 34

Major proposed changes to the regulations (cont. ) n Management of an identified FCOI Major proposed changes to the regulations (cont. ) n Management of an identified FCOI by the Institution (cont. ) − Key elements of the Institution’s management plan n n n The role and function of the conflicted Investigator in the research project The rationale for including the conflicted Investigator in the research project The conditions of the management plan How the management plan will safeguard objectivity in the research project Confirmation of the Investigator’s agreement to the management plan How the management plan will be monitored to ensure Investigator compliance Other information as needed 35

Major proposed changes to the regulations (cont. ) n Management of an identified FCOI Major proposed changes to the regulations (cont. ) n Management of an identified FCOI by the Institution (cont. ) CURRENT: - No requirement PROPOSED: − If FCOI is one that was not disclosed or reviewed in a timely manner, the Institution must also implement a mitigation plan which shall include review and determination as to whether any PHS-funded research conducted prior to identification and management of the FCOI was biased 36

Major proposed changes to the regulations (cont. ) n Information on an identified FCOI Major proposed changes to the regulations (cont. ) n Information on an identified FCOI reported by the Institution to PHS Awarding Component CURRENT: - Grant/Contract number Project Director/Principal Investigator (PD/PI) or Contact PD/PI Name of Investigator with FCOI Whether FCOI was managed, reduced, or eliminated PROPOSED: - Current requirements, plus: - Value of the financial interest $0 -4, 999; $5 K-9, 999; $10 K-19, 999; amounts between $20 K-$100 K by increments of $20 K or statement that a value cannot be readily determined - Nature of FCOI, e. g. , equity, consulting fees, travel reimbursements, honoraria, and description of how FCOI relates to PHS-funded research - Key elements of the Institution’s management plan 37

Major proposed changes to the regulations (cont. ) n Timing of reporting of an Major proposed changes to the regulations (cont. ) n Timing of reporting of an identified FCOI to the PHS Awarding Component CURRENT: - Prior to the Institution's expenditure of any funds under the award - Within 60 days for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award PROPOSED: - Current requirements, plus annual updates on any previously -identified FCOI for the duration of the research project 38

Major proposed changes to the regulations (cont. ) n Scope of the regulation CURRENT: Major proposed changes to the regulations (cont. ) n Scope of the regulation CURRENT: - Does not cover Small Business Innovation Research/Small Business Technology Transfer Research (SBIR/STTR) Phase I applications PROPOSED: - Includes SBIR/STTR Phase I applications 39

Major proposed changes to the regulations (cont. ) n Investigator training CURRENT: - No Major proposed changes to the regulations (cont. ) n Investigator training CURRENT: - No requirement PROPOSED: - FCOI training required for Investigators before engaging in PHS-funded research, and every two years thereafter 40

Major proposed changes to the regulations (cont. ) n HHS authority to inquire about Major proposed changes to the regulations (cont. ) n HHS authority to inquire about FCOI CURRENT: - The HHS may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in PHS-funded research PROPOSED: - Clarifies that HHS authority applies before, during, or after an award with regard to any Investigator disclosure of financial interests, whether or not the disclosure resulted in the Institution’s determination of a FCOI 41

Information n OER FCOI Web Site • http: //grants. nih. gov/grants/policy/coi/ n Mailbox for Information n OER FCOI Web Site • http: //grants. nih. gov/grants/policy/coi/ n Mailbox for inquiries • [email protected] nih. gov n Mailbox for inquiries about the NPRM • [email protected] nih. gov 42

Questions? Diane Dean Director, Division of Grants Compliance and Oversight, OPERA/OER diane. dean@nih. gov Questions? Diane Dean Director, Division of Grants Compliance and Oversight, OPERA/OER diane. [email protected] gov 301 -435 -0930 Kathy Hancock Assistant Grants Compliance Officer, Division of Grants Compliance and Oversight, OPERA/OER kathy. [email protected] gov 301. 435. 1962 43