Policies and Procedures
Policy on Financial Conflict of Interest in Research Funded by Federal Agencies
Summary Statement
A conflict of interest (COI) is any circumstance where personal, professional, financial or other private interests of a person or institution compromise or have the potential to compromise the exercise of professional judgment or obligations, or may be perceived as doing so. In August 2011, recognizing the increasingly complex relationships between biomedical researchers and private industry and in light of the importance of maintaining the public trust, the U.S. Department of Health and Human Services issued revised COI regulations for applicants to and awardees of the Public Health Service (including the NIH). Given the importance of demonstrating careful management of the public’s investment in our research activities, this policy is intended to signify that Praxis Bioresearch (the Company), in applying for or receiving funding through a grant or cooperative agreement from any federal agency, is in full compliance with all the regulatory requirements.
A. POLICY
(1) Introduction
The 2011 revised regulation, Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding Is Sought, sought to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under Public Health Service (PHS) grants (e.g., NIH grants) or cooperative agreements will be free from bias resulting from an investigator’s financial conflicts of interest. This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation. (http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf). Company also applies this policy to all federally-funded research, including National Science Foundation (NSF) Grants and CooperativeAgreements.
The policy that follows defines significant financial interests and the disclosure of such interests. These are interests that could directly affect the design, conduct, or reporting of research administered by Company. The Company Designated Official will review disclosures to determine if financial interests may create an actual orpotential financial conflict of interest with the project and the institutional responsibilities of the investigator(s).Federal regulations require that financial conflicts of interest are appropriately reported and managed.
Per the regulation, an Institution applying for or receiving PHS funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements, and immediately upon making the Institution’sFinancial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).
This policy is intended to signify that Company, in applying for or receiving PHS funding from a grant or cooperative agreement that is covered by the 2011 revised regulation, is in full compliance with all the regulatory requirements. In addition, we voluntarily elect to follow this policy for all other federally funded research to be administered by Company.
(2) Scope
The regulation and this Policy apply to research (defined at the end of this policy) and include any activity for which research funding is available through a federal grant or cooperative agreement administered by Company. The regulation and this Policy explicitly apply to research authorized under the regulation, such as a research grant, career development grant, center grant, individual fellowship award, infrastructure award, institutional training grant,program project, conference and workshop grant, and research resources award.
Federal award programs that are excluded from the regulation and this Policy are the Small Business InnovativeResearch (SBIR) and Small Business Technology Transfer Research (STTR) Phase I applications.
The regulation and this Policy are applicable to awardees, subrecipients, subgrantees and collaborators (e.g., subcontractors or consortium members). The 2011 revised regulation is applicable to each Institution that applies for or receives PHS funding for research through grants or cooperative agreements and, through theimplementation of the regulation by each Institution, to each Investigator planning to participate in, or participating in, such research. A subrecipient relationship is established when federal funds flow down from or through an awardee Institution to another individual or entity and the subrecipient will be conducting a substantive portion of thefederally-funded research project and is accountable to the awardee institution for programmatic outcomes andcompliance matters. Accordingly, as a recipient of federal funds from an awardee Institution, the Financial Conflict of Interest regulation applies to subrecipients (e.g., subcontractors or consortium members). See 42 CFR 50.604 (c).
(3) Who Needs to Know
All Investigators who may apply for, receive, plan to participate in or who are participating in such research as is conducted through federal grants or other awards to the Company covered by this policy are responsible to know this policy and comply with its requirements.
(4) Policy
Company will fully comply with the Federal Rule titled Responsibility of Applicants for Promoting Objectivity inResearch as posted in the Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations §42 CFR Part 50, as well as the requirements of the National Science Foundation and other federal funders in respect to all grants or awards for which federal funding is sought or received. The requirements of the policy and the management of the processes that are necessary under this regulation are delineated in the Procedures which appear below.
B. PROCEDURES
REGULATORY REQUIREMENTS
The regulations require the Company to:
1) Require that each Investigator who is planning to participate in PHS-funded research disclose to theDesignated Compliance Officer at Company the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for federally-fundedresearch.
2) Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure ofsignificant financial interests at least annually, in accordance with the specific time period prescribed by the Institution, during the period of the award.
(a) Such disclosure shall include any information that was not disclosed initially to the Institution or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a federally funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).
(b) Require each Investigator who is participating in the PHS-funded research to submit an updateddisclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.
INVESTIGATOR RESPONSIBILITIES
As a condition of applying for federally funded grants, awards or other funds subject to the regulations outlined inthis Policy, Investigators are responsible for and required to:
1) Complete online FCOI training
2) Report all Financial Conflicts of Interest
3) Participate in and comply with any Company FCOI Management Plan, including any retrospective review and/or mitigation plan; and
4) Support the Company with any FCOI requirements as appropriate with any sub-recipients or sub-awardees if the Investigator is the Primary Investigator.
5) All Investigators at the Company must sign a letter stating that they have reviewed and agree to abide by all FCOI requirements.
The regulation covers all financial interests that have monetary value, whether or not the value is readilyascertainable.
The 2011 revised regulation defines a “Significant Financial Interest” as follows:
1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
(a) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(b) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated,exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(c) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
2) Investigators also must 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 their institutional responsibilities; this includes reimbursed or sponsored travel by a private for-profit or non-profit but does not apply to travel that is reimbursed or sponsored by a federal, state, orlocal government agency, a U.S. Institution of higher education as defined at 20 U.S.C. 1001(a), an academicteaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. Disclosure shall be on a form provided by the Company which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration of the travel. In accordance with the Company’s FCOI policy, it will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the federally fundedresearch.
3) The term significant financial interest does not include the following types of financial interests:
(a) salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rightsassigned to the Company and agreements to share in royalties related to such rights;
(b) income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
(c) income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, a U.S. 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; and
(d) or income from service on advisory committees or review panels for a federal, state, or local governmentagency, a U.S. Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teachinghospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
These financial interests are not included in the definition of significant financial interest regardless of total dollar amount (the threshold is not applicable due to the source of funding).
INSTITUTIONAL RESPONSIBILITIES
1) The Company shall provide training as follows:
(a) Inform each Investigator of the Institution’s policy on financial conflicts of interest;
(b) Inform each Investigator of the Investigator’s responsibilities regarding disclosure of significant financial interests and of these regulations; and
(c) Require each Investigator to complete online training regarding FCOI prior to engaging in researchrelated to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply:
(i) The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators
(ii) An Investigator is new to an Institution; or
(iii) An Institution finds that an Investigator is not in compliance with the Institution’s financial conflict of interest policy or management plan.
2) Institution will solicit disclosures of significant financial interests from each Investigator who is planning toparticipate in, or is participating in, federally funded research. The Company will monitor for compliance with the policy. If the Company learns of an SFI that was not timely disclosed or was not timely reviewed, the Company, shall, and no later than the sixtieth (60th) day after learning of the SFI:
(a) Determine whether the SFI is an FCOI; and
(b) If an FCOI exists, implement an interim management plan or implement other interim measures to ensure the objectivity of the research going forward.
If an FCOI was not timely identified or managed or if an Investigator fails to comply with a management plan, the Company shall no later than the 120th day after determining noncompliance:
(a) complete and document a retrospective review and determination as to whether research conducted during the period of noncompliance was biased in the design, conduct, or reporting of the research; and
(b) implement any measures necessary with regard to Investigator’s participation in the research between the date that the noncompliance is identified and the date the retrospective review is completed.
3) The institution will maintain guidelines to determine whether an Investigator’s significant financial interest isrelated to federally funded research and, if so related, whether the significant financial interest is a financial conflict of interest. The designated company compliance officer will review any SFIs to determine if an SFI constitutes a FCOI, including whether:
(a) It could be reasonably determined that an Investigator’s significant financial interest is related tofederally-funded research and that the significant financial interest could be affected by the federally-funded research; or
(b) The federally funded research is related to an entity whose financial interest could be affected by the research. The Company may involve the Investigator in the determination of whether a significant financial interest is related to the research.
(i) It could be reasonably determined that a financial conflict of interest exists because a significantfinancial interest could directly and significantly affect the design, conduct, or reporting of federally funded research.
4) The institution will manage all financial conflicts of interest, (including any financial conflicts of a subrecipientInvestigator) in accordance with §50.605 (a) including:
(a) Developing and implementing a management plan and, if necessary, a retrospective review and mitigation report; and
(b) Maintaining records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under the Institution’s policy orretrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the federal agency or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations.
5) The institution has established enforcement mechanisms and provides for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate to each specific circumstance.Enforcement mechanisms may include follow-up for information, withdrawal of funding or disciplinary action up to and including termination.
6) The institution shall provide initial and ongoing FCOI reports to the PHS and NSF as required pursuant to §50.605(b). All FCOI reports will be reported to the NIH through electronic Research Administration (eRA) commons FCOI module and will contain the followings
(a) Project number;
(b) PD/PI or Contact PD/PI if a multiple PD/PI model is used;
(c) Name of the Investigator with the FCOI;
(d) Name of the entity with which the Investigator has an FCOI;
(e) Value of the financial interest (in increments)
(f) Description of how financial interest relates to research,
(g) Key Elements of Management Plan
7) Use of Sub-recipients — If any part of the federally-funded research is conducted through a subrecipient (e.g., subcontractors or consortium members), the Office of Sponsored Research, with the support of the Primary Investigator (i.e., awardee Institution), will take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by
(a) Incorporating as part of a written agreement (contract) with the subrecipient terms that establishwhether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s Investigators.
(i) If the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interestpolicy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee Institution for disclosing significant financial interests that are directly related to the subrecipient’s work for the awardee Institution;
(ii) Additionally, if the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart;
(iii) Alternatively, if the subrecipient’s Investigators must comply with the awardee Institution’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for thesubrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this subpart.
(b) Providing FCOI reports to the federal awarding agency regarding all financial conflicts of interest of allsubrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
DEFINITIONS
“Entity” as used in the Financial Conflict of Interest regulation: Entity means any domestic or foreign, public or private,organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.
“Financial Conflict of Interest”: A Financial Conflict of Interest exists when the Institution, through its designatedofficial(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a federally-fundedresearch project and could directly and significantly affect the design, conduct or reporting of the research.
“Institution” for purposes of the Financial Conflict of Interest Regulation: Institution means any domestic or foreign,public or private, entity or organization (excluding a Federal agency) that is applying for or that receives federal research funding.
“Institutional responsibilities”: Institutional responsibilities are defined by the 2011 revised regulation as anInvestigator’s professional responsibilities on behalf of the Institution. It includes such activities as research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such asInstitutional Review Boards.
“Investigator”: For the purpose of this policy Investigator means 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 federal agency, or proposed for such funding, which may include, for example, collaborators or consultants. It does not restrict “investigator” to the PI (Principal Investigator). Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel,faculty) the risk is that an unidentified FCOI may comprise the research enterprise.
In addition, the Investigator’s spouse and dependent children have been eliminated from the definition of “Investigator” under the 2011 revised regulation; however, they are referenced in the definition of “Significant Financial Interest” because the Investigator must also disclose Significant Financial Interests of his/her spouse anddependent children. (See definition of Significant Financial Interest).
“Public Health Service” :PHS means the Public Health Service of the U.S. Department of Health and HumanServices, and any components of the PHS to which the authority involved may be delegated. PHS granting agencies include (but are not limited to): Administration for Children and Families (ACF), Agency for Healthcare Research andQuality (AHRQ), Centers for Disease Control and Prevention (CDC), Department of Health and Human Service (DHHS/OS), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), the National Institutes of Health (NIH) and Substance Abuse and Mental Health Services Administration (SAMHSA) (see www.globalhealth.gov for a complete list of all HHS Operating Divisions).
“Research”:The definition of the term Research provides a non-exhaustive list of examples of the different types of PHS-funding mechanisms to which the regulation applies such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, Institutional training grant, program project, or research resources award. The regulation defines “Research” as any such activity (described at 42 CFR 50.603) for which research funding is available from a PHS or NSF Awarding Component through a grant or cooperativeagreement.
“Senior/Key Personnel”:As referenced in the 2011 revised regulation, Senior/Key Personnel in funded research means the Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel bythe Institution in the grant application, progress report, or any other report submitted to the federal agency by the Institution under the regulation.
Additional References:
Subpart F—Promoting Objectivity in Research