Policy on Financial Conflict of Interest in Research Funded by Federal Agencies

As required by 42 CFR Part 50, Subpart F https://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm

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 Expression Therapeutics, 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.

 

POLICY

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. Expression Therapeutics applies this policy to all federally-funded research conducted and administered by our company.

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 conducted and administered by Expression Therapeutics. Expression Therapeutics will review disclosures to determine if financial interests may create an actual or potential 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’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).

This policy is intended to signify that Expression Therapeutics, 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.

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 Expression Therapeutics. The regulation and this Policy explicitly apply to research authorized under the regulation, including Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) Phase II 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 the implementation 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 the federally-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance
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). Refer to 42 CFR 50.604 (c).

Who Needs to Know

All staff who provide support to Expression Therapeutics and its personnel on sponsored research and all staff and 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 Expression Therapeutics covered by this policy are responsible to know this policy and comply with its requirements.

Policy

Expression Therapeutics will fully comply with the Federal Rule titled Responsibility of Applicants for Promoting Objectivity in Research as posted in the Federal Register / Vol. 76, No. 165 / Thursday, August 25, 2011 / Rules and Regulations §42 CFR Part 50 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.

 

PROCEDURES

REGULATORY REQUIREMENTS

Require that each Investigator who is planning to participate in PHS-funded research disclose to Expression Therapeutics management of any significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for federally-funded research.

Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution, during the period of the award.

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).

Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure 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 in this Policy, Investigators are responsible for and required to:

To fully review the regulations and their obligations under the regulations as outlined in this document;
Report all Financial Conflicts of Interest in accordance with the procedures set forth by this document.

What financial interests are covered by the regulation and what is a Significant Financial Interest?

The regulation covers all financial interests that have monetary value, whether or not the value is readily ascertainable.

The 2011 revised regulation defines a “Significant Financial Interest” as follows:

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:
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;
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
Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

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, 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.

The term significant financial interest does not include the following types of financial interests:
salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by Expression Therapeutics, including intellectual property rights assigned to the Expression Therapeutics and agreements to share in royalties related to such rights;
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;
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
or income from service on advisory committees or review panels for 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.

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).

EXPRESSION THERAPEUTICS RESPONSIBILITIES

Expression Therapeutics shall provide the following:
Inform each Investigator of the Institution’s policy on financial conflicts of interest;
Inform each Investigator of the Investigator’s responsibilities regarding disclosure of significant financial interests and of these regulations; and
Inform each investigator of any revised financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators

Expression Therapeutics will solicit disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, federally funded research. (That is, a faculty member must be an Investigator on a federal grant or subaward awarded to Expression Therapeutics.)

Expression Therapeutics will manage all financial conflicts of interest, (including any financial conflicts of a subrecipient Investigator) in accordance with §50.605 (a) including:
Developing and implementing a management plan and, if necessary, a retrospective review and mitigation report; and
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 or retrospective 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.

Expression Therapeutics shall provide initial and ongoing FCOI reports to the PHS and NSF as required pursuant to § 50.605(b)

Use of Sub-recipients — If any part of the federally-funded research is conducted through a subrecipient (e.g., subcontractors or consortium members), Expression Therapeutics will take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by

Incorporating as part of a written agreement (contract) with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s Investigators.
Providing FCOI reports to the federal awarding agency regarding all financial conflicts of interest of all subrecipient 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 designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a federally-funded research 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 an Investigator’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 as Institutional 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) of the federally-funded research award.  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 and dependent children. (See definition of Significant Financial Interest).

“Public Health Service”
PHS means the Public Health Service of the U.S. Department of Health and Human Services, 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 and Quality (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).

“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 cooperative agreement.

“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 by the Institution in the grant application, progress report, or any other report submitted to the federal agency by the Institution under the regulation.