Controller Financial Conflict of Interest (FCOI)

Financial Conflict of Interest
Approved by: Senior Staff	Approval Date: July 23, 2012
Related Policies: Significant Financial Conflict of Interest Form Amherst College Scientific Misconduct Policy Amherst College Policies Related to External Grants and Contracts Amherst College Conflict of Interest Policy - Staff Handbook	Primary Office Responsible for Administering this Policy: Office of the Provost and Dean of the Faculty
Revision History: None	Procedures: ________________

The 2011 revised regulation, Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought, seeks to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest.  This regulation is commonly referred to as the Financial Conflict of Interest (FCOI) regulation.

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 no later than August 24, 2012, 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 Amherst College, 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 and include any activity for which research funding is available from PHS through a grant or cooperative agreement.  The regulation and this Policy explicitly apply to research authorized under the PHS Act or other statutory authority, 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.

PHS award programs that are excluded from the regulation and this Policy are the Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) Phase I applications.

The regulation and this Policy are applicable to awardees, sub-recipients, 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 sub-recipient relationship is established when federal funds flow down from or through an awardee Institution to another individual or entity and the sub-recipient will be conducting a substantive portion of the NIH-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 sub-recipient (e.g., subcontractors or consortium members).  See 42 CFR 50.604 (c).

Who Needs To Know This Policy

All staff who provide support to the College and its faculty on sponsored research and all faculty, staff, and/or all Investigators who may apply for, receive, plan to participate in or who are participating in such research as is conducted under PHS grants or other awards covered by this policy are responsible to know this policy and comply with its requirements.

Policy

Amherst College 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  as respects all grants or awards for which Public Health Service 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 following Procedures which are incorporated by reference into this policy.

Procedures

1) INVESTIGATOR REQUIRED TO REPORT CONFLICTS OF FINANCIAL INTEREST

Amherst College will:

(a)  require that each Investigator who is planning to participate in the PHS-funded research disclose to the Office of the Dean of the Faculty the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS funded research.

(b)  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.

(i) 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 PHS-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).

(c)  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 PHS-funded grants, awards or other funds subject to the regulations outlined in this Policy, Investigators are responsible for and required to:

1.  attend College provided or other required training on the regulations and their obligations under the regulations
2. report all Financial Conflicts of Interest to the Dean of the Faculty in accordance with the procedures set forth by the Office of the Dean of the Faculty.
3. participate in and comply with any College FCOI Management Plan, including any retrospective review and/or mitigation plan.
4. supply the Office of the Dean of the Faculty with any FCOI as appropriate with any sub-recipients or sub-awardees if the Investigator is the Primary Investigator.

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:

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:

i) 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;

ii) 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

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

iv) Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities, including payments made on behalf of the investigator and reimbursed or sponsored travel by a private for-profit or non-profit agency. The investigator is responsible for identifying these transactions, even if an exact monetary value is not readily available.

v) Investigators do not need to report: travel that is reimbursed or sponsored by a federal, state, or local government agency, an 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. 

vi) Disclosure shall be on the Disclosure of Significant Financial Interest form provided by the Office of the Comptroller, which will include: the purpose of the trip; the identity of the sponsor/organizer; the destination; and the duration of the travel.  In accordance with this policy, the Office of the Dean of the Faculty 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 PHS-funded research.

2) The term significant financial interest does not include the following types of financial interests:

i) salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the College, including intellectual property rights assigned to the College and agreements to share in royalties related to such rights;

ii) 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;

iii) income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an 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;

iv) or income from service on advisory committees or review panels for a federal, state, or local government agency, an 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.

Please refer to the related conflict of interest policies and confer with the Dean of the Faculty Office if you have questions about Amherst College’s disclosure requirements.

Institutional Responsibilities

1) Training  — The Dean of the Faculty Office shall:

(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.

(c) Require each Investigator to complete training regarding the same prior to engaging in research related 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 Amherst College.

(iii) An Institution finds that an Investigator is not in compliance with the Institution’s financial conflict of interest policy or management plan.

2) Additional Responsibilities of the Dean of the Faculty Office

a) A designated Associate Dean of the Faculty will solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.

b) The Office of the Dean of the Faculty will maintain guidelines to determine whether an Investigator’s significant financial interest is related to PHS funded research and, if so related, whether the significant financial interest is a financial conflict of interest.

i)  An Investigator’s significant financial interest is related to PHS-funded research when the Institution, through its designated official(s), reasonably determines that the PHS-funded research could be affected by the significant financial interest;

ii) Or the PHS funded research is in an entity whose financial interest could be affected by the research. The College may involve the Investigator in the determination of whether a significant financial interest is related to the PHS-funded research.

iii) A financial conflict of interest exists when the College, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

c) The Office of the Dean of the Faculty will manage all financial conflicts of interest, (including any financial conflicts of a sub-recipient Investigator) in accordance with §50.605 (a) including:

(i)  Develop and implement a management plan and, if necessary, a retrospective review and mitigation report.

(ii) Maintain 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 PHS or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42 (b) for different situations.

d) The Office of the Dean of the Faculty 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 an including termination.

3) The Office of the Dean of the Faculty shall provide initial and ongoing FCOI reports to the PHS as required pursuant to § 50.605(b)

4) Use of Sub-recipients —  If any part of  the PHS-funded research is conducted through a sub-recipient (e.g., subcontractors or consortium members), the Office of the Dean of the Faculty with the support of the Primary Investigator (i.e., awardee Institution) will take reasonable steps to ensure that any sub-recipient Investigator complies with this subpart by

(a) Incorporating as part of a written agreement (contract) with the sub-recipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the sub-recipient will apply to the sub-recipient’s Investigators.

(i) If the sub-recipient’s Investigators must comply with the sub-recipient’s financial conflicts of interest policy, the sub-recipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the sub-recipient cannot provide such certification, the agreement shall state that sub-recipient 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 sub-recipient’s work for the awardee Institution;

(ii) Additionally, if the sub-recipient’s Investigators must comply with the sub-recipient’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the sub-recipient 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 sub-recipient’s Investigators must comply with the awardee Institution’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient 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 PHS Awarding Component regarding all financial conflicts of interest of all sub-recipient 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 PHS-funded research project and could directly and significantly affect the design, conduct or reporting of the PHS-funded 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 PHS research funding.

 “Institutional responsibilities”

“Institutional responsibilities” are defined by the 2011 revised regulation as an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on Financial Conflict of Interest. It includes such activities as research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. 

“Investigator”

For the purpose of this policy  “Investigator” means the project director or principal investigator and any other person at Amherst College, who is responsible for the design, conduct, or reporting of research or proposed for such funding by certain Federal Agencies. Typically this will include the Principal Investigator and co-Investigators, Sub-recipients and Collaborators. For the purpose of this disclosure requirement, the term "Investigator" includes the Investigator's spouse and dependent children.

"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)(See http://www.globalhealth.gov/about-us/operating-divisions/ for a complete list of all HHS Operating Divisions).

"Research"

Research is any activity (described at 42 CFR 50.603) for which research funding is available from a PHS Awarding Component (e.g., NIH) through a grant or cooperative agreement. It may include: a research grant, career development award, center grant, individual fellowship award, infrastructure award, Institutional training grant, program project, or research resources award.

 “Senior/Key Personnel”

As referenced in the 2011 revised regulation, “Senior/Key Personnel” in PHS-funded research
Senior/Key Personnel 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 PHS-funded agency by the Institution under the regulation.

 “Sub-recipient”

A sub-recipient is an entity that receives a sub-award from the prime recipient under an award and is accountable to the prime recipient for the use of the Federal funds provided by the sub-award.