This Financial Conflict of Interest Policy (“Policy”) applies to each Investigator who is planning to or is participating in PHS-funded research. The University has additional conflict of interest procedures applicable to non PHS-funded projects.
II. POLICY STATEMENT
The purpose of this Policy is to promote objectivity in research by establishing guidelines for reporting and resolving financial conflicts of interest for research. This policy is intended to comply with regulations regarding financial conflicts of interest (“FCOI”) for Public Health Service (“PHS”) funded research, 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94 (the “Regulations”).
The principal missions of the University are the education of students and the generation and dissemination of knowledge. In pursuit of these missions, faculty and staff routinely engage in research and undertake projects sponsored by external funding agencies. External support generally benefits the University and is encouraged.
A. TRAINING REQUIREMENTS
a) The authorized Institutional Official shall inform each Investigator of:
Investigator’s disclosure responsibilities; and
b) The authorized Institutional Official shall require each Investigator to complete FCOI training:
Prior to engaging in research;
At least every 4 years; and
a. University revises this Policy that affects requirements of Investigators;
b. An Investigator is new to an Institution; or
c. An Investigator is not in compliance with this Policy or Management Plan.
B. DISCLOSURE, REVIEW AND MONITORING REQUIREMENTS
a) An SFI disclosure form is required from all Investigators involved in or proposing to participate in research.
b) The authorized Institutional Official shall require each Investigator to disclose SFIs (and those of the Investigator’s Immediate Family) related to the Investigator’s institutional responsibilities:
No later than at the time of application for research;
At least annually during the period of the award or research project; and
Within 30 days of discovering or acquiring a new SFI.
c) Institution shall designate one or more Institutional Official(s), to solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s Immediate Family) related to an Investigator’s institutional responsibilities.
d) Institution shall provide adequate guidelines for the designated Institutional Official(s) to determine whether an Investigator’s SFI is related to the research and, if so related, whether the SFI is an FCOI.
e) The authorized Institutional Official shall require its designees, prior to Institution’s expenditure of research funds, to:
Review all Investigator SFI disclosures;
Determine if any SFIs relate to the research;
Determine if an FCOI exists; and
Develop and implement Management Plans, as needed to manage FCOIs.
f) The authorized Institutional Official shall review disclosures of SFIs, make determination of FCOIs, and implement a Management Plan, when required, within 60 days for an Investigator who is new to participating in the research project or for an existing Investigator who discloses a new SFI.
g) The authorized Institutional Official shall review disclosures of SFIs, make determination of FCOIs, and implement a Management Plan, when required, within 60 days whenever an Institution identifies an SFI that was not disclosed timely by an Investigator or not previously reviewed by the Institution.
h) The authorized Institutional Official shall take such actions as necessary to manage FCOIs, including any financial conflicts of a sub-recipient Investigator, if applicable, and monitor Investigator compliance with Management Plans until completion of the project.
C. REPORTING REQUIREMENTS TO NIH FOR PHS-FUNDED RESEARCH
a) The authorized Institutional Official shall send initial, annual (i.e., ongoing) and revised FCOI reports, including all reporting elements required by the Regulation, to the PHS Awarding Component for the Institution and its sub-recipients, if applicable, as required by the Regulations:
Prior to the expenditure of funds;
Within 60 days of identification for an Investigator who is newly participating in a project;
Within 60 days for new, or newly identified, FCOIs for existing Investigators;
At least annually (at the same time the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the Management Plan, if applicable, until completion of the project; and
Following Retrospective Review to update a previously submitted report, if appropriate.
b) The authorized Institutional Official shall notify the PHS Awarding Component promptly if, during a Retrospective Review, bias is found with the design, conduct or reporting of PHS-funded research and to include the requirement to submit a Mitigation Report in accordance with the Regulation.
The procedures must include all Mitigation Report reporting elements as required by the Regulation.
c) The authorized Institutional Official shall notify the PHS Awarding Component promptly if an Investigator fails to comply with this Policy or a FCOI Management Plan that appears to have biased the design, conduct or reporting of the PHS-funded research.
The Institution shall notify the PHS Awarding Component promptly and take any corrective action for noncompliance with this Policy or the Management Plan.
D. MAINTENANCE OF RECORDS
a) The authorized Institutional Official shall maintain all FCOI-related records for:
At least 3 years from the date the final expenditures report is submitted to the PHS Awarding Component, if applicable;
From other dates specified in 45 C.F.R. 74.53(b) and 92.42(b), where applicable, as may be published from time to time.
E. ENFORCEMENT MECHANISM, REMEDIES AND NONCOMPLIANCE
a) The authorized Institutional Official shall adequately enforce and provide for employee sanctions or other administrative actions to ensure Investigator compliance
b) The authorized Institutional Official shall complete and document Retrospective Reviews within 120 days of the Institutional Official’s determination of noncompliance for SFIs not disclosed timely or previously reviewed, or whenever an FCOI is not identified or managed in a timely manner, and shall document the reviews consistent with the Regulation.
c) The purpose of a PHS-funded clinical research project may be to evaluate the safety or effectiveness of a drug, medical device or treatment. In certain circumstances, the Department of Health and Human Services may determine that such PHS-funded research project was designed, conducted or reported by an Investigator with a FCOI that was not managed or reported by the Institution as required by the Regulation. In such instance, the authorized Institutional Official shall require the Investigator involved to:
Disclose the FCOI in each public presentation of the results of the research; and
Request an addendum to previously published presentations.
Institution may require similar disclosures for non-PHS-funded research.
F. SUBRECIPIENT REQUIREMENTS
a) Where applicable, the authorized Institutional Official shall establish, via a written agreement, whether the sub-recipient will follow this Policy or the FCOI policy of the sub-recipient.
b) If applicable, the authorized Institutional Official shall obtain a certification from the sub-recipient that its FCOI policy complies with the Regulation.
c) If applicable, the Institution shall include in the written sub-recipient agreement a requirement for the sub-recipient to report identified FCOIs for its Investigators in a time frame that allows the awardee Institution to report identified FCOIs to the PHS Awarding Component as required by the Regulation.
d) Alternatively, if applicable, Institution shall include in the written agreement a requirement to solicit and review sub-recipient Investigator disclosures that enable Institution to identify, manage and report identified FCOIs to the PHS Awarding Component.
G. PUBLIC ACCESSIBILITY REQUIREMENTS
a) The authorized Institutional Official shall make this Policy publicly accessible by posting it on its website.
b) For PHS-funded research only, the authorized Institutional Official shall make available information concerning identified FCOIs held by senior/key personnel publicly accessible prior to the expenditure of funds. The information will:
a. Include the minimum elements as provided in the Regulation;
b. Be posted on a public website or made available within 5 calendar days of written request;
c. Be updated, at least annually (website only but any response to a written request should include the updated information);
d. Be updated, within 60 days of a newly identified FCOI (website only by any response to a written request should include the updated information); and
e. Remain available for 3 years from the date the information was most recently updated.
A. The defined terms used in this Policy are those used in the Regulations, 42 C.F.R. Part 50, Subpart F and 45 C.F.R. Part 94.
“Disclosure of Significant Financial Interest means an Investigator’s disclosure of significant financial interests to Institution.”
“Financial Conflict of Interest (or FCOI) means a significant financial interest that could directly and significantly affect the design, conduct or reporting of the research.”
“FCOI report means an Institution’s report of a Financial Conflict of Interest to a PHS Awarding Component.”
“Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.”
Immediate Family means spouse or spousal equivalent and dependent children.
Institution means Arcadia University, including its schools and colleges.
Institutional Official (sometimes also referred to as Authorized Institutional Official) for the purpose of this Policy means that person designated by the Institution, or individual school or college, as the person responsible for administration of financial conflicts of interest pursuant to this Policy, or the more specific policy or procedures of the applicable school or college.
“Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of Institution, and as may be defined by Institution in its policies on conflicts of interest. Such Institutional Responsibilities may include, for example, research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data Monitoring committees.”
“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 or proposed for such funding, which may include, for example, collaborators or consultants.” For the purposes of this Policy, the term individual shall be synonymous with Investigator.
Manage or management of FCOI or “means taking action to address the FCOI, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.” A Management plan is usually prepared in cases when FCOI is identified.
“PD/PI means a project director or principal Investigator of a research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this Policy.”
“PHS Awarding Component means the unit of the PHS funding the research.”
“Research means a systematic investigation, study or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. This term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).” For purposes of this Policy, research is limited to the above activities when funded by PHS.
“Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report under this Policy.”
SFI Disclosure Form means the disclosure form and accompanying documentation that an Investigator or individual must submit to Institution disclosing any SFI or confirming that there is no SFI.
“Significant Financial Interest or SFI means:
a. Financial Interest consisting of one or more of the following interests of the Investigator and the Investigator’s Immediate Family that reasonably appears to be related to the Investigator’s Institutional Responsibilities, including but not limited to:
i. With regard to any publicly traded entity, 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 the disclosure, when aggregated, exceeds $5,000. This includes:
a) Remuneration for salary and services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); and
b) Equity interest including 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, if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or if the Investigator or his/her Immediate Family holds any equity interest (e.g. stock, stock option or other ownership interest) in the entity; or
iii. Intellectual property rights and interests (e.g. patents and copyrights), upon receipt of income related to such rights and interests.
b. Any reimbursed sponsor 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 the Investigator’s Institutional Responsibilities, other than travel that is reimbursed or sponsored by:
i. A federal, state or local government agency (Public Agency);
ii. An institution of higher education as defined at 20 U.S.C. 1001(a); or
iii. An academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.
c. Significant Financial Interest does not include:
i. Salary or other remuneration paid by Institution, if the Investigator is employed by Institution, including intellectual property rights assigned to the Institution and agreements to share royalties related to those 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 Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education; or
iv. Income from service on advisory committees or review panels for a Public Agency, institution of higher education, academic teaching hospital, medical center or research institute that is affiliated with an institution of higher education.”