This policy is written to conform to the Public Health Service regulations regarding Financial Conflicts of Interest, 42 Code of Federal Regulations Part 50, Subpart F. These regulations require that all individuals who participate in the design, conduct, or reporting of research funded by the Public Health Service (“PHS”) complete training on financial conflicts and disclose personal financial interests that could give rise to an actual conflict of interest or the appearance of a conflict. A copy of the full text of the regulations and the final rule implementing the regulations published in the Federal Register can be accessed at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.
I. SCOPE
This policy is applicable to all Investigators (as defined below) involved in Public Health Service (PHS) federally sponsored research projects (“Research”) for or on behalf of BSC. This policy also extends to any subcontractors, sub-grantees or sub-awardees (collectively “Subrecipients”) at other institutions conducting Research for or on behalf of BSC, as further described below. This policy should be read in conjunction with BSC’s Code of Conduct and Conflict of Interest policy which provide general instruction on preventing, recognizing, and mitigating conflicts of interest. The requirements of this policy are intended to supplement, not replace, the disclosure obligations and processes set forth in the Code of Conduct and Conflict of Interest policies.
II. DEFINITIONS
Financial Conflict of Interest (FCOI) means a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of Research funded by PHS.
Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
Institutional Responsibilities means an Investigator’s professional activities on behalf of BSC (e.g., research, research consultation, administration, or service on panels such as Institutional Review Boards (IRBs) or Data and Safety Monitoring Boards (DSMBs)).
Investigator means any Principal Investigator, project manager, research analyst, or member of the research team identified as senior/key personnel on the grant or contract application, progress report, or any other report; and/or other individuals that the Principal Investigator/project manager identifies as responsible for or having substantial independent decision making with respect to the design, conduct or reporting of the Research funded by the PHS or proposed for such funding, including collaborators or consultants.
Significant Financial Interest (SFI) means:
(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 appear 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. 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);
(iii) intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests; or
(iv) any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse or dependent children) that is related to the Investigator’s Institutional Responsibilities. This disclosure requirement excludes travel that is reimbursed or sponsored by an U.S. 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.
(2) The term significant financial interest does not include the following types of financial interests:
(i) salary, royalties, or other remuneration paid by BSC to the Investigator if the Investigator is currently employed or otherwise appointed by BSC, including intellectual property rights assigned to BSC and agreements to share in royalties related to such rights;
(ii) any ownership interest in BSC held by Investigator;
(iii) 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;
(iv) income from seminars, lectures, or teaching engagements sponsored by an U.S. 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; or
(v) income from service on advisory committees or review panels for an U.S. 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.
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 and that is PHS-funded pursuant to a grant or contract. The 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).
III. TRAINING REQUIREMENTS
Each Investigator, including subrecipient Investigator(s), will receive a copy of this policy and must complete FCOI training regarding this policy and the Investigator’s responsibilities regarding disclosure of significant financial interests before engaging in Research, and at least every four years. Investigators must complete FCOI training immediately under the following circumstances:
- BSC’s FCOI policies change in a manner that affects Investigator’s requirements
- An Investigator is new to BSC
- BSC finds an Investigator to be noncompliant with BSC’s FCOI policy or management plan
IV. IDENTIFICATION OF FINANCIAL CONFLICTS OF INTEREST
BSC will appoint a designated official within the Global Compliance Department who will oversee and review disclosures of significant financial interests from each Investigator who participates in, or intends to participate in, PHS-funded Research.
BSC’s designated official will determine whether an FCOI exists, which occurs when BSC’s designated official reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded Research.
V. DISCLOSURE PROCEDURES
Investigators are required to disclose to BSC all their Significant Financial Interests (including those of the Investigator’s spouse and dependent children) that reasonably appear to be related to their Institutional Responsibilities:
(1) at the time of application for PHS-funded research;
(2) no later than thirty (30) days from the date of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new Significant Financial Interest; and
(3) at least annually during the period of award.
Investigators must also disclose any reimbursed or sponsored travel expenses which constitute a Significant Financial Interest under this Policy. This disclosure must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Travel expenses paid by a third party through a grant to, or a contract with BSC do not need to be reported.
BSC Subrecipients: Where BSC carries out PHS-funded research through subgrantees, contractors, subcontractors or collaborators, BSC will take reasonable steps to ensure that Investigators working for such entities comply with the FCOI regulation. For PHS-funded research, BSC will incorporate in a written agreement with any subrecipient terms that establish whether BSC’s FCOI policy or the subrecipient’s FCOI policy will apply to subrecipient Investigators and will include time periods to meet disclosure and/or FCOI reporting requirements. If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the subrecipient must certify as part of the agreement with BSC that its FCOI policy complies with the PHS FCOI regulation. If the subrecipient cannot provide such a certification, the agreement between BSC and the subrecipient will state that subrecipient Investigators are subject to BSC’s FCOI policy for disclosing significant financial interests that are directly related to the subrecipient’s work for BSC. Please see 42 CFR Section 50.604(a) for grants and cooperative agreements and 45 CFR Part 94.4(a) for contracts. With respect to grants or cooperative agreements, this arrangement should be defined in a formal written agreement with each participant.
BSC Investigators who receive PHS subawards: If BSC will be a subrecipient/subcontractor to another entity on a PHS award/contract, a BSC investigator or department may receive a form from the prime grantee/contractor asking BSC to certify whether BSC will use its own FCOI policy or whether BSC will use the prime recipient/contractor’s policy. The answer is always that BSC uses its own FCOI policy. BSC does not agree to use or follow any other entity’s FCOI policy, forms, or procedures.
BSC will maintain records related to all Investigator disclosures of financial interests and BSC’s review of and response to such disclosures and all actions under this policy or retrospective review, for at least three years from the date BSC submits the final expenditures report to PHS.
VI. REPORTING OF FINANCIAL CONFLICTS OF INTEREST TO PHS AWARDING COMPONENTS
For PHS awarded grants and cooperative agreements, BSC will submit all required FCOI reports to the PHS Awarding Component through the electronic Research Administration (eRA) Commons FCOI Module.
Submission of Initial FCOI Reports: Before BSC’s expenditure of any funds under a PHS-funded research project, BSC will provide to the PHS Awarding Component an FCOI report and ensure that BSC has implemented a management plan for any FCOI. If BSC identifies an FCOI and eliminates it prior to the expenditure of PHS-awarded funds, BSC is not required to submit an FCOI report to the PHS Awarding Component.
Submission of FCOI Reports during ongoing PHS-funded Research: For any FCOI that BSC identifies during an ongoing PHS-funded research project (such as, upon participation of an Investigator who is new to the project, or for newly identified FCOIs for existing Investigators), BSC will provide to the PHS Awarding Component, within 60 days, an FCOI report regarding the FCOI and ensure that a management plan has been implemented.
Annual FCOI report: For any FCOI previously reported by BSC, BSC will provide an annual FCOI report that addresses the status of the financial interest and any changes to the management plan. Annual FCOI reports will specify whether the FCOI is still being managed or explain why the FCOI no longer exists. Annual FCOI reports must be submitted to the PHS (e.g., through the eRA Commons for grants and cooperative agreements) for the duration of the project period (including extensions with or without funds) at the same time as when BSC is required to submit the annual progress report (i.e., two months prior to the start date or 45 days prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension (e.g., submission of an extension notification in the eRA Commons or submission of a BSC prior approval request, whichever is applicable.) The annual FCOI report is not to be submitted as part of the annual progress report. The annual FCOI report is submitted separately through the eRA Commons FCOI Module.
All FCOI reports must include the following information: • 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, • Name of the entity with which the Investigator has a FCOI, • Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria), • Value of the financial interest 1. $0 – $4,999 2. $5K – $9,999 3. $10K – $19,999 4. Amounts between $20K - $100K by increments of $20K. Amounts above $100K by increments of $50K or a statement that a value cannot be readily determined, • A description of how the financial interest relates to PHS-funded research and the basis for BSC’s determination that the financial interest conflicts with such research, • Key elements of the BSC management plan (defined below in section V), and • An FCOI report for any FCOIs identified for subrecipient Investigators.
VII. MANAGEMENT PLANS FOR FINANCIAL CONFLICTS OF INTEREST
Prior to BSC’s expenditure of any funds under a PHS-funded research project, the BSC designated official(s) will review all Investigator disclosures of Significant Financial Interests; determine whether any SFIs relate to PHS-funded research; determine whether an FCOI exists; and, if so, develop and implement a management plan that specifies the actions that have been and will be taken to manage the FCOI.
The key elements of the management plan include: ●The role and principal duties of the conflicted Investigator in the research project; ●Conditions of the management plan; ●How the management plan is designed to 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; and ●Other information as needed.
Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to: ● Public disclosure of financial conflicts of interest (e.g., when presenting or publishing research); ● For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; ● Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias, resulting from the FCOI; ● Modification of the research plan; ● Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; ● Reduction or elimination of the financial interest (e.g., sale of an equity interest); and ● Severance of relationships that create financial conflicts.
Updated or annual FCOI reports must include the status of the management plan (i.e., whether the financial conflict is still being managed or explain why the financial conflict no longer exists) and a description of any changes to the management plan since the last FCOI report was submitted to the PHS Awarding Component. PHS may, at any time, request additional information regarding all conflicting interests identified by BSC and how those interests have been managed, reduced or eliminated to protect the research from bias and may inquire into BSC’s procedures and actions regarding FCOIs in research funded by PHS, including a requirement for submission, or review on site, of all records pertinent to compliance with the regulation.
VIII. RETROSPECTIVE REVIEW AND MITIGATION REPORTS
If BSC identifies a significant financial interest that was not disclosed timely by an Investigator, was not previously reviewed by the Institution during a PHS-funded research project, or for any other reason, the BSC designated official will, within 60 days, review the significant financial interest, determine whether it is related to PHS research, and determine whether a conflict of interest exists. If an FCOI is identified, the BSC designated official will implement a management plan specifying the actions to manage the conflict of interest going forward.
If an FCOI is not identified or managed in a timely manner, including: ● Failure by the Investigator to disclose a Significant Financial Interest that is determined by BSC or a collaborator to constitute an FCOI; ● Failure by BSC or a collaborator to review or manage such an FCOI; or ● Failure by the Investigator to comply with a Financial Conflict of Interest management plan; the BSC designated official will, within 120 days of BSC’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. BSC will document the retrospective review, which will include at least the following key elements: ●Project number; ●Project title; ●PD/PI or contact PD/PI if a multiple PD/PI model is used; ●Name of the Investigator with the FCOI; ●Name of the entity with which the Investigator has an FCOI ●Reason(s) for the retrospective review; ●Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.); ●Findings of the review; and ●Conclusions of the review. If bias is found, BSC will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include, at a minimum, the key elements documented in the retrospective review above, a description of the impact of the bias on the research project, and BSC’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, BSC will submit FCOI reports annually as prescribed by the regulation.
BSC will monitor an Investigator’s compliance with a management plan on an ongoing basis until the completion of the PHS-funded Research.
IX. REPORTS TO THE PUBLIC FOR PHS-SUPPORTED RESEARCH
As required by Federal regulations and upon written request, BSC will provide to a requestor written information about Financial Conflicts of Interest of an individual who is listed as a Senior or Key Personnel on a PHS award. Requests must sent to Global.Compliance@bsci.com. The request must identify the specific PHS project number and the name of Investigator for whom information is being requested. The request must include a named recipient and return address with a physical street address; P.O. Boxes are not acceptable. BSC will note in its written response that the information is current as of the date of the correspondence and is subject to updates at least annually and within sixty (60) days of BSC’s identification of a new FCOI, which must be requested under separate cover by the requestor. The following information will be provided to the requestor: • Name of the entity in which the FCOI is held • Project Number • Name of the Investigator with an FCOI; • Investigator’s title and role with respect to the Research project; • Nature of the Financial Interest (e.g. equity, consulting fee, travel reimbursement, honorarium); and • Value of the Financial Interest (in ranges), or a statement that the interest is one whose valued cannot be readily determined through reference to public prices or other reasonable measure of fair market value.
BSC is not required to and pursuant to this policy will not respond to a request regarding information concerning a significant financial interest that has been disclosed to BSC if: (1) the significant financial interest was disclosed but is not still held by the senior/key personnel; (2) BSC determined that the significant financial interest did not relate to the PHS-funded research; and (3) BSC determined that the significant financial interest was not an FCOI.
BSC will retain information regarding any FCOIs and significant financial interests set forth in this Section VII for at least three years from the date in which such information was most recently updated.
X. COMPLIANCE
Failure by an individual to comply with the terms of this policy, to file a complete and truthful financial disclosure for pending proposals, or when a new financial interest is obtained, or failure to comply with any conditions or restrictions directed or imposed, including failure to cooperate with appointed project monitoring bodies, will be grounds for discipline. Agreements with consultants who either fail to file a complete disclosure or fail to comply with any conditions or restrictions imposed may be terminated. Similarly, agreements with subrecipient organizations may be terminated if that organization fails to comply with its obligations under the PHS regulations. In any case in which the U.S. Department of Health and Human Services determines that a PHS-funded research project of clinical research 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 an FCOI that was not managed or reported by BSC as required by the PHS regulation, BSC will 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.
If an Investigator fails to comply with this policy, or an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded Research, BSC will promptly notify the PHS awarding component of the corrective action to be taken.