FCOI Policy

 Financial Conflict of Interest Policy

The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50  Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and an organization must take in order to promote objectivity in research. The regulations apply to all PHS funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business Innovation Research or Small Business Technology Transfer program grants), and subawards where the originating sponsor is PHS.

Definitions

Institutional responsibilities mean an Investigator’s professional activities on behalf of  Coram.  Specifically, these include:

  • Externally sponsored research or scholarly activities (includes activities such as proposing, conducting, and analyzing research and disseminating results);

  • Research (includes participation in study sections, peer review of manuscripts, or effort on non-sponsored research);

  • Special Service activities on behalf of Coram including institutional   community service.

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 an award, subaward, or proposed for such funding, which may include, for example, collaborators or consultants. Coram’s Principal Investigator/Project Director, upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.

 Significant Financial Interest means:

  • 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 on behalf of Coram.

  • 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 for the investigator, investigator’s spouse and dependent children, 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);
    • With regard to intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income of greater than $5,000 related to such rights and interests;
    •   With regard to third party reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse/dependent children), a significant financial interest exists if the remuneration received, when aggregated, is greater than $5,000 and is related to the Investigator’s institutional responsibilities (i.e., administrative or research).  

    •  With regard to any foreign financial interest, 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.

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

  • Salary, royalties, or other remuneration paid by Coram to the Investigator if the Investigator is currently employed or otherwise appointed by Coram, including intellectual property rights assigned to Coram 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 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

    • 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.

 

 

Disclosure

Prior to the submission of an application to the PHS Grantee for funding, the Principal Investigator and all other Investigators at Coram must have disclosed to Coram’s designated official an up-to-date listing of their Significant Financial Interests [SFIs] (and those of their spouse and dependent children), as defined above. Any new Investigator, who, subsequent to the submission of an application to the PHS Grantee for funding from the PHS Grantee, or during the course of the research project, plans to participate in the project, must similarly disclose their SFI to the designated official promptly and prior to participation in the project.

Each Investigator who is participating in research under an award that originates from PHS must submit an updated disclosure of SFI at least annually, during the period of the award. Such disclosure must include any information that was not disclosed initially to Coram, pursuant to this Policy, or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on a PHS- funded project directly as a PHS Grantee and/or indirectly through a subaward that was transferred from another Institution), and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

Each Investigator who is participating in research under a prime award or subaward where the prime award originates from PHS must submit an updated disclosure of SFI (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.

For third party reimbursed or sponsored travel with a remuneration greater than $5,000, the disclosure must include at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. This disclosure requirement excludes travel paid for by Coram and does not apply to travel that is reimbursed or sponsored by an U.S. federal, state, or local government agency, an 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.

Disclosures of foreign financial interests. Investigators, including subrecipient Investigators, must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or foreign governments (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).

 

 

 

 

Review by Coram’s Designated Official

The designated official will conduct reviews of disclosures. The designated official will review any SFI that has been identified in a disclosure; these interests will be compared to each research award funded by PHS on which the Investigator is identified as responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the award and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that research award.

Guidelines for Determining “Relatedness” and Financial Conflict of Interest

The designated official will determine whether an Investigator’s SFI is related to the research under a prime award or subaward supported by a PHS prime award and, if so, whether the SFI is a Financial Conflict of Interest. An Investigator’s SFI is related to the research under the award when the designated official reasonably determines that the SFI could be affected by the research conducted under the award; or is in an entity whose financial interest could be affected by the research. The designated official may involve the Investigator in the determination of whether an SFI is related to the research supported by the award.

A Financial Conflict of Interest exists when the designated official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

In determining if an Investigator’s SFI is related to the research under a prime award or subaward supported by a PHS prime award, and if so, whether the relationship creates a FCOI, the designated official will consider the role of the Investigator and the opportunity (if any), to bias the results, the nature of the research being proposed, and the value of the SFI in relation to the size and value of the entity.  In addition, the designated official may also consider the following factors:

  1. Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes; or

  2. Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely; or

  3. Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention); or

  4. Where the research involves human subjects, whether there are double blind conditions or the involvement of a data and safety monitoring board; or

  5. Where the SFI is in a privately held company, whether the researcher’s SFI could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and STTRs); or

  • The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or

  • Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser’s technology, the amount of commercialization payments received by the Investigator from that technology, both currently or in the future; or

  • The number and nature of relationships an Investigator has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts; or

  • Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the SFI; or

  • Whether other scientific groups are independently pursuing similar questions; or

  • Whether sufficient external review of the research conducted and the reporting of research results exist to mitigate undue bias; or

  • Whether the goal of the project is a comparative evaluation of a technology in which an Investigator has an SFI; or

  • Whether the project involves an award to an entity in which the Investigator has an SFI.

Management of Significant Financial Interests that Pose Financial Conflict(s) of Interest

If a conflict of interest exists, the designated official will determine by what means (such as the individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee) the conflict should be avoided or managed in order to mitigate undue bias. In making those determinations, the designated official will be guided by the principles discussed in this Policy. The designated official will also take into consideration whether the Investigator’s ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications.

Examples of conditions that might be imposed to manage a Financial Conflict of Interest include, but are not limited to:

  1. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
    1. For research projects involving human subjects research, disclosure of Financial Conflicts of Interest directly to human participants;
    1. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
    1. Modification of the research plan;
    1. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
    1. Reduction or elimination of the financial interest (e.g., sale of an equity interest);
    1. Severance of relationships that create financial conflicts;
    1. For research projects involving human subjects research, use of a data and safety monitoring board;
    1. Double-blind conditions;
    1. Provisions to conduct the work simultaneously at multiple sites;
    1. Written disclosure of the conflict to all individuals working on the research project;

    1. Annual reports on the research progress to the designated official.

If the designated official determines that a conflict exists, he/she will communicate the determination and the means that has been identified for eliminating or managing the conflict, in writing, to the individual, to the relevant Principal Investigator/Project Director, and the appropriate direct supervisor. The designated official will keep a record of the disclosure and other relevant information for at least three years. If the designated official prescribes monitoring of the activity, he/she will describe what monitoring shall be performed and what records are to be kept.

No expenditures on a prime award or subaward supported by a PHS prime award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the designated official necessary to manage the Conflict of Interest.

The designated official will keep a record of Investigator disclosures of financial interests and the designated official’s review of, and response to, such disclosure and all actions under this policy. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the award and relevant PHS Regulations.

Public Accessibility to Information Related to Financial Conflicts of Interest

Prior to the expenditure of any funds under a prime award or subaward funded by a PHS prime award, Coram will ensure public accessibility, via a publicly accessible Web site or by written response to any requestor within five business days of a request, of information concerning any SFI disclosed that meets the following three criteria:

  • The Significant Financial Interest was disclosed and is still held by senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel by Coram in the award application, progress report or any other report submitted to the PHS;

  • Coram has determined that the Significant Financial Interest is related to NIH funded research; and

  • Coram has determined that the Significant Financial Interest is a Financial Conflict of Interest.

The information that Coram will make available via a publicly accessible Web site or in a written response to any requestor within five days of request will include, at a minimum, the following:

  • The Investigator’s name;

  • The Investigator’s title and role with respect to the research project;

  • The name of the entity in which the Significant Financial Interest is held;

  • The nature of the Significant Financial Interest; and

  • The approximate dollar value of the Significant Financial Interest in the following ranges: $0 to $4,999; $5,000 to $9,999; $10,000 to $19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

If Coram uses a publicly accessible Web site to comply with the public disclosure requirements of the PHS regulations, the information posted will be updated at least annually, and within sixty days of receipt or identification of information concerning any additional Significant Financial Interest of the senior/key personnel for the PHS-funded research project that had not been previously disclosed, or upon the disclosure of a Significant Financial Interest of senior/key personnel new to the PHS-funded research project, if it is determined by the designated official that the Significant Financial Interest is related to the research and is a Financial Conflict of Interest.

If Coram responds to written requests for the purposes of public accessibility, it will ascertain from the Investigator that the information provided is current as of the date of the correspondence, and will note in its written response that the information is subject to updates, on at least an annual basis and within 60 days of the Coram’s identification of a new Financial Conflict of Interest, which should be requested subsequently by the requestor.

Information concerning the Significant Financial Interests of an individual, as limited by this Policy, will remain available, for responses to written requests or for posting via Coram’s publicly accessible Web site for at least three years from the date that the information was most recently updated.

 

Reporting of Financial Conflicts of Interest

Prior to the expenditure of any funds under a prime award or subaward funded by a PHS prime award, Coram will provide to the PHS a FCOI report compliant with PHS regulations regarding any Investigator’s Significant Financial Interest found to be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding management plan.

While an award is ongoing (including any extensions with or without funds), Coram will provide to the PHS an annual FCOI report that addresses the status of the FCOI and any changes in the management plan.

For any Significant Financial Interest that is identified as conflicting subsequent to an initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), Coram will provide to the PHS, within forty-five days, an FCOI report that includes the following:

  •       The project number

  •       The PD/PI or Contact PD/PI if there are multiple PD/PIs

  •       The name of the investigator with the FCOI

  •       The name of the entity with which the investigator has an FCOI

  • The nature of the Significant Financial Interest (SFI), for example, equity interest, consulting fee, travel reimbursement, honorarium

  • The value of the financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value

    • When the value of the financial interest is given, the following dollar ranges will be used: $0 to $4,999 dollars; $5,000 to $9,999; $10,000 to $19,999. For amounts higher than $19,999 dollars, amounts between $20,000 and $100,000 can be given in increments of $20,000, and amounts above $100,000 can be given in increments of $50,000

  •  A description of how the financial interest relates to the NIN-funded research and the basis for Coram’s determination that the financial interest conflicts with such research

  • A description of the key elements of Coram’s management plan, including:
    • The role and principal duties of the conflicted investigator in the research project
    • The 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

    • Other information as needed

Training Requirements

Each Investigator must complete training on Coram Conflict of Interest Policy Applicable to An Award Issued by the Public Health Services prior to engaging in research related to any PHS-funded award and at least every four years, and immediately (as defined below) when any of the following circumstances apply:

  1. Coram revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators (training is to be completed within the timeframe specified in communications announcing such changes);

  2. An Investigator is new to Coram research under a prime award or subaward issued under a PHS prime award (training is to be completed prior to his/her participation in the research); or

  3. Coram finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the designated official).

In fulfillment of the training requirement, Coram requires its investigators to do the following:

  1)  Read this Financial Conflict of Interest policy;

  2)  Complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and expectations of this Policy.  All investigators must print a certification of completion at the end of training and retain it for audit purposes.  

  3) Complete an in-person or virtual discussion of Financial Conflicts of Interest with Coram’s Designated Official.

Failure to Comply with Coram’s Conflict of Interest Policy Applicable to Public Health Service Funded Award:  Retrospective Review

When a FCOI is not identified or managed in a timely manner, including, for example, because the underlying Significant Financial Interest is not disclosed timely by an Investigator; or because a FCOI was not timely reviewed or reported by a second tier subrecipient or by Coram; or because an investigator failed to comply with a management plan; then Coram will, within 120 days of Coram’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research. Coram shall document the “retrospective review” which will include at least the following key elements: 

  1. Project number;

  2. Project title;

  3. PD/PI or contact PD/PI if a multiple PD/PI model is used;

  4. Name of the Investigator with the FCOI;

  5. Name of the entity with which the Investigator has a FCOI;

  6. Reason(s) for the retrospective review;

  7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);

  8. Findings of the review; and

  9. Conclusions of the review.

If bias is found, Coram will notify NIH promptly and submit a mitigation report.  If the FCOI was previously reported to the NIH, the mitigation report will be submitted as a “Revised FCOI Report.”  The mitigation report will include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and Coram’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, Coram shall submit FCOI reports annually in accordance with the regulation and terms and conditions of the award agreement. Depending on the nature of the FCOI, Coram may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the FCOI is identified and the completion of Coram’s independent retrospective review.

Subawards

Coram requires compliance with pertinent FCOI requirements as mandated by PHS regulation by all recipients of subawards:

  1. If applicable, obtain a certification from the recipient of a subaward that its FCOI policy complies with the regulation.

  2. If applicable, include in the written subaward agreement a requirement for the recipient of the subaward to report identified FCOIs for its Investigators in a time frame that allows Coram to report identified FCOIs to PHS as required by the regulation.

  3. Alternatively, if applicable, include in the written agreement a requirement to solicit and review subaward Investigator disclosures that enable Coram to identify, manage, and report identified FCOIs to PHS.

Clinical Research

If the Coram determines that one of its funded clinical research projects 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 a FCOI that was not reported to Coram, the Investigator involved will be required to disclose the FCOI conflict in each public presentation of the results of the research and to request an addendum to previously published presentations.

 

 

Failure to Comply with This Policy

 

No expenditures of funds on a prime award or subaward supported by a PHS prime award will be permitted unless the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any designated FCOI management plan.

Any failure by an individual to adhere to this Policy may be cause for disciplinary action, including, in severe cases, termination.