NBDF General Conflict of Interest Discslosure

NBDF Policy on Financial Conflicts of Interest (FCOI) in Federally Sponsored Research Activities

The organization rebranded to NBDF in August 2023. Previously, the organization was known as the National Hemophilia Foundation or NHF since 1948.

 

NBDF General Conflict of Interest Disclosure

Application of Policy

This Policy 4.4 applies to all voting members of the Board. It does not apply, therefore, to ex officio members.

Definitions

As used throughout this Policy 4.4:

  1. The terms “Employment,” “Employ,” and “Employee” refer to ordinary employment as a W-2 employee, whether full- or part-time.
  2. The term “Family Member” in reference to an individual means the individual’s spouse and children and any person who lives in the individual’s household.

Standards of Conduct

The Board commits itself and its members to ethical, professional, and lawful conduct.

Accordingly:

  1. Board members must dedicate themselves to the interests of NBDF (the “Organization”) and of the community the Organization serves. Board members bear a fiduciary duty to protect the Organization’s integrity, trustworthiness in the eyes of the public, financial health, and fidelity to its mission.
  2. Board members shall discharge their duties honestly and in good faith. They shall exercise the degree of care, diligence, and skill that a reasonably prudent person would exercise in comparable circumstances.
  3. A Board member aware of credible information that suggests that a Board policy has been violated by another Board member or by the CEO has an affirmative obligation to bring the concern to the Board Chair or the Board as a whole, as appropriate.
  4. In the performance of their responsibilities, Board members shall treat each other, staff, and community members with respect and professionalism, and will uphold the dignity of the Organization.
  5. Board members must refrain from abusing their positions or authority. In particular, but without limitation –
    1. Board members may not engage in business (including but not limited to the provision of compensated professional or consulting services) with the Organization on behalf of themselves or outside entities in which they or a Family Member have a financial interest. In extraordinary circumstances, the Board may vote to waive this restriction but only if (a) the terms of the arrangement are fully disclosed, and (b) no comparable alternative vendor is reasonably available.
    2. Neither a Board member nor a Family Member may, during a period of Board service, (1) be an Employee of the Organization, or (2) seek or secure Employment with the Organization.
    3. Board members may not appropriate for their personal use or exploitation, or for use or exploitation by any unauthorized person or entity, any resource, opportunity, or advantage that belongs to the Organization. In the course of their Board activities, Board members may become privy to nonpublic information belonging to the Organization or another entity. Board members must refrain from using such information for personal profit or advantage or enabling any unauthorized persons or entities to use such information for their profit or advantage.
  6. Board members shall support the legitimacy and authority of the Board’s final determination on any matter. They shall not hold themselves out to the media or the public as having the authority to speak on behalf of the Organization or the CEO unless in fact so authorized.
  7. Board members should maintain the confidentiality of any nonpublic Organization communications or information (for example, matters taken up in executive session, internal evaluations of staff, donor information, vendor negotiations, and proposals for funding).

Conflicts of Interest

Board members should at all times be attentive to their ability to carry out their responsibilities in a manner unaffected by outside influences or interests.

A conflict of interest exists when a Board member has or is subject to an outside interest that compromises, or could reasonably appear to an outside observer to compromise, the Board member’s ability to exercise independent and objective judgement in the performance of organizational duties. Outside interests of concern can be financial or non-financial. For example, they may involve business transactions, investment interests, fiduciary duties owed to other organizations, offers of employment, family relationships, or friendships.

Board members should be transparent and forthcoming about outside interests that could give rise to conflicts of interest. Accordingly –

  • Board members shall submit to the Organization annual written disclosures of any such interests of which they are aware.
  • Board members shall promptly supplement or update their annual filings whenever they acquire or become aware of having additional interests that could give rise to conflicts of interest.
  • Whenever a Board member has an outside interest that poses a conflict of interest with respect to a specific matter that is before the Board for discussion or a vote, regardless of whether the outside interest has previously been disclosed in a written disclosure, the Board member shall expressly bring the conflict of interest to the attention of the Board or its presiding officer in advance of the Board discussion or vote. If a Board member is uncertain whether an interest poses a conflict of interest or could appear to a reasonable observer to pose a conflict of interest, he or she should seek guidance from the Board Chair in advance of the meeting or submit the issue to the Board’s judgement at the meeting.
  • If a Board member has a reasonable basis to believe that another Board member has a conflict of interest with respect to a specific matter that is before the Board for discussion or a vote, he or she should bring the potential conflict of interest to the attention of the Board or its presiding officer in advance of the Board discussion or vote.

Board members who declare themselves to have, or are determined by the Board to have, a conflict of interest with respect to a matter before the Board shall be recused from participating in the discussion of or vote upon the matter. The recusal and the reason for the recusal shall be recorded in any minutes of the meeting duly kept or produced. In any instance, the Board may vote to waive recusal with respect to participation in discussion, in which case the minutes shall record such waiver. Where the Board deems it appropriate, the Board may require a Board member with a conflict of interest with respect to a matter to physically (or telephonically, if applicable) absent himself or herself from the Board discussion or vote.

Interests Ordinarily Not Permitted

Certain outside interests conflict so significantly or pervasively with the duty of loyalty a Board member owes the organization that they are not ordinarily permitted. If an individual has any of the interests specified below, the individual will ordinarily be ineligible to serve or continue serving as a Board member. (Note that an interest of lesser magnitude or consequence than specified below – for example, an ownership interest below $25,000 – can still constitute a conflict of interest with respect to a particular matter before the Board and may still require disclosure and management through the procedures discussed in the preceding section.)

  1. The individual or any Family Member is Employed by an entity that manufactures drugs, medical devices, or biological products intended primarily for use by patients with a bleeding disorder.
  2. The individual or any Family Member is Employed by a for-profit entity that offers or provides as a substantial line of business medical services (e.g., home health care, specialty pharmacy services, infusion support) to patients with bleeding disorders, if the individual or family member works in or with the division of the entity offering or providing such medical services.
  3. The individual or any Family Member receives non-Employment consulting income, advisory committee fees, or other service compensation (monetary or in-kind) from an entity described in paragraph 1 or 2 above, and such remuneration from any single entity exceeds $5000 per year.
  4. The individual or any Family Member has an ownership interest currently valued at more than $25,000 in an entity described in paragraph 1 or 2 above. An “ownership interest” includes, but is not limited to, stock, stock options, and the like, but does not include stock held through a mutual fund, pension fund, or other investment vehicle over which the individual exercises no investment decision-making control.
  5. The individual or any Family Member is Employed by, or serves on the board of, an advocacy organization, including a member chapter of NBDF, concerned primarily with serving the needs or advancing the welfare of persons with bleeding disorders.
  6. The individual or any Family Member receives from an entity described in paragraph 1 or 2 above non-negligible gifts, gratuities, or other benefits not available as a general matter to other members of the community at large.

In certain circumstances, the Board may vote to permit a prospective or sitting Board member to serve or continue serving on the Board while also having one or more of the interests listed above. Such waivers should be granted only on compelling grounds and when the need for the individual’s expertise or qualifications outweighs the risk of biased judgement. Unless further limited by the Board, a waiver shall be good for the calendar year in which it is granted and continuing until the first regular meeting of the Board in the next calendar year, at which time it shall lapse unless renewed by the Board as then constituted.

  • Example 1:
    Dr. X is a hematologist widely recognized for her expertise on von Willebrand Disease. Dr. X is appointed to an advisory committee of a manufacturer of clotting factors and is compensated at the market rate for her services. The Board votes to allow Dr. X to remain on the Board, because she is the only physician member and is needed, among other things, for her ability to evaluate MASAC recommendations and because NBDF is undertaking a major new VWD awareness campaign.
  • Example 2:
    Professor Y is a geneticist with a bleeding disorder. He works at a prominent university and writes and consults on the creation of DNA biorepositories. His clients include many companies that manufacture drugs for orphan diseases, including biologics manufacturers focused on bleeding disorders. The Board votes to permit Professor Y to serve on the Board in light of his perspectives as a consumer and his knowledge of biobanking and because his services to industry do not relate to the development or promotion of particular products.

Waivers of the principles stated in paragraphs 1 through 6 above should be limited in duration to only as long as is necessary. Where feasible, waivers may be conditioned upon compliance with measures designed to manage or mitigate the risks posed by the Board member’s outside interests.

Failures to Comply with Code of Conduct

If the Board becomes aware of a possible violation of this policy by a Board member, then the Board – acting as a whole or through an officer, committee, or other delegatee – shall make such inquiry or investigation as it deems warranted. If the Board determines that the policy was violated, the Board shall take appropriate remedial or disciplinary action, including but not limited to removal of the Board member as an officer, committee member, or director.

Back To Top

 

NBDF Policy on Financial Conflicts of Interest (FCOI) in Federally Sponsored Research Activities

Definitions

Institution refers to any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for or that receives NIH research funding.

Investigator means the Project Director or Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

Institutional responsibilities means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and services on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

Manage means taking action to address a financial conflict of interest, 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.

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 NIH by the Institution under the regulation.

Significant Financial Interest (SFI) is defined by the regulation as:

  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:
    1. 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 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;
    2. 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
    3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  2. Investigators also must disclose the occurrence of any reimburses 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; provided, however, that this disclosure requirement does not apply to 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.  The Institution’s FCOI policy will specify the details of this disclosure, which will include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination of disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHSfunded research.
  1. 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 the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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, an Institution of higher education as defined at 200 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 a federal, state, or local governmental 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.

Overview

1. Purpose

This policy formalizes the compliance of the National Bleeding Disorders Foundation (NBDF) with the regulation as prescribed by Federal grantmaking agencies per 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought.”  

2. Applicability

All Investigators are required to disclose to NBDF any real or apparent financial conflict(s) of interest that may directly impact the subject of research.  Investigators are all persons, regardless of title or position, who are responsible for the design, conduct or reporting of research proposed for funding by Public Health Services (PHS) and the National Institutes of Health (NIH), including collaborators or consultants.  Additionally, this policy applies to the spouse and/or dependent children of each Investigator.

3. NBDF Responsibility

Per this policy, NBDF is responsible for (i) maintaining an up-to-date and enforced administrative process to identify and manage FCOI; (ii) enforcing investigator compliance with the regulation; (iii) providing ongoing FCOI reports; (iv) making FCOI and Significant Financial Interests (SFI) information available to the U.S. Department of Health & Human Services/NIH upon request; and (v) fully complying with the regulation’s requirements.

Policy

1. Investigator/Key Personnel Responsibility

  1. Investigators conducting PHS/NIH-funded research through NBDF are required to disclose to the Grants Administrator (Research Dept.) all significant financial interests (SFI) relevant to the Investigator’s Institutional responsibilities.  Disclosures must occur:
    1. Prior to or at the time of application for PHS/NIH-funded research;
    2. At least annually during the duration of the award;
    3. Within 30 days of becoming aware of a new SFI; or iv. Within 30 days of the elimination of a financial conflict of interest.
  2. Investigators are required to complete the annual disclosure even if no SFI exist.

2. Institution Responsibility

  1. NBDF will update and enforce this written policy in accordance with 42 CFR 50, Subpart F, and make the policy and applicable Federal regulations available on the NBDF website.
  2. NBDF will inform each Investigator and key personnel of the following:
    1. This policy and the corresponding Federal regulations;
    2. Responsibility of an Investigator and key personnel to disclose any SFI to the Grants Administrator (Research Dept.), who will consult with the Chief Science Officer (CSO).
  3. NBDF will require Investigators participating in PHS/NIH-funded research to complete the FCOI Training tutorial at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
  4. Prior to engaging in research related to any PHS/NIH-funded grant;
    1. At least every four years; and
    2. Immediately if:
      1. FCOI policy updates affect requirements of Investigators;
      2. Investigator is new to NBDF; or
      3. Investigator is not in compliance with the policy or management plan. iv. Upon course completion, Investigators will submit a certificate of completion to the Grants Administrator (Research Dept.).
  5. NBDF will ensure Investigator subrecipient compliance with regulation and reporting.
    1. When applicable, NBDF will establish, via written agreement, whether the subrecipient will follow the FCOI policy of the awardee Institution or the FCOI policy of the subrecipient.  If applicable, NBDF will:
      1. Obtain certification from the subrecipient that its FCOI policy complies with 42 CFR 50, Subpart F;
      2. Include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its Investigators within a timeframe that allows the awardee Institution to report identified FCOIs to the NIH as required by the regulation; and/or
      3. Alternatively, include in the written agreement a requirement to solicit and review subrecipient Investigator disclosures that enable the awardee Institution to identify, manage, and report identified FCOIs to the NIH.
  6. NBDF designates the Chief Science Officer (CSO) as the Institutional official responsible for ensuring the policy is adhered to on a timely basis.  The Grants Administrator (Research Dept.) will serve as the delegated individual tasked with soliciting and reviewing disclosures from each Investigator who is planning to participate in, or is participating in, PHS/NIH-funded research at NBDF.  As necessary, the Administrator will convene an ad hoc committee composed of the CSO, Head of Research, and Vice President of Advancement.
  7. All FCOI-related records (Investigator disclosures and the Institution’s review of and response to such disclosures, as well as all actions under the Institution’s policy or retrospective review, if applicable) will be kept on file for at least three years from the date the final expenditures report is submitted to the PHS (NIH).  When applicable, the date may differ from the submission date as specified in 45 CFR 75.361.
  8. In each application for PHS/NBDF-funded research, NBDF will certify that it:
    1. Has in effect an updated FCOI policy for all PHS-funded research activities;
    2. Will promote and enforce compliance with this policy;
    3. Will manage FCOI and provide initial and ongoing reports to the organizational unite of the PHS that funds the research; and
    4. Agrees to make information promptly available to PHS regarding the disclosure and review of any FCOI.

3. Reviewing Disclosures

  1. If an Investigator discloses an SFI, the Grants Administrator (Research Dept.) will notify the Chief Science Officer, Head of Research, and Vice President of Advancement to form an ad hoc FCOI Committee (Committee).  The committee will:
    1. Determine if the Investigator’s SFI is related to a PHS/NIH-funded research project and, if so, whether that SFI is an FCOI;
    2. Solicit written statements/additional information from all parties;
    3. Evaluate available evidence; and iv. Issue a report to NBDF’s President and Chief Executive Officer, who will make the final decision.
  2. An Investigator’s SFI is related to PHS/NIH-funded research when NBDF, through its designated officials, reasonably determines that the SFI:
    1. Could be affected by the PHS/NIH-funded research or
    2. Is an entity whose financial interest could be affected by the research.  
  3. An FCOI exists when NBDF, through its designated officials, determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research.  The review process must be completed within 60 days of receipt of an SFI.
  4. If the Committee determines an FCOI exists, conditions or restrictions that might be imposed to manage it include but are not limited to:
    1. Public disclosure of FCOI (e.g., when presenting or publishing the research);
    2. For research projects involving humans, disclosure of FCOI directly to participants; 
    3. 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;
    4. Modification of the research plan;
    5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
    6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
    7. Severance of relationships that create financial conflicts. 
  5. The actions required to manage the FCOI will be identified in a management plan, and compliance with the management plan will be monitored by the Committee on an ongoing basis until completion of the PHS/NIH-funded research project.  The Committee may determine that additional measures are necessary with regard to the Investigator and the FCOI.
  6. If the Committee identifies that an SFI exists that was either not disclosed or not disclosed in a timely manner by an Investigator or key personnel, the Committee will follow the same procedures as outlined in this section.
  7. If an FCOI is not identified or managed in a timely manner, including failure by the Investigator or key personnel to report an SFI that constitutes an FCOI; failure of NBDF to review or manage an FCOI; or failure by the Investigator or key personnel to comply with a management plan, the Committee will:
    1. Within 60 days, complete a retrospective review of the research, including the Investigator’s activities to determine whether the research conducted during the time period of the noncompliance was biased in design, conduct, or reporting of such research.
    2. The retrospective review will be documented and include the following elements:
      1. Project number;
      2. Project title;
      3. Name(s) of project director or principal Investigator; 
      4. Name of the Investigator or key personnel with the FCOI;
      5. Name of the entity with which the Investigator/key personnel has an FCOI;
      6. Reason(s) for the retrospective review;
      7. Detailed methodology of the review process, composition of the review panel, and the documents reviewed; and
      8. Conclusions of the review.
    3. Based on the findings of the retrospective review, the Committee will update any previously submitted FCOI reports, specifying actions taken to manage the FCOI.
    4. If the retrospective review determines that the research was biased, the Committee will promptly notify the PHS organizational unit funding the research and submit a mitigation report.  The mitigation report will include, but is not limited to:
      1. All information described in (3)(g)(ii);
      2. A description of the impact of the bias on the research project;
      3. NBDF’s plan of action or actions taken to eliminate or mitigate the effects of the bias.

Reporting FCOI to PHS/NBDF

  1. NBDF will send initial, annual, and revised FCOI reports, including all required information defined in the regulation to the NIH via the eRA Commons FCOI Module for the Institution and its subrecipients, if applicable, as required by the regulation and stated below:
    1. Prior to the expenditure of funds;
    2. Within 60 days of identification for an Investigator newly participating in the project;
    3. Within 60 days for new, or newly identified, FCOIs for existing Investigators; iv. At least annually (at the same time as when the Institution is required to submit the annual progress report, multiyear progress report, if applicable, or at time of extension).  The annual report will provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project; and
    4. After a retrospective review to update a previously submitted report, if new information is discovered following completion of the review.
  2. FCOI reports submitted to NIH will include but not be limited to the following information:
    1. Project number;
    2. Investigator or key personnel contact;
    3. Name of the investigator with the FCOI;
    4. Name of the entity with which the Investigator has the FCOI;
    5. Nature of the SFI;
    6. Value of the financial interest;
    7. Description of how the financial interest relates to the PHS/NIH-funded research and why the Institution determined that the financial interest conflicts with such research; and
    8. Description of the key elements of the Institution’s management plan, including: 1.
      1. Role and principal duties of the conflicted Investigator or key personnel;
      2. Conditions of the management plan;
      3. How the management plan is designed to safeguard objectivity in the research; 4. Confirmation of the Investigator’s agreement to the management plan; and 5. Additional information as needed.

Remedies

  1. If an Investigator or key personnel fails to comply with this policy or if an FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Committee will promptly notify the organizational unit of PHS/NIH that funds the research of any corrective action that has or will be taken.
  2. The PHS/NIH will consider the information submitted and may require or recommend additional action.
  3. NBDF will submit, or permit onsite review of, all records pertinent to the review of a financial disclosure of FCOI to the PHS/NIH.  The PHS may determine on the basis of any review that the FCOI will bias the objectivity of the research to such an extent that further corrective action is needed.  This may include the imposition of special award conditions, suspension of funding, or other enforcement action.

Public Accessibility to FCOI Information

  1. NBDF’s FCOI policy can be accessed by the public at hemophilia.org.   
  2. Information made publicly available will:
    1. Include the minimum elements as provided in 42 CFR 50.605(a)(5)(i)-(iv);
    2. Be updated at least annually;
    3. Be updated within 60 days of a newly identified FCOI; and
    4. Remain available for three years from the date the information was most recently updated.
Back To Top