Financial Conflict of Interest in Research

Financial Conflict of Interest in Research (Revision 41)

Content:

PURPOSE:

Boys Town National Research Hospital/Father Flanagan’s Boys’ Home and any affiliates (known collectively as Boys Town, BT or “Institution”) are committed to “Promoting Objectivity in Research”, as defined by the HHS regulation 42 CFR Part 50 Subpart F, which establishes standards that provide a reasonable expectation that the design, conduct, or reporting of research results will be free from bias resulting from any Investigator’s conflicting financial interest.

Application to all research, regardless of funding source:

While only activity funded by the Public Health Services require notification to the PHS funding agency of such conflicts and any mitigation plan, Boys Town chooses to require our researchers to also fully comply with these Financial Conflict of Interest (FCOI) requirements for any sponsor-funded research, including development of a mitigation plan and disclosure to participants for any conflicts related to the funding source.  

This policy applies to all persons at BT who meet the definition of Investigator, Support Personnel, Key Staff and Post-Doctorate Fellows (known collectively as “Investigator”), and applies to all Institutional activities meeting the definition of research, regardless of funding source. This includes physician-researchers and any clinicians on the protocol staff.

Research not funded by the Public Health Service (PHS) may be subject to agency-specific regulations relating to financial conflicts of interest in research. Affected Investigators must comply with those regulations in addition to this policy and are advised to review such regulations prior to submission of a research proposal or application.   

POLICY:

• All Investigators shall disclose all known Significant Financial Interests, foreign or domestic, of the Investigator and those of the Investigator's family members.
• New investigators must complete online form Statement of Significant Financial Interest, available in Lockpath.
• The online form must be updated annually, or any time reportable information is changed or added.
• In all cases, Financial Conflicts of Interest will be satisfactorily managed, reduced, or eliminated in accordance with this Policy.

• The BT Research Compliance Officer will oversee compliance with this policy for applicable research conducted at BT.

DEFINITIONS:

Disclosure: An Investigator statement to BT of any Significant Financial Interests. 

Equity interest: Any stock, stock option, or other ownership interest.

Family member: Investigator’s spouse or dependent children. 

Financial Conflict of Interest (FCOI): A financial conflict of interest exists when the institution's designated official reasonably determines that could directly and significantly affect the design, conduct, or reporting of the research.

Institutional responsibilities: An Investigator’s responsibilities on behalf of BT, including research, research consultation, training of students, consulting or other services to third parties related to Investigator’s academic field and/or academic subject matter expertise, or institutional committee memberships or service on panels, such as Institutional Review Boards or Data and Safety Monitoring Boards.

Investigator: The Principal Investigator or any other person, regardless of title or position, involved in the design, conduct, or reporting of a research project. 

Remuneration: Salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).

Significant Financial Interest (SFI): Anything of monetary value that reasonably appears to be related to the Investigator’s institutional responsibilities and is received, obtained, or held directly or indirectly by the Investigator and/or a family member, including one or more of the following interests:

• With regard to any publicly traded entity:  the value of any remuneration received from the entity in the 12 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.

• With regard to any non-publicly traded entity:  the value of any remuneration received exceeds $5,000, or when the Investigator and/or dependent family member holds any equity interest.

• Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests, excluding income paid by Boys Town.

• Reimbursed or sponsored travel in any amount (Note: $0 threshold), only if received by a Sponsored- or PHS-funded Investigator.

• The term Significant Financial Interest does NOT include the following types of financial interests:
  • Salary, royalties, or other remuneration paid by BT to the Investigator.
  • 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 U.S. Federal, state, or local government agency, a U.S. institution of higher education, or an academic teaching hospital, medical center, or research institute that is affiliated with a U.S. institution of higher education.
  • Income from service on advisory committees or review panels for a U.S. Federal, state, or local government agency, a U.S. institution of higher education, or an academic teaching hospital, medical center, or research institute that is affiliated with a U.S. institution of higher education.

Sponsor: Any organization or entity providing funding for a research project, including foundations, commercial companies, associations or other for- or non-for-profit entities.

Sponsored travel: Travel and related expenses that are paid on behalf of the Sponsor- or PHS-funded Investigator and are not reimbursed to the Investigator and are related to the Investigator’s institutional responsibilities.

Subrecipient: Sub-grantees, contractors, collaborators, or subcontractors.

PROCEDURE:

1. Disclosure of Significant Financial Interests

The online form in Lockpath will be completed in accordance with the following:

• Annual Disclosure: Investigators shall submit an updated disclosure form annually.
• New Research Projects. Any study personnel not having completed a disclosure within the past 12 months must complete and submit a disclosure form before any research project application may be submitted to an external sponsor, or for internal funding, or to the Institutional Review Board, Institutional Animal Care and Use Committee, or Institutional Biosafety Committee.
• Investigator Added to an Existing Project. If an annual disclosure form has not been submitted, the Investigator to be added to an existing research project shall complete and submit a disclosure form.
• New Financial Interest or increase in value of an existing financial interest. Any Investigator or family member who acquires a new Financial Interest or discovers an increase in value of an existing financial interest over the stated threshold value during the period of a research project must submit an updated disclosure form via Lockpath within 30 days of discovering or acquiring the Financial Interest.
• Additional Information. Investigators shall provide such additional information about disclosures as may be requested at any time by the Executive Vice President of Healthcare or his/her designee or the RCO.
• Intellectual Property Rights. BT’s VP of Research shall provide a report to the RCO of any intellectual property rights and agreements paid by BT or the Investigator. The RCO shall determine whether a Financial Conflict of Interest exists and whether a management plan is required. The involved Investigator shall be required to comply with any such management plan, and the Financial Conflict of Interest identified shall be disclosed as required.

2. Review Process

Review by the Research Compliance Officer. The Research Compliance Officer (RCO), or designee, will review each disclosure form to ensure that it has been properly completed by the Investigator to determine the existence of any Significant Financial Interest.

• If NO Significant Financial Interest is disclosed, the disclosure form is filed, the Chairs of the IRB and IACUC are informed, and no further action is required.

• If a Significant Financial Interest IS disclosed:
  • The RCO shall determine whether it is related to any grants or contracts, or to any current research activities. The nature of the study is reviewed relative to the Significant Financial Interest.
  • The RCO shall then determine whether any Financial Conflict of Interest exists and, if so, how to manage, reduce, or eliminate the Financial Conflict of Interest. No project funds shall be released until a final determination has been made.
  • The RCO will then notify the Chairs of the IRB and IACUC of the determination, and if necessary, notify the appropriate financial department to place a hold on any funding.
    • The IRB or IACUC shall independently review the Significant Financial Interest and Financial Conflict of Interest determination.
    • The IRB/IACUC may accept or decline the RCO’s determination and resolution in service of their responsibility for protecting the rights and welfare of human subjects and the welfare of research animals.
    • The IRB/IACUC may withhold approval of the study until the Committee’s recommendations to the RCO to manage, reduce, or eliminate the Financial Conflict of Interest are met.
    • The IRB/IACUC has the final authority to determine whether any interest and its management allow the research to be approved.

Determinations. The following are possible determinations the RCO may make regarding Financial Conflicts of Interest:

• No Financial Conflict of Interest. The RCO shall notify the Investigator in writing, and this correspondence shall be included in the project file.
• Financial Conflict of Interest. The RCO will contact the investigator and determine how to manage, reduce, or eliminate the Financial Conflict of Interest before expenditure of project funds, including development and implementation of a management plan and, if necessary, a retrospective review and mitigation report. Examples of conditions or restrictions that might be imposed in a management plan include, but are not limited to:
  • Public disclosure of Financial Conflicts of Interest (e.g., when presenting or publishing the research)
  • For research projects involving human subjects, 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 Financial Conflict of Interest
  • 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 Significant Financial Interest (e.g., sale of an equity interest)
  • Severance of relationships that create financial conflicts
  • The RCO may grant an exception on a case-by-case basis if the Investigator provides compelling reasons to maintain the Significant Financial Interest and participate in the research. These compelling circumstances or facts shall be consistent with the rights and welfare of human subjects and the welfare of animal subjects.

Nondisclosure or Non-review. If BT identifies a Significant Financial Interest that was not previously disclosed by an Investigator or, for whatever reason, was not previously reviewed by BT during an ongoing research project (e.g., was not reviewed or reported by a subrecipient), the RCO shall, within 60 days, determine whether a Financial Conflict of Interest exists and whether a management plan is required.

• If it is determined that a Financial Conflict of Interest exists, the RCO will notify the Investigator and implement, on at least an interim basis, a management plan specifying the actions that have been and will be taken to manage such Financial Conflict of Interest going forward.
• Depending on the nature of the Financial Conflict of Interest, BT may determine that additional interim measures are necessary regarding the Investigator’s participation in the research project between the date that the Financial Conflict of Interest or the Investigator’s noncompliance is determined and the completion of BT’s retrospective review.

3. Appeal Rights:

The Investigator may appeal the determination and management plan by submitting a written request and any supporting materials to the RCO for reconsideration within 14 days after receiving notification of the management plan. The RCO shall review the request and supporting materials and issue a new determination, to be reviewed by the IRB/IACUC.  The Investigator shall sign any management plan required by the RCO (or IRB/IACUC) before any funds may be expended. The final determination shall not be subject to further appeal.

4. Ongoing Monitoring:

Whenever BT implements a management plan, BT, through the Research Compliance Officer, shall monitor Investigator compliance with the management plan on an ongoing basis until the research is completed. 

5. Records Retention:

The Research Compliance Office shall retain records of all disclosures and BT’s review of and response to each disclosure as follows:

• PHS-Funded Projects: Three years after the date of submission of the final expenditures report or, where applicable, from other dates specific in 45 CFR 74.53 (b) for different situations.

• NSF-Funded Projects: Three years beyond the termination or completion of the project, or until the resolution of any NSF action involving those records, whichever is longer.

• All Other Externally or Internally Funded Projects: Three years after the termination or completion of the project.

6. Enforcement, Sanctions, and Noncompliance

General. Investigators shall fully comply with this Policy. Examples of breaches of this Policy include, but are not limited to:

• Failure to submit the disclosure form

• Intentionally filing an incomplete, erroneous, or misleading disclosure form

• Failing to provide any additional information requested by the Research Compliance Officer

Failure to comply with this Policy may result in disciplinary action, ranging from a public letter of reprimand to dismissal and termination of employment or affiliation with BT. Disciplinary action shall be consistent with and subject to BT’s progressive disciplinary policy or applicable sections of the Employee Handbook. 

PHS Notification. Prior to BT’s expenditure of any funds under a PHS-funded research project, the Institution shall provide to the PHS awarding component a Financial Conflict of Interest report regarding any Investigator’s Financial Conflict of Interest and ensure that the Institution has implemented a management plan. 

• In cases in which the Institution identifies a Financial Conflict of Interest and eliminates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit a Financial Conflict of Interest report to the PHS awarding component. 

• For any Financial Conflict of Interest that the Institution identifies after its initial report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the Institution shall provide to the PHS awarding component, within 60 days, an updated Financial Conflict of Interest report regarding the conflict and ensure that the Institution has implemented a management plan. 

Retrospective Review of Sponsor- or PHS-Funded Projects. When a Financial Conflict of Interest is not identified or managed in a timely manner,  the RCO shall, within 120 days of the  determination of noncompliance, complete a retrospective review of the Investigator’s activities and the Sponsor- or PHS-funded research project.  This review shall determine whether there was any bias in the design, conduct, or reporting of the Sponsor- or PHS-funded research, or any portion thereof, conducted during the time period of the noncompliance.  

The RCO shall document the retrospective review, including, but not limited to, the following key elements:

• Protocol number and title

• Funding agency or sponsor

• Project Director/Principal Investigator

• Name of the Investigator who has (or their family member has) the Financial Conflict of Interest

• Name of the entity with which the Investigator/family member has a Financial Conflict of Interest

• 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)

• Findings of the review

• Conclusions of the review

Failure to Comply. If an Investigator’s failure to comply with this Policy or a management plan appears to have biased the design, conduct, or reporting of the Sponsored- or PHS-funded research, the RCO shall promptly notify the Sponsor or PHS awarding component of the corrective action taken or to be taken. The RCO may notify the IRB/IACUC at this time if necessary to protect the health and welfare of human subjects and/or health of research animals.

Mitigation Report. If, after conducting a retrospective review, the Institution finds that it is warranted, it shall update the previously submitted Financial Conflict of Interest report, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the Institution shall notify the Sponsor or PHS awarding component promptly and submit a mitigation report to the Sponsor or PHS awarding component. 

The mitigation report must include, at a minimum, the key elements documented in the retrospective review, as well as a description of the impact of the bias on the research project (e.g., 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) and the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias. Thereafter, the Institution shall submit Financial Conflict of Interest reports annually.

Any Financial Conflict of Interest report required under paragraphs (1) (2), or (3) above shall include sufficient information to enable the Sponsor or PHS awarding component to understand the nature and extent of the Financial Conflict of Interest, and to assess the appropriateness of the Institution’s management plan. 

Elements of the Financial Conflict of Interest report shall include, but are not limited to, the following: 

• Protocol number and title.

• Name of the Investigator who has (or family member has) the Financial Conflict of Interest.

• Name of the entity with which the Investigator/family member has a Financial Conflict of Interest.

• Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium).

• Value of the financial interest:
  • $0–$4,999
  • $5,000–$9,999
  • $10,000–$19,999
  • amounts between $20,000–$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

• A description of how the financial interest relates to the Sponsor- or PHS-funded research, and the basis for the Institution’s determination that the financial interest conflicts with the research.

• A description of the key elements of the Institution’s management plan, including:
  • 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
  • Other information as needed

Ongoing Monitoring. For any Financial Conflict of Interest associated with an ongoing Sponsor- or PHS-funded research project that was previously reported by the Institution, the Institution shall provide to the Sponsor or PHS awarding component an annual Financial Conflict of Interest report that addresses the status of the conflict and any changes to the management plan. These annual reports will be required for the duration of the Sponsor- or PHS-funded research project, including extensions with or without funds.

The annual Financial Conflict of Interest report shall specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists. 

Federal Agency Actions. In some cases, the U.S. Department of Health and Human Services (HHS) may determine that a PHS-funded clinical research project 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 Financial Conflict of Interest that was not managed or reported by the Institution as required. In these cases, the Institution shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research, and to request an addendum to previously published presentations.

Other Sponsors. The RCO shall notify any other sponsor of Financial Conflicts of Interest and management plans imposed, as required by sponsor policy or contractual obligation.

7. Other Requirements

PHS Certification. The appropriate Institutional official shall certify on each PHS-funded proposal that the Institution has in effect an up to date, written, and enforced administrative process to identify and manage Financial Conflicts of Interest, shall promote and enforce Investigator compliance with the requirements of 42 CFR Part 50 and 45 CFR Part 94, including those pertaining to disclosure of Significant Financial Interests, shall manage Financial Conflicts of Interest and provide initial and ongoing Financial Conflict of Interest reports to the PHS awarding component, consistent with 42 CFR Part 50 and 45 CFR Part 94, agrees to make information available to HHS, promptly upon request, relating to any Investigator disclosure and the Institution’s review of and response to such disclosure, whether or not the disclosure results in the Institution’s determination of a Financial Conflict of Interest, and shall fully comply with the requirements of 42 CFR Part 50 and 45 CFR Part 94.

8. Public Accessibility

Policy Availability. The RCO  shall post and maintain this Policy on a publicly accessible BT web site. BT shall make its written policy available to any requestor within five business days of a request.

Financial Conflict of Interest Public Accessibility Notice. Within a reasonable time after determining an Investigator has a Financial Conflict of Interest and, for PHS-funded research, prior to the Institution’s expenditure of any funds for that research, the RCO shall ensure the public accessibility of information concerning any Financial Conflicts of Interest held by Investigators participating in PHS-funded research. Response to all written requests for information shall be provided within five business days of receipt of the request. Written requests may be sent to the Research Compliance Officer/Director, Organizational Compliance, 14100 Crawford Street, Boys Town, NE, 68010. 

The information included in a response to a request for information shall include, at a minimum, the following:

• The Investigator’s name, title, role with respect to the research, and the protocol number/title of the research project.

• The name of the entity in which the Significant Financial Interest is held and the nature of the Significant Financial Interest.

• The approximate dollar value of the Significant Financial Interest (dollar ranges are permissible: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000–$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.

In any case in which the PHS determines that an NIH-funded 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 a conflicting interest that was not  managed or reported by the Institution as required by the regulation, the Institution must require the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.  Institution’s Financial Conflict of Interest policy may have additional requirements.

Other requirements. The RCO shall update the information annually. In addition, the RCO shall update the information within 60 days of the Institution’s receipt or identification of information concerning any additional Financial Conflict of Interest of the Investigator that was not previously disclosed, or upon the determination of Financial Conflict of Interest of Investigators new to the research project.  Information concerning the Financial Conflict of Interest of an individual shall remain available via written request for three years from the date that the information was most recently updated.

9. Investigator Education and Training Requirements

Initial Training. All current Investigators shall be informed of and trained on this Policy, including the responsibilities regarding disclosure of Significant Financial Interests, and the PHS Federal regulations on Financial Conflict of Interest. All Investigators must complete initial Financial Conflict of Interest training before beginning work on any research project.

Training Updates. Investigators shall complete re-training on Financial Conflict of Interest every three years after initial training, or more often when any of the following circumstances apply:

• The Institution revises its Financial Conflict of Interest policies or procedures in any manner that affects the requirements of Investigators.

• The Institution finds that an Investigator is not in compliance with this Policy or a management plan.

Compliance Office Services. The Compliance Office shall provide and/or arrange for and track required training. Training can be via CITI Compliance Training or any successive educational service.

10. Federally Funded Subcontracts

If BT carries out Federally funded research through a subrecipient, BT will take reasonable steps to ensure that any subrecipient Investigator complies with Federal requirements for Financial Conflicts of Interest by completing BTNRH Subrecipient Commitment form, available upon request from the Manager of Research Administration, incorporating as part of the written agreement with the subrecipient terms that require the subrecipient to:

• Apply its Financial Conflict of Interest policy to its Investigators.

• Certify that its policy complies with applicable Federal regulations.

• Agree to report all identified Financial Conflicts of Interest to the Institution within a reasonable, stated time period. Such time period(s) shall be sufficient to enable the Institution to provide timely Financial Conflict of Interest reports, as necessary, to the Federal agency.

BT is also charged with providing Financial Conflict of Interest reports to the Federal agency regarding all Financial Conflicts of Interest of all subrecipient Investigators (i.e., prior to the expenditure of any funds and within 60 days of any subsequently identified Financial Conflict of Interest. If the subrecipient does not have a Financial Conflict of Interest policy or refuses to apply the policy or certify compliance of the policy with Federal regulations, the agreement with the subrecipient shall:

• Require the subrecipient’s Investigators to comply with this Policy.

• Specify time period(s) for the subrecipient to submit all Investigator disclosures of Significant Financial Interests to the Institution. Such time period(s) shall be sufficient to enable the Institution to comply with its review, management, and reporting obligations.

Disclosures submitted by subrecipients shall be reviewed by the BT RCO, and any Financial Conflicts of Interest shall be managed and monitored as set forth in this Policy.  

11. Administration and interpretation. Questions regarding this Policy may be directed to the Research Compliance Office or the Office of General Counsel at the Institution.

12. Amendments or termination of this policy. BT reserves the right to modify, amend, or terminate this Policy at any time. Nothing in this Policy should be construed as a contract between the Institution and its employees.