Purpose and Scope
This policy is intended to comply with regulations regarding financial conflicts of interest and allow Seven Bridges to identify and manage any such conflicts its staff may be subject to. It applies to all staff members and outside consultants working on designated projects.
This policy shall be posted publicly on the Seven Bridges website, www.sevenbridges.com.
Disclosure
All staff members, as well as outside consultants, working on designated projects must disclose all Significant Financial Interests reasonably related to their responsibilities at Seven Bridges. A Significant Financial Interest is defined as the following:
With regard to any publicly traded entity, a Significant Financial Interest (SFI) exists if the value of any remuneration received from the entity, in the 12 (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. Included are payments and equity interests;
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 12 (twelve) months preceding the disclosure, when aggregated, exceeds $5,000, or when the staff member or consultant (or the staff member or consultant’s spouse or dependent children) holds any equity interest; or
Intellectual property rights and interests, upon receipt of income related to such rights and interest.
Significant Financial Interests do not include the following:
Income from seminars, lectures, teaching, service on advisory or review panels for US government agencies, US institutions of higher education, US academic teaching hospitals, US medical centers, or US research institutes affiliated with an institution of higher learning;
Income from investment vehicles such as mutual funds and retirement accounts, as long as the staff member, or consultant, does not directly control the investment decisions made in these vehicles; or
Income from, or equity interest, in Seven Bridges Genomics Inc., or any of its branches or subsidiaries.
If a staff member or consultant is unsure if an SFI is reasonably related to their responsibilities, they should contact the Legal Department for guidance.
Disclosure shall be made via the Financial Conflict of Interest Disclosure Webform.
Initial disclosures shall be made by each staff member, or consultant, within one week of training on the policy (see next section), and in any case prior to beginning work on any Public Health Service (PHS)-funded research.
Subsequent disclosures shall be made (a) by any staff member, or consultant, within 30 (thirty) days of discovering or acquiring a new Significant Financial Interest; and (b) annually, by all staff members and consultants during the second half of March.
It is the responsibility of the General Counsel or their designee to solicit initial and annual disclosures. It is the responsibility of the individual staff member, or consultant, to make disclosures related to the acquisition or discovery of new Significant Financial Interests without prompting.
Designated projects shall include any project funded by the PHS, including the National Institutes of Health, and any other projects designated by the General Counsel. Those outside consultants working on designated projects must agree, in writing, to abide by the terms of this policy and provide all required disclosures.
Training
All staff members shall be trained on this policy within one week of joining the company. All outside consultants working on designated projects shall be trained on this policy prior to beginning work on the designated project.
Any refresher training for all staff shall be held every two (2) years in the first half of March in even-numbered years, and within one week of any change to this policy that affects disclosure requirements.
Any staff member found not to be in compliance with this policy, or a conflict management plan established under this policy, shall be trained within one week.
Upon completion of training, all staff shall acknowledge training via this webform.
Review and Conflict Management
All disclosures of Significant Financial Interests shall be reviewed by the General Counsel.
The General Counsel shall determine whether the SFI:
is related to a project the staff member is working on, or the designated project in the case of outside consultants
is related to research funded by the Public Health Service (PHS), including the National Institutes of Health
creates a Financial Conflict of Interest (FCOI), defined as an SFI that could directly and significantly affect the design, conduct, or reporting of the project
If the General Counsel determines that an FCOI exists, the General Counsel or their designee shall develop a Conflict Management Plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:
Public disclosure of FCOIs (e.g., when presenting or publishing the 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);
Severance of relationships that create financial conflicts.
The relevant staff member or outside consultant shall agree, in writing to abide by the terms of the management plan.
The General Counsel or their designee shall monitor compliance with the management plan until completion of the project.
Records Retention
All disclosures, FCOI Reports, management plans, retrospective reviews, mitigation reports, and other records generated under this policy shall be retained for a minimum of 6 (six) years. In the case of PHS-funded research, records will be kept for at least 3 (three) years from the date the final expenditures report or the applicable quarterly or annual financial report is submitted to the relevant agency.
Enforcement and Sanctions
The General Counsel or their designee is responsible for ensuring that disclosures are made in a timely manner, and following up with any staff members or outside consultants who do not make disclosures by the indicated deadline.
If a staff member is found not to have disclosed a Significant Financial Interest, either as part of their initial disclosure or subsequently, the General Counsel or their designee shall refer the matter to the CEO, who shall consider the nature of the failure to disclose to determine an appropriate sanction.
The determination of sanctions shall take into account, but not necessarily be bound by, the following guidelines:
Unintentional or careless violations shall generally result in retraining on this policy, and may result in a verbal or written warning. Repeated or particularly flagrant violations may result in stronger sanctions.
Intentional violations regarding Significant Financial Interests, not found to constitute Financial Conflicts of Interest, shall generally result in a verbal warning or a written warning, as well as, retraining on this policy. Repeated or particularly flagrant violations may result in stronger sanctions.
Intentional violations regarding Significant Financial Interests found to constitute Financial Conflicts of Interest shall result in a written warning, as well as, retraining on this policy. Depending on the nature of the interest and the conflict, stronger sanctions including suspension without pay or termination may also be imposed.
If an outside consultant is found not to have disclosed a Significant Financial Interest, either as part of their initial disclosure or subsequently, the General Counsel or their designee shall refer the matter to the CEO, who shall consider the nature of the failure to disclose, and the recourse available under the agreement with the outside consultant to determine an appropriate remedy.
Special Requirements for PHS-funded Research
The following procedures shall only apply to PHS-funded research, including any projects funded by the National Institutes of Health and NCI.
REPORTING
Prior to expenditure of any funds under a PHS-funded research project, Seven Bridges shall provide to the contact designated in the relevant contract or grant document an FCOI Report identifying any Financial Conflicts of Interest relating to the PHS-funded research.
The FCOI Report shall include the following:
the Project number and title;
the PD/PI, or Contact PD/PI if a multiple PD/PI model is used;
the name of the staff member, or outside consultant, with the FCOI;
the name of the entity with which the staff member or outside consultant has an FCOI;
the nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
the value of the 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;
a description of how the financial interest relates to the PHS-funded research, and the basis for Seven Bridges’ determination that the financial interest conflicts with such research;
a description of the key elements of the Institution's management plan, including 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; and
any other information the General Counsel deems necessary to enable the relevant government agency to understand the nature and extent of the financial conflict, and to assess the appropriateness of the management plan.
For any FCOI relating to PHS-funded research that is identified subsequent to the initial FCOI report, Seven Bridges shall provide to the contact designated in the relevant contract or grant document an FCOI Report identifying any FCOI, as described above, within 60 (sixty) days.
If any FCOI is identified concerning key personnel, as defined in the relevant contract or grant document, a public disclosure of the following information shall be posted on the Seven Bridges website at the same location as this policy is posted:
the staff member or outside consultant’s name;
the staff member or outside consultant’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 (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.
The public disclosure shall be posted prior to the expenditure of funds, shall be updated at least annually during the course of the PHS-funded project, as well as, within 60 (sixty) days of the identification of any new FCOI, and shall remain available for 3 (three) years following the most recent update.
Review of Improperly-Handled Financial Conflicts of Interest
The following procedures shall be carried out whenever an FCOI is not identified or managed in a timely manner, including failure by the staff member or outside consultant to disclose a Significant Financial Interest that is determined by the Institution to constitute an FCOI; failure by Seven Bridges to review or manage such an FCOI; or failure by the staff member or outside consultant to comply with an FCOI management plan:
The CEO shall appoint a review panel consisting of 3 (three) senior employees not reporting to the General Counsel.
Within 120 days of the determination of noncompliance, the review panel shall complete a retrospective review of the staff member or outside consultants’ 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.
The review panel shall document the retrospective review in a record including at least the following key elements:
Project number and title;
PD/PI or contact PD/PI if a multiple PD/PI model is used;
Name of the staff member or outside consultant with the FCOI;
Name of the entity with which the staff member or outside consultant 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);
Findings of the review; and
Conclusions of the review.
Based on the results of the retrospective review, if appropriate, the CEO shall update the previously submitted FCOI Report, specifying the actions that will be taken to manage the FCOI going forward
If bias is found, the CEO is required to promptly notify the contact designated in the relevant contract, or grant document, and submit a mitigation report to that contact. The mitigation report must 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 Seven Bridges’ plan of action(s) taken to eliminate, or mitigate, the effect of the bias (e.g., 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).
Depending on the nature of the FCOI, the CEO may determine that additional interim measures are necessary with regard to the staff member or outside consultant’s participation in the PHS-funded research project between the date that the FCOI, the staff member, or outside consultant’s noncompliance is determined, and the completion of Seven Bridges’ retrospective review.