Sciogen

The purpose is to establish policy for implementation of agency requirements related to financial disclosures by employees of Sciogen, LLC (the company), involved with submitting proposals and notifications to agencies in the event a financial conflict of interest (FCOI) is identified.  This policy will be modified as necessary to maintain compliance with the requirements of external agency.

1. Introduction

Company Policy on Conflict of Commitment and Interest establishes requirements for company employee’s disclosures of financial interests and professional relationships in outside entities that would reasonably appear to be related to Company responsibilities, and for annual certifications of policy compliance. In addition, Company’s policy requires that employees participating in grant application from an external sponsor comply with any financial disclosure or notification requirements of that sponsor.

Certain federal agencies have specific requirements for disclosure and management of personal financial interests related to their sponsored research projects.  The focus of these requirements is to ensure responsible stewardship of federal funds and to promote research free from bias resulting from Employee financial conflicts of interest.  Agencies with such requirements include the Public Health Service (PHS) and related components such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA). This policy provides specific guidance related to the requirements of PHS.

2.  Definitions

1. Company Official means the individual(s) designated by the Company to review disclosures of significant financial interests and determine whether there is a financial conflict of interest.
2. Financial conflict of interest (FCOI) means a significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
3. Financial interest means anything of monetary value, whether or not the value is readily ascertainable. 
4. Company Responsibilities means an employee’s professional responsibilities on behalf of the Company.
5. Investigator means the project director (PD) or principal investigator (PI) any Company employee contributing effort to a PHS funded project 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, designated by the PI/PD.  
6. 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.
7. PD/PI means a project director or principal investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator.
8. Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Company.
9. Significant Financial Interest means: 
   1. Financial Interests Related to an Employee’s Company Responsibilities: A Significant Financial Interest (SFI) is a financial interest consisting of one or more of the following interests of the employee.  The Employee (and those of the Employee’s spouse and dependent children) must disclose any such SFI that reasonably appear to be related to the Employee’s Company responsibilities:
      1. With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. 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, an SFI 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 Employee (or the Employer’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. The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Company to the Employee if the Employee is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights.
   3. SFI also does not include income from investment vehicles, such as mutual funds and retirement accounts, as long as the Employee does not directly control the investment decisions made in these vehicles; and
   4. SFI also does not include income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency in the United States, a United States public or non-profit institution of higher education (as defined at 20 U.S.C. 1001(a)) or its affiliated hospital, medical center or research institute; or income from service on advisory committees or review panels for a Federal, state, or local government agency in the United States, or  a United States institution of higher education.

3. Policy

3.1. Disclosure

Regular Disclosure Requirements

All company employees who are planning to participate or who are participating in PHS-funded research at the Company must disclose all financial interests, including those of their spouse and dependent children, that could reasonably be related to the Employee’s Company Responsibilities.  Such disclosures must be made on an annual basis or within thirty days of discovering or acquiring (e.g. through purchase, marriage, or inheritance) a new SFI. SFIs disclosed will be identified and reviewed in accordance with this policy.  

PHS-Funded Research Disclosure Requirements

For each project proposed to or funding by PHS, the following people are considered Employees for purposes of this policy:

• the Principal Investigator (PI), and
• all company employees contributing effort to a PHS sponsored project.

All Company Employees are required to complete a disclosure for the proposal. All disclosed financial interests of the company employees, including those of their spouses or dependent children, are reviewed to identify SFIs that may reasonably appear to be related to the proposed research project, and a determination is made whether there is an FCOI.  All FCOI are eliminated or managed, in accordance with this policy, to ensure compliance with PHS requirements prior to expenditure of PHS funds. In addition to fulfilling disclosure requirements, all Employee complete training, as described below, before expenditure of PHS funds.

3.2. Review of Disclosures by the Designated Company Official

The company will identify and appoint a Designated Company Official to assume the review responsibility for all Company Employees.  All financial interests of the Company Employee are reviewed by the Designated Company Official.  Any financial interest that qualifies as an SFI and that may reasonably appear to be related to the proposed research project is further reviewed by the Designated Company Official to determine whether there is an FCOI and, if so, the FCOI is eliminated or managed and reported to PHS, as applicable, in accordance with this policy and in compliance with PHS requirements regarding conflict of interest. All FCOI identified that are specifically related to PHS-funded research are eliminated or managed prior to expenditure of PHS funds. 

3.3. Determining if an SFI is Related to PHS-funded Research

An SFI is related to the PHS-funded research when the Designated Company Official reasonably determines that the SFI could affect PHS-funded research. The Company may involve the employee in the Designated Company Official’s determination of whether an SFI is related to the PHS-funded research. An SFI with an Entity would be reasonably considered related to the Employee's research study in circumstances such as the following:

• Entity is a collaborator on or provider of materials, products, data or trainee support for the PHS-funded research or is a licensee with improvement rights to technology likely to arise out of the PHS-funded research. 
• Investigator or Entity has financial interests that could reasonably be considered to have a potential influence on the design, conduct or reporting of the PHS funded research.
• Entity has a reasonable possibility of being financially affected by the PHS funded research.
• Entity owns intellectual property, materials, or data that may be used in research at the company.

3.4. FCOI Determination

A financial conflict of interest (FCOI) exists when the Designated Company Official reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

Timing of Review and Requirements

1. Newly Funded Project

Prior to Company’s expenditure of any funds under a PHS- funded research project, the Designated Company Official(s) shall review all Employees SFI disclosures and:

• determine whether the SFI relates to PHS-funded research; 
• determine whether a financial conflict of interest (FCOI) exists; 
• if there is an FCOI, either take steps to eliminate the conflict or develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI; and 
• If an FCOI is not eliminated and a management plan is implemented, Company must file an FCOI report with the appropriate PHS awarding component.

2. Ongoing Project (Timely Disclosure)

In the course of an ongoing PHS-funded research project (timely disclosure), should an Employee who is new to participating in the research project disclose a SFI or should an existing Employee disclose a new SFI to the Company, the Designated Company Official shall, within sixty days, review the disclosure of the SFI and:

• determine whether the SFI relates to PHS-funded research; 
• determine whether a financial conflict of interest (FCOI) exists; 
• if there is an FCOI, either take steps to eliminate the conflict or develop and implement, on at least an interim basis, a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI. Depending on the nature of the SFI, the Company may determine that additional interim measures are necessary with regard to the Employee’s participation in the PHS- funded research project between the date of disclosure and the completion of Company’s review; and
• if an FCOI is not eliminated and a management plan is implemented, the Company must file an FCOI report (or update an existing one) with the appropriate PHS awarding component within 60 days.

3. Ongoing Project (Failure to Timely Disclose or Review)

In the course of an ongoing PHS-funded research project, should the Company identify an SFI that was not disclosed timely by an Employee or, for whatever reason, was not previously reviewed by the Company during an ongoing PHS-funded research project, the Designated Company Official shall, within sixty days, review the SFI and: 

• determine whether the SFI relates to PHS-funded research; 
• determine whether a financial conflict of interest (FCOI) exists; 
• if there is an FCOI, either take steps to eliminate it or develop and implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;
• if there is an FCOI, complete a retrospective review, within 120 days. Depending on the nature of the FCOI, the Company may determine that additional interim measures are necessary with regard to the Employee’s participation in the PHS-funded research project between the date that the financial conflict of interest or the Employee’s noncompliance is determined and the completion of Company’s retrospective review; and
• If an FCOI is not eliminated and a management plan is implemented, the Company must file an FCOI report (or update an existing one) with the appropriate PHS awarding component within 60 days.

3.5. FCOI Management and Monitoring

Management of an identified FCOI requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report (described below).  Examples of conditions or restrictions that Company may impose to manage a FCOI include, but are not limited to: (i) Public disclosure of FCOI (e.g., when presenting or publishing the research); (ii) 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; (iii) Modification of the research plan; (iv) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; (v) Reduction or elimination of the financial interest (e.g., sale of an equity interest); or (vi) Severance of relationships that create financial conflicts. 

The management plan should include: (A) A description of the SFI and the FCOI (B) Role and principal duties of the conflicted Employee in the research project; (C) Specific conditions of the management plan; (D) A description of how the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Employee’s agreement to the management plan; (F) How the management plan will be monitored to ensure Employee compliance.  The appropriate Employee shall sign and certify each manage plan, along with the Designated Company Official.  

The Employee will provide an update to the details of the management plan at least annually, and more often if circumstances related to the SFI change.  Such plans shall remain in effect until the completion of the PHS-funded research project, or until the FCOI is eliminated, whichever comes first. 

3.6. FCOI Reports to PHS

Prior to Company’s expenditure of any funds under a PHS-funded research project, the Company shall provide to the PHS awarding component, through the NIH eRA Commons, an FCOI report regarding any Employee’s SFI found by Company to be conflicting and ensure that the Company has implemented management plan in accordance with the PHS regulations. In cases in which Company identifies an FCOI and eliminates the conflict prior to the expenditure of PHS-awarded funds, Company will not submit an FCOI report.

For any SFI that the Company identifies as conflicting subsequent to Company’s initial FCOI report and during an ongoing PHS-funded research project (e.g., upon the participation of an Employee who is new to the research project), the Company shall provide an FCOI report to the PHS Awarding Component, within sixty days. 

Where an FCOI report involves a SFI that was not disclosed timely by an Employee or, for whatever reason, was not previously reviewed or managed by the Company (e.g., was not timely reviewed or reported by a subrecipient), in addition to providing an FCOI report, the Company also is required to complete a retrospective review (see below) to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. If bias is found, the Company is required to notify and promptly and submit a mitigation report to the PHS Awarding Component.

After initial submission of an FCOI report, the Company shall provide the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. The Company shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

The FCOI report shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict and to assess the appropriateness of Company’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to, the following: (i) Project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) Name of the Employee with the financial conflict of interest; (iv) Name of the entity with which the Employee has a financial conflict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee); (vi) 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; (vii) A description of how the financial interest relates to the PHS-funded research and the basis for Company’s determination that the financial interest conflicts with such research; and (viii) A description of the key elements of Company’s management plan, including: (A) Role and principal duties of the conflicted Employee in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Employee’s agreement to the management plan; (E) How the management plan will be monitored to ensure Employee compliance; and (F) Other information as needed.

3.7. Retrospective Review

Whenever an FCOI is not identified or managed in a timely manner, including failure by the Employee to timely disclose a SFI that is later determined by the Company to constitute a FCOI; failure by the Company to timely review or manage such an FCOI; or failure by the Employee to comply with a FCOI management plan, Company shall, within 120 days of Company’s determination of noncompliance, complete a retrospective review of the Employee’s funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. 

Under PHS policy, the Company is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of 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 Employee with the FCOI; (5) Name of the entity with which the Employee has a financial conflict of interest; (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); (8) Findings of the review; and (9) Conclusions of the review. 

Based on the results of the retrospective review, if appropriate, the Company shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. 

If bias is found, Company is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must 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 Company’s plan of action or actions 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). 

Thereafter, the Company will submit FCOI reports annually, as specified elsewhere in this policy. 

3.8. Remedies for Non-Compliance

The Chief Scientific Officer of the Company is responsible for interpretation and overall coordination of the policy. Violation of any part of this policy may cause an employee to be subject to sanctions.

Whenever an FCOI is not identified or managed in a timely manner, including failure by the Employee to disclose a SFI that is determined by the Company to constitute a FCOI; failure by the Company to review or manage such a FCOI; or failure by the Employee to comply with a FCOI management plan, the Company shall, within 120 days of Company’s determination of noncompliance, complete a retrospective review of the Employee’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

If the failure of an Employee to comply with Company’s financial conflicts of interest policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Company shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. 

The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, which may include directing the Company on how to maintain appropriate objectivity in the PHS-funded research project, requiring the Company to submit records, submit to on-site review, accept special award conditions, suspension of funding, or other enforcement actions until the matter is resolved.

4. Public Accessibility

This PHS Policy is available on a publicly accessible website and has been made available to PHS via its NIH eRA Commons.

Information concerning FCOIs held by senior/key personnel is made publicly accessible by a written response to any award agency within five business days of a request or as required by law.  This information provided will include: the Employee’s name; the Employee’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 pre-specified dollar ranges), or a statement that a value cannot be readily determined. This information will remain accessible for at least three years from the date that it was most recently updated.

5.Employee Training

Each Employee must complete training regarding Company’s policy on financial conflicts of interest, the Employee’s responsibilities regarding disclosure of significant financial interests, and of these specific PHS requirements.  Training must be completed prior to engaging in research related to any PHS-funded grant and refreshed at least every four years.  

Additional training must be completed when (1) Financial conflict of interest policies are revised in a manner that changes researcher requirements; (2) A employee is new to the organization; and (3) A employee is non-compliant with financial conflict of interest policies and procedures.

6. Subawards

When the Company carries out PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), the Company, as the awardee Institution, will take reasonable steps to ensure that all subrecipient Investigators comply with PHS FCOI policy.  The Company will incorporate, as part of a written agreement with the subrecipient, terms that establish that (1) the subrecipient’s financial conflicts of interest policy is compliant with PHS FCOI policy, (2) all subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, and (3) there is a specified time period for the subrecipient to report all identified conflicts of interest to the Company, where this time period is sufficient to enable the Company to provide timely FCOI reports to the PHS as required.  The subrecipient shall certify that its policy complies with PHS FCOI policy. 

7. Records

The Company will maintain records relating to all Employee disclosures of financial interests and Company’s review of and response to such disclosures (whether or not a disclosure resulted in Company’s determination of a financial conflict of interest) and all actions under Company’s policy for PHS COI review or retrospective review, as applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in PHS regulations.