Policy Statement

OncoC4, Inc. is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest. OncoC4 has implemented this policy to identify, manage, reduce, or eliminate financial conflicts of interest.

This policy provides guidance to help personnel manage situations in their personal affairs, employment outside of OncoC4, and financial activities that may appear to conflict with their responsibilities and to ensure the OncoC4 and its employees comply with applicable federal laws when participating in research funded by the Public Health Service (PHS). OncoC4’s personnel should promptly disclose the circumstances of any situation that might be covered by this policy. This policy applies to any OncoC4 member acting as Investigator or as a Senior/Key personnel on any PHS research project and any Sub-recipient of that project.

 

Reason for Policy

This procedure is designed to comply with PHS regulations (42 CFR Part 50 Subpart F, Promoting Objectivity in Research, 45 CFR Part 94, Responsible Prospective Contractors). These standards and procedures are intended to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements, or contracts will be free from bias resulting from Investigator FCOIs. OncoC4’s Conflict of Interest Policy implements the requirements of these federal regulations. The policy is also intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to OncoC4’s other research activities. For non-PHS research, the specific steps, timing, determinations, documentation, and notifications may be tailored as appropriate but will remain focused on maintaining OncoC4’s high standards for research integrity and effectively eliminating or managing actual or potential financial conflicts of interest.

 

Definitions

For purposes of this policy, the following definitions apply:

Company Official (CO) is the individual designated by OncoC4 to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.

Company Responsibilities means the Investigator’s responsibilities associated with his or her OncoC4 appointment or position, such as research, teaching, administration, and internal and external professional committee service.

Financial conflict of interest (FCOI) means a significant financial interest (SFI) that could directly and significantly affect the design, conduct, or reporting of research.

Immediate family refers to an Investigator’s spouse and dependent children.

Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants.

PHS means the U.S. Public Health Service, an operating division of the U.S. Department of Health and Human Services (HHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health.

PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.

PHS-funded Research means research funded under PHS grants, cooperative agreements, or contracts.

Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

Research means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.

Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the OncoC4 in the grant application, progress report, or any other report submitted to the PHS by the OncoC4 under the regulation.

Sub-recipient means any party that has entered into an Agreement with OncoC4 as a sub-grantee, subcontractor, collaborator, contractor, or consultant.

Significant financial interest (SFI) means a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s OncoC4 Responsibilities:

1. With regard to interests in any publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure and any equity interest in the entity as of the date of disclosure, in which the value 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 interests in any non-publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure, in which the value when aggregated exceeds $5,000, or when the Investigator or his/her immediate family 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.

Significant financial interests also include any reimbursed 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 the Investigator’s OncoC4 project 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.

Significant financial interest does not include the following:

• Salary, royalties, or other remuneration paid by OncoC4 (or a subrecipient as applicable) to the Investigator if the Investigator is currently employed or otherwise appointed by OncoC4, including that paid for intellectual property rights assigned or licensed to OncoC4 and agreements to share in royalties related to such rights;
• Any ownership interest in OncoC4 (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);
• 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 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education; or
• Income from service on advisory committees or review panels for 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.

 

Responsibilities

Company Official (CO) or his/her designee:

• Informing OncoC4 Investigators/Senior/Key Personnel of their obligations and responsibilities under this policy and any related regulations.
• Must record and review all Financial Interest Disclosure forms from PHS-funded researchers to determine whether a FCOI exists.
• Must provide required information concerning FCOIs to the expenditure of PHS funds, and must update such information at least annually and within 60 days of changes to Statement of Financial Interest Disclosure forms, whichever occurs first.
• Must prepare the Public Financial Conflict of Interest Disclosure Form, including the following information, for reported FCOIs such that it can be made publicly available upon request:
  • Project/Contract number
  • Investigator’s name
  • Investigator’s title and role with respect to the research project
  • Name of the entity in which the relevant significant financial interest (SFI) is held
  • Nature of the relevant SFI (e.g., equity, consulting fees, travel reimbursement, honoraria, etc.)
  • Approximate dollar value of the relevant SFI (dollar ranges are permissible: $5,000-$9,999; $10,000-$19,999; etc.)
• For reported FCOIs, must develop a FCOI management plan to include: role and principal duties of the Investigator with the FCOI; how the FCOI Management Plan is designed to safeguard objectivity in the PHS research project; confirm that Investigator agrees with the FCOI Management Plan; and how the FCOI Management Plan will be monitored.
• Must maintain for three years records of all Statement of Financial Interest Disclosure form records and FCOI Management Plans.
• Maintains the FCOI Policy and Procedure on the OncoC4’s external website.
• Must ensure compliance with FCOI policy and procedures.
• In cases where a potential FCOI exists, assists in the development and implementation of FCOI Management Plan for FCOI is developed in consultation with the CO and Investigator. The FCOI Management Plan must be completed in advance of the OncoC4’s spending PHS funds and a summary of the management plan must be included in the FCOI Report.
• Taking reasonable steps to ensure that Investigators for Sub-recipients fully comply with this policy or provide OncoC4 with sufficient assurances to enable OncoC4’s compliance with all applicable laws or regulations.

PHS-Funded Investigators/Senior/Key Personnel:

• Must complete FCOI training prior to engaging in a PHS research project and thereafter, every four years.
• Must complete and submit to the CO a Financial Interest Disclosure Form prior to working on PHS-funded projects.
• Must update the Financial Interest Disclosure Form annually or within 30 days of a change in financial status (acquisition of new financial interest), whichever occurs first.
• Must follow management plan as prescribed by the CO for FCOIs.

Sub-Recipient:

• Must complete and submit to OncoC4 a Sub-Recipient FCOI disclosure form prior to working on PHS funded projects.
• Sub-recipient organization will certify that it has a PHS FCOI compliant policy in place or that it intends to have one in place at the time of the award or that it will abide by OncoC4’s policy.
• Sub-recipient organization will certify that the investigators, senior and/or key personnel will complete required training.

 

SFI Review Process

The CO reviews each SFI received from OncoC4 personnel. If necessary, the CO collects additional information from the disclosing individual and/or from other individuals who possess relevant information. The CO determines whether the disclosed financial interests are significant, whether they are related to the individuals research responsibilities at the OncoC4, and whether a management plan is required. In conducting this review, the CO considers factors such as the value of the individual’s financial interest and how it could affect their ability to objectively complete their research with the OncoC4.

If a significant financial interest is deemed to be a financial conflict of interest, the CO will develop a management plan in consultation with the Investigator. The goal of the management plan is to reduce or eliminate the financial conflict of interest, which can include reducing or eliminating the financial conflict of interest and to ensure that the design, conduct and reporting of research will be free from bias. The management plan may include, but is not limited to: (1) requiring the individual to recuse him/herself from particular decisions or activities related to the research, (2) requiring the individual to inform certain persons or institutions about the conflict of interest and the management plan (e.g. relevant review bodies, research sponsors, co-investigators, journals to which manuscripts about the research are submitted, media, etc.), (3) requiring others to review decisions in which the individual participates, (4) requiring the individual to reduce, modify or eliminate a financial interest (e.g. divesting ownership, restricting the sale or exercise of stock and stock options, and deferring or waiving royalties or milestone payments), or (5) requiring the individual to vacate a position.

 

Reporting

OncoC4 will comply with federal regulations regarding reporting of financial conflicts of interest (e.g. by submitting FCOI reports to the awarding institution, as required). OncoC4 will comply with federal FCOI regulations regarding making publicly available information on identified FOCIs held by Investigators and Key personnel on PHS-funded research projects.

 

Record Keeping

OncoC4 will comply with federal regulations regarding maintaining records relating to all disclosures of financial interests and the OncoC4’s review of, and response to, such disclosures. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by OncoC4 with respect to each financial conflict of interest will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 74.53(b) or 48 CFR Part 4, Subpart 4.7.

 

Confidentiality

OncoC4 will, to the extent possible, protect the confidentiality of disclosures. In every instance, OncoC4 will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to OncoC4 staff only on a need-to-know basis and will not be disclosed outside of OncoC4 unless necessary to comply with contractual, legal, or regulatory requirements.

 

Training and Education

OncoC4 Investigators/Senior/Key Personnel receive training to promote objectivity in research and to ensure Investigator compliance with regard to the applicable regulations and significant financial interest disclosure obligations.

 

Investigator Noncompliance

Failure to comply with the OncoC4’s FCOI policy includes failing to submit a required disclosure, providing false information, omitting required information, failing to maintain confidentiality, failure to carry out duties prescribed by these policies, and refusal or failure to comply with a management plan adopted under these policies. A failure to comply with these policies may result in a decision by the CO to suspend the research project or to refuse to approve a new research project for the individual who fails to comply.

A failure to comply is also subject to: (1) formal admonition, (2) ineligibility of the individual to apply for federal research grants, (3) additional sanctions per research funding agency (such as requiring investigator financial conflict of interest training), up to and including sponsor suspension of function per application federal regulations (note: the OncoC4 will comply with federal financial conflict of interest requirements regarding non-compliance retrospective review and corrective action), and/or (4) termination of employment.

 

Availability of the Policy

The OncoC4 will maintain an up-to-date written, enforced policy on financial conflicts of interest that complies with applicable regulations, including any federal financial conflict of interest regulations. The policy will be posted and available via the OncoC4’s publicly accessible website. The OncoC4 will inform covered individuals of the policy and of their responsibilities regarding disclosure. The OncoC4 will inform covered individuals in the event the policy is revised and updated.

 

Point of Contact

If you have a conflict of interest or if you have a question to discuss, contact the OncoC4 Administrator at admin@OncoC4.com.