Cytorum Inc.

Financial Conflict of Interest Policy

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PURPOSE

The purpose of this Financial Conflict of Interest (FCOI) policy is to document the requirements and responsibilities associated with identifying and managing financial conflicts of interest to safeguard the integrity of Cytorum, Inc. research and to comply with federal regulations.

This policy has been developed to address and comply with the specific federal agency requirements as defined in the 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F).  This regulation was developed to promote objectivity in research by establishing standards that provide a reasonable expectation ensuring the design, conduct and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. See https://grants.nih.gov/grants/policy/coi/index.htm for more information regarding the policy.

These regulations do not cover Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Program Phase I applications or awards but do apply to applicants and recipients under the SBIR/STTR Program Phase II.

KEY DEFINITIONS

The following definitions are provided as a reference and are considered key definitions in understanding the federal regulations of FCOI.   A complete list of official definitions can be found at 42 CFR 50.603.

Institution – means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) applying for, or receiving NIH research funding. Herein, institution shall be Cytorum, Inc.

Designated Official - is the individual designated to oversee the financial conflicts of interest process, including notification of Principal Investigators about the FCOI Policy, and solicitation and review of disclosures of significant financial interests.

Investigator – means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, 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 service 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 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 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) – 

(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:

(i) 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, when aggregated, exceeds $5,000

(ii) 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

(iii) Upon receipt of income related to intellectual property rights and interests (e.g. patents, copyrights)

(2) Investigators also must disclose the occurrence of 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 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. For example, if the PI travels to a scientific seminar but does not pay or receive reimbursement by Cytorum directly (i.e. the travel was paid for by a third party/sponsor), the PI is required to disclose basic information to Cytorum relating to the trip, such as purpose of the trip, identity of the payer/sponsor, destination and duration. 

(3) The term significant financial interest does not include the following types of financial interests: 

(i) salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution;

(ii) intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;

(iii) any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;

(iv) 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;

(v) 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

(vi) income from service on advisory committees or review panels for a federal, state or local government agency, 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.

SUMMARY OF PROCESS

Significant Financial Interests (SFI) shall be disclosed on the Significant Financial Interest Disclosure Form by an Investigator requesting government-sponsored funds for a research project or by an Investigator when a Significant Financial Interest arises during the course of research using government-sponsored funds. Regardless of whether a SFI exists, all Investigators and key personnel are required to submit a SFI Disclosure Form annually.

It is the Principal Investigator's responsibility to ensure those with financial interests in research are identified and make the required disclosures in conjunction with submission of a research proposal.

The Significant Financial Disclosure Form and supporting materials are forwarded to the Designated Official for review. The Designated Official, in collaboration with senior management, will be responsible for evaluating and instituting a plan for managing any disclosed financial interests, for producing institutional reports and other required reports to external sponsors and governmental agencies, and for the general administration and enforcement of this policy. 

Advance approval by the CEO is required prior to applying for or engaging in government-sponsored research. A SFI review must be completed before any expenses are incurred under an award.

Annual updates are required of all Investigators and key personnel participating in government-sponsored research.  Any Investigator who has acquired a new or increased financial interest during the course of a research project shall report it immediately to the Designated Official.  Annual updates and newly acquired interests are reported using the Significant Financial Interest Disclosure Form. 

TRAINING

The NIH Financial Conflict of Interest tutorial was designed by the National Institutes of Health (NIH) to provide education training on what constitutes financial conflict of interest.  This course is required for anyone involved with an NIH funded project, which includes all Investigators, consultants and employees of Cytorum engaged in NIH-funded research or its compliance.

The course is accessible at https://grants.nih.gov/grants/policy/coi/fcoi-training.htm.  Upon completion of the training, a certificate of completion must be turned into the Designated Official.  You should retain a copy for your records.  This training is required prior to engaging in research relating to any NIH-funded grant or as deemed necessary by Cytorum due to changes in the FCOI policy, non-compliance of the Investigator/Key Personnel or Investigators new to Cytorum.  At a minimum, the FCOI training shall be taken every four (4) years.

PROCEDURES

A. Identification of Persons Required to Disclose a Significant Financial Interest - It shall be the responsibility of the Principal Investigator of a research project or grant application to identify all Investigators who need to disclose SFI under this policy and to ensure that a SFI Disclosure Form is prepared and submitted.  In addition, the Principal Investigator shall be responsible for ensuring that annual updates and disclosures of new or increased financial interests are disclosed, and revised SFI disclosures are completed when revisions to the FCOI policy are made that impact the requirements of investigators.

B. Submission and Review of Significant Financial Interest Disclosure Form - Every individual having a requirement for SFI disclosure under this policy shall prepare a fully-completed SFI Disclosure Form that shall be submitted to the Designated Official.  An initial review of the SFI Disclosure Form will be conducted by the Designated Official to determine 1) whether the SFI relates to the government-sponsored research project, and if so, 2) whether the SFI constitutes a financial conflict of interest under this policy and applicable regulations. If an Investigator does not file a timely SFI disclosure form, or the form was not previously reviewed by the Designated Official, it will be reviewed within 60 days of identification. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research. Prior to expenditure of funds from new government-sponsored research projects, the Designated Official will review all Investigator SFI forms again to determine whether they relate to the project, and if so, whether an FCOI exists.

If it is determined that there is a potential conflict of interest, then steps will be taken to determine what measures are needed to address the SFI identified in the SFI Disclosure Form.  A management plan may be required to outline the terms, conditions and restrictions, if any, to ensure compliance with this policy.   The management plan may require one or more of the following actions (but not limited to) to be taken in order to manage, reduce or eliminate any actual or potential conflict of interest: 

●      Public disclosure of significant financial interests;

●      Review of research protocols by independent reviewers;

●      Monitoring of research by independent reviewers;

●      Modification of research plan;

●      Disqualification from participation in all or a portion of the research funded;

●      Divestiture of significant financial interests;

●      Severance of relationships that create actual or potential conflicts

All management plans are required to be signed by the Investigator and the Designated Official. 

Prior to expenditure of any funds under PHS-funded projects, and for three years following the most recent update, Cytorum shall ensure public accessibility, via written response to any requestor within five business days of a request, of information concerning any currently-existing FCOI that has not been eliminated. The information will include the Investigator’s name, title, and role in the project, the name of the entity in which the SFI is held, the nature of the SFI, and the approximate dollar value of the SFI 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. For clarity, and to ensure Investigator confidential information is protected, only SFI that is deemed to be an FCOI with PHS-funded projects, and which has not been eliminated, will be disclosed.

C. Annual Reporting and After-Acquired Significant Financial Interests – All Investigators shall provide annual SFI Disclosure reports or more frequently if required by the management plan.  Any Investigator who acquires a new or increased SFI shall promptly submit a new SFI Disclosure Form within 30 days of discovering or acquiring the new SFI.  It is the Principal Investigator’s responsibility to ensure that any newly acquired Investigator on a research project submits the required SFI report to the Designated Official. 

D. Violations of Conflict of Interest Policy – Investigators are expected to comply fully and promptly with this policy. Whenever a person has violated this policy, including failure to make a required disclosure of financial interests or failure to comply with a requirement of the management plan, the Designated Official shall make recommendations to the CEO regarding the impositions of sanctions or disciplinary proceedings against the violating individual.

In addition, Cytorum shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy, as per 42 CFR 50.606(a).  The federal agency may take its own action as it deems appropriate, including the suspension of the funding for the Investigator until the matter is resolved.

If HHS determines that a clinical NIH-funded 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 neither disclosed nor managed, Cytorum shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if necessary. 

E. Record Keeping – Records of Investigator SFI Disclosure forms, and of actions taken to manage actual or potential conflicts of interest, shall be retained by Cytorum for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR 50.604(i) and 45 CFR 75.361 for different situations. 

F. Sub-recipient Requirements – Sub-award recipients must comply with this policy or provide certification that their organization is in compliance with the Federal policy, 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR part 50 subpart F) and that their portion of the research project, as detailed in their sub-award agreement, is in compliance with their institutional policies.  If a FCOI is identified by the sub-award recipient, they are required to notify the Designated Official of the existence of the conflicting interest within 30 days of the identification of the interest.  In addition, the sub-award recipient must certify and assure that any reported conflicting interest has been managed, reduced or eliminated in accordance with federal regulations. 

G. Federal Reporting – Upon request, Cytorum will provide HHS/NIH staff, on a need-to-know basis, with information relating to any Investigator disclosure of significant financial interests; Cytorum’s review of, and response to, such disclosure; and whether the disclosure resulted in Cytorum’s determination of a financial conflict of interest. If bias is found with the design, conduct, or reporting of NIH-funded research, Cytorum will promptly notify NIH and submit a Mitigation Report.

In addition, the following reports will be submitted as required by the HHS:

1. Initial report – prior to Cytorum’s expenditure of any funds under a NIH-funded research project, Cytorum must provide to the NIH an FCOI report regarding any Investigator SFI found by Cytorum to be a financial conflict of interest in accordance with the regulation.
2. During on-going NIH-funded research projects – Cytorum shall submit an FCOI report within 60 days after its determination that a new FCOI exists.  If a FCOI was not disclosed timely, Cytorum shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance as outlined in 42 CFR 50.605(a)(3).
3. Annual FCOI report – For any FCOI previously reported to the NIH, Cytorum shall provide an annual FCOI report addressing the status of the FCOI and any changes to its related management plan.

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