FCOI Policy

1. General Policy. The principles articulated herein are intended to provide guidance in the management of formal relationships between employees of Radiant Creative Group (“Company”) and their external constituencies in order to ensure that the design, conduct, and reporting of sponsored research will not be biased by any conflicting financial interests. Under the Public Health Service (PHS) and National Science Foundation (NSF) final rules on Objectivity in Research, each investigator is required to disclose a listing of his/her significant financial interests, as well as those of his/her spouse and dependent children, that would reasonably appear to be affected by the research purpose for funding by the PHS or the NSF. If, after reviewing of these disclosures, it is determined that the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research, the Company will report the existence of such conflicting interests to the sponsor and act to protect the resulting research from bias owing to the conflict of interest. This policy statement is intended to satisfy current Federal rules for disclosure with regard to projects funded by the PHS or the NSF as well as State of Texas statutes involving conflict of interest situations.
2. Scope. This policy and the associated procedures are applicable immediately to all sponsored program activity at Radiant Creative Group carried out by Company employees, consultants, scientists, trainees, technicians, and other agents or research collaborators (“Company employees”). The policy and the associated procedures are derived from the rules on Objectivity in Research promulgated by the PHS and the NSF. These procedures will be followed whenever Radiant Creative Group or its employees submit a request for funding from any external agency, whether it is the PHS, the NSF, or another Federal agency. This document articulates Company policy on the management or elimination of conflicts of significant financial interest between outside constituencies and the associated funded activities carried out by Company. While this policy focuses upon avoiding or at least managing, conflicts of significant financial interest, its primary purpose is to promote compliance with the standards of Objectivity in Research.

1. Conflict of Significant Financial Interest is considered to occur whenever a Company employee, or a family member of the Company employee, has an existing or potential financial or other material interest that impairs or appears to impair, the Company employee’s independence and objectivity in the discharge of his/her responsibilities to and/or for the Company; or, alternatively, conflict of significant financial interest is considered to occur whenever a Company employee receives financial or other material benefits through inappropriate use of knowledge or information confidential to the Company.
2. Company Employee is any individual employed on a full- or part-time basis by the Company and is receiving, or will receive, compensation for such employment. (Includes Consultants, Agents, and Research Collaborators of Company).
3. Investigator is the principal investigator, co-principal investigators, or any other Company employee responsible for the design, conduct, or reporting of externally funded scientific research activities.
4. Family member includes the Company employee’s spouse and children or other adults who qualify as dependents under the Internal Revenue Code definitions.
5. Project implies any externally funded activity such as basic, applied, or developmental research, or other activity conducted by Company employees on behalf of the Company.
6. Significant Financial Interest is any item of monetary value including, but not limited to: 1) salary or other payments for services rendered such as consulting fees; 2) equity interests such as stocks, stock options, or other ownership interest; and 3) intellectual property rights such as patents copyrights and royalties from such intellectual property rights. Significant Financial Interest does not include: 1) Company remuneration such as salary or royalties; 2) consulting fees from service on advisory committees or review panels for public or nonprofit entities; or 3) financial interest in business enterprises or entities where the value of such interests would not be anticipated to exceed $10,000 per annum or represent more than a five percent (5%) ownership interest. The value of such equity interests is to be determined on the basis of public prices or other reasonable measures of fair market value.
7. Negative Finding means a determination has been made that no conflict of significant financial interest exists.
8. Positive Finding means a determination has been made that a conflict of significant financial interest does exist and, therefore, appropriate administrative action will be required as given under III.D. below.

RESPONSIBLE PERSONNEL

Director of Research, Chief Executive Officer

1. MANDATORY DISCLOSURE OF SIGNIFICANT FINANCIAL INTERESTS
   In accord with relevant Federal and State of Texas regulations, the Company is required to manage, eliminate, or reduce any potential conflicts of significant financial interests that may be inherent in the personal financial interest of an investigator. Company, therefore, requires investigators to disclose to the Company, any significant financial interest, including those of his/her family members, which would reasonably appear to be affected by the project being funded by external government agencies. Investigators are required to provide updated disclosure information during the time period in which the proposal is pending, annually during the time period of an award, or whenever new significant financial interests are obtained by the investigator.
   1. Disclosure Form must be completed annually
   2. Investigators must notify the Company within 30 days of acquiring or discovering (e.g., through purchase, marriage, or inheritance) any new Significant Financial Interest.
2. THE FOLLOWING SIGNIFICANT FINANCIAL INTERESTS MUST BE DISCLOSED
   1. With regard to any publicly traded entity, 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, 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)
   3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests
   4. 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.
3. IDENTIFICATION OF CONFLICTS OF SIGNIFICANT FINANCIAL INTEREST The Director of Research, in conjunction with Company leadership, will review each Financial Disclosure submitted and shall make the determination of whether or not a conflict of significant financial interest exists. If the Director of Research determines that no conflict of significant financial interest exists, the resulting negative finding will be filed in the Company’s Legal and Human Resource files. For negative findings, no further review is required.
4. APPEAL OF POSITIVE FINDINGS
   1. Investigators may appeal a resulting positive finding to the Chief Executive Officer for a review of the conflict of significant financial interest determination reached by the Director of Research. The review of an appealed positive finding must be completed prior to the expenditure of any funds under an award. In reviewing positive findings, the Chief Executive Officer will be guided by the following principles:
      1. Assure adherence to all relevant Company policies
      2. Give full considerations to the nature and extent of the financial interests in the relationship of the investigator, and/or the investigator’s family members, with the external constituencies
      3. Give special consideration to the terms and conditions of sponsored project agreements that mitigate or complicate the given situation
      4. Consult fully with the investigator and obtain additional information from the investigator, as deemed appropriate to the management of the apparent conflict of significant financial interest.
5. MANAGING POSITIVE FINDINGS OF SIGNIFICANT FINANCIAL INTEREST Following the determination of a positive finding, or upon receipt of the review by the Chief Executive Officer, The Director of Research shall make a final determination involving one of the administrative actions:
   1. Accepting the sponsored project award;
   2. Not accepting the sponsored project award; or
   3. Accepting the sponsored project award subject to suitable modifications in the award documentation or in the investigator’s, or his/her family’s, affiliation with the external constituencies involved. Reasonable modifications under option
   4. above might include one or more of the following actions;
      • Requiring that public disclosure of the identified financial interests be made;
      • Requiring that the data and research results be reviewed by independent reviewers identified by the President and the investigator;
      • Requiring that the research plan be modified;
      • Requiring that the investigator be disqualified from participation in a portion of the research;
      • Requiring that the investigator and/or her/his family member(s) divest certain significant financial interests related to the positive finding; or
      • Requiring that the investigator and/or his/her family members(s) sever relationships that create the conflict of significant financial interest.

    

6. MANAGEMENT PLAN Should management of a potential or actual significant financial conflict of interest be required, the Designated Research Official will draft a Management Plan. Such plans will be designed to meet applicable legal requirements, facilitate the local resolution or management of any conflict, minimize administrative burden, and protect the confidentiality of disclosed information. Final management plans are reviewed and approved by the Director of Research. The Management Plan must include the following:
   1. The role and principal duties of the conflicted Investigator in the research project
   2. Conditions of the management plan
   3. How the management plan is designed to safeguard objectivity in the research project
   4. Confirmation of the Investigator’s agreement to the management plan
   5. How the management plan will be monitored to ensure Investigator compliance
   6. Other information as needed
7. COMPLIANCE If an investigator who is required under this policy to file a conflict of significant financial interest disclosure fails to do so or fails to disclose a significant financial interest on the disclosure form, the investigator may be subject to company and legal procedures. If an unreported significant financial interest involves a research project administered by the Company, appropriate administrative action required by the funding agency will also be taken. Radiant Creative Group will promptly notify the funding agency if it is determined that the company is unable to manage satisfactorily any conflict of significant financial interest. Intentional disregard for this policy, including non-adherence to the agreed-upon management plan, shall constitute serious misconduct and may be the basis for further administrative or legal inquiry.
8. REPORTS TO FUNDING AGENCIES As a condition of eligibility to receive grants for research from the Public Health Service, Radiant must provide reports on financial conflicts of interest to the appropriate PHS Awarding Component in accordance with relevant PHS rules and regulations.
9. TRAINING Company key research personnel will receive training on this material at the time of implementation and whenever this policy is updated. New key research personnel will receive training as part of their employee orientation. Training will be conducted immediately if this policy is revised and affects the requirements of Investigators, or if an Investigator is not in compliance with the policy or management plan.
10. RECORDS RETENTION Radiant must maintain records of all financial disclosures and all actions taken with respect to any conflict of interest covered by this policy for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 CFR 74.53(b) and 92.42(b) for different situations.