Financial Conflict of Interest Policy

 

I.  Background

The National Science Foundation (NSF) and the National Institutes of Health and other Public Health Service (PHS) funding agencies have unique Financial Conflict of Interest (FCOI) reporting and management/oversight requirements. The purpose of this policy is to ensure compliance with these important regulations referred to in this document as the “FCOI Regulations”.  All Investigators defined below and as stated in the application, applying for funds from NSF or PHS agencies, are obligated to comply with the requirements of the FCOI Regulations and this policy.  This policy fulfills the requirements of grantee institutions as put forth in the National Institutes of Health’s guidelines (see http://grants.nih.gov/grants/policy/coi/index.htm) and the National Science Foundation’s conflict of interest policies (see http://www.nsf.gov/pubs/policydoc/pappguide/nsf08_1/aag_4.jsp#IVA).

For purposes of this policy, all references to PHS refer to the specific PHS funding agency from which the Investigator is seeking funding (see list of PHS agencies, below).   PHS agencies require awardee institutions to ensure objectivity in research through compliance with PHS comprehensive regulations, “Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought and Responsible Prospective Contractors” issued at 42 CFR Part 50, Subpart  F, which can be found at: http://grants.nih.gov/grants/policy/coi/ 

The FCOI regulations covering PHS-funded activities provide for more complete disclosure, together with compulsory reporting to the applicable PHS funding agency. Disclosure to NSF or PHS is required for ALL “Significant Financial Interests” that reasonably appear related to the Investigator(s) “Institutional Responsibilities.”  As more precisely defined below, “Significant Financial Interests” include all travel reimbursements of any amount, any equity interest in a privately-held entity and all other financial interests having a value in excess of $5,000.  All financial interests of a lesser amount are not subject to the FCOI regulations remain subject to disclosure and management under the institutional policy on Conflicts of and any other applicable policy or procedures.

 

 II. Definitions

“Investigator” is defined as the Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who would be responsible for the design, conduct, or reporting of research funded by NSF or PHS, or proposed for such funding, including subawardees, consultants and unpaid collaborators. 

“Institutional Responsibilities” means an Investigator’s professional responsibilities on behalf of O-Ray Pharma, Inc., including, but not limited to activities such as research, teaching, clinical or other professional practice, academic activities, scholarly events, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

“Significant Financial Interest” (SFI) is defined as:

• Publicly Traded Entities - 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. 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.
• Privately Held Entities - 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 domestic partner and dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
• Intellectual Property - Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income that exceed $5,000 related to such rights and interests.
• Travel Reimbursements - 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 (as defined above) in the twelve months preceding the disclosure. However, 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.

Exclusions to Significant Financial Interests - The term “Significant Financial Interest” does not include the following:

• Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by O-Ray Pharma, Inc. including intellectual property rights assigned to O-Ray Pharma, Inc. and agreements to share in royalties related to such rights.
• 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.
• 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.

“Financial Conflict of Interest (FCOI)” is defined as an SFI that could directly and significantly affect the design, conduct, or reporting of NSF- or PHS-funded research.

• “Public Health Service (PHS) agencies” include the following:
• National Institutes of Health (NIH)
• Food and Drug Administration (FDA)
• Centers for Disease Control and Prevention (CDC)
• Indian Health Service (IHS) 
• Health Resources and Services Administration (HRSA)
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substance and Disease Registry (ATSDR)
• Any other sponsor who has adopted PHS FCOI financial disclosure requirements

 

III. Timing of Required Disclosures

Investigators must provide all required financial disclosures at the time a proposal is submitted.

In addition, Investigators must update those financial disclosures:

a. Within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage or inheritance) any new Significant Financial Interest; and

b. Annually within the period of the award, beginning with the anniversary date of the original disclosure.

 

IV. Disclosure Procedures

When a project is sponsored by NSF or PHS, either directly or through a third party (via subawards), all Investigators must complete a Statement of Financial Interests Disclosure Form which can be found on Auritec Pharmaceutical Inc.’s website and available for completion by the lead Investigator, co-investigators, and any other person regardless of title responsible for the design, conduct, or reporting of the research funded by NSF or PHS.  The Statement of Financial Interests Disclosure Form must be filled out no later than at the time the application for PHS-funded research.

The Statement of Financial Interests Disclosure Form will conform to the requirements of the FCOI regulations and include a link to the FCOI regulations and the NSF and PHS Conflict of Interest Websites. The Statement of Financial Interests Disclosure Form asks Investigators to identify any of the  Investigator’s Significant Financial Interests (and those of the Investigator’s spouse or domestic partner and dependent children) related to the work being performed and that reasonably appear to be related to the Investigator’s Institutional Responsibilities (as defined above).

The Significant Financial Interest disclosure must include, at a minimum, the name of the entity, the nature of the financial interest (e.g., equity, consulting fee), the monetary value of the financial interest or its approximate value if the interest is one whose value cannot readily be determined, and any supporting documentation to make a determination of whether a FCOI exists (such as a copy of the applicable consulting agreement or stock purchase agreement).  For disclosures relating to travel, at a minimum, they must include the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and the approximate monetary value.  In addition, the Investigator must cooperate with all requests from the applicable NSF or PHS awarding Contracting Officer (CO) for additional information.  All such internal disclosures will be treated as confidential personnel information with all necessary precautions to protect any sensitive proprietary company or sponsor information.

Investigators are also required to update disclosures of Significant Financial Interests during the period of the award at least annually. The Grants Manager is responsible for obtaining these annual updates. New disclosures must be provided when Investigators begin employment at O-Ray Pharma, Inc..  The Investigator must report disclosure within 30 days of discovering or acquiring a new SFI.

The lead Investigator on a proposed PHS application for funding is responsible for obtaining disclosures on the Statement of Financial Interests Disclosure Form for all participating investigators, co-investigators, laboratory technicians, and administrative support personnel responsible for the design, conduct, or reporting of the research. 

While the requirements of the FCOI regulations do not apply to PHS-funded Phase I SBIR or STTR awards, the Grants Manager will request FCOI disclosures from each Investigator in accordance with regular conflict of interest procedures. 

 

V.  Review of Financial Disclosures

The following process shall apply to financial disclosures submitted by Investigators.

1. Determination of Financial Conflicts of Interest. The Grants Manager shall review each disclosed Significant Financial Interest; determine whether such SFI relates to federally-funded research, and, if so related, determine whether a Financial Conflict of Interest exists; and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate such conflict or interest. The Grants Manager may, depending on the scope of the potential conflict, request that additional staff or faculty serve on an ad hoc review committee to assist in its timely review.  
2. Financial Conflict of Interest.  A Financial Conflict of Interest exists when the Grants Manager reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of federally-funded research or educational activities.
3. Management of Financial Conflicts of Interest.  If the Grants Manager determines that a Significant Financial Interest constitutes a Financial Conflict of Interest, the Grants Manager will convene a committee consisting of persons unrelated to O-Ray Pharma, Inc.titled the “COI Committee”. The COI Committee will review the research, the financial interests in question, and the areas of conflict, and devise a plan for the management of the Financial Conflict of Interest (a “Management Plan”) with a combination of elements it deems most conducive to the continued objective pursuit of research. The Management Plan may include conditions or restrictions to manage, reduce, or eliminate Financial Conflicts of Interest, which may include (but are not limited to): a) monitoring of research by independent reviewers; b) modification of the research plan; c) disqualification from participation in the portion of the federally-funded research that would be affected by Significant Financial Interests; d) divestiture of Significant Financial Interests; e) severance of relationships that create conflicts; or f) public disclosure of Financial Conflicts of Interest. The Investigator will be consulted as to the implementation of the Management Plan; the Investigator must agree to the plan before the research can proceed. If the COI Committee and the Investigator cannot agree upon a management plan, the relevant regulatory bodies and funding agencies will be notified.
4. Reporting of Financial Conflicts of Interest.
   1. Sponsoring agency. Significant Financial Interests that are determined by the Grants Manager to be Financial Conflicts of Interest will be reported to the sponsoring agency in accordance with its requirements within 60 days of the original disclosure.
   2. Public request. As required by sponsoring agency regulations, information on the nature of such Conflicts of Interest will be made available to members of the public by the RIO in response to inquiries specifying the investigator name and the research project in question within 5 business days of receipt of such requests.

 

VI. Reporting Financial Conflicts of Interests to NSF and PHS

Prior to any funds being expended under NSF- or PHS-funded grants, cooperative agreements or contracts, the Grants Manager must verify that O-Ray Pharma, Inc. has implemented a Management Plan in accordance with the FCOI regulations and report to the applicable NSF or PHS funding agency the existence of any FCOI.  If the Grants Manager identifies a FCOI and eliminates it prior to the expenditure of any PHS-awarded funds, O-Ray Pharma, Inc. is not required to submit a FCOI report to the respective agency.

The Grants Manager is also responsible for notifying the CEO and COO of any FCOIs reported on all on-going PHS-funded research projects. For any FCOIs reported the Grants Manager is responsible for providing the sponsoring agency an annual report that conforms to the requirements of the FCOI regulations for the duration of the research project in the time and manner specified by the applicable funding agency.

For any Significant Financial Interest that the Grants Manager identifies as being a FCOI subsequent to O-Ray Pharma, Inc.’s initial FCOI report on the award, the report will be made to the applicable funding agency and a management plan will be implemented, at least on an interim basis, within sixty (60) days of that identification.  Such a disclosure could include a new Significant Financial Interest received by the Investigator during the on-going research project, or a Significant Financial Interest held by an Investigator who is new to the research project. If such FCOI disclosure is one that was not timely made to the applicable funding agency, for whatever reason, the COI Committee is required under the FCOI regulations to conduct a “Retrospective Review” of the Investigator’s activities and the research project. The retrospective review must be completed within 120 days of determining the Investigator was in noncompliance of SFI disclosure requirements and any previously submitted report updated with the new FCOI finding.

If bias is found during the course of this review, a Management/Mitigation Plan will also be required to be submitted. These reviews and reports must be made in accordance with the requirements of the FCOI regulations and contain the following elements: 1) Project number; 2) Project title; 3) Program Director/Principal Investigator (PD/PI) or contact PD/PI if a multiple PD/PI model is used; 4) Name of the Investigator with the FCOI; 5) Entity with which the Investigator 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 (i.e., facts and observations); and 9) Conclusions of the review (i.e., determination and recommended actions).

O-Ray Pharma, Inc. must maintain FCOI-related records for at least three years after the termination of the activity (date of the final financial report and progress report to the funding agency).  

 

VI. Mandatory Training

The Grants Manager is responsible for informing all Investigators about the NSF and PHS FCOI regulations including the requirement for disclosure of Significant Financial Interests (SFI) relating to the Investigator’s Institutional Responsibilities. Prior to engaging in research related to any NSF- or PHS-funded grant, cooperative agreement or contract, Investigators are required to complete training regarding these FCOI regulations which is available at: http://grants.nih.gov/archive/grants/policy/coi/tutorial/fcoi.htm .  Refresher training must be completed every four (4) years thereafter or immediately when any of the following occur: 1) the FCOI policy, procedures or the Statement of Financial Interests Disclosure Form are revised in any manner that affects the requirements of Investigators; 2) new Investigators are appointed at O-Ray Pharma, Inc.; or 3) O-Ray Pharma, Inc. finds that an Investigator is not in compliance with the FCOI regulations or the management plan.

 

VII. Enforcement

If an Investigator fails to comply with this FCOI Policy or a management plan and the non- compliance appears to have biased the design, conduct or reporting of the NSF- or PHS-funded research, the Grants Manager, as required under the FCOI Regulations, shall promptly notify the agency of the corrective action taken or to be taken. In all cases the Conflict of Interest Committee will comply with the requirements to conduct retrospective reviews and prepare management/mitigation report, if needed, for submission to the applicable funding agency as required under the FCOI Regulations. The agency may take its own action as it deems appropriate, which may include suspension of funding, or require Auritec Pharmaceuticals to take further action to maintain the objectivity of the research.

For clinical research projects supported by the PHS, if the Department of Health and  Human Services determines that a PHS-funded project of clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, was designed, conducted, or reported by an Investigator with a FCOI that was not properly disclosed or managed as required under the FCOI Regulations, O-Ray Pharma, Inc. must require the Investigator(s) to disclose the FCOI in each public presentation (such as articles, manuscripts and oral presentations, including classroom materials) of the results of the research and to request an addendum to previously published presentations.

 

VIII. Subrecipient Requirements

Prior to including a Subrecipient in an NSF- or PHS-funded research proposal, the Grants Manager will verify that all proposed subrecipients have a financial conflict of interest policy that conforms to the requirements of the FCOI regulations.   With respect to these subgrantees, subcontractors, and collaborators, the Grants Manager must require these entities to enter into a written agreement and make a certification to  O-Ray Pharma, Inc. at  the  time  of  award  that  its  financial  conflict  of  interest  policy complies with the FCOI regulations.   The written agreement will include all of the terms required under the FCOI regulations. The terms can be found at: http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf

The Grants Manager will report to the PHS funding agency any FCOI that is identified by any subgrantee, subcontractor, or collaborator of O-Ray Pharma, Inc. in the manner required under the FCOI regulations, prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

 

IX. Public Access

O-Ray Pharma, Inc. will make these procedures, as well as the policy on Conflict of Interest in Externally Funded Research, accessible on the O-Ray Pharma, Inc. website. These procedures will be reviewed regularly with changes updated on the website annually.

In addition, prior to any funds being expended under PHS-funded grants, cooperative agreements or contracts, O-Ray Pharma, Inc. will make information about reported FCOIs public. Within five (5) business days following a request for information concerning any Significant Financial Interests which was disclosed and continues to be held by an Investigator on the project, and which is determined to be a FCOI related to the NSF- or PHS-funded research, the Grants Manager will provide a written response to the requestor or make the requested information available on O-Ray Pharma, Inc. publicly accessible Web site. The information the Institution makes available via a publicly accessible Web site, or in a written response to any requestor, shall include, at a minimum, the following: the Investigator's name; the Investigator'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. Any changes to disclosures previously provided in a written response will be provided to the original requested within 60 days.