Purpose and Scope

Hispanic Access Foundation (“Hispanic Access”) 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. This Financial Conflict of Interest Policy (“Policy”) is implemented to identify, manage, reduce, or eliminate financial conflicts of interest. This Policy describes certain legal obligations applicable to Investigators’ disclosure of potential financial conflicts of interest. The policy and the associated procedures are derived from the final rules on Objectivity in Research promulgated by the PHS and the NSF as implemented in the 2011 Final Rule for grants and cooperative agreements. This policy and the associated procedures are applicable to all PHS sponsored program activity carried out by Hispanic Access Employees. These procedures will be followed whenever Hispanic Access or its employees submit a request for funding from any external agency, whether it is the PHS, the NSF or another Federal agency.

Definitions

The following definitions apply to this policy:

• Disclosure of Significant Financial Interests means an Investigator's significant financial interests (“SFI”) disclosure.
  
  
• Family Member means the Hispanic Access Employee's spouse and children or other adults who qualify as dependents under the Internal Revenue Code definitions.
  
  
• Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
  FCOI Report means Hispanic Access’ report of a financial conflict of interest to a PHS Awarding Component.
  
  
• Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.
  
  
• Investigator is defined as the Project Director (PD), Principal Investigator (PI), consultants, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposal for such funding.
  
  
• 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.
  
  
• PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 CFR Part 50, Subpart F.
  
  
• 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.
  Hispanic Access Employee means any individual employed on a full- or part-time basis by Hispanic Access and is receiving, or will receive, compensation (including consultants, agents, and research collaborators of Hispanic Access).
• Significant financial interest means:
  
  • 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:
    
    
    • 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;
      
      
    • 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
      Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income in excess of $5,000 related to such rights and interests.
      
      
  • Investigators also must disclose the occurrence of any reimbursed or sponsored travel in excess of $5,000 (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 located in the United States, a United States 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 a United States Institution of higher education. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
    
    
  • The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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 located in the United States, a United States 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 a United States Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education.

Process

An Investigator is required to comply with the policy and procedures outlined below. Investigators also include collaborators and consultants. Investigators are required to: 1) disclose any significant financial interests (SFIs) at the time of application for federal PHS funding by completing and signing a disclosure form, and submitting this to the Designated Official at Hispanic Access, 2) disclose SFIs using the disclosure form at least on an annual basis during the course of an award, 3) disclose within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) any new SFI, and 4) take part in FCOI training at least once every four years.

Investigators receive training to promote objectivity in research and to ensure Investigator compliance with regard to the applicable regulations and significant financial interest disclosure obligations. Hispanic Access requires Investigators to complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm every four years, and when: 1) Hispanic Access revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations, 2) an Investigator is new to Hispanic Access, or 3) Hispanic Access finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management plan.

To identify conflicts of financial interest, the following procedures will be followed: 1) all investigators involved in the project/proposal are required to complete, sign and submit the SFI Disclosure Form, 2) the Investigator must list all of their SFIs (and those of the Investigator's Family Members) that reasonably appear to be related to the Hispanic Access Research; 3) the form requires the Investigator to include, at 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. If needed, Hispanic Access may request supporting documentation to determine whether an FCOI exists; 4) for SFI disclosures related to sponsored or reimbursed travel, the disclosure must include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and the approximate monetary value, 5) the Investigator is required to submit an updated SFI Disclosure during the period of the award at least annually, and within 30 days of discovering or acquiring a new SFI.

In conjunction with the administrative review of applications for grants, the CEO will review each SFI disclosure submitted and shall make the determination of whether a conflict of significant financial interest exists. An Investigator's SFI is related to PHS-funded research when Hispanic Access, through its designated official, reasonably determines that the SFI could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. An FCOI exists when the institution reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. If the CEO determines that no conflict of significant financial interest exists, the resulting negative finding will be filed in Hispanic Access Employee’s Legal and/or Human Resource files. For negative findings no further review is required.

In cases in which Hispanic Access identifies a financial conflict of interest and is able to resolve the matter, Hispanic Access is not required to submit an FCOI report to the PHS Awarding Component. For any significant financial interest that Hispanic Access identifies as conflicting and is not able to resolve, Hispanic Access will, within 60 days, submit an FCOI report regarding the financial conflict of interest and ensure that Hispanic Access has implemented a management plan. Any FCOI report required by PHS will 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 Hispanic Access’ management plan. For any financial conflict of interest previously reported, Hispanic Access will provide an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan. The annual FCOI report will specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. Hispanic Access will provide annual FCOI reports for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

Noncompliance

If an Investigator who is required under this policy to file a SFI disclosure fails to do so or fails to disclose a significant financial interest on the disclosure form, the Investigator may be subject to company inquiry. If an unreported significant financial interest involves a research project administered by Hispanic Access, appropriate administrative action required by the funding agency will also be taken. Hispanic Access will promptly notify the funding agency if it is determined that the company is unable to satisfactorily manage 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 inquiry.

Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:

• Failure by the Investigator to disclose a Significant Financial Interest that is determined by the Institution to constitute a Financial Conflict of Interest;
• Failure by the Institution to review or manage such a Financial Conflict of Interest; or
• Failure by the Investigator to comply with a Financial Conflict of Interest management plan;

the Institution shall, within 120 days of the Institution’s determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and the research project to determine whether any research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.

The Institution shall document the retrospective review which must include at least the following key elements:

• Project number;
• Project title;
• PD/PI or contact PD/PI if a multiple PD/PI model is used;
• Name of the Investigator with the FCOI;
• Name of the entity with which the Investigator has a financial conflict of interest
• Reason(s) for the retrospective review;
• Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
• Findings of the review; and
• Conclusions of the review.

If bias is found, the Institution must notify the funding agency promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” 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 the Institution’s plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., 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 Institution will submit FCOI reports annually as prescribed by the regulation.

Clinical Research

In any case that a clinical 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 conflicting interest that was not reported or managed as required by this Policy or the applicable regulations, then Hispanic Access shall, at minimum, require the Investigator involved to disclose the conflicting interest in each public presentation of the results of the Research and to request an addendum to previously published presentations. An Investigator who has failed to report a Significant Financial Interest related to clinical Research will also be subject to sanctions under this Policy.

Records

Hispanic Access will maintain all SFI disclosures, training certifications, management plans, reports and all related records of actions taken by Hispanic Access with respect to disclosures of financial interests for a period of three years from the date of submission of the final expenditures report to the PHS as governed by 42 CFR Part 50 Subpart F, and from other dates specified in 45 CFR 75.361, where applicable.