Effective August 24, 2012, UPPS 02.02.07, Researcher Conflicts of Interest in Research and Sponsored Program Activities, has been updated in accordance with the Public Health Service Regulation at 42 C.F.R. Part 50, Subpart F. In addition, changes have been made to the submission procedures for Financial Interest Disclosures.
Changes to the PHS regulation originally went into effect in August, 2011 — universities had a year to complete full compliance. Texas State instituted the majority of the PHS FCOI requirements in Fall, 2011. These recent policy and procedure updates complete the required implementation.
Key points for all faculty researchers:
The Office of Research Integrity & Compliance welcomes the opportunity to discuss this issue with researchers. Please contact Becky Northcut for additional information or assistance.
The following agencies are PHS Awarding Components, also often collectively referred to as “PHS agencies,” “PHS funding components,” or “PHS funders.”
As stated in UPPS 02.02.07, to ensure the highest level of objectivity in research, Texas State University applies the PHS standards for definition of Substantial Financial Interest to all research, regardless of funding source or funding status.
As long as the PHS minimum standards are met, per PHS guidance, "The Institution may have more stringent financial disclosure requirements."
Depending on the contents of their disclosure, PHS-funded researchers may have to complete additional items or processes not required of researchers who do not receive PHS funds
The 2011 revised regulation defines a “Significant Financial Interest” as follows: “
(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 interestexists 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;
(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) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(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.
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, 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.”
The Institution may have more stringent financial disclosure requirements. Please refer to the Institution’s conflict of interest policy and confer with the Institution’s designated official(s) to determine the Institution’s disclosure requirements.
A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.
Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for or that receives NIH research funding.
Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.
No. “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, which may include, for example, collaborators or consultants. Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases. In addition, the Investigator’s spouse and dependent children have been eliminated from the definition of “Investigator” under the 2011 revised regulation; however, they are referenced in the definition of “Significant Financial Interest” because the Investigator must also disclose Significant Financial Interests of his/her spouse and dependent children. (see definition of Significant Financial Interest).
“Institutional responsibilities” are defined by the 2011 revised regulation as an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on Financial Conflict of Interest, which may include, for example, activities such as research, research consultation, teaching, professional practice, Institutional committee memberships, and service on panels such as Institutional Review Boards. The Institution can include other professional responsibilities within the definition, as appropriate.
The regulation covers all financial interests that have monetary value, whether or not the value is readily ascertainable.
At Texas State, yes. The PHS regulations exempt Phase I SBIR/STTRs, but Texas State applies the same requirements to both Phase I and Phase II SBIR/STTR applications/awards.
There are two levels of training. The first is very brief, is required of everyone, and is accomplished during the SFI disclosure process: Texas State is required to have a process to inform all researchers of Investigator responsibilities for disclosure of Significant Financial Interests and of the Institution’s specific policy on financial conflicts of interests.
The second level of training is only required for PHS-funded researchers. It must be completed prior to account set up and engaging in research. PHS-awarded researchers must complete a brief online training that covers NIH/PHS-specific procedures and policy.