Financial Conflict of Interest Policy

Conducting good research is an important aspect of ISURTEC’s mission. Our science requires reproducing results, assessing statistical variance, and understanding the scientific principles underlying our work. However, biased research can undermine our best efforts. To eliminate financial conflicts of interests and reduce perceptions of bias, ISURTEC has put in place the following policy:

ISURTEC requires that each investigator, subrecipients, subgrantees and collaborators affiliated with ISurTec by the NIH, NSF, DOD, or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts). This legislation supports preserving the public’s trust that the research supported by the NIH is conducted without bias and with the highest scientific and ethical standards.

Definitions

Investigator

An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct or reporting of research funded by PHS. This term includes both the principal investigator and the key personnel on each grant or contract.

Training Requirement

ISURTEC personnel who conduct research on federally funded grants and contracts are required to complete training related to Financial Conflict of Interest (FCOI). The training must be performed prior to the application for a federal grant or contract and updated no-less than every four years or as designated based on grant or role circumstances. Training should be performed for every new investigator, whenever ISURTEC revises its FCOI policy, and repeated if an investigator is not in compliance with the policy or its management plan within 120 days.

Significant Financial Interest (SFI)

Significant Financial Interest is defined by the regulations as:

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 reasonable appears to be related to the Investigators 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and 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 remunerations 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 interests (e.g. stock, stock options, or other ownership interest) or
- Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
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, medical center, or research institute that is affiliated with an 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 a FCOI with the PHS-funded research.
The term significant financial interest does not include the following types of financial interests: salaries, 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 retirements 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, 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.

Publication

ISURTEC will make its FCOI policy publicly available on its website. In addition, information on identified FCOIs will be publicly available within 5 calendar days of a written request with updated information.