CYIL vol. 14 (2023)

CYIL 14 (2023) CONFLICT OF INTEREST IN MEDICAL RESEARCH study. Study designs that utilize approaches such as multiple investigators (most of whom do not have a disclosable interest), blinding, objective endpoints, or measurement of endpoints by someone other than the investigator may adequately protect against any bias created by a disclosable financial interest. 44 If FDA determines that the financial interests of any clinical investigator raise a serious question about the integrity of the data, FDA will take any action it deems necessary to ensure the reliability of the data, including initiating agency audits of the data derived from the clinical investigator in question; requesting that the applicant submit further analyses of data, e.g., to evaluate the effect of the clinical investigator’s data on the overall study outcome; requesting that the applicant conduct additional independent studies to confirm the results of the questioned study; and refusing to treat the covered clinical study as providing data that can be the basis for an agency action. 45 Conflict of interest disclosure and management from the perspective of NIH Conflict of interest within programs or projects for health services which are supported in whole or in part by federal financial assistance, whether by grant or contract, administered by the Public Health Service (further referred to as PHS), are regulated under the 42 CFR § 50.601 and ff., as a part of promoting objectivity in research. According to the CFR, this goal is to be achieved by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service grants or cooperative agreements (further referred to as PHS-funded research) will be free from bias resulting from investigators’ financial conflicts of interest. Under the 42 CFR §50.603, financial conflict of interest is defined as a significant financial interest that could directly and significantly affect the design, conduct or reporting research funded by the public health system. Significant financial interest means a financial interest consisting of one and more of the following interests of an investigator 46 (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities: i) any remuneration 47 received from a publicly traded entity in the twelve months preceding the disclosure and any equity interest in the entity as of the date of disclosure, when aggregated, exceeding $5 000; ii) any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeding $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); iii) intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. Without explicitly calling a reimbursed or sponsored travel a significant financial interest, its disclosure might be needed under specific circumstances. 46 i.e., 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 funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants. 47 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. 44 Cf. the 21 CFR § 54.5(b). 45 Cf. the 21 CFR § 54.5(c).

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