CYIL vol. 14 (2023)

HELENA VAN BEERSEL KREJČÍKOVÁ CYIL 14 (2023) The legal framework set up by the 42 CFR § 50.601 and ff. is applicable to each institution 48 that is applying for, or that receives, research funding from PHS (regardless of whether by means of a grant or cooperative agreement) and to each investigator 49 who is planning to participate in, or is participating in, such research. For that, implementation of rules under the 42 CFR § 50.601 and ff. by the institution is crucial. 50 This means that the whole mechanism of how conflicts of interest are identified, disclosed, and managed within the PHS-funded research, significantly differs from FDA’ s evaluation procedure under the 21 CFR § 54 and ff. First and foremost, the entity responsible for the identification and management of conflicts of interest of individual investigators is the institution. It is the institution that is required to adopt its own policy on financial conflicts of interest and has responsibilities regarding disclosure and management of its investigators’ (and of sub-recipients’ investigators, if that is the case) financial conflicts of interest. The institution shall as a rule maintain an up-to-date, written, enforced policy on financial conflict of interest (consisting of, among others, defining the institutional responsibilities of investigators, e.g., research, teaching, etc. 51 ), publicly available via websites. The policy needs to comply with the 42 CFR § 50.601 and ff., yet it may adopt even more stringent standards; in that case the institution shall adhere to its own (stricter) standards. 52 The institution shall inform all the investigators about its policy and their responsibilities 53 and establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure investigator compliance as appropriate. 54 Each investigator who is planning to participate in the PHS-funded research is required to disclose to the institution’s designated official(s) 55 the investigator’s significant financial interests (and those of the investigator’s spouse and dependent children) no later than at the time of application for PHS-funded research. Thereafter, whilst participating in the research, the investigator is required to submit an updated disclosure of significant financial interest at least annually, if not required more often by the institution, and in addition, within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest. 56 The institution shall provide guidelines consistent with the 42 CFR § 50.601 and ff. for the designated institutional official(s) to determine whether an investigator’s significant financial interest is related to PHS-funded research and, if so, whether the significant financial 49 Under 42 CFR § 50.603, an 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 funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants. 50 Cf. 42 CFR § 50.602 If exceptionally it is an individual, rather than an Institution, who is applying for, or receives, PHS research funding, case-by-case determinations on the steps to be taken will be made to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a financial conflict of interest of the individual. 51 Cf. the 42 CFR § 50.603. 48 Under 42 CFR § 50.603, an institution means any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, PHS research funding.

52 Cf. the 42 CFR § 50.604 (a). 53 Cf. the 42 CFR § 50.604 (b). 54 Cf. the 42 CFR § 50.604 (j). 55 Cf. the 42 CFR § 50.604 (d). 56 Cf. the 42 CFR § 50.604 (e.)

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