CYIL vol. 14 (2023)

HELENA VAN BEERSEL KREJČÍKOVÁ CYIL 14 (2023) The institution is responsible for sending to the PHS Awarding Component the initial, subsequent, and annual reports on financial conflict of interests and all retrospective reviews, 59 including sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the institution’s management plan, as specified further in the 42 CFR § 50.605 (b) (3). The PHS Awarding Component and/or United States Department of Health and Human Services (further referred to as the HHS) may inquire at any time before, during, or after the award, into any investigator’s disclosure of financial interests and the institution’s review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the institution’s determination of a financial conflict of interest. An institution is required to submit, or permit the on-site review of, all records pertinent to compliance with the CFR, whilst the confidentiality of all records of financial interest will be maintained to an extent stipulated by law. Based on its review of records or other information that may be available, the PHS Awarding Component may decide that a particular financial conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed, or that the institution has not managed the financial conflict of interest in accordance with the CFR. In that case, specific award conditions under 45 CFR § 75.207 60 or suspension of funding or other enforcement action under 45 CFR § 75.371 61 may be temporarily imposed. In any case in which the HHS determines that a PHS-funded project of clinical research 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 financial conflict of interest that was not managed or reported by the institution as required by the CFR, the institution shall require the investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations. 59 Cf. the. 42 CFR § 50.605 60 These additional Federal Award conditions may include items such as the following: (1) Requiring payments as reimbursements rather than advance payments; (2) Withholding authority to proceed to the next phase until receipt of evidence of acceptable performance within a given period of performance; (3) Requiring additional, more detailed financial reports; (4) Requiring additional project monitoring; (5) Requiring the non-Federal entity to obtain technical or management assistance; or (6) Establishing additional prior approvals. 61 If the HHS awarding agency or pass-through entity determines that non-compliance cannot be remedied by imposing additional conditions, the HHS awarding agency or pass-through entity may take one or more of the following actions, as appropriate in the circumstances: (a) Temporarily withhold cash payments pending correction of the deficiency by the non-Federal entity or more severe enforcement action by the HHS awarding agency or pass-through entity. (b) Disallow (that is, deny both use of funds and any applicable matching credit for) all or part of the cost of the activity or action not in compliance. (c) Wholly or partly suspend (suspension of award activities) or terminate the Federal Award. (d) Initiate suspension or debarment proceedings as authorized under the 2 CFR part 180 and HHS awarding agency regulations at the 2 CFR part 376 (or in the case of a pass-through entity, recommend such a proceeding be initiated by a HHS awarding agency). (e) Withhold further Federal Awards for the project or program. (f) Take other remedies that may be legally available.

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