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PASCALL'S FINANCIAL CONFLICT OF INTEREST (FCOI) POLICY

January 26, 2021

Training Requirements [42 CFR 50.604(b)]

PASCALL shall inform each Investigator of:

  • The policy on financial conflicts of interest;

  • The Investigator's responsibilities regarding disclosure of significant financial interests; and

  • These regulations.

PASCALL shall require each Investigator to complete training regarding the same:

  • prior to engaging in research related to any PHS-funded grant;

  • at least every four (4) years; and

  • immediately when any of the following circumstances apply:

    • PASCALL revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;

    • An Investigator is new to the company; or

    • PASCALL finds that an Investigator is not in compliance with the financial conflict of interest policy or management plan.

Training will be conducted according to L2-SP-007 Human Resource SOP 


Disclosure, Review and Monitoring Requirements [42 CFR 50.603, 50.604(e) (1)-(3)]

PASCALL shall:

  • require that each Investigator who is planning to participate in the PHS-funded research disclose to the designated official(s) the Investigator's significant financial interests (and those of the Investigator's spouse and dependent children) no later than the time of application for PHS-funded research.

  • require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by PASCALL, during the period of the award. Such disclosure shall:

    • include any information that was not disclosed initially to the company pursuant to paragraph (e)(1) of this section, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution);

    • include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

  • require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.


[42 CFR 50.604(d)]

(d) PASCALL shall designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS- funded research.

[42 CFR 50.604(f)]

(f) PASCALL shall provide guidelines consistent with this subpart for the designated official(s) to determine whether an Investigator's significant financial interest is related to PHS-funded research and, if so related, whether the significant financial interest is a financial conflict of interest.

An Investigator's significant financial interest is related to PHS-funded research when PASCALL, through its designated official(s), reasonably determines that the significant financial interest: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research.

The company may involve the Investigator in the designated official(s)'s determination of whether a significant financial interest is related to the PHS-funded research. A financial conflict of interest exists when the company, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

[42 CFR 50.605(a)(1)]

Management of financial conflicts of interest.

  • Prior to PASCALL's expenditure of any funds under a PHS-funded research project, the designated official(s) of an Institution shall, consistent with § 50.604(f):

    • review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to PHS-funded research;

    • determine whether a financial conflict of interest exists; and

    • if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.

    • Conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:

  • Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

  • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;

  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;

  • Modification of the research plan;

  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;

  • Reduction or elimination of the financial interest (e.g., sale of an equity interest); or

  • Severance of relationships that create financial conflicts.



[42 CFR 50.605(a)(2)]

(a)(2) Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to PASCALL, the designated official(s) shall, within sixty (60) days:

  • review the disclosure of the significant financial interest;

  • determine whether it is related to PHS-funded research;

  • determine whether a financial conflict of interest exists; and,

  • if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest.

  • Depending on the nature of the significant financial interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date of disclosure and the completion of the company's review.



[42 CFR 50.605(a)(3)(i-iii)]

(a)(3) Whenever PASCALL identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the company during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty (60) days:

  • review the significant financial interest;

  • determine whether it is related to PHS-funded research;

  • determine whether a financial conflict of interest exists; and, if so: implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;

(ii)(A) In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including:

  • failure by the Investigator to disclose a significant financial interest that is determined by PASCALL to constitute a financial conflict of interest;

  • failure by the company to review or manage such a financial conflict of interest; or

  • failure by the Investigator to comply with a financial conflict of interest management plan,

the company shall, within 120 days of the company's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

PASCALL is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:

  • Project number;

  • Project title;

  • PD/PI or contact PD/PI if a multiple PD/PI model is used;

  • Name of the Investigator with the FCOI;

  • Name of the entity with which the Investigator has a financial conflict of interest;

  • Reason(s) for the retrospective review;

  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

  • Findings of the review; and

  • Conclusions of the review.

Based on the results of the retrospective review, if appropriate, PASCALL shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, PASCALL is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

The mitigation report must include:

  • at a minimum, the key elements documented in the retrospective review above;

  • a description of the impact of the bias on the research project;

  • the company's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

Thereafter, the company will submit FCOI reports annually, as specified elsewhere in this subpart.


Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the company's retrospective review.



[42 CFR 50.604(g)] [42 CFR 50.605(a)(4)]

PASCALL shall take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subrecipient Investigator pursuant to paragraph (c) of this section.

Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report pursuant to § 50.605(a).

(a)(4) Whenever PASCALL implements a management plan pursuant to this subpart, the company shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.


Reporting Requirements to NIH [42 CFR 50.604(h)] [42 CFR 50.605(b)]

PASCALL shall provide initial and ongoing FCOI reports to the PHS as required pursuant to §50.605(b).

Reporting of financial conflicts of interest.

Prior to the company's expenditure of any funds under a PHS-funded research project, PASCALL shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's significant financial interest found by PASCALL to be conflicting and ensure that the company has implemented a management plan in accordance with this subpart.

In cases in which the company identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the company shall not submit an FCOI report to the PHS Awarding Component.

For any significant financial interest that PASCALL identifies as conflicting subsequent to the company's initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the company shall:

  • provide to the PHS Awarding Component, within sixty (60) days, an FCOI report regarding the financial conflict of interest and ensure that the company has implemented a management plan in accordance with this subpart.

  • Pursuant to paragraph (a)(3)(ii) of this section, where such FCOI report involves a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by the company (e.g., was not timely reviewed or reported by a subrecipient), the company also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research.

  • Additionally, pursuant to paragraph (a)(3)(iii) of this section, if bias is found, the company is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

  • Any FCOI report required under paragraphs (b)(1) or (b)(2) of this section shall include 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 company's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:

    • Project number;

    • PD/PI or Contact PD/PI if a multiple PD/PI model is used;

    • Name of the Investigator with the financial conflict of interest;

    • Name of the entity with which the Investigator has a financial conflict of interest;

    • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);

    • Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999;$10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;

  • A description of how the financial interest relates to the PHS-funded research and the basis for the company's determination that the financial interest conflicts with such research; and

  • A description of the key elements of the company's management plan, including:

    • Role and principal duties of the conflicted Investigator in the research project;

    • Conditions of the management plan;

    • How the management plan is designed to safeguard objectivity in the research project;

    • Confirmation of the Investigator's agreement to the management plan;

    • How the management plan will be monitored to ensure Investigator compliance; and

    • Other information as needed.

    • For any financial conflict of interest previously reported by the company with regard to an ongoing PHS-funded research project, PASCALL shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project.

The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. PASCALL shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

In addition to the types of financial conflicts of interest as defined in this subpart that must be reported pursuant to this section, PASCALL may require the reporting of other financial conflicts of interest in its policy on financial conflicts of interest, as the company deems appropriate.


[42 CFR 50.605(a)(3)(iii)]

(a)(3)(iii) Based on the results of the retrospective review, if appropriate, PASCALL shall:

  • update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward;

  • If bias is found, PASCALL is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the company's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

Thereafter, PASCALL will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS- funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the company's retrospective review.


[42 CFR 50.606(a)]

(a) If the failure of an Investigator to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, PASCALL shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken.

The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the company for further action, which may include directions to the company on how to maintain appropriate objectivity in the PHS-funded research project. PHS may require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.

Corrective and preventive actions will be managed according to L2-SP-008 Corrective and Preventive Action SOP 



Maintenance of Records [42 CFR 50.604(i)]

PASCALL maintain records relating to all Investigator disclosures of financial interests and the company's review of, and response to, such disclosures (whether or not a disclosure resulted in the company's determination of a financial conflict of interest) and all actions under the company's policy or retrospective review, if applicable, for at least three (3) years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

FCOI-related records will be maintained according to L2-SP-002 Record Control SOP.

Enforcement Mechanisms and Remedies and Noncompliance [42 CFR 50.604(j)]

PASCALL establishes adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.


[42 CFR 50.605(a)(3)]

(a)(3) Whenever the company identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the company during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty (60) days:

  • review the significant financial interest;

  • determine whether it is related to PHS-funded research;

  • determine whether a financial conflict of interest exists; and, if so: implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;

(ii)(A) In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including:

  • failure by the Investigator to disclose a significant financial interest that is determined by the company to constitute a financial conflict of interest;

  • failure by the company to review or manage such a financial conflict of interest; or

  • failure by the Investigator to comply with a financial conflict of interest management plan, the company shall, within 120 days of the company's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

PASCALL is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:

  • Project number;

  • Project title;

  • PD/PI or contact PD/PI if a multiple PD/PI model is used;

  • Name of the Investigator with the FCOI;

  • Name of the entity with which the Investigator has a financial conflict of interest;

  • Reason(s) for the retrospective review;

  • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);

  • Findings of the review; and

  • Conclusions of the review.


[42 CFR 50.606(c)]

(c) 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 company as required by this subpart, PASCALL 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 .


Subrecipient Requirements [42 CFR 50.604(c)]

(c) If PASCALL carries out the PHS-funded research through a subrecipient (e.g., subcontractors or

consortium members), the company (awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by:

  • Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient's Investigators.

  • If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee Institution for disclosing significant financial interests that are directly related to the subrecipient's work for the awardee Institution;

  • Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart;

  • Alternatively, if the subrecipient's Investigators must comply with the awardee Institution's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this subpart.

  • Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.


Public Accessibility Requirements [42 CFR 50.604(a)]

PASCALL maintains an up-to-date, written, enforced policy on financial conflicts of interest that

complies with this subpart, and make such policy available via a publicly accessible Web site.

If, however, PASCALL acquires a presence on a publicly accessible Web site during the time of the PHS award, the requirement to post the information on that Web site will apply within 30 calendar days.

If the company maintains a policy on financial conflicts of interest that includes standards that are more stringent than this subpart (e.g., that require a more extensive disclosure of financial interests), PASCALL shall adhere to its policy and shall provide FCOI reports regarding identified financial conflicts of interest to the PHS Awarding Component in accordance with the company's own standards and within the timeframe prescribed by this subpart.



[42 CFR 50.605(a)(5)(i)-(iv)]

(5)(i) Prior to PASCALL's expenditure of any funds under a PHS-funded research project, the company shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the company that meets the following three criteria:

The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;

  • PASCALL determines that the significant financial interest is related to the PHS-funded research; and

  • PASCALL determines that the significant financial interest is a financial conflict of interest.

  • The information that PASCALL makes available via a publicly accessible Web site or written response to any requestor within five (5) business days of a request, shall include, at a minimum, the following:

    • the Investigator's name;

    • the Investigator's title and role with respect to the research project;

    • the name of the entity in which the significant financial interest is held;

    • the nature of the significant financial interest; and

    • the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

If PASCALL uses a publicly accessible Web site for the purposes of this subsection, the information that the company posts shall be updated at least annually.

In addition, the company shall update the Web site within sixty (60) days of the company's receipt or identification of information concerning any additional significant financial interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a significant financial interest of senior/key personnel new to the PHS-funded research project, if the company determines that the significant financial interest is related to the PHS-funded research and is a financial conflict of interest.

The Web site shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the company's identification of a new financial conflict of interest.

If the company responds to written requests for the purposes of this subsection, the company will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the company's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.

Information concerning the significant financial interests of an individual subject to paragraph (a)(5) of this section shall remain available, for responses to written requests or for posting via the company's publicly accessible Web site for at least three (3) years from the date that the information was most recently updated.

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