Conflict of Interest
Deep Creek Pharma
Financial Conflict of Interest Policy
12 April 2023
The federal Public Health Service (PHS) has adopted regulations (42 CFR Part 50 Subpart F and 45 CFR
Part 94) on Promoting Objectivity in Research. These regulations describe the actions an individual and
an organization must take in order to promote objectivity in PHS-funded research. The regulations apply
to all PHS funded grants, cooperative agreements, research contracts (but not Phase 1 Small Business
Innovation Research or Small Business Technology Transfer program grants), and subawards where the
originating sponsor is PHS.
Financial conflict of interest (FCOI): a significant financial interest that could directly and significantly
affect the design, conduct, or reporting of PHS-funded research.
HHS: the Department of Health and Human Services
Institutional responsibilities: an Investigator’s professional activities on behalf of Deep Creek Pharma
(DCP) (e.g., administration, research or consulting).
Investigator: 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 award, or
proposed for such funding, which may include, for example, collaborators or consultants. DCP’s Principal
Investigator/Project Director, upon consideration of the individual’s role and degree of independence in
carrying out the work, will determine who is responsible for the design, conduct, or reporting of the
PHS: the Public Health Service of the U.S. Department of Health and Human Services, and any
components of the PHS to which the authority involved may be delegated, including the National
Institutes of Health (NIH).
NIH: the biomedical research agency of the PHS
Significant Financial Interest (SFI):
(1) 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 reasonably appear to be related to the
Investigator’s institutional responsibilities on behalf of DCP.
(i) 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 for
the investigator, investigator’s spouse and dependent children, exceeds $5,000. 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;
(ii) With regard to any non-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, when aggregated, exceeds $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); or
(iii) With regard to intellectual property rights and interests (e.g., patents, copyrights), a
significant financial interest exists upon receipt of income of greater than $5,000 related to such
rights and interests.
(2) The term significant financial interest does not include the following types of financial interests:
(i). Salary, royalties, or other remuneration paid by DCP to the Investigator if the Investigator is
currently employed or otherwise appointed by DCP, including intellectual property rights
assigned to DCP and agreements to share in royalties related to such rights;
(ii). Income from investment vehicles, such as mutual funds and retirement accounts, as long as
the Investigator does not directly control the investment decisions made in these vehicles;
(iii). Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or
local government agency located in the United States (U.S.), a U.S. Institution of higher
education, an academic teaching hospital, a medical center, or a research institute that is
affiliated with a U.S. Institution of higher education; or
(iv). Income from service on advisory committees or review panels for a federal, state, or local
government agency located in the U.S., a U.S. Institution of higher education, an academic
teaching hospital, a medical center, or a research institute that is affiliated with a U.S. Institution
of higher education.
(2) Investigators must disclose the occurrence of any foreign or domestic 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 the
Investigator’s institutional responsibilities. The details of this disclosure will include at a
minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and
the duration. The disclosure requirement does not apply to travel that is reimbursed or
sponsored by the following:
a federal, state, or local government agency located in the United States,
a United States Institution of higher education,
an academic teaching hospital,
a medical center, or
a research institute that is affiliated with a United States Institution of higher education.
Foreign Financial Interests - Investigators must disclose all foreign financial interests (which includes
income from seminars, lectures, or teaching engagements, income from service on advisory committees
or review panels, and reimbursed or sponsored travel) received from any foreign entity, including
foreign Institutions of higher education or a foreign government (which includes local, provincial, or
equivalent governments of another country) when such income meets the threshold for disclosure (e.g.,
income in excess of $5,000).
Prior to the submission of an application to the NIH Grantee for funding, the Principal Investigator and
all other Investigators at DCP must have disclosed to DCP’s designated official an up-to-date listing of
their Significant Financial Interests [SFIs] (and those of their spouse and dependent children), as defined
above. Any new Investigator, who, subsequent to the submission of an application to NIH for funding
from NIH, or during the course of the research project, plans to participate in the project, must similarly
disclose their SFI to the designated official promptly and prior to participation in the project.
Each Investigator who is participating in research under an NIH award must submit an updated
disclosure of SFI at least annually, during the period of the award. Such disclosure must include any
information that was not disclosed initially to DCP pursuant to this Policy, or in a subsequent disclosure
of SFI (e.g., any financial conflict of interest identified on a NIH funded project directly as a NIH Grantee
and/or indirectly through a subaward) that was transferred from another Institution), and must include
updated information regarding any previously disclosed SFI (e.g., the updated value of a previously
disclosed equity interest).
Each Investigator who is participating in research under an award from NIH must submit an updated
disclosure of SFI (including reimbursed travel) within thirty (30) days of discovering or acquiring (e.g.,
through purchase, marriage, or inheritance) a new SFI.
Review by DCP’s Designated Official
The designated official will conduct reviews of disclosures. The designated official will review any SFI
that has been identified in a disclosure; these interests will be compared to each research award on
which the Investigator is identified as responsible for the design, conduct, or reporting of the research to
determine if the SFI is related to the award and, if so, whether the SFI creates a Financial Conflict of
Interest (FCOI) related to that research award. The designated official has been designated as DCP
President William Gmeiner.
Guidelines for Determining “Relatedness” and Financial Conflict of Interest
The designated official will determine whether an Investigator’s SFI is related to the research under a
NIH award and, if so, whether the SFI is a financial conflict of interest. An Investigator’s SFI is related to
the research under the NIH award when the designated official reasonably determines that the SFI:
could be affected by the research conducted under the award; or is in an entity whose financial interest
could be affected by the research. The designated official may involve the Investigator in the
determination of whether a SFI is related to the research supported by the award.
A financial conflict of interest exists when the designated official reasonably determines that the SFI
could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.
In determining if an Investigator’s SFI is related to the research under a NIH award, and if so, whether
the relationship creates a FCOI, the designated official considers the role of the Investigator and the
opportunity (if any), to bias the results, the nature of the research being proposed, and the value of the
SFI in relation to the size and value of the entity. In addition, the designated official may also consider
the following factors:
1. Whether the research is of a basic or fundamental nature directed at understanding basic scientific
2. Whether the degree of replication and verification of research results is such that immediate
commercialization or clinical application is not likely; or
3. Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI
is a patent, or an interest in a company that has licensed the invention); or
4. Where the research involves human subjects, whether there are double blind conditions or the
involvement of a data and safety monitoring board; or
5. Where the SFI is in a privately held company, whether the researcher’s SFI could result in the
researcher having influence over company decisions, or whether the research could have a
significant impact on the company’s business or financial outlook (excluding Phase I SBIRs and
6. The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or
7. Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser’s
technology, the amount of commercialization payments received by the Investigator from that
technology, both currently or in the future; or
8. The number and nature of relationships an Investigator has with an entity. Multiple entanglements
can create a relationship with an outside entity that is stronger than the sum of the parts; or
9. Whether the goal of the research is to validate or invalidate a particular approach or methodology
that could affect the value of the SFI; or
10. Whether other scientific groups are independently pursuing similar questions; or
11. Whether sufficient external review of the research conducted and the reporting of research results
exist to mitigate undue bias; or
12. Whether the goal of the project is a comparative evaluation of a technology in which an Investigator
has a SFI; or
13. Whether the project involves a subaward to an entity in which the Investigator has a SFI.
Management of Significant Financial Interests that Pose Financial Conflict(s) of Interest
If a conflict of interest exists, the designated official will determine by what means – such as the
individual’s recusal from decisions affecting the conflicting entity, abstention from the external activity,
modification of the activity, and/or monitoring of the activity by a subcommittee – the conflict should be
avoided or managed in order to mitigate undue bias. In making those determinations, the designated
official will be guided by the principles discussed in this Policy the designated official will also take into
consideration whether the Investigator’s ongoing role is necessary to continue advancing the research,
based upon the factors such as the uniqueness of his or her expertise and qualifications.
Examples of conditions that might be imposed to manage a financial conflict of interest include, but are
not limited to:
a). Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the
research, to research personnel working on the study, to the Institution Review Board,
Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.);
b). For research projects involving human subjects research, disclosure of financial conflicts of
interest directly to human participants in the informed consent document;
c). 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
d). Modification of the research plan;
e). Change of personnel or personnel responsibilities, or disqualification of personnel from
participation in all or a portion of the research;
f). Reduction or elimination of the financial interest (e.g., sale of an equity interest);
g). Severance of relationships that create financial conflicts;
h). For research projects involving human subjects research, use of a data and safety monitoring
i). Double-blind conditions;
j). Provisions to conduct the work simultaneously at multiple sites;
k). Written disclosure of the conflict to all individuals working on the research project;
l). Annual reports on the research progress to the designated official.
m). Disclosure at any presentation of information related to the FCOI.
If the designated official determines that a conflict exists, it will communicate its determination and the
means it has identified for eliminating or managing the conflict, in writing, to the individual, to the
relevant Principal Investigator/Project Director, and the appropriate direct supervisor. The designated
official will keep a record of the disclosure and other relevant information for at least three years. If the
designated official prescribes monitoring of the activity, it will describe what monitoring shall be
performed and what records are to be kept.
No expenditures on a NIH award will be permitted until the Investigator has complied with the
Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined
by the designated official necessary to manage the Conflict of Interest. The designated official will
communicate, in writing, with the NIH Grantee to notify it of the existence and the nature of a Financial
Conflict of Interest and whether the conflict has been managed, reduced, or eliminated. No
expenditures can be incurred until the NIH Grantee has reported the FCOI to NIH. The NIH Grantee will
notify DCP when it may incur expenditures.
The designated official will keep a record of Investigator disclosures of financial interests and the
designated official’s review of, and response to, such disclosure and all actions under this policy. Such
records will be maintained and kept for at least three years from the date the final expenditures report
is submitted or, where applicable, from other dates specified in 45 C.F.R. 75.361 for different situations.
Public Accessibility to Information Related to Financial Conflicts of Interest
Prior to the expenditure of any funds under a NIH award, DCP will ensure public accessibility, by written
response to any requestor within five business days of a request, of information concerning any SFI
disclosed that meets the following three criteria:
(i). The SFI was disclosed and is still held by the senior/key personnel. Senior/key personnel are
the PD/PI and any other person identified as senior key personnel by DCP in the award
application, progress report or any other report submitted to the NIH Grantee;
(ii). DCP has determined that the SFI is related to the research funded through an award; and
(iii). DCP has determined that the SFI is a financial conflict of interest.
The information that DCP will make available via a publicly accessible Web site or in a written response
to any requestor within five days of request will include, at a minimum, the following:
(i). The Investigator’s name;
(ii). The Investigator’s title and role with respect to the research project;
(iii). The name of the entity in which the Significant Financial Interest is held;
(iv). The nature of the Significant Financial Interest; and
(v). The approximate dollar value of the Significant Financial Interest in the following ranges: $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 DCP uses a publicly accessible Web site to comply with the public disclosure requirements of the NIH
regulations, the information posted will be updated at least annually, and within sixty days of receipt or
identification of information concerning any additional Significant Financial Interest of the senior/key
personnel for the NIH-funded research project that had not been previously disclosed, or upon the
disclosure of a Significant Financial Interest of senior/key personnel new to the NIH-funded research
project, if it is determined by the designated official that the Significant Financial Interest is related to
the research and is a financial conflict of interest.
Information concerning the SFI of an individual, as limited by this Policy, will remain available, for
responses to written requests or for posting via DCP’s publicly accessible Web site for at least three
years from the date that the information was most recently updated.
Reporting of Financial Conflicts of Interest
Prior to the expenditure of any funds under an award funded by NIH, DCP will provide to NIH a FCOI
report compliant with NIH regulations regarding any Investigator’s Significant Financial Interest found to
be conflicting and will ensure that the Investigator has agreed to and implemented the corresponding
While the award is ongoing (including any extensions with or without funds), DCP will provide to NIH an
annual FCOI report that addresses the status of the FCOI and any changes in the management plan.
For any Significant Financial Interest that is identified as conflicting subsequent to an initial FCOI report
during an ongoing NIH-funded research project (e.g., upon the participation of an Investigator who is
new to the research project), DCP will provide to NIH, within 60 days , an FCOI report regarding the
financial conflict of interest and ensure that DCP has implemented a management plan and the
Investigator has agreed to the relevant management plan.
Each Investigator must complete training on DCP’s Financial Conflict of Interest Policy Applicable to an
Award Issued by Public Health Services prior to engaging in research related to any NIH award and at
least every four years, and immediately (as defined below) when any of the following circumstances
1). DCP revises this Policy, or procedures related to this Policy, in any manner that affects the
requirements of Investigators (training is to be completed within the timeframe specified in
communications announcing such changes);
2). An Investigator is new to DCP research under a NIH award (training is to be completed prior to
his/her participation in the research); or
3). DCP finds that an Investigator is not in compliance with this Policy or a management plan issued
under this Policy (training is to be completed within 30 days in the manner specified by the designated
In fulfillment of the training requirement, DCP requires its investigators to complete the National
Institutes of Health’s Financial Conflict of Interest tutorial located at:
http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm in accordance with the requirements and
expectations of this Policy. All investigators must print a certification of completion at the end of training
and retain it for audit purposes.
Failure to Comply with DCP’s Conflict of Interest Policy Applicable to Public Health Service Funded
When a FCOI 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 Institution to constitute a FCOI;
failure by the Institution to review or manage such a FCOI; and failure by the Investigator to comply
with a management plan; then DCP will within 120 days:
a) Complete a retrospective review of the Investigator’s activities and the research project to determine
any bias in the design, conduct or reporting of research;
b) Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B);
c) Document DCP’s determination as to whether any research, or portion thereof, conducted during the
period of time of the Investigator’s non-compliance with this Policy or a Financial Conflict of Interest
management plan, was biased in the design, conduct, or reporting of such research;
If bias is found, DCP shall notify NIH promptly and submit a mitigation report to NIH via the eRA
Commons FCOI Module that shall address the following:
Impact of the bias on the research project and
DCP’s plan of action or actions taken to eliminate or mitigate the effect of the bias.
Thereafter, DCP shall submit FCOI reports annually to NIH, in accordance with the regulation and terms
and conditions of the award agreement. Depending on the nature of the Financial Conflict of Interest,
DCP may determine that additional interim measures are necessary with regard to the Investigator’s
participation in the research project between the date that the Financial Conflict of Interest is identified
and the completion of DCP’s independent retrospective review.
If HHS determines that one of its funded clinical research projects 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 DCP, DCP
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
Subrecipient FCOI Compliance
A subrecipient relationship is established when federal funds flow down from or through DCP to another
individual or entity and the subrecipient will be conducting a substantive portion of a PHS-funded
research project and is accountable to DCP for programmatic outcomes and compliance matters.
Subrecipients, who include but are not limited to collaborators, consortium members, consultants,
contractors, subcontractors and subawardees, are subject to DCP’s terms and conditions, and as such,
DCP will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the
federal FCOI regulation. DCP will incorporate, as part of a written agreement with the subrecipient,
terms that establish whether DCP’s FCOI Policy or that of the subrecipient’s institution will apply to the
If the subrecipient’s FCOI policy applies to the subrecipient Investigator, the subrecipient institution will
certify as part of the agreement with DCP that it is in compliance with the federal FCOI regulation and
that the institution’s portion of the project is in compliance with the FCOI policy. If the subrecipient
cannot provide the certification, the agreement shall state that the subrecipient Investigator is subject
to DCP’s FCOI Policy for disclosing SFI that are directly related to the subrecipient’s work for DCP. DCP
will, if applicable, submit a FCOI report to the NIH through the eRA Commons FCOI Module for any FCOIs
identified for a subrecipient Investigator.
If the subrecipient’s conflict of interest policy applies to the subrecipient Investigator, the agreement
shall specify the time period for the subrecipient to report all identified FCOIs to DCP. Such time period
must be sufficient to enable DCP to provide timely FCOI reports to the NIH as necessary, through the
eRA Commons FCOI Module.
If the subrecipient Investigator is subject to DCP’s Investigator FCOI Policy, the agreement shall specify
the time period for the subrecipient to submit all Investigator disclosures of SFI to DCP. Such time
period shall be sufficient to enable DCP to comply with its review, management, and reporting
obligations under the regulation. DCP will submit any NIH FCOI reports for a subrecipient Investigator
through the eRA Commons FCOI Module.
Maintenance of Records
Records of financial disclosures and any resulting action will be maintained by the Institution for at least
three years from the date of submission of the final expenditures report or, where applicable, from
other dates specified in 45 C.F.R. 75.361 for different situations. DCP will retain records for each
competitive segment as provided in the regulation.
Failure to Comply with This Policy
No expenditures of funds on an award supported by NIH will be permitted unless the Investigator has
complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any
designated official-approved FCOI management plan.
DEEP CREEK PHARMA
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