PUPOSE:
The primary goal of this policy is to promote objectivity by establishing standards that provide a reasonable
expectation that the design, conduct, and reporting of research funded under Public Health System grants,
cooperative agreements and contracts will be free from bias resulting from Investigator financial conflicts of
interest.
The policy and procedures outlined are intended to meet the most recent requirements published by the
federal government regarding revised Financial Conflict of Interest (FCOI) Regulation, Promoting
Objectivity in Research on August 25, 2011 (42 CFR Part 50 Subpart F and 45 CFR 94).
Regulation 42 CFR 604(b) requires all individuals responsible for the design, conduct, or reporting of
research by any grant or sponsored trial agreement to undergo initial Financial Conflict of Interest (FCOI)
training and are required to be trained at least every 4 years. Dayton Clinical Oncology Program (DCOP)
investigators will review the policy and undergo training prior to conducting research (newly rostered) and
yearly, when completing other yearly DCOP forms. The required training is completed by reading the
following and signing the attestation page. Information included in the training portion of this document is
also available at: https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html
POLICY:
Any investigator responsible for the design, conduct, or reporting of research activities funded or proposed
for funding at DCOP by external sources must reveal all current Significant Financial Interests (SFI) that
would reasonably appear to be affected by the research.
DEFINITIONS:
Code of Federal Regulations (CFR) – Codification of the general and permanent rules published by the
departments and agencies of the Federal Government.
42 CFR Part 50 Subpart F - Code of Federal Regulation Promoting Objectivity in Research
https://www.ecfr.gov/current/title-42/part-50
Investigator-refers to the Principal Investigator , co-investigator and any other person,
regardless of title or position, who is responsible for the design, conduct or reporting of NIH-funded
research, including subgrantees, contractors, consortium participants, collaborators, or consultants.
Institution-refers to any domestic or foreign, public, or private, entity or organization (excluding a federal
agency) that is applying for, or that receives, NIH research funding.
Regulation or FCOI regulation-refers to 42 CFR Part 50 Subpart F, Promoting Objectivity in Research,
which applies to both grants and cooperative agreement
Disclosure-refers to the investigator’s disclosure of Significant Financial Interests (SFIs) to their
institution.
Report-refers to the institution’s report of identified FCOIs to the NIH.
Significant Financial Interest (SFI) - Any current financial interest of the investigator and his/her
immediate family that could reasonably appear to be affected by the activities proposed for funding; or any
interest held by the investigator and his/her immediate family in a business entity (company, corporation,
or other enterprise) whose financial interests might reasonably appear to be affected by such activities.
PROCEDURE:
Investigator Responsibilities
Per 42 CFR 604(b), Investigators must complete FCOI Training prior to engaging in research related
to any PHS-funded grant, every four years. Investigators will attest to completing the training yearly
when completing other DCOP forms and immediately if DCOP revises its FCOI policy that affects the
requirements of Investigators, an Investigator is new to an Institution or if an Investigator is not in
compliance with the policy or management plan.
The Investigator will complete a Financial Interest Disclosure Form (FIDF) at least annually and
immediately if the following conditions are present: if DCOP revises its FCOI policy so that it affects
the requirements of the investigators if an investigator is new to DCOP or if an Investigator is not in
compliance with the policy or management plan.
The Investigator must disclose a significant financial interest (SFI) (and those of the Investigator’s
spouse and dependent children) related to the Investigator’s responsibilities that meets or exceeds the
regulatory definition of SFI. The SFI must be disclosed no later than at the time of application for PHS-
funded research, at least annually during the period of the award and within 30 days of discovering or
acquiring a new SFI.
Significant Financial Interests
Any investigator responsible for the design, conduct, or reporting of research activities funded or
proposed for funding at Dayton Clinical Oncology Program by external sources must reveal all current
Significant Financial Interests (SFI) that would reasonably appear to be affected by the research.
Specifically, significant financial interests might include, but are not limited to, any of the following:
Anything of significant monetary value, including salary or other payments for services such as
consulting fees or honoraria; Direct equity interests such as stock, stock options, or ownership
interests; Intellectual property rights owned by the investigator such as patents, copyrights, and
royalties from such rights.
Significant financial interests do not include: Financial interests in business enterprises or entities that,
when aggregated for the investigator and his/her immediate family, meet both of the following tests;
the financial interest does not exceed $5,000 in value as determined through reference to public prices
or other reasonable measures of fair market value, and the financial interest does not represent more
than a five percent ownership interest in any single entity; Salary, royalties, or other remuneration from
Dayton Clinical Oncology Program; Salary, royalties, or other payments that, when aggregated for the
investigator and his/her immediate family, are not expected to exceed $5,000 during the next 12-
month period; Income from seminars, lectures, or teaching engagements sponsored by public or
nonprofit entities; Income from service on advisory committees or review panels for public or nonprofit
entities.
An investigator may choose to disclose any other financial or related interest that might present an
actual, potential, or perceived conflict of interest. Disclosure can be a key factor in protecting an
individual's reputation and career from potentially harmful allegations of misconduct.
Disclosure of Significant Financial Interest
All individuals responsible for the design, conduct, or reporting of research by any grant or sponsored
trial agreement, are required to file a Financial Interest Disclosure Form (FIDF).
Investigators must submit a FIDF on an annual basis.
Whenever a new transaction or activity is proposed that might involve a potential conflict of interest or
whenever there is a change in interests that might pose a conflict of interest or whenever there is
change in a previously reported potential conflict of interest. Report within 30 days.
Whenever the institution revises this FCOI policy that affects requirements of investigators.
Disclosure Review
Dayton Clinical Oncology Program President & CEO will provide timely review of completed Financial
Interest Disclosure Forms (FIDF) and will notify interested parties upon completion of such review. The
review will determine whether an Investigator’s FIDF contains a significant financial interest, and if so
whether the SFI is a financial conflict of interest related to ongoing clinical trials
If the Disclosure being reviewed is that of the Dayton Clinical Oncology Program President & CEO,
Principal Investigator, or Associate Principal Investigator, the Dayton Clinical Oncology Program Board
of Directors will complete the review process.
Dayton Clinical Oncology Program will send initial, annual and revised FCOI reports, including all
reporting elements required by the regulation, to the NIH as required by the most recent regulation.
This process will include the following time points: prior to the expenditure of funds; within 60 days of
identification for an Investigator who is newly participating in the project; within 60 days for new, or
newly identified FCOIs for existing Investigators; at least annually (at the same time Dayton Clinical
Oncology Program is required to submit the annual progress report) to provide the status of the FCOI
and any changes to the management plan, if applicable; until the completion of the project and
following a retrospective review to update a previously submitted report, if appropriate.
Management Plans for reported Conflict of Interest
Upon reviewing an individual Financial Interest Disclosure Form with possible conflict, the Dayton
Clinical Oncology Program President & CEO, Principal Investigator, and Associate Principal
Investigator, after discussion with the individual, will decide whether a management plan is needed.
Should management of a potential or actual significant financial conflict of interest be required, the
Investigator and Dayton Clinical Oncology Program President & CEO, Principal Investigator, and
Associate Principal Investigator will draft a "Management Plan." These written plans will manage,
reduce, or eliminate the significant financial interest(s). Such plans will be designed to meet applicable
legal requirements, facilitate the local resolution or management of any conflict, minimize
administrative burden, and protect the confidentiality of disclosed information.
Management plans may include a single element or several elements such as: Public disclosure of
significant financial interests (e.g., when presenting or publishing the research; to staff members
working on the project; to Institution’s Institutional Review Board(s); For research projects involving
human subjects research, disclosure of financial conflicts of interest directly to participants; Change of
personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a
portion of the research; divestiture of significant financial interests; and/or other arrangements that
manage, reduce, or eliminate a potential financial conflict of interest.
The Dayton Clinical Oncology Program Board of Directors will be responsible for developing a
Management Plan for any significant financial conflicts involving the Dayton Clinical Oncology
Program President & CEO, Principal Investigator, or Associate Principal Investigator.
Compliance
As part of the Financial Disclosure Statement, each Investigator must certify that if it is determined that
a significant financial conflict exists, the investigator will adhere to all conditions or restrictions imposed
upon the project and will cooperate fully with the individual(s) assigned to monitor compliance.
Dayton Clinical Oncology Program will complete and document retrospective reviews within 120 days
of the determination of noncompliance for SFIs not disclosed or previously reviewed or whenever an
FCOI is not identified or managed in a timely manner and to document the reviews consistent with the
regulation.
Dayton Clinical Oncology Program will notify NIH promptly and take corrective action if an Investigator
fails to comply with Dayton Clinical Oncology Program’s FCOI policy or a FCOI management plan
appears to have biased the design, conduct, or reporting of the NIH-funded research.
Dayton Clinical Oncology Program will post this FCOI policy and any identified significant financial
conflicts on the public webpage at http://daytonncorp.org/ The website will be updated annually and
within 60 days of identifying any new FCOIs.
Enforcement
Failure to properly disclose significant financial interests or to adhere to conditions or restrictions
imposed by the Management Plan will be considered a deviation from accepted standards of
conducting research at Dayton Clinical Oncology Program.
The Dayton Clinical Oncology Program President & CEO, Principal Investigator, and Associate
Principal Investigator will investigate alleged violations of this policy. Breaches of policy include failure
to file the necessary disclosure statements; knowingly filing incomplete, erroneous or misleading
disclosure forms, or failure to comply with procedures prescribed by the Management Plan. If the
Dayton Clinical Oncology Program President & CEO, Principal Investigator, and Associate Principal
Investigator determine that the policy has been violated, they may impose sanctions including, but not
limited to, notification of sponsor and termination of award; formal admonition; a letter to the
investigator's personnel file, or suspension of enrollment privileges. This will be reported to NIH
through eRA Commons or most current recommendation per NIH.
Records
The President & CEO will maintain records of all disclosures and associated activities securely and
confidentially. All records will be maintained 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. 74.53(b) and
92.42 (b) for different situations.
Records will not be routinely provided to sponsors unless such is an agency requirement, and the
agency submits a written request. Disclosure statements and associated information will not be
released without notification to the investigator.