Objective research is of paramount importance to SAFEBVM Corp. (“SafeBVM”). SafeBVM’s financial conflict of interest (FCOI) policy meets the expectation that the design, conduct, and reporting of research will be free from bias resulting from financial interests. This policy provides a framework to comply with requirements of 42 CFR 50, Subpart F, “Responsibility of Applicants for Promoting Objectivity in Research” for which PHS Funding is Sought” (FCOI Regulation), of the Federal Register pertaining to PHS-funded research, and is intended to ensure the research is free from bias due to financial conflicts of interest, and that potential financial conflicts of interests are identified, managed, reduced, or eliminated.
This Policy describes types of Financial Conflict of Interest (FCOI), identifies when
disclosure should be provided, and explains SafeBVM’s administration and enforcement
procedures. The policy is applicable to Senior/Key Personnel/ Investigators as defined
below, who participate in SafeBVM’s research. Participation includes having an active role
in the development of protocols, the conduct of clinical trials, as well as the reporting
of study results.
| Designated Official(s): | Person(s) responsible for the implementation of the FCOI Policy, designated by SafeBVM. |
| Equity Interest: | Any stock, stock option or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. |
| Financial Interest: | Anything of non-trivial monetary value, regardless of whether the value is readily ascertainable. |
| Financial Conflict of Interest (FCOI) | A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research. |
| Immediate Family: | Investigator/senior/key personnel’s spouse or domestic partner and dependent children. |
| Investigator: | The project director or principal investigator (PD/PI) 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 subgrantees, contractors, consortium participants, collaborators or consultants. |
| Institution: | Any domestic or foreign, public or private, entity or organization (excluding a federal agency), including Medical Device companies, that submits a proposal, or that receives, PHS research funding. SafeBVM is considered an “Institution” for the purposes of this policy. |
| Institutional responsibilities: | Any key/senior personnel/investigator’s professional responsibilities conducted on behalf of SafeBVM and as defined by SafeBVM, including, but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards (IRB) or Data and Safety Monitoring Boards (DSMB). |
| PHS: | 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). |
| Regulation or FCOI regulation: | 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, which applies to both grants and cooperative agreements. |
| Remuneration: | Salary and any payment for services, including consulting fees, honoraria, and paid authorship. |
| Research: | A systematic investigation, study, or examination designed to develop or contribute to generalizable knowledge relating broadly to public health including behavioral and social-sciences research. basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from PHS but excluding applications for Phase I under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. |
| Senior/Key Personnel: | The Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the SafeBVM in the grant application, progress report, or any other report submitted to the PHS/NIH by SafeBVM under the regulation. |
| Significant Financial Interest (SFI): | Financial interest consisting of one or more of the following interests of the investigator/senior/key personnel (and those of the investigator/senior/key personnel ’s spouse and dependent children) that reasonably appears to be related to the Investigator/senior/key personnel’s institutional responsibilities: |
With regard to any publicly traded entity a SFI 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 exceeds $5,000. For the 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 in
stock, stock options or other ownership interest, as determined through reference
to public prices and other reasonable measures of fair market value;
With regard to any non-publicly traded entity, a significant financial interest
exists if the value of any remunerations from the entity in the twelve
months preceding the disclosure, when aggregated, exceeds $5,000, or when the
Investigator/senior/key personnel (or the Investigator/senior/key personnel ’s
spouse or dependent children) holds any equity interests (e.g. stock, stock
options, or other ownership interest) or
Intellectual property rights and interests (e.g. patents, copyrights), upon
receipt of income related to such rights and interests.
Investigator/senior/key personnel s also must disclose the occurrence of any
reimbursed or sponsored travel (i.e., that which is paid on behalf of the
investigator/senior/key personnel and not reimbursed to the
investigator/senior/key personnel so that the exact monetary value may not be
readily available) related to their responsibilities to SafeBVM; provided,
however, that this disclosure requirement does not apply to travel that is
reimbursed or sponsored by a federal , state or local government agency, an
institution of higher education as defined at 20
U.S.C. 1001(a), an academic teaching hospital, medical center, or research
institute that is affiliated with an Institution of higher education. SafeBVM’s
FCOI policy will specify the details of this disclosure, which will include, at a
minimum, the purpose of the trip, the identity of the sponsor/organizer, the
destination, and the duration. In accordance with SafeBVM’s FCOI policy, SafeBVM
Designated Official(s) will determine if further information is needed, including
a determination or disclosure of monetary value, in order to determine whether the
travel constitutes a FCOI with the PHS-funded research.
The term significant financial interest (SFI) does not include the following types
of financial interests: salaries, royalties or other remuneration paid by SafeBVM
to the investigator/senior/key personnel if the investigator/senior/key personnel
is currently employed or otherwise appointed by SafeBVM, including intellectual
property rights assigned to SafeBVM and agreements to share in royalties related
to such rights; any ownership interest in SafeBVM held by the
investigator/senior/key personnel; income from investment vehicles, such as mutual
funds and retirements accounts, as long as the investigator/senior/key personnel
does not directly control the investment decisions made in these vehicles; income
from seminars, lectures or teaching engagements sponsored by a federal , state or
local government agency an Institution of higher education as defined at 20 U.S.C.
1001(a), an academic teaching hospital, a medical center, research institute that
is affiliated with an Institution of higher education; or income from service on
advisory committees or review panels for a federal, state or local government
agency an Institution of higher education as defined at 20 U.S.C. 1001(a), an
academic teaching hospital, a medical center, or a research institute that is
affiliated with an Institution of higher education.
The extramural research program for small businesses that is established by the Awarding
Components of the Public Health Service and certain other Federal agencies under Public
Law 97-219, the Small Business Innovation Development Act, as
amended. For purposes of this subpart, the term SBIR Program also includes the Small
Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.
A financial conflict of interest related to SafeBVM’s activities may occur when an
investigator/senior/key personnel employed or appointed by SafeBVM has a significant
financial interest that compromises, or appears to compromise, that individual’s
independence and objectivity in the discharge of his/her SafeBVM responsibilities in the
design, conduct, or reporting of SafeBVM’s research. Investigators/senior/key personnel
should avoid conflicts and the potential for conflicts resulting from financial
arrangements with third parties that could have a special interest in a SafeBVM protocol.
Disclosure:
Senior/key personnel/investigators are required to disclose SFIs (and those of the
investigators, senior/key personnel’s immediate family). This disclosure will be made
at least annually during the award period [to include any information that was not
disclosed initially to SafeBVM or updated information regarding any previously
disclosed SFI] and within 30 days of discovering or acquiring a new SFI (such as
through purchase, marriage or inheritance).
SafeBVM will name “Designated Official(s)” to manage the FCOI policy. The designated
official(s) will take action to address a financial conflict of interest, which can
include reducing or eliminating the financial conflict of interest, to ensure, to the
extent possible, that the design, conduct, and reporting of research will be free from
bias.
If a determination is made that a FCOI exists SafeBVM’s Designated Official(s) will
recommend a suitable action plan or management plan to eliminate or manage the FCOI
consistent with the objectives of this policy.
The action plan shall provide for its periodic review and updating at least annually. In
the event that there is no reasonable way to manage a FCOI then the
investigator/senior/key personnel may be prohibited from participating in the related
Research until such a time as the FCOI is eliminated.
Examples of 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; and
SafeBVM shall review the proposed action plan or management plan and can approve,
modify and approve additional work. Final review and determination must be
completed prior to the expenditure of any PHS funds for the applicable Research.
A conflict should be managed, reduced, or eliminated within sixty (60) days of its
identification by designated official(s). SafeBVM’s Designated Official(s) shall be
responsible for monitoring and enforcing any management plan.
This shall also apply when, in the course of an ongoing PHS-funded research project, an
investigator/senior/key personnel who is new to participating in the research project
discloses a significant financial interest or an existing investigator/senior/key
personnel discloses a new significant financial interest to SafeBVM.
Enforcement
If a senior/key personnel/investigator fails to comply with SafeBVM’s FCOI policy, within
120 days of discovery by SafeBVM, SafeBVM shall complete a retrospective review of the
senior/key personnel/investigator’s activities to determine potential bias.
If a bias is found, SafeBVM shall submit a mitigation report to the NIH, in accordance
with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research
project and the actions it has taken to mitigate the bias.
SafeBVM will work with the investigator/senior/key personnel to set up an FCOI management
plan to mitigate the situation.
Companywide, SafeBVM is required to mandate that senior/key personnel/investigator
disclose the FCOI in each public presentation with research results if it was not reported
up front. In extreme cases of bias, the investigator/senior/key personnel may lose the
right to work on the project.
Training:
All persons subject to the SafeBVM Financial Conflict of Interest Policy will be
required to train on the policy by reading and affirming their understanding of, and
intent to comply with the FCOI policy and every four (4) years thereafter. Immediate
training will be required if SafeBVM revises this policy in a manner that affects the
investigator/senior/key personnel, when an investigator/senior/key personnel is new to
SafeBVM, or as a result of a finding of noncompliance with this policy or a management
plan, or other related misconduct.
SafeBVM’s senior/key personnel or investigators/study directors may also demonstrate
understanding of FCOI by using the NIH web-based training which can be accessed online.
Web-based Training: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
Unless otherwise covered by a third-party FCOI Policy as agreed with SafeBVM, each
investigator/senior/key personnel is required to complete training on SafeBVM’s FCOI
Policy by reading and affirming the policy or demonstrate training on the NIH web based
training on the following occasions:
Prior to engaging in research related to any PHS-funded grant,
At least every 4 years, and
Immediately if:
SafeBVM revises the FCOI Policy in a manner that affects requirements of
investigator/senior/key personnel,
An investigator/senior/key personnel is new to SafeBVM, or
An investigator is not in compliance with the FCOI Policy or
management plan.
Reporting: As required by 42 CFR Part 50, Subpart F, SafeBVM shall file a
report with the NIH providing information on every identified FCOI and
the manner in which the FCOI is being or has been managed, reduced, or
eliminated. Reports shall include the elements required by these
regulations. SafeBVM will notify NIH promptly if bias is found with
the design, conduct, or reporting of NIH-funded research, and file a
Mitigation Report in accordance with federal regulations.
Records Management: The records of all financial disclosures and all actions taken by
SafeBVM will be maintained for at least three years from the date of
submission of the final expenditures report.
Subrecipients: When carrying out the PHS-funded research through a subrecipient (e.g.,
subcontractors or consortium members), SafeBVM must incorporate by written agreement
(e.g., subaward contract) that the investigator/senior/key personnel of the subrecipient
institution is required to either:
Comply with the SafeBVM’s FCOI Policy, or
Comply with the FCOI Policy of the subrecipient institution and have said
institution certify that its policy complies with 42 CFR Part 50 Subpart F. The
written agreement, under either policy, must specify the time period for the
subrecipient to provide investigator/senior/key personnel disclosure and report of
any FCOI to SafeBVM.
It is suggested that at least 30 days from the reporting deadline for SafeBVM’s
annual disclosures, or in cases of discovery or acquiring new SFI a maximum of 10
business days be considered to which the subrecipient is to report to SafeBVM, to
enable SafeBVM to comply timely with its review, management, and reporting
obligations.
SafeBVM will provide FCOI reports to the PHS Awarding Component regarding all
financial conflicts of interest of all subrecipient investigator/senior/key
personnel s prior to the expenditure of funds and within 60 days of any
subsequently identified FCOI.
SafeBVM’s Financial Conflict of Interest Policy shall be posted on the public portion of the
SafeBVM website. In addition, upon receipt of a written request for information concerning
identified FCOI’s held by Senior/Key Personnel (as defined by regulation), SafeBVM will make that
information available within five (5) business days of the request. The information shall include
all elements required by 42 CFR Part 50, updated through the date of the response.