miRecule Financial Conflicts of Interest Policy

Policy Statement
As a professional research corporation, MiRecule is committed to protecting the integrity and
objectivity of its research activities by ensuring that the design, conduct, and reporting of
research will not be biased or appear to be biased by a personal financial conflict of interest.
MiRecule has implemented this policy to identify, manage, reduce, or eliminate financial
conflicts of interest.
The procedures described in this policy were created and designed primarily to comply with the
specific regulatory requirements for U.S. Public Health Service (PHS)-sponsored research but
are also intended to provide a basic framework and standards for identifying, evaluating, and
managing potential financial conflicts of interest relating to MiRecule’s other research activities.
For non-PHS research, the specific steps, timing, determinations, documentation, and
notifications may be tailored as appropriate but will remain focused on maintaining MiRecule’s
high standards for research integrity and effectively eliminating or managing actual or potential
financial conflicts of interest.

Reason for Policy
This policy and related procedures have been developed to identify, manage, mitigate,
neutralize, or eliminate actual, apparent, and potential financial conflicts of interest. The policy
was written to be in conformance with the Code of Federal Regulations (CFR) 42, Part 50,
Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which Public
Health Service (PHS) Funding Is Sought[1] and 45 CFR Part 94, Responsible Prospective
Contractors.
[1]These regulations do not cover Small Business Innovation Research (SBIR)/Small Business
Technology Transfer (STTR) Program Phase 1 applications or awards but do apply to
applicants and recipients under the SBIR/STTR Program Phase II. SBIR is the extramural
research program for small business that was established by the Awarding Components of PHS
and certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation
Development Act, as amended. The term SBIR Program includes the STTR Program, which
was established by Pub. L. 102-564.

Definitions
For purposes of this policy, the following definitions shall apply:

Designated Official is the individual designated by MiRecule to oversee the financial conflicts
of interest process, including solicitation and review of disclosures of significant financial
interests.
Equity interest includes any stock, stock option, or other ownership interest, and its value may
be determined through reference to public prices or other reasonable measures of fair market
value.
Financial conflict of interest means a significant financial interest that could directly and
significantly affect the design, conduct, or reporting of research as determined by MiRecule
through the Designated Official.
Financial interest means anything of monetary value, whether or not the value is readily
ascertainable.
Immediate family refers to an Investigator’s spouse and dependent children.
Investigator means the project director/principal investigator and any other person who is
responsible for the design, conduct, or reporting of the research or proposed research.

PHS means the U.S. Public Health Service, an operating division of the U.S. Department of
Health and Human Services (HHS), and any components of the PHS to which the authority
involved may be delegated, including the National Institutes of Health.
PHS Awarding Component means the organizational unit of the PHS that funds the research
that is subject to 42 CFR Part 50, Subpart F, and 45 CFR Part 94.
PHS-funded Research means research funded under PHS grants, cooperative agreements, or
contracts.
Public Health Service Act, or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Remuneration includes, for example, salary and any payment for services not otherwise
identified as salary (e.g., consulting fees, honoraria, paid authorship).
Research means a systematic investigation, study, or experiment designed to develop or
contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded Research, the term includes any such activity for which research funding is
available from a PHS Awarding Component through a grant, cooperative agreement, or
contract, whether authorized under the PHS Act or other statutory authority.
Significant financial interest means a financial interest consisting of one or more of the
following interests of the Investigator and his/her immediate family that reasonably appear to be
related to the Investigator’s MiRecule project responsibilities, including:
1. With regard to interests in any publicly traded entity, a financial interest consisting of
any remuneration received from the entity in the 12 months preceding the
disclosure and any equity interest (e.g., stock, stock option, or other ownership
interest) in the entity as of the date of disclosure, in which the value when
aggregated exceeds $5,000;
2. With regard to interests in any non-publicly traded entity, a financial interest
consisting of any remuneration received from the entity in the 12 months preceding
the disclosure, in which the value when aggregated exceeds $5,000, or when the
Investigator or his/her immediate family holds any equity interest (e.g., stock, stock
option, or other ownership interest); or
3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of
income related to such rights and interests.

Significant financial interests also include any 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 MiRecule project
responsibilities, 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; a medical
center; or a research institute that is affiliated with an institution of higher education.
Significant financial interest does not include the following:
 Salary, royalties, or other remuneration paid by MiRecule (or a subrecipient as
applicable) to the Investigator if the Investigator is currently employed or otherwise
appointed by MiRecule, including that paid for intellectual property rights assigned
or licensed to MiRecule and agreements to share in royalties related to such rights;
 Any ownership interest in MiRecule (or a subrecipient as applicable) held by the
Investigator (e.g., Employee Stock Ownership Plan);
 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;
 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; or a 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.

Procedures
Responsibilities of MiRecule’s Designated Official
The Designated Official or his/her designee shall be responsible for the following:
 Informing MiRecule Investigators of their obligations under this policy and any
related regulations;
 Reviewing disclosures of significant financial interest with MiRecule’s Administrator
to determine whether they are related to the subject research and, if so, whether
they constitute financial conflicts of interest;
 Screening and managing potential financial conflicts of interest;
 Maintaining all records relating to disclosures of financial interests, MiRecule’s
review of and response to such disclosures, and any related actions under this
policy;
 Ensuring inclusion of any required certifications in applications for funding or
contract proposals; and
 Reporting and disclosure as required under this policy and applicable regulations.

For PHS-funded research, the Designated Official shall also have the following responsibility:
 Taking reasonable steps to ensure that Investigators for subrecipients (e.g.,
subgrantees, subcontractors, or collaborators) fully comply with this policy or
provide MiRecule with sufficient assurances to enable MiRecule’s compliance with
all applicable laws or regulations. To this end, the written agreement between
MiRecule and the subrecipient will specify whether MiRecule’s or the subrecipient’s
financial conflicts of interest policy will apply to the subrecipient’s Investigators and,
if the subrecipient’s policy will apply, the Designated Official will:
o Obtain certification from the subrecipient that its policy complies with
MiRecule’s policy and the applicable regulations (absent such
certification, MiRecule’s policy will apply to the subrecipient’s
Investigators, and
o Establish time periods for subrecipient reporting of financial conflicts of
interest to MiRecule that enable MiRecule to report such conflicts in a
timely manner, as required under its policy and the applicable
regulations.

If MiRecule’s policy will apply to the subrecipient Investigators, MiRecule will be responsible for
meeting the requirements of this policy and the reporting obligations reflected in the applicable
regulations.

Internal Reporting Requirements
For PHS-funded research in particular, as part of the funding application or proposal and prior to
performing any work on the research, each Investigator who is planning to participate in the
research is required by regulation to complete a Significant Financial Interest Disclosure (SFID)
Form and submit the SFID Form to MiRecule’s Administrator. This requirement also applies to
Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-
funded research. SFID Forms will be provided to Investigators in conjunction with the annual
training and will be otherwise made available. MiRecule’s Administrator will review SFID
submissions with the Designated Official. The information reported on the SFID Form includes a
listing of the Investigator’s known significant financial interests and those of his/her immediate

family that reasonably appear to be related to the research or that are in entities whose financial
interests could be affected by the research.
MiRecule Investigators in non-PHS-funded research who have any significant financial interest
that may reasonably appear to be affected by the research are also expected to complete the
SFID Form and submit it to MiRecule’s Administrator.
Investigators are expected to submit an updated SFID Form during the period of the award as
necessary (at least annually for PHS-funded research). The annual update will typically be done
in conjunction with completion of the annual training. Such disclosures shall include any
information that was not previously disclosed; any change in information regarding any
previously disclosed significant financial interest; or, within 30 days of discovery or acquisition,
any new significant financial interest (e.g., an interest acquired through purchase, marriage, or
inheritance).

Determination and Management of Financial Conflicts of Interest
Upon receipt of a completed SFID Form, the Designated Official shall determine whether an
Investigator’s significant financial interest is related to the subject research and, if so, whether
the interest constitutes a financial conflict of interest under this policy and any applicable
regulations. The Investigator may be required to submit additional information as part of the
process. A disclosed interest may be related to the subject research either because the interest
could be affected by the research or because it is in an entity whose financial interest could be
affected by the research. A financial conflict of interest exists if the significant financial interest
could directly and significantly affect the design, conduct, or reporting of the research.
If MiRecule determines that a financial conflict of interest exists, a financial conflicts of interest
management plan will be implemented and monitored on an ongoing basis. The management
plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following
are examples of conditions or restrictions that might be imposed:
 Disclosure to research participants or the public of significant financial interests
(e.g., when presenting or publishing the research);
 Monitoring of research by independent reviewers;
 Modification of the research plan;
 Disqualification of staff from participation in all or a portion of the research;
 Reduction or divestiture of a financial interest; or
 Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, MiRecule may require the
management of conflicting financial interests in other ways as it deems appropriate.

External Reporting Requirements
MiRecule will disclose financial conflicts of interest as required by applicable laws or regulations.
Before expending any funds under a PHS award, MiRecule will ensure public accessibility by
posting financial conflicts of interest information on a publicly available web site or by
responding in a timely manner to written requests as required under the regulations. The
Designated Official will also report to the PHS Awarding Component, as detailed in the
regulations, the existence of any financial conflict of interest that has not been eliminated and
will ensure that MiRecule has implemented a plan to manage the conflict.
If a financial conflict of interest is identified after its initial reporting and during ongoing research
(e.g., through participation of a new Investigator) and has not been eliminated, MiRecule will
provide the PHS Awarding Component with an update within 60 days and ensure that it has
implemented a plan to manage the conflict. If the financial conflicts of interest report involves a
significant financial interest that was not disclosed by an Investigator or not previously reviewed
or managed by MiRecule (e.g., not reviewed or reported by a subrecipient in a timely manner),
MiRecule will undertake a retrospective review. Such retrospective review will determine
whether there was bias in the design, conduct, or reporting of the PHS-funded research, or
portion thereof, conducted prior to the identification and management of the conflict. If bias is

found, MiRecule will promptly notify the PHS Awarding Component and submit a mitigation
report. Upon request, MiRecule will provide HHS with information relating to any Investigator
disclosure of significant financial interests; MiRecule’s review of, and response to, such
disclosure; and whether the disclosure resulted in MiRecule’s determination of a financial
conflict of interest.

Confidentiality
MiRecule will, to the extent possible, protect the confidentiality of disclosures. In every instance,
MiRecule will endeavor to balance the privacy interests of individuals with its responsibility and
obligation to identify and manage conflicts of interest. Disclosures will be available to MiRecule
staff only on a need-to-know basis and will not be disclosed outside of MiRecule unless
necessary to comply with contractual, legal, or regulatory requirements.

Investigator Noncompliance
If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or
potential financial conflict of interest), MiRecule may take appropriate disciplinary action, which
may include, without limitation, termination of the Investigator’s participation in the research. In
addition, for PHS-funded research, failure to comply with this policy or the applicable regulations
shall result in the following:
 If the Investigator’s failure to comply with this policy or a financial conflicts of interest
management plan has biased the design, conduct, or reporting of the PHS-funded
research, MiRecule shall promptly notify the PHS Awarding Component of the
corrective action taken or to be taken;
 MiRecule will make available to HHS all records pertinent to financial conflicts of
interest and the management of those conflicts; and
 If HHS determines that a clinical PHS-funded research project 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 neither disclosed nor managed, MiRecule shall require disclosure
of the conflicting interest in each public presentation of the results of the research
and shall request an addendum to previously published presentations, if necessary.

Training and Education
Investigators receive training to promote objectivity in research and to ensure Investigator
compliance with regard to the applicable regulations and significant financial interest disclosure
obligations. The training module and other resources developed by NIH will be updated as
appropriate and can be accessed through the NIH Web site.
MiRecule requires Investigators to complete such training annually, and when any of the
following occurs:
 MiRecule revises its financial conflicts of interest policy or procedures in any
manner that affects the Investigator’s obligations;
 An Investigator is new to MiRecule; or
 MiRecule finds that an Investigator is not in compliance with this policy or a financial
conflicts of interest management plan.

Retention of Records
The Designated Official will retain financial conflicts of interest disclosure forms and other
supporting information consistent with MiRecule’s Record Retention policy. For PHS-funded
research, records of all financial disclosures, whether or not they result in a reporting obligation,
and all actions taken by MiRecule with respect to each financial conflict of interest will be
retained for at least 3 years from the date of submission of the final expenditures report or final
payment on the contract or, where applicable, from other dates specified in 45 CFR 74.53(b) or
48 CFR Part 4, Subpart 4.7.
Point of Contact

If you have a conflict of interest or if you have a question to discuss, contact the MiRecule
Administrator at FCOI at MiRecule.com.