A. Disclosure of Significant Financial Interests means an Investigator disclosing information about a Significant Financial Interest (SFI) to IBT.

 

B. Financial Conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

 

C. FCOI Report means an Institution’s report of a financial conflict of interest to a PHS Awarding Component.

 

D. Financial Interest means anything of monetary value, whether or not the value is readily ascertainable.

 

E. HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

 

F. Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.

 

G. Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

 

H. Investigator means 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 the PHS (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants.

 

I. Manage means taking 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.

 

J. PD/PI means a project director or principal investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.

 

K. PHS means 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).

 

L. PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to 42 C.F.R. Part 50, Subpart F.

 

M. Public Health Service Act (PHS Act) means the statute codified at 42 U.S.C. 201 et seq.

 

N. 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). The term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

 

O. Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by IBT in the grant application, progress report, or any other report submitted to the PHS by IBT.

 

P. Significant Financial Interest (SFI)

i) 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 appears to be related to the Investigator’s institutional responsibilities:

1. 1. 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, 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;

   2. 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

   3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

 

ii) Investigators also must disclose the occurrence of 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 their institutional 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. 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 Chief Operating Officer will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

 

iii) The term significant financial interest does not include the following types of financial interests:

1. salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights;

2. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization;

3. 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;

4. 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

5. 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.

 

Q. Small Business Innovation Research (SBIR) Program means 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 42 C.F.R. Part 50, Subpart F, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.

 

R. Subrecipient means a consultant or subcontractor performing work under a Government Award who is not employed by IBT.

 

IV. RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

 

IBT shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with 42 C.F.R. Part 50, Subpart F, and make such policy available to any requestor within five business days of a request.

 

 

IBT shall inform each Investigator of the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and renew training every four years, and immediately when (a) revision of financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators; (b) an Investigator is new to IBT; or (c) an Investigator is not in compliance with its financial conflict of interest policy or management plan.

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Subrecipient Requirements

 

Awardee Institutions are responsible for monitoring subrecipient’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest to the National Institute of Health (NIH).

 

IBT will take reasonable steps to ensure that any subrecipients (i.e., subcontractors or consortium members) performing work under a PHS-funded research project comply with the PHS Financial Conflict of Interest regulations by:

 

A. 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.

1.  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 42 C.F.R. Part 50, Subpart F. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of IBT for disclosing significant financial interests that are directly related to the subrecipient’s work for IBT;

2. 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 IBT. Such time period(s) shall be sufficient to enable IBT to provide timely FCOI reports, as necessary, to the PHS as required by the FCOI policy;

3. Alternatively, if the subrecipient’s Investigators must comply with IBT’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 IBT. Such time period(s) shall be sufficient to enable IBT to comply timely with its review, management, and reporting obligations under the FCOI policy.

 

B. Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with 42 C.F.R. 50, Subpart F, i.e., prior to the expenditure of funds and within sixty (60) days of any subsequently identified FCOI.

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V. DISCLOSURE, REVIEW, AND MONITORING OF FINANCIAL

INTERESTS DISCLOSED BY INVESTIGATORS

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IBT designates the Chief Operating Officer as the institutional official to solicit and review

disclosures of significant financial interest from each investigator who is planning to participate in,

or is participating in, sponsored research. In the event the Chief Operating Officer has a conflict

of interest, the Chief Executive Officer of IBT shall fulfill the duties typically performed by the Chief

Operating Officer.

Each Investigator who is planning to participate in the PHS-funded research is required to:

1. Disclose to the Chief Operating Officer 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.8 Market Place, Suite 500

Baltimore, MD 21202

Office: 443-451-7175, Fax: 443-451-7179

2. Submit an updated disclosure of significant financial interests at least annually, in

accordance with the specific time period prescribed by IBT, during the period of the award.

Such disclosure shall include any information that was not disclosed initially to IBT, 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)

and shall include updated information regarding any previously disclosed significant

financial interest (e.g., the updated value of a previously disclosed equity interest).

3. 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.

Each FCOI disclosure will be reviewed by the Chief Operating Officer or the Chief Executive

Officer. The Chief Operating Officer is responsible for determining when an actual or potential

conflict of interest exists in a given situation — that is, when a Significant Financial Interest could

directly and significantly affect the design, conduct, or reporting of PHS-funded research — and

for taking action as necessary to manage such conflicts of interest, including development and

implementation of a management plan.

If it is found that a Significant Financial Interest could directly and significantly affect the

design, conduct, or reporting of the federally funded research, the Director of Research will take

actions as necessary to manage financial conflicts of interest, including any financial

conflicts of a subrecipient Investigator. 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).

MANAGEMENT AND REPORTING OF FINANCIAL CONFLICTS OF INTEREST

Prior to the expenditure of any funds under a PHS-funded research project, the Chief Operating

Officer shall 1) review all Investigator disclosures of significant financial interests; 2) determine

whether any significant financial interests relate to PHS-funded research; and 3) 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.

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 interests (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;8 Market Place, Suite 500

Baltimore, MD 21202

Office: 443-451-7175, Fax: 443-451-7179

• Modification of the research plan;

• Change of personnel or personnel responsibilities, or disqualifications 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.

For any significant financial interest that IBT identifies as conflicting subsequent to IBT’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), IBT shall provide to the PHS Awarding

Component, within sixty (60) days, an FCOI report regarding the financial conflict of interest and

ensure that IBT has implemented a management plan in accordance with 42 C.F.R. Part 50,

Subpart F. Pursuant to §50.605(a)(3)(ii), 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 IBT (e.g., was not timely reviewed or reported by a

subrecipient), IBT 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.

If bias is found, IBT is required to notify the PHS Awarding Component promptly and submit a

mitigation report to the PHS Awarding Component.

FCOI report 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

IBT’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;

• 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 IBT’s determination that the financial interest conflicts with such research; and

• A description of the key elements of IBT’s management plan, including:

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

o Conditions of the management plan;

o How the management plan is designed to safeguard objectivity in the research

project;8 Market Place, Suite 500

Baltimore, MD 21202

Office: 443-451-7175, Fax: 443-451-7179

o Confirmation of the Investigator’s agreement to the management plan;

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

and

o Other information as needed.

For any financial conflict of interest previously reported by IBT with regard to an ongoing PHS

funded research project, IBT 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. IBT 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.

VII. RECORD MANAGEMENT

IBT shall maintain records relating to all Investigator disclosures of financial interests and IBT’s

review of, and response to, such disclosures (whether or not a disclosure resulted in IBT’s

determination of a financial conflict of interest) and all actions under IBT’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 4S C.F.R 7S.361 for

different situations.

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