INTRODUCTION

This tutorial reviews the main requirements of and the responsibilities for compliance with the 2011 revised Federal regulation on Financial Conflict of Interest (FCOI) for grants or cooperative agreements at 42 CFR Part 50 Subpart F, Promoting Objectivity in Research

The FCOI regulation promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct or reporting of research funded under NIH grants will be free from bias resulting from Investigator FCOIs

Institutions are required to implement policies and procedures consistent with the regulation

FC

OI

Train

ing

FOCUS OF THE REVISED REGULATIONSThe 2011 revised regulation includes comprehensive changes, focusing on these areas in particular:• Definition of a Significant Financial Interest (SFI);• Extent of Investigator’s disclosure of information to

Institutions regarding their SFI;• Institution’s management of identified FCOIs;• Information reported to the Public Health Service

(PHS) funding component (e.g., NIH);• Information made accessible to the public (i.e.

Institution’s FCOI policy and FCOIs of Senior/Key Personnel); and

• Investigator training. FC

OI

Train

ing

PURPOSE

FC

OI

Train

ing

The FCOI regulation was established to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants will be free from bias resulting from Investigator FCOIs

The NIH is committed to safeguarding the public’s trust in Federally-supported research that is conducted with the highest scientific and ethical standards

APPLICABILITY

FC

OI

Train

ing

Who is covered by this regulation?

• Institution: Midwestern University (MWU) is a domestic, private organization that applies for and receives NIH research funding by means of grants, therefore, these regulations apply to MWU

• Investigator: Is broadly defined as 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 NIH, or proposed for such funding, including persons who are subgrantees, contractors, consortium participants, collaborators, or consultants

DEFINITIONS

FC

OI

Train

ing

In addition to understanding the definitions of Institution and Investigator, there are several other definitions that you must know to understand the FCOI regulation

• Research: This regulation applies to basic and applied research and product development, including research grants, career development awards, center grants, individual fellowship awards, infrastructure awards, institutional training grants, program project grants, or research resources awards

• This includes all of MWU’s most commonly awarded grants, such as NIH R15s (AREA grants), R01s, R21s, and R03s

DEFINITIONS

FC

OI

Train

ing

• Institutional Responsibilities: This means an Investigator’s professional responsibilities on behalf of the Institution, and as defined by the Institution, 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 and Biosafety Committees

• Institutional Official (IO): The official designated responsible for soliciting and reviewing disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to their institutional responsibilities; at MWU the IO is the Director of the Office of Research & Sponsored Programs (ORSP)

• Financial Interest: This means anything of monetary value, whether or not the value is readily ascertainable

DEFINITIONS

FC

OI

Train

ing

• Financial Conflict of Interest (FCOI): Means a Significant Financial Interest (SFI) that could readily and significantly affect the design, conduct, or reporting of the NIH-funded research

• Manage: Means taking action to address an FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias

• Senior/Key Personnel: Means the Project Director/Principal Investigator (PD/PI) and any other person identified as Senior/Key Personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the regulation

DEFINITIONS

FC

OI

Train

ing

• Significant Financial Interest (SFI): Is defined as: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 appears to be related to the Investigator’s institutional responsibilities:

a. 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 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 interests includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

DEFINITIONS

FC

OI

Train

ing

• Significant Financial Interest (SFI; continued):

b. With regard to any non-publicly traded entity, a SFI 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 interests);

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

DEFINITIONS

FC

OI

Train

ing

• Significant Financial Interest (SFI; continued):2. 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 (such as MWU), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

DEFINITIONS

FC

OI

Train

ing

• Significant Financial Interest (SFI):2. (continued) At a minimum, the Institution will need

to know the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The institutional official (IO) determines what 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.

DEFINITIONS

FC

OI

Train

ing

• Significant Financial Interest (SFI; continued):3. The term SFI does not include the following types of financial

interests: 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; income from seminars, lectures, teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education, 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

OVERVIEW OF RESPONSIBILITIES

FC

OI

Train

ing

The regulation promotes the objectivity of NIH-funded research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded by NIH grants will be free from bias resulting from Investigator’s FCOIs.

The Investigator, the Institution, and the NIH all have responsibilities under the regulation

• The majority of the remainder of this training will focus on the Investigator’s responsibilities, while just touching upon the responsibilities of the Institution and the NIH

INVESTIGATOR RESPONSIBILITIES

FC

OI

Train

ing

As mentioned, these regulations apply to Investigators, as the term was already defined in a broad sense.

In other words, these responsibilities are not limited to the Principal Investigators or Key Personnel, but rather apply to all individuals responsible for the design, conduct, or reporting of the research.

Any questions on applicability should be directed to the Office of Research & Sponsored Programs (ORSP)

INVESTIGATOR RESPONSIBILITIES

FC

OI

Train

ing

What does the regulation require the Investigator to do?• Through the implementation of the FCOI regulation

by the Institution, the investigator is responsible for completing FCOI training prior to engaging in NIH-funded research and thereafter, every four years and immediately when any of the following circumstances apply:

o MWU revises its FCOI policies and procedures in any manner that affects the requirements of Investigators;

o An Investigator is new to an Institution;o An Institution finds that an Investigator is not in compliance

with the Institution’s FCOI policy or management plan

INVESTIGATOR RESPONSIBILITIES

FC

OI

Train

ing

What does the regulation require the Investigator to do (cont’d)?• Submitting to the Institution’s designated IO at the

time of application, a listing of his/her known SFIs (and those of his/her spouse and dependent children):o That reasonably appear to be related to the Investigator’s

institutional responsibilities;o Any reimbursed or sponsored travel related to the

Investigator’s institutional responsibilities as required in the regulation;

• During the period of award, updating all financial disclosures to the Institution according to its policy, either on an annual basis or within 30 days of the acquisition or discovery of new SFIs

RESPONSIBILITIES OF THE INSTITUTION

FC

OI

Train

ing

The Institution’s responsibilities under the regulation are extensive and include:•Developing and Implementing an Institutional Policy•Evaluating SFIs •Identification of FCOIs•Development of Management plans•Compliance with Regulations•Reporting to the NIHThe NIH’s responsibilities include:•Oversight•Education and Outreach

WHAT ELSE DO I NEED TO DO?

FC

OI

Train

ing

• Next, please read MWU’s Conflict of Interest on Extramurally Funded Programs Policy, which can be found on the ORSP website• If you have any questions about your responsibilities after

reviewing these training slides and/or after reviewing MWU’s policy, please contact the ORSP at x6394 on the Downers Grove campus or at x3728 on the Glendale campus

• Once you have reviewed these slides and have read our policy, please fill out the next slide completely, documenting that you have received MWU’s FCOI Training

• Finally, please fill out the Conflict of Interest Policy Disclosure Form C, and return it to the ORSP along with your documentation of training certificate

MIDWESTERN UNIVERSITY 

OFFICE OF RESEARCH AND SPONSORED PROGRAM

I certify that I have successfully:

• Completed MWU’s Financial Conflict of Interest Training;• Read MWU’s “Conflict of Interest on Extramurally Funded Programs”

policy and;• Have asked the Office of Research & Sponsored Programs any

questions.

Completed this Day of ,20

Signature

Print Name