FCI Policy — INRC

Financial Conflicts of Interest Policy

Last Updated: August 20, 2021

I. Introduction

The International Narcotics Research Conference, Inc. (INRC) has an obligation to its members to

conduct its activities transparently and with integrity. The INRC is committed to avoiding financial

conflicts of interest that may compromise, or appear to compromise, the integrity and objectivity of

research and the safety of human research subjects. Because the INRC encourages its

members to engage in outside activities and relationships that enhance its missions, real or

perceived conflicts of interest may arise.

The keystone of an effective program for identifying and dealing with financial conflicts of interest is full

disclosure of those financial interests that reasonably appear related to one’s institutional

responsibilities. This Policy provides guidance and procedures for disclosure by Investigators (as

defined below) of their relative significant financial interests. After the disclosure, the INRC can make

an informed judgment about a particular activity and require appropriate oversight, limitations, or

prohibitions in accordance with this policy.

This Policy deals with financial conflicts of interest of individual Investigators. Financial conflicts of

interest related to research that are institutional in scope are not covered by this Policy.

Federal regulations governing financial conflicts of interest for Public Health Service-funded

activities are promulgated at 42 CFR Part 50 and 45 CFR Part 94.

II. Purpose

INRC is a membership organization whose mission includes among other things, the development and

advancement of research on addiction as well as the development of the careers of its members.

To this end, the Executive Committee is elected by the members to oversee and govern all

administrative and fiscal activities, policies and public statements of the INRC in a fair and

impartial manner. This primary responsibility is made more significant by the fact that many of the

activities of INRC are supported with government funding, which also requires assurance of

impartiality through the management of any actual or perceived conflicts of interest (COI) among

Executive Committee members.

Therefore, in order to assure INRC members and financial sponsors that all actual and perceived COIs

are identified and addressed, this policy instructs all INRC Executive Committee members on:

1. What constitutes a real or perceived conflict of interest;

2. The requirements and procedures each Executive Committee member should take to report

any real or perceived conflict of interest; and

3. How to handle any identified conflict of interest as they are identified in the course of

Executive Committee discussions.

Pursuant to state statutes and Federal regulations, this regulation sets forth policies and

procedures to ensure that the personal financial interests of an Investigator do not compromise

the objectivity with which research is designed, conducted, and reported or the welfare of human

research subjects.

III. Applicability

This Policy is applicable to INRC insofar as it applies for, or receives, PHS research funding by

means of a grant or cooperative agreement and, through the implementation of this Policy by

INRC, to each Investigator who is planning to participate in, or is participating in, such research.

This regulation shall apply to Investigators on any sponsored agreement that is in preparation, has

been submitted to a sponsor, or is currently funded, and to Investigators involved in

institutionally-sponsored research.

IV. Definitions

The following definitions apply to this Policy, unless a different definition is used by an applicable

federal agency. In that case, the definition used in the federal agency’s regulations will apply.

A. Equity Interest

Equity interest means stock, stock options, warrants, partnership or other ownership interests.

Excluded from this definition are equity interests held in publicly-traded mutual funds or

retirement programs the investment of which is not under the control of the Investigator or family

member.

B. Family Member

Family member means an Investigator’s spouse and dependent children.

C. Financial Conflict of Interest (FCOI)

Financial conflict of interest means a Significant Financial Interest (as defined below) that could

directly and significantly affect the design, conduct, or reporting of research or other activity that

is sponsored by NIH or another extramural agency.

D. Financial Interest

Financial interest means anything of monetary value or potential monetary value, whether or not

the value is readily ascertainable. Without limiting the foregoing, a financial interest may exist

where an Investigator and/or his/her Family member, or business/professional organization could

obtain or could be denied a financial benefit from an Investigator’s action.

E. Investigator

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, or proposed for such funding, which may include, for example, collaborators or

consultants. For INRC, an Investigator may include President, Treasurer, members of the

Executive Committee, and Communication Officer.

F. Institutional Official

Institutional Official means the individual with authority and responsibility for overseeing

implementation of this regulation and for ensuring consistent administrative review of Disclosure

Statements. The President shall designate a member of the Executive Committee to serve as

the Institutional Official. The President shall also designate a second member of the

Executive Committee to serve as an alternate Institutional Official, who will act as Institutional

Official when the primary Institutional Official is an Investigator making disclosures and

otherwise acting within the procedures set forth in this Policy.

G. Institutional Responsibilities

Institutional responsibilities means an Investigator’s professional responsibilities on behalf of

INRC, and as defined by INRC in its policy on financial conflicts of interest. Such responsibilities

may include, but are not limited to, activities such as research, consulting for outside entities,

teaching, professional practice, committee memberships, administration, extension or outreach,

as well as service on institutional panels such as Travel Awards, Young I nvestigator Awards and

Founders Awards.

H. Manage

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.

I. Outside Entity

Outside entity means any entity recognized by law through which business for profit is conducted

(including sole proprietorship, partnership, firm, corporation, holding company, joint stock

company, receivership or trust), or not-for-profit organization (including association, foundation,

charitable organization, etc.).

J. Public Health Service (PHS)

Public Health Service (PHS) means an operating unit of the U.S. Department of Health and Human

Services (HHS), any components of the PHS to which the authority involved may be delegated,

including the National Institutes of Health (NIH).

K. Remuneration

Remuneration means all salary and wages, including professional income from consulting fees,

speaking fees, any payment for services not otherwise identified as salary or wages from INRC

(e.g., honoraria, paid authorship, travel reimbursement, gifts), licensing revenue (royalty payments

for inventions), royalties for books, publications or reports, or equity interests. Excluded from this

definition is employment salary and equity interests held in publicly-traded mutual funds or

retirement programs the investment of which is not under the control of the Investigator or family

member.

L. Research

Research means a systematic investigation, study or experiment designed to develop or

contribute to generalizable knowledge. The term encompasses basic and applied research such as

bench work, clinical trials, or other work and product development, and other forms of creative

activity. The term includes any such research or creative activity conducted by members under

the auspices of their employed University or Institution, or conducted in situations in which INRC

positions or titles are utilized in resultant publications, presentations, or other forms of

intellectual property, irrespective of whether such research is funded by grant, contract,

cooperative agreement, gift, or general funds. The term also includes collaborative work with a

manufacturer, a distributor, or a sponsor of the research, and includes tangible or intangible

inventions, discoveries, patents, or ideas necessary for development, utilization, or processes

associated with the activity.

M. Significant Financial Interest

Significant financial interest means:

(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:

(i) 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

(ii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income

related to such rights and interests.

(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 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 Institution'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 the Institution's FCOI policy, the institutional

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 an FCOI

with the PHS-funded research.

(3) The term significant financial interest 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; any ownership interest in the Institution held by the Investigator, if the

Institution is a commercial or for-profit organization; 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.

N. Sponsored Agreement

Sponsored agreement means a grant, contract, cooperative agreement, clinical study or clinical

trial agreement, and subagreements or subcontracts thereof.

V. Policy

(1) INRC shall require that each Investigator who is planning to participate in the PHSfunded

research disclose to INRC 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. Such disclosure shall be made on a Financial

Interests Disclosure Statement (Disclosure Statement), the form of which shall be

prescribed by INRC.

(2) Each Investigator who is participating in the PHS-funded research shall submit an

updated Disclosure Statement at least annually, in accordance with the specific time

period prescribed by INRC, during the period of the award. Such disclosure shall

include any information that was not disclosed initially to INRC pursuant to paragraph

(1) of this section, or in a subsequent Disclosure Statement (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) Each Investigator who is participating in the PHS-funded research must submit an updated

Disclosure Statement within thirty days of discovering or acquiring (e.g., through purchase,

marriage, or inheritance) a new significant financial interest.

(4) Disclosure is required whether or not the Investigator has a significant financial interest to

report. The Disclosure Statement shall include the financial interests of the Investigator and

those of his or her spouse and dependent children.

(5) An Investigator required to disclose under this regulation shall submit an updated Disclosure

Statement within 30 days of acquiring a new significant financial interest that reasonably

appears related to his or her institutional responsibilities.

(6) New Investigators who are required to disclose under this regulation shall complete a

Disclosure Statement within 30 days of their employment start date.

(7) Investigators who apply for or receive funding through a PHS grant, cooperative agreement, or

contract, shall disclose each instance of reimbursed or sponsored travel (i.e., paid on behalf of

the Investigator rather than being reimbursed) that reasonably appears related to their

institutional responsibilities within 30 days of the completion of such travel.

(8) Prior to INRC’s expenditure of PHS grant funding, Disclosure Statements shall be reviewed

by the Institutional Official or designee to determine if any significant financial interests

relate to PHS-funded research, and to assess whether or not a financial conflict of interest

exists.

(9) If a financial conflict of interest appears to exist, the Institutional Official shall

recommend courses of action designed to manage, reduce, or eliminate the conflict.

VI. Disclosure Procedures

A. Disclosures shall be made using either (i) a secure, web-based Disclosure Statement;

or (ii) a paper Disclosure Statement submitted to the Institutional Official, maintained by

the Institutional Official.

B. Individuals required to disclose under this regulation shall be notified electronically during

the month of February each year of the need to file a Disclosure Statement during the

month of March.

C. Individuals required to disclose under this regulation to report a new financial interest may

access their Disclosure Statement upon request in order to file an updated Disclosure

Statement and to review their current Disclosure Statement.

D. Individuals may access their Disclosure Statement history upon request during normal

business hours.

E. After completing a Disclosure Statement, the individual shall be required to certify that:

1. He or she has read and understands their responsibilities under this Financial

Conflicts of Interest Policy, the INRC Policy on Conflict of Interest Disclosure and

Resolution, and other applicable INRC policies;

2. The disclosure is accurate and complete to the best of their knowledge; and

3. He or she agrees to update their disclosure with thirty (30) days of acquiring a new

financial interest that reasonably appears related to their institutional

responsibilities.

VII. Disclosure Statement Review Procedures

A. The Disclosure Statement review shall be done using either (i) a secure, web-based system

maintained by the Institutional Official; or (ii) hard copies of the Disclosure

Statement distributed to the Institutional Official under a duty of confidentiality. Further

access shall be restricted to those individuals authorized in writing by the Institutional

Official.

B. The review shall be the responsibility of the Institutional Official, who may delegate in

writing to one or more persons day-to-day responsibility for reviewing Disclosure

Statements. The Institutional Official will provide guidelines to assist the reviewer(s) in

assessing whether or not a significant financial interest appears to constitute a financial

conflict of interest. However, the Institutional Official shall be directly responsible for

reviewing each Disclosure Statement where a real or perceived financial conflict of

interest appears to exist. The administrative review shall be completed within 60 days

after the certified Disclosure Statement has been submitted.

C. The Institutional Official may involve the Investigator in the determination of whether a

disclosed significant financial interest is related to the Investigator’s research or other