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Executive Summary
- Recommended Expanded ACG Conflict of Interest (COI) Policy and Change
to ACG Conflict of Interest Committee
Purpose: Address risks associated with undisclosed conflicts, potential impact
on ACG decision-making from Board member affiliations with industry; and
appearance of potential impropriety/bad press from activities of President
and potentially other officers when they speak for pharmaceutical companies.
- General Policy—Central Conclusions/Tenets
Central Conclusions/Proposed Tenets of ACG Conflict of Interest Policy
By Ad Hoc Committee
- ACG should fashion a more extensive Conflict of Interest Disclosure
Policy, bringing together the best of the current ACG disclosure, plus
relevant elements of more extensive policies such as those from the
Mayo Clinic, Cleveland Clinic, etc.
- Building upon the comprehensive COI information collected from
faculty for the ACG Annual Meeting, Postgraduate Course, and Regional
meetings, the same information will be collected annually from the
ACG Board of Trustees, members of the ACG Educational Affairs Committee,
Research Committee, and Management Committee of the ACG Institute.
A summary of this information will be posted on the ACG website.
- The current Conflict of Interest Task Force, which may
expand by 1-2 additional members, will serve to review all COI disclosures
and shall also make inquiries as to questions or allegations which
may arise.
- The ACG President, during the year he/she serves shall
be precluded
from making any public statements or talks on behalf of any
industry company, defined as any invited talk, grand rounds or other
appearance
which involves payment from a company of any honorarium payment
for travel or other expenses or any other payment. This shall not
preclude (a) the presentation of oral presentations which reports on
any
research
study which was designed, initiated and managed by the President,
which was initiated prior to the date the individual became
ACG President; or (b) completion of any expert testimony assignment
which
the individual
had accepted before commencing his/her term as President of
the College.
EXCEPTION: The President may seek an exception for specific appearances/talks
if and only if it has been approved in advance by the ACG
Executive Committee.
-
Recognizing the potential for the impact
of conflict of interest
on selection and publication of items which may appear
in the American Journal of Gastroenterology, the Editors
shall be
asked to voluntarily
and appropriately limit their public statements/talks
on behalf of industry, as they see fit to preserve the
integrity of
the journal,
and the COI Task Force shall be available to counsel
on such statements/talks, as well as to monitor for instances
of the appearance
of actual or
potential conflict.
-
The President should not alone
make any decisions on behalf of the College which could
have an impact on one or more industry companies.
Rather, such ACG decisions should be made by either the
Executive Committee or the full ACG Board. A policy
for decision-making with
respect to entering new initiatives with industry in
the areas of physician and patient education through
the
ACG Institute was established
at the June, 2005 meeting and shall remain unchanged
(any decision or commitment on behalf of ACG be made
by the
Institute Director/President/plus
another Institute officer appointed by the Institute Director).
-
General COI conflict information
should be made available on the website for the Board
of Trustees, Educational
Affairs, and faculty
of the Postgraduate Course, Annual Meeting, and Regional
courses.
-
COI task force members report to the
ACG Board of Trustees.
-
COI task force members
shall consist of and/or be selected as follows:
- the immediate Past President of ACG (for a one-year term);
- the Director of the ACG Institute (to serve as
long as the individual serves in the position);
- the Executive
Director of ACG (to serve as long as the individual
serves in that position); and
- two (two-year terms), one appointed
each year (following the initial one-time only transitional appointments
of one
member
with a one-year term, and a second with a two-year term)
by the President
from among members of the Board of Trustees, Past Presidents,
or other members of the College, with the requirement that
each of
these appointments also needs to be confirmed by vote of
the Board of Trustees. In making these appointments, the President
shall
consider the desirability of having at least one member of
this Committee who is not also a member of the ACG Board
of
Trustees.
The term of these appointees may be terminated by majority
vote of the board in the face of an actual or alleged breach
of any
aspect of the ACG Conflict of Interest policy or the appearance
thereof.
- Any ACG staff member in a position of Vice President, Deputy
Director or higher shall be required to complete a COI policy agreement
and the information shall be kept on file.
- The COI Committee shall
establish the frequency/schedule of its meetings, with the exception
that the Committee is expected to
meet quarterly.
- ACG shall publish all significant elements
of ACG’s approach
to the ACCME disclosure requirements, including all requirements
added this year (2005) on content/design of research studies to be
published. This is not a publication of the ACCME’s statement,
but of the ACG’s adopted policies which have been implemented
to address the ACCME requirements
- Managing Conflicts of Interest in Decision-Making Processes
In order to identify and manage potential conflicts of interest for individuals,
the Disclosure form for Potential Conflicts of Interest in Purchasing and
Other Decision-Making Processes should be used by all entities of the College
considering a decision involving an expenditure of $5,000 or greater. This
disclosure is required for all members involved in the decision-making
process, including those who initiate, review and make decisions about
proposals to purchase goods or services, publish materials in the name
of the College and/or develop meetings or other programs for the College.
Individuals who disclose a potential conflict should recuse themselves
from leading the purchase or decision-making process and recuse themselves
from voting during the process. (They may participate in all discussions.)
Recusal should be documented in meeting minutes or proceedings. Disclosure
information should be available to all those participating in the purchasing
or decision-making process and should be included as part of the record
documenting the final decision.
For questions or assistance, please contact the ACG office or a member
of the Conflict of Interest Committee.
APPENDIX: Supplemental Statement of Policy and Detailed Clarifications
AMERICAN COLLEGE OF GASTROENTEROLOGY
CONFLICT OF INTEREST POLICY
The stature of the American College of Gastroenterology has grown exponentially
in recent years. As its visibility increases, it will come under increasing
scrutiny by other organizations, government and the public. The College’s
current excellent reputation could be compromised if its membership or the
groups noted above were to lose confidence in the integrity of the organization.
This would most likely occur in the event of impropriety or even perceived
impropriety on the part of anyone in a policy making position in the College – its
Officers, Trustees, Governors and/or Committee Members. The Board of Trustees
has therefore deemed it appropriate to develop and maintain a Conflict of
Interest Policy.
The Policy has been developed to be simple, realistic and workable. The
Policy Makers of the Organization must be free of outside influence and be
motivated solely by altruistic principles and their responsibilities to the
College. Their expertise in Gastrointestinal Disease may lead them to have
other personal and professional interests and commitments, some of which
might be the cause of a Conflict of Interest. This policy would also apply
to individuals who are advising the College on policy issues even though
they themselves are not members. (For example – a member of the FDA
Committee.)
I-A DUTIES TO DISCLOSE CONFLICT OF INTERESTS
Each member of the American College of Gastroenterology shall disclose all
of his/her potential conflicting material interests which he/she may identify
during the course of his/her service as either an Officer, Trustee, Governor,
committee member of the College, or an invited speaker for a regional or
national meeting. This disclosure shall be made to the College at the earliest
possible time.
Definition of Conflict of Interest
A conflict of interest occurs when there is a divergence between an individual’s
or the College’s private interest in their professional obligations
either to a patient or to a society such that an independent observer might
reasonably question research, investment, leadership or other actions taken
by the individual or the College that may have been influenced by consideration
of a significant financial conflict of interest. Conflict of interest depends
on the situation, and not on the character or actions of an individual.
The mere appearance of a conflict of interest may be just as serious and
potentially damaging as an actual lack of objectivity. Apparent conflicts
of interest should be evaluated and managed with the same degree of consideration
as to known conflicts of interest.
The potential for conflict of interest will increase as ACG leadership and
its staff, acting as Board members or full-time employees of ACG, form new
partnerships, relationships and alliances with industry.
Conflicts of Interest most often occur in the following: leadership decisions,
publications, scientific publications, investment decisions and research.
Management strategies may include, but are not limited to the following:
- Full disclosure of potential conflicts to the decision-making body
at the time of purchase discussions
- Recusal from chairing a decision-making
process
- Recusal from final decision-making process
- Retention of equity until
research or purchase decision is completed
- Documentation of recusal
in meeting or purchase decision minutes
- Publications and Scientific Presentations – ACG
will apply to all those involved in generating publications and/or scientific
presentations the standards adopted by the College to satisfy the requirements
of the
ACCME
and all other related criteria.
Guidelines for Management of Conflict
The first step in identifying significant conflict of interest is full disclosure
of relevant information. The next step is evaluation of the disclosed information
to determine whether a significant conflict of interest is present. If a
conflict is identified, the third step is to institute measures for management
of the conflict. In most instances, disclosure of the conflicting or potentially
conflicting interest will itself suffice to protect the integrity of the
subject’s activity. In other words, once such a conflict is fully disclosed
to the pertinent parties, they generally will be able to evaluate the possible
influence of disclosed interest.
II-A Covered individuals
- General Application
This policy applies to all persons who:
- Are members of ACG and/or are employees or staff of ACG at the
vice-president or deputy director level or higher;
- Seek to make presentations at any ACG meeting or to submit any materials
to ACG-sponsored publications; or
- Are in leadership roles, i.e., participate
on the ACG Board of Trustees, Institute leadership, committees, and
task forces, or in any volunteer
activity in an official capacity for the society.
- Persons related to covered individuals:
With respect to any person listed in section 3.1 and thus considered a “covered
individual,” other persons related to them shall also be considered
a “covered individual” if they have a relationship as spouse,
dependent child or adult child employed by the sponsor, or any other relationship
involving the sharing of income or assets.
III-A Areas of Likely Conflict or Appearance of Conflict of Interest
- Leadership Decisions (All references hereinafter to $5,000 refers
to a total amount the individual receives in any 12-month period from a
particular
company. This amount does not include any honorarium amount paid by the
College regardless of whether company funds have been received by ACG to
help support
the activity)
For those in a leadership role, full disclosure and subsequent management
of conflict of interest is essential in order to maintain credibility,
trust and effectiveness with patients, staff and ACG’s external
stakeholders.
For Leadership Decisions made by staff on behalf of ACG, the Conflict
of Interest Committee should review and suggest a management strategy
for the following potential conflicts of interest:
- Holders of equity, excluding investments in mutual funds,
including, but not limited to pharmaceutical or device companies,
as well as all entities that work for or with pharmaceutical and/or
device companies;
- Recipients of Board of Directors’ fees of >$5,000
per year;
- Recipients within the previous 12 months of license
fees, royalties or contractual rights to receive future royalties
of >$5,000
per year where the leadership decision is directly related
to the licensed technology of interest to the individual;
- Recipients
within the previous 12 months of consulting fees, honoraria,
salary, gifts, or other emoluments or other in-kind
compensation of >$5,000 where the leadership decision
is directly related to the licensed technology of interest
to the individual;
- Recipients of consulting fees, honoraria,
salary, gifts, or other emoluments or other in-kind compensation
of >$5,000;
- Recipients of unrestricted or education
grants >$5,000
within previous 12 months.
Management strategies include, but are not limited to the following:
- Full disclosure of significant financial conflicts of interest
to the decision-making body;
- Recusal from chairing a decision-making
process that could indirectly affect the relationship of the person
with the company or its
competitors and ACG;
- Recusal from final decision-making process
that could directly or indirectly affect the relationship of
the person with the company
or its competitors and
ACG;
- Documentation of recusal in meeting minutes.
- Committee Decisions
For Committee Decisions requiring ACG approval, the Conflict of Interest
Committee should review and develop management strategies to address potential
conflicts of interest in the following situations:
- Holders of equity, excluding investments in mutual funds, but including and
not limited to pharmaceutical or device companies, as well as entities that
work for or with pharmaceutical and/or device companies. NOTE: Committee
members with stock options or stock in privately held companies may
not undertake sponsored research for that company through ACG. All stocks and stock options
owned should be disclosed to the Conflict of Interest Committee prior to
the initiation of any sponsored research.
- Recipients within the previous 12
months of license fees, royalties or contractual rights to receive
future royalties of >$5,000 per year
where the research is DIRECTLY related to the licensed technology of
interest to the individual.
- Recipients of consulting fees,
honoraria, salary, gifts, or other emoluments or other in-kind compensation
of >$5,000 per year.
- Recipients of unrestricted research or education
grants within previous 12 months.
- Recipients of research or education
grants within previous 12 months that provide funds of $5,000 or
more in excess of those required for
reasonable expenses incurred in the performance of the research or educational
activity.
- Individuals involved with other current negotiations with a potential
sponsor that could lead to any of the above relationships.
IV-A. Financial interests or relationships requiring disclosure. The following
interests or relationships should be disclosed:
- Employment or leadership position:
Any full or part-time employment or service as an officer or Board member
for an entity having an investment, licensing, or other commercial interest
in the subject matter consideration, including but not limited to pharmaceutical
or device companies, as well as all for-profit companies that work for
or with pharmaceutical and/or device companies, must be disclosed.
- Advisory role:
Consultant or advisory arrangements with an entity having an investment,
licensing, or other commercial interest in the subject matter under consideration
must be disclosed if consultation was performed or payments made for such
consultation within one year of the activity or subject matter in question.
This also includes any paid or unpaid working relationship with any venture
capital, investment banking or other company which anticipates response
to or makes recommendations which may be influenced by internal knowledge
of specifics on company research, marketing, FDA filings or the like.
- Stock ownership; including warrants, stock options, profits interests,
partners, joint members or other relationships which could result in a potential
financial interest or benefit at some time in the future:
Any ownership interest (except when invested in a diversified fund not
controlled by the covered individuals) in a start up company, the stock
of which is not publicly traded, or in any publicly traded company, including
but not limited to pharmaceutical or device companies, as well as all for-profit
companies that work for or with pharmaceutical and/or device companies must
be disclosed if the company is an entity having an investment, licensing,
or other commercial interests in the subject matter under consideration.
- Honoraria:
Honoraria are reasonable payments for specific speeches, seminar presentations,
or appearances. Disclosure of honoraria is required when paid directly
to the covered individual by an entity having an investment, licensing,
or other commercial interests in any subject matter under consideration
or which might arise in the presentation or questions and when provided
within two years of the activity or subject matter in question.
- Research Funding:
All payments associated with conduct of clinical research project in
question must be disclosed if provided by the trial sponsor or agents
employed by the sponsor.
- Expert testimony:
Provision of an expert testimony must be disclosed when the testimony
related to the subject matter under consideration.
- Other remuneration:
The value of trips, travel, gifts, or other in-kind payments not directly
related to research activities must be disclosed if received from an entity
having an investment, licensing, or other commercial interest in the subject
matter under consideration and when received within one year of the activity
of subject matter in question. De Minimus payments totaling less than
$100 are excluded from disclosure requirements. These payments exclude
research related costs and travel.
V-A. Additional Potential Conflicts of Interests
In addition to the specific examples resulting in conflict of interest cited
earlier, the following would also be considered as possible conflicts of interest:
- An investigator undertakes clinical or basic research when the
investigator or the investigator’s immediate family has a financial,
managerial or ownership interest in the sponsoring organization.
- A staff member accepts significant gratuities or special favors from
sponsors of investigations or providers of health care products.
- A staff member enters into a consulting arrangement as a member
of
an advisory board or protocol evaluator with an organization
or company that is presently sponsoring his or her research study.
This is permissible
under certain circumstances, but requires approval from the Conflict
of Interest Committee.
- ACG employees perform services for a
company in which the
employee has an ownership interest or receives any type of remuneration.
- Organizational resources are used without authorization or
reimbursement for personal purposes or to support the activities
of a
company in which the staff person holds a financial or other interest.
- A staff member associates his or her name or work with ACG in
such
a way as to profit monetarily by trading on the reputation and
goodwill of ACG.
- Privileged information acquired in connection
with one’s professional
responsibilities is used for personal gain without authorization.
- Access to privileged information developed within ACG is provided
to any external entity with or without personal gain.
- Equipment,
instruments or supplies are purchased from a firm in
which the staff has a financial or other interest.
- A staff
member influences the negotiation of contracts between ACG
and an outside organization with which that person has a
financial interest or other relationship.
Definitions
The term does not include:
- Salary from ACG
- Income from seminars, lectures or teaching
engagements sponsored by nonprofit entities;
- Income from
service on advisory committees or review panels for nonprofit
entities; or
- Equity financial interests in business enterprises
or entities regardless of value.
Investigator
Investigator is defined as any individual responsible for the design, conduct or reporting of the activity funded or to be funded by the sponsored project.
VI-A. For those in a leadership role, full disclosure and subsequent management
of conflict of interests is essential in order to maintain credibility, trust
and effectiveness with ACG members and society at large. For leadership decisions
made by staff on behalf of ACG or for leadership decisions made by non-staff
of ACG (e.g. members of the Board of Trustees), the conflict of interest review
board should review and suggest a management strategy where a potential conflict
of interest may exist. Management strategies include, but are not limited
to:
- Recusal from final decision making processes in their trusted capacity
at ACG whenever a personal or potential
conflict of interest could directly or indirectly affect ACG.
- Documentation
of recusal in the meeting minutes.
- Recommending limited industry
contacts by certain key (e.g. ACG president) individuals.
VII-A. Investment decisions
ACG investment decisions should continue to reflect the ethical and responsible
stewardship of operational and development funds. Investment decisions should
be unrelated to clinical practice, research or educational activity.
VIII-A. Research decisions:
For research funding decisions made by ACG committees or clinical research
institute, full disclosure is required from individuals engaged in this process.
The conflict of interest review board should be consulted in order to obtain
advice on management of any potential or perceived conflict.
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