ACG Conflict of Interest Policy
- Executive Summary
- American College of Gastroenterology Conflict of Interest Policy
- 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 Web site.
- 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 shall 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 Web site 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 annually.
- 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.
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 and whether they are >$5,000 per year;
- Recipients within the previous 12 months of license fees, royalties or contractual rights to receive future royalties where the leadership decision is directly related to the licensed technology of interest to the individual and whether they are >$5,000 per year;
- Recipients within the previous 12 months of consulting fees, honoraria, salary, gifts, or other emoluments or other in-kind compensation where the leadership decision is directly related to the licensed technology of interest to the individual and whether they are >$5,000;
- Recipients of consulting fees, honoraria, salary, gifts, or other emoluments or other in-kind compensation and whether they are >$5,000;
- Recipients of unrestricted or education grants within previous 12 months and whether they are >$5,000.
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 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 the conduct of the 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 is 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.
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 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. MANAGEMENT STRATEGIES
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 ACG Conflict of Interest Committee 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 ACG Conflict of Interest Committee should be consulted in order to obtain advice on management of any potential or perceived conflict.