Policy on Conflicts of Interest and Interactions between Industry and Faculty, Staff and Students of the Commonwealth Medical College
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Effective Date: February 1, 2010
Policy Revision Date : 2013-04-10
Introduction / Purpose:
The Commonwealth Medical College has a mission to educate physicians and scientists to serve society using a community-based, patient-centered, Interprofessional and evidence-based model of education that is committed to inclusion promotes discovery and utilizes innovative techniques. These goals require that faculty, students, trainees, and staff of TCMC and physicians and other TCMC employees at all regional locations interact with representatives of the pharmaceutical, biotechnology, medical device, and hospital equipment supply industry (hereinafter Industry), in a manner that advances the use of the best available evidence so that medical advancements and new technologies become broadly and appropriately used. While the interaction with Industry can be beneficial, Industry influence can also result in unacceptable conflicts of interest that may lead to increased costs of healthcare, compromise of patient safety, negative socialization of students and trainees, bias of research results, and diminished confidence and respect among patients, the general public and regulatory officials. Because provision of financial support or gifts may exert an impact on recipients behavior, TCMC has adopted the following policy to govern the interactions between Industry and TCMC personnel.
This policy has been designed to reflect the best available literature on conflict of interest and is intended to provide guiding principles that members of the TCMC community as well as representatives of Industry can use to assure that their interactions result in optimal benefit to clinical care, education, research, and maintenance of the public trust.
Governance and Enforcement:
Associate Dean for Admissions and Student Affairs, Administration & Staff: Associate Dean for Finance and Administration and Faculty: Associate Dean for Research and Economic Development/Associate Dean for Faculty Affairs and Faculty Development
Student, Faculty and Administration: Policy on Conflicts of Interest and
Interactions with Industry
The Commonwealth Medical College has a mission to educate physicians and scientists to serve society using a community-based, patient-centered, Interprofessional and evidence-based model of education that is committed to inclusion promotes discovery and utilizes innovative techniques. These goals require that faculty, students, trainees, and staff of TCMC and physicians and other TCMC employees at all regional locations interact with representatives of the pharmaceutical, biotechnology, medical device, and hospital equipment supply industry (hereinafter Industry), in a manner that advances the use of the best available evidence so that medical advancements and new technologies become broadly and appropriately used. While the interaction with Industry can be beneficial, Industry influence can also result in unacceptable conflicts of interest that may lead to increased costs of healthcare, compromise of patient safety, negative socialization of students and trainees, bias of research results, and diminished confidence and respect among patients, the general public and regulatory officials. Because provision of financial support or gifts may exert an impact on recipients behavior, TCMC has adopted the following policy to govern the interactions between Industry and TCMC personnel. This policy has been designed to reflect the best available literature on conflict of interest and is intended to provide guiding principles that members of the TCMC community as well as representatives of Industry can use to assure that their interactions result in optimal benefit to clinical care, education, research, and maintenance of the public trust.
A. Scope of Policy
This policy applies to all faculty, staff, and students of TCMC and to all healthcare professionals and staff employed and/or contracted at regional locations of TCMC, and to all facilities owned or controlled by the TCMC. While this policy addresses many aspects of Industry interaction, it supplements the existing conflict of interest policies of TCMC, particularly as they apply to research conflicts of interest:
Faculty Research Conflict of Interest Policy on Commercial Support of CME Policy on Faculty Private Interest Employee Consulting Policy Objectivity in Research Policy
In all cases where this policy is more restrictive than other TCMC conflict of interest policies, this policy shall take precedence. This policy applies to interactions with all sales, marketing, or other product-oriented personnel of Industry, including those individuals whose purpose is to provide information to clinicians about company products, even though such personnel are not classified in their company as sales or marketing.
B. Statement of Policy
It is the policy of TCMC that clinical decision-making, education, and research activities are free from influence created by improper financial relationships with, or gifts provided by Industry. For purposes of this policy, Industry is defined as all pharmaceutical manufacturers, and biotechnology, medical device, and hospital or laboratory equipment supply entities and their representatives. These general principles should guide interactions and relationships between TCMC personnel and Industry representatives. The following specific limitations and guidelines are directed to certain specific interactions. For situations not specifically addressed, TCMC personnel should consult in advance with their deans or department chairs or their administrators to obtain further guidance and clarification.
C. Specific Activities
1. Support of Continuing Education in the Health Sciences
Industry is not permitted to provide direct financial support for educational activities, including Continuing Medical Education CME. Industry may contribute unrestricted educational funds to a central fund or oversight body at TCMC, which, in turn, would disburse funds for programs that are independent of any industry input or control. In order to ensure that potential for bias is minimized, all CE events hosted or sponsored by TCMC, must comply with the ACCME Standards for Commercial Support of Educational Programs (or other similarly rigorous, applicable standards required by other health professions), whether or not CE credit is awarded for attendance at the event. All such agreements for Industry support must be negotiated through and executed by the TCMC Department of Continuing Education and must comply with all policies for such agreements. Any such educational program must be open on equal terms to all interested practitioners, and may not be limited to attendees selected by the company sponsor(s). Industry funding for such programming should be used to improve the quality of the education provided and should not be used to support hospitality, such as meals, social activities, etc., except at a modest level. Industry funding may not be accepted for social events that do not have an educational component. Industry funding may not be accepted to support the costs of internal department meetings or retreats (either on or off campus). TCMC facilities (clinical or non-clinical) may not be rented by or used for Industry funded and/or directed programs, unless there is a CE agreement for Industry support that complies with the policies of the Department of CE. At TCMC sponsored Continuing Education programs, if there is an area utilized and designated for vendor displays, that area will be separate from the location assigned for the educational presentations. Any materials utilized by the industry vendors will be subject to the guidelines established in Section 3. Promotional materials shall be limited to those which do not include product brand names and logos. Additionally, no gifts or enticements such as food or snacks will be permitted at these displays.
2. Industry Sponsored Meetings or Industry Support for Off-Campus Meetings Personnel may not accept payment, gifts or financial support from industry to attend lectures and meetings. (An exception may be made for modest meals, if part of a larger program.) TCMC faculty, personnel, students or TCMC providers or staff may participate in or attend Industry-sponsored meetings or other off-campus meetings where Industry support is provided, only if: a. The activity is designed to promote evidence-based clinical care and/or advance scientific research
b. The financial support of Industry is prominently disclosed c. Industry does not pay attendees travel and expenses
d. Attendees do not receive gifts or other compensation for attendance
e. Meals provided are modest (value comparable to Standard Meal Allowance as specified by IRS)
f. All lecture content is determined by the TCMC speaker and reflects a balanced assessment of the
current science and treatment options, and the speaker makes clear that the views expressed are the views of the speaker and not that of TCMC
g. Compensation is reasonable and limited to reimbursement of reasonable travel expenses and a
modest honorarium not to exceed $2,500 per event
3. Gifts and Provision of Meals
TCMC personnel shall not accept or use personal gifts (including food) from representatives of Industry, regardless of the nature or dollar value of the gift. Although personal gifts of nominal value may not violate professional standards or anti-kickback laws, such gifts do not improve the quality of patient care, and research has shown they may subtly influence clinical decisions, and add unnecessary costs to the healthcare system. Gifts from Industry that incorporate a product or company logo (e.g., pens, notepads or office items such as scales or tissues) introduce a commercial, marketing presence that is not appropriate to a non-profit educational and healthcare system. Meals or other hospitality funded directly by Industry may not be offered in any facility owned and operated TCMC. TCMC personnel may not accept meals or other hospitality funded by industry, whether on-campus or off-campus, or accept complimentary tickets to sporting or other events or other hospitality from Industry. Modest meals provided incidental to attendance at an off-campus event that complies with the provisions of subsection 2, above, may be accepted. It is recommended that Volunteer Clinical Faculty appointed by TCMC adhere to the standards set forth in this document. Ultimately, abiding by the policies of TCMC, and to what extent they choose to interact with industry is at the discretion of the individual volunteer clinician. All full-time and part-time TCMC clinicians as well as TCMC Medical Students will act in accordance with TCMC policy at all times, including during time spent in the community with TCMC Volunteer Clinical Faculty. Industry wishing to make charitable contributions to TCMC may contact the Institutional Advancement Office. Such contributions shall be subject to any applicable policies maintained by TCMC.
4. Consulting Relationships
The Commonwealth Medical College recognizes the obligation to make the special knowledge and intellectual competence of its faculty members available to government, business, labor, and civic organizations, as well as the potential value to the faculty member and TCMC. However, consulting arrangements that simply pay TCMC personnel a guaranteed amount without any associated duties (such as participation on scientific advisory boards that do not regularly meet) shall be considered gifts and are consequently prohibited. In order to avoid gifts disguised as consulting contracts, where TCMC personnel have been engaged by Industry to provide consulting services, the consulting contract must provide specific tasks and deliverables, with payment commensurate with the tasks assigned. All such arrangements between individuals or units and outside commercial interests must be reviewed and approved prior to initiation in accordance with appropriate TCMC policies. Consulting relationships with Industry may be entered into only with the prior permission of a faculty member s dean, department chair or administrator. In addition, prior review and written approval from the faculty member s dean is required if consulting relationships with any one company (including the parent and subsidiary companies) will pay the faculty member or the institution in excess of $5,000 in any twelvemonth period. For employees of TCMC who are not faculty, prior written approval of the appropriate supervisor within TCMC is required for any outside consulting. The Commonwealth Medical College reserves the right to require faculty and employees to request changes in the terms of their consulting agreements to bring those consulting agreements into compliance with TCMC policies.
5. Frequent Speaker Arrangements (Speakers Bureaus) and Ghostwriting
While one of the most common ways for TCMC to disseminate new knowledge is through lectures, speaker s bureaus sponsored by Industry may serve as little more than an extension of the marketing department of the companies that support the programming. Before committing to being a speaker at an Industry-sponsored event, careful consideration should be given to determine whether the event meets the criteria set forth in Section 2 of this policy, relating to Industry Sponsored Meetings. TCMC personnel may not participate in, or receive compensation for, talks given through a speaker s bureau or similar frequent speaker arrangements if any of the following are true:
(a) Events do not meet the criteria of Section 2;
(b) Content of the lectures given is provided by Industry or is subject to any form of prior approval by either representatives of Industry or event planners contracted by Industry
(c) Content of the presentation is not based on the best available scientific evidence
(d) Company selects the individuals who may attend or provides any honorarium or gifts to the attendees.
Under no circumstances may TCMC personnel be listed as co-authors on papers ghostwritten by Industry representatives. In addition, TCMC personnel should always be responsible for the content of any papers or talks that they give, including the content of slides. Speaking relationships with company or company event planners are subject to review and approval of the participant s administrator, department chair, or dean as delineated in Section 4, Consulting Relationships.
6. Industry Support for Scholarships or Fellowships and other Educational Funds to
Students and Trainees
The Commonwealth Medical College may accept industry support for scholarships and discretionary funds to support trainee or student travel or non-research funding provided that the following criteria are met: Industry support for scholarships and fellowships must comply with all TCMC requirements for such funds, including a written pledge agreement through the Development Office. It will be maintained in an appropriate restricted account, managed at the school as determined by the Dean. The School of Medicine department, program or division will select the recipients of such funds, with no involvement by the donor industry. Written documentation of the selection process will be maintained. Industry support for other student or trainee activities, including travel expenses or attendance fees at conferences, must be accompanied by a written agreement and will only be accepted into a common pool of discretionary funds, which will be maintained under the direction of the Dean. Industry cannot designate contributions to fund specific recipients or specific expenses. Departments may apply to use monies from this pool to pay for reasonable travel and tuition expenses for residents, students, or other trainees to attend conferences or training that have legitimate educational merit. Recipients will be selected by the department based on merit and/or financial need. Proper documentation must accompany the request. Final approval and possible exceptions shall be at the discretion of the Dean.
Utilization of drug or device samples at TCMC or any affiliated clinics, hospitals or other healthcare facilities will be judicious and cost-effective. Utilization of drug samples will be at the discretion of the appropriate medical care provider solely for the purpose of patient care (e.g., allowing patients to begin early treatment; testing a therapeutic option prior to filling a prescription; offering an alternative for individuals having difficulty affording their medicines). Where there is a specific program in place, the policy must prevent samples from being given directly to physicians by pharmaceutical sales representatives . Utilization of equipment or device samples will be deemed appropriate when health care practitioners are developing a familiarity with new materials. Samples of any kind are not intended for personal use by faculty, staff or students. The sale or trade of any industry related sample is strictly prohibited. Wherever possible, a central distribution and documentation site for drug samples should be established in each healthcare facility that maintains storage of such samples. Ideally, samples should be logged in through a designated and secure sample storage process. Logs should include the name of the medication, lot number, expiration date, date of receipt, quantity received, and the name of the individual receiving the samples, including those received on behalf of a group practice. Logs should be maintained in the healthcare facility for a specified time as designated per policy. All samples will be labeled and dispensed in accordance with federal and state laws. A Sample Medication Form should be used to document dispensing information, patient counseling and auxiliary notes. Utilization of vouchers is preferable to actual physical drug samples. The preferred method of obtaining pharmaceuticals for indigent patients would be through specific corporate plans which provide such product directly to the patient.
8. Site Access for Industry Representatives:
Pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non- marketing purposes, such as training on devices or equipment.) All Industry professionals wishing to gain access to TCMC designated sites will be required to check into the facility through a centralized, appointed individual. Purposes which are appropriate for site visits include the exchange of scientific information, dissemination of materials/information regarding new therapeutic options, and training or discussions which can lead to the advancement of healthcare. Name badges are required for all industry personnel when visiting a TCMC site. Industry representatives are prohibited from roaming areas frequented by clinicians or faculty. They may provide informational material, such as product literature or journal articles, only at the request of a faculty or staff member. Industry representatives are not permitted to market their products anywhere inside the medical sciences building and associated clinics and offices, with the exceptions of the above listed activities. Prior to gaining access, the individual must have a scheduled appointment with appropriate TCMC personnel. There may be designated times for Industry representatives to convene in a specific location as pre-determined by department heads in order for questions to be answered or for information to be disseminated regarding new equipment or therapeutic options. Any marketing activities will be limited as per sections 1 and 3 of this policy.
Upon an initial visit to a TCMC site, industry representatives will be provided a distributor policy sheet which will outline procedures that they must follow while visiting the facility.
9. Medical School Curruculumn:
Students are trained to understand institutional conflict-of-interest policies and recognize how industry promotion can influence clinical judgment. Students are informed during their first orientation of the conflict of Interest policy and the policy is disseminated on an annual basis to students as a reminder. The policy is also to be discussed with students prior to them embarking on their first clinical experiences in MD Year 1 and MD 2, as well as in the MBS clinical experiences. Prior to the MD 3 year, faculty review the policy with students and ensure that they understand the process for reporting incidents of Conflict of Interest via their Regional Associate Dean or the Associate Dean for Admission's and Student Affairs.
10. Policy Enforcement:
TCMC faculty and staff will disclose all ties to industry. and/or disclose such relationships to patients when such a relationship might represent an apparent conflict of interest on an annual basis, using the TCMC Conflict of Interest disclosure form. This information will be included on the faculty information pages on the TCMC website.
Faculty and Staff: Any violations of this policy should be reported to the Department for Faculty Affairs and Faculty Development or for students to the Regional Associate Deans or the Associate Dean for Admissions and Student Affairs where it will be directed to appropriate supervisory personnel and department deans. The Conflict of Interest committee will be notified of proposed violations to this policy or to other relevant policies. Possible consequences of policy violation include but are not limited to: counseling, training, privilege reduction or revocation, requiring repayment of monies acquired in violation of policies, fines or termination. Industry personnel: Any violations of this policy may be subject to any of the following disciplinary actions: Warnings issued to corporation and supervisory personnel (written &/or verbal); Access to TCMC and business privileges revoked for offending representative and other company personnel; Lengthy restriction by all personnel from any access to the property for varying lengths
Faculty council, Staff council, Student council,Vice Dean, AD Fac Affrs & Fac