Policy and Guidelines for Interactions between the James H. Quillen College of Medicine, East Tennessee State University, and commercial interests ( i.e., any entity producing, marketing, re-selling or distributing health care goods or services consumed by, or used on, patients).
Adopted April 1, 2009.

Purpose

The purpose of this policy is to establish guidelines for interactions with commercial interests for medical staff, faculty, staff, students, and trainees of the James H. Quillen College of Medicine, East Tennessee State University. The intent of this policy to recognize the potentially positive and important value of many of the interactions with commercial interests while providing a framework for an ethical relationship that avoids conflicts of interest that could influence patient care, research objectivity, the integrity of our education and training programs, or the reputation of individual faculty members or the institution.

Policy Statement

It is the policy of the James H. Quillen College of Medicine that interactions with commercial interests should be conducted so as to avoid or minimize conflicts of interest. When conflicts of interest do arise they must be managed appropriately, as described herein.

Principles for Interaction

As the James H. Quillen College of Medicine and commercial interests both share the goal of improving the health of our population, the following principles should be used in guiding interactions:

1. The interactions should serve to enhance the health of the public.

2. The interactions should be transparent.

3. All of the interactions must reflect high standards of medical professionalism that reach beyond applicable laws and regulations.

4. The interactions should involve reciprocal communications, with knowledgeable parties on both sides of the interactions.

5. The interactions should support and enable the free exchange of information in appropriate settings, assuring such exchanges are evidence-based and free of bias to the maximum possible extent.

Scope of Policy and Guidelines for Interaction

This policy addresses many types of interactions with commercial interests, e.g. pharmaceutical and device marketing, training, educational support of students and trainees, and continuing medical education. Its scope includes interactions with commercial interests both on-site and off-site.

1. Gifts to Individuals

a. Personal gifts from commercial interests may not be accepted anywhere at the Quillen College of Medicine, college clinical offices, or training sites. It is strongly advised that no form of personal gift from commercial interests be accepted under any circumstance.

b.Examples of prohibited transactions include but are not limited to the following:

i. Individuals may not accept gifts or compensation for listening to a sales talk by an industry representative.

ii. Individuals may not accept gifts or compensation for prescribing or changing a patient's prescription.

iii. Individuals must consciously and actively divorce clinical care decisions from any perceived or actual benefits expected from any company. It is unacceptable for patient care decisions to be influenced by the possibility of personal financial gain.

iv. Food supplied by a commercial interest is considered a personal gift and is not permitted at the Quillen College of Medicine, college clinical sites, or functions. This does not apply when food is provided in connection with ACCME accredited programming or through unrestricted grants to departments or divisions that follow ACCME guidelines.

v. Individuals may not accept compensation from commercial interests, including the defraying of costs, for simply attending a CME or other activity or conference unless the individual is speaking or otherwise actively participating or presenting at the event.

2. Pharmaceutical Samples

a. Sample medications are centrally managed at all ETSU facilities, in accordance with guidelines outlined by MEAC, ETSU Family Medicine and Associates, and individual departments.

b. Sample medications may only be dispensed to patients.

3. Site Access by Industry Representatives

a. Access of the representatives of commercial interests to individuals is limited to non-patient areas ( e.g., private physician offices at a practice location or conference rooms) and must take place by appointment or the invitation of a faculty member, with the following exceptions:

i. Access by device manufacturer representatives to patient care areas is permitted by appointment or invitation by faculty members or clinic supervisors.

ii.Device manufacturer representatives may not be present during patient interactions unless there has been prior disclosure and consent by the patient. Such interactions must be limited to in-service training or assistance on devices and equipment.

b.Medical students and trainees may be included for educational purposes. These interactions must occur under the supervision of a faculty member.

4. Support for Educational and other Professional Activities

a. The Department of Continuing Education for Health Professionals administers all accredited CME activities to ensure compliance with ACCME standards ( www.accme.org).

b. All educational events sponsored by the James H. Quillen college of Medicine and its departments or divisions must be compliant with ACCME Standards for Commercial Support ( www.accme.org) whether or not CME credits are awarded, and whether or not they are held on or off campus.

5. Participation in Programs Sponsored by Commercial Interests

a. Faculty, staff, students, and trainees are strongly encouraged to avoid attending or speaking at meetings and conferences that are exclusively or primarily organized, underwritten, or presented by commercial interests because of the high potential for perceived or real conflict of interest. This provision does not apply to meetings of professional societies that may receive partial support from commercial interests or to meetings supported by commercial interests governed by ACCME Standards. It also does not apply to special and specific training on the use of new patient care medical devices for which alternate sources of education and training are not available.

b.Individuals who participate ( e.g., by giving a lecture, organizing the meeting) in meetings and conferences supported in part or in whole by commercial interests and not governed by ACCME Standards should follow these guidelines:

i.Financial support by commercial interests is fully disclosed by the meeting sponsor.

ii.The meeting or lecture content is determined by the speaker and not the commercial interest.

iii. Participants, including the ETSU participant, are being expected to provide a fair and balanced assessment of therapeutic options and to promote objective scientific and educational activities and discourse.

iv.The ETSU participant is not required by a commercial interest to accept advice or services concerning speakers, content, etc., as a condition of the sponsor's contribution of funds or services.

v. The ETSU participant makes clear that content reflects individual views and not the views of ETSU.

vi. The use of the ETSU name in non-ETSU events is limited to the identification of the individual by his or her title and affiliation.

6. Sponsorship of Scholarships and Other Educational Funds for Trainees by Commercial Interests

a. Educational grants that are compliant with the ACCME standards ( www.accme.org) may be received from commercial interests but must be administered by the Department of Continuing Education for Health Professionals, departments or divisions and not by individual faculty.

b.No quid pro quo may be involved for donated scholarship or educational funds.

c. The evaluation and selection of recipients of scholarships or grants is the sole responsibility of ETSU or of a nonprofit-granting industry, with no involvement by the donor commercial interest.

7. Professional Travel

a. Direct payments by commercial interests to ETSU faculty, staff, students, and trainees is not allowed other than for reimbursement of direct travel when the faculty, staff, student, or trainee is providing a legitimate service for which the travel is necessary and is reasonable in relation to the services provided.

8. Ghostwriting

a. ETSU faculty, staff, students, and trainees are prohibited from having publications or professional presentations of any kind, oral or written, ghostwritten by any party, industry or otherwise.

b. This does not apply to transparent writing collaboration with attribution between academic and industry investigators, medical writers, and/or technical experts.

9. Boards of Directors, Advisory Boards, and Consulting

a. ETSU faculty, staff, students, and trainees are allowed to interact as members of boards and/or as consultants via professional service agreements, as long as such activities are conducted in full compliance with the ETSU Conflict of Interest Policyand ETSU training program policies (/com/gme/current_resources/handbook.php and )

10. Publications

a. In scholarly publications, individuals must disclose their related financial interests in accordance with the International Committee on Medical Journal Editors ( http://www.icmje.org).

11. Purchasing

a. Individuals having a direct role in making institutional decisions on equipment or drug procurement must disclose any financial interest they or their immediate family have in companies that might substantially benefit from the decision. They must also disclose any research or educational interest they or their department have that might substantially benefit from the decision. This provision does not include indirect ownership such as stock held through mutual funds.