GME Policy on Resident/Fellow Relationships with Commercial Industry

I. PURPOSE

The purpose of this policy is to establish guidelines for interactions with Industry representatives specifically for residents and fellows in New York Medical College (“NYMC”) sponsored programs. Interactions with Industry occur in a variety of contexts, including marketing, sales and acquisition of new pharmaceutical products, medical devices, hospital and research equipment and supplies onsite, on-site training of newly purchased devices, the development of new devices, educational support of trainees, and continuing medical education. Trainees also participate in interactions with Industry off campus and in scholarly publications. Many aspects of these interactions are positive and important for promoting the educational, clinical and research missions of NYMC. However, these interactions must be ethical, free from influence created by improper financial relationships with, or gifts provided by, representatives of Industry and cannot create conflicts of interest that could endanger patient safety, data integrity, the integrity of our education and training programs, or the reputation of the trainee or the institution.  This policy supplements the Policy on Interactions with the Pharmaceutical, Biotechnology, Medical Device, Hospital and Research Equipment and Supplies Industries.  

II. POLICY

It is the policy of NYMC that educational, clinical and research activities involving residents and fellows must be free from influence created by improper financial relationships with, or gifts provided by, representatives of Industry and that thereby interactions with Industry shall be conducted so as to avoid or minimize real or perceived conflicts of interest. When conflicts of interest do arise they must be addressed appropriately, consistent with the specific limitations as described in the procedures of this policy.

III. SCOPE

This policy applies to all residents and fellows enrolled in an ACGME or CODA-accredited or recognized program sponsored by New York Medical College. 

IV.  DEFINITIONS 

Resident refers to any person enrolled in a residency program accredited by the ACGME or CODA and sponsored by NYMC.

Fellow refers to any person enrolled in a fellowship program accredited by the ACGME and sponsored by NYMC. 

ACGME is the Accreditation Council for Graduate Medical Education

CODA is the Commission on Dental Accreditation

Industry is defined as the pharmaceutical, biotechnology, medical device, hospital and research equipment and supplies industries.

V.  PROCEDURES

A. Specific Limitations on Industry Interactions 

1. Residents and fellows in NYMC sponsored programs shall not receive gifts from Industry nor accept compensation from Industry for listening to a sales talk/presentation by an Industry representative. Residents and fellows may not accept compensation from Industry for prescribing or changing a patient’s prescription or medical device.

2. Residents and fellows must consciously and actively divorce academic and clinical care decisions from any real or perceived benefits expected from Industry. It is unacceptable for educational, research and patient care decisions to be influenced by the possibility of personal financial gain. 

3. Residents and fellows may not accept compensation, including the defraying of costs, for simply attending a Continuing Medical Education (“CME”) or other activity or conference, unless the resident or fellow is speaking or otherwise actively participating or presenting at the event. 

4. Distribution of samples should comply with Federal Drug Administration and hospital guidelines. Residents and fellows should avoid direct distribution of samples. 

B. Site Access by Industry Sales and Marketing Representatives 

1. Industry sales and marketing representatives are not permitted in any patient care areas except to provide in-service training on devices and other equipment and then only by appointment. (Note: The requirements of existing vendor policies at NYMC’s affiliated hospitals continue in full force and effect.) Industry sales and marketing representatives are permitted in non-patient care and non-public areas by appointment only. Appointments will normally be made for such purposes as: 

a.  In-service training of NYMC personnel for research or clinical equipment or devices already purchased.
b. Evaluation of new purchases of equipment, devices, or related items. 

2. Appointments to obtain information about new drugs in the formulary will normally be issued by the hospital or medical center’s pharmacy. Appointments may be made on a per visit basis or as a standing appointment for a specified period of time, at the discretion of the faculty member, his or her division or department, or designated hospital or medical center personnel issuing the invitation and with the approval of appropriate hospital management. Involvement of residents and fellows in such meetings should occur only for educational purposes and only under the direct supervision of an NYMC faculty member. 

3. All requests for CME Industry support and receipt of funds must be coordinated and overseen by the NYMC Continuing Medical Education Office or the appropriate Continuing Medical Education Office for the event.  Residents and fellows should be aware of the Standards for Commercial Support of the Accreditation Council for Continuing Medical Education (“ACCME”). They provide useful guidelines for evaluating all forms of Industry interaction, both on and off campus.  The Standards may be found at https://www.accme.org/publications/accme-standards-for-commercial-support.  All CME education events and programs sponsored or supported by Industry must be offered only by ACCME-accredited providers and must be compliant with ACCME Standards for Commercial Support whether or not CME credit is awarded. 

4. Residents and fellows should evaluate very carefully their own participation in programs (such as meetings and conferences) that are fully or partially sponsored or run by Industry 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 Industry support, meetings governed by ACCME Standards, and the like. 

5. Residents and fellows who attend, but do not actively participate in (e.g., by serving as a speaker, organizing the meeting) programs accredited by the ACCME supported in part or in whole by Industry are prohibited from: 

a. Accepting payment for attendance at Industry-sponsored meetings; and/or 
b. Accepting gifts from Industry at such events. 

6. Residents and fellows must timely disclose to their department heads when participating in such programs. 

7. Residents and fellows who actively participate in programs accredited by the ACCME supported in part or in whole by Industry (e.g., by speaking, organizing the meeting) are required to: 

a. Provide prior timely notice to their department heads before participating in such programs; 
b. Accept only payments at fair market value for such active participation; and, 
c. Observe all of the following guidelines:

i. Any financial support provided to the resident or fellow is fully disclosed by the meeting sponsor; 
ii. The meeting or lecture content is determined by the speaker and not the Industry sponsor; 
iii. Speakers are expected to provide a fair and balanced assessment of therapeutic options and to promote objective scientific and educational activities and discourse;
iv. The resident or fellow is not required by an Industry sponsor to accept advice or services concerning speakers, content, etc., as a condition of the Industry sponsor’s contribution of funds or services; 
v. The speaker/lecturer discloses that the content reflects individual views and not the views of NYMC, or its affiliated hospitals; and
vi. The use of the NYMC name in a non-NYMC event is limited to the identification of the individual by his or her title and affiliation.

C. Industry-Sponsored Scholarships and Other Educational Funds for Students and Trainees 
Industry support of residents and fellows should be free of any actual or perceived conflict of interest, must be specifically for the purpose of education and must comply with all of the following provisions: 

1. The recipient of such funds must be selected without involvement by the Industry donor; 

2. All scholarships or other educational funds from Industry are provided to NYMC and not directly to the student or trainee, however funds for certain activities, i.e., hotel stays and travel, may be paid directly by the professional society providing the scholarship or educational funds; 

3. The department, program or division at or affiliated with NYMC has determined that the funded conference or program has educational merit; and

4. The recipient is not subject to any implicit or explicit expectation of providing something in return for the support, i.e., a “quid pro quo.” 

D.  Meals 

Except for food provided in connection with ACCME-accredited programming and in compliance with ACCME guidelines, meals or other types of food directly funded by Industry are considered personal gifts and will not be permitted or provided. All residents and fellows shall adhere to this standard of behavior whether on-site at or off-site from NYMC and its affiliated hospitals. 

C.  Professional Travel 

Residents and fellows may not accept travel funds from Industry other than for legitimate reimbursement or contractual services.  Residents and fellows should also refer to program and institutional moonlighting policies pertaining to compensated and uncompensated professional work outside of their training program.

D. Ghostwriting and Disclosure of Relationships with Industry 

1. Residents and fellows are prohibited from publishing articles under their own name or permitting other professional presentations of any kind, oral or written, that are written in whole or material part by any party, Industry or otherwise.

2. In scholarly publications, physicians, faculty, staff, students and trainees of NYMC must disclose their related financial interests in accordance with the International Committee of Medical Journal Editors. 

3. Faculty with supervisory responsibilities for students, residents, trainees or staff should ensure that a faculty’s conflict or potential conflict of interest does not affect or appear to affect his or her supervision of the student, trainee, or staff member. 

4. Faculty, staff, students and trainees having a direct role making institutional decisions on equipment or drug procurement must timely disclose any financial interest they or their immediate family have in any particular manufacturer of pharmaceuticals, devices, or equipment, or any provider of services before the purchasing decision is made and refrain from any involvement in purchasing decisions relevant to the conflicting interests. Such financial interests include equity ownership, compensated positions on advisory boards, a paid consultancy, or other forms of compensated relationship. They must also disclose any research or educational interest they or their department have that might substantially benefit from the purchasing decision. If an individual’s expertise is reasonably necessary in the evaluation of any product, that individual’s financial ties to any manufacturer of that or any related product must be timely disclosed to those charged with the responsibility for making the purchasing decision. 

E. Board of Directors, Advisory Board, and Consulting Relationships

1. Activities or titles that constitute or imply managerial or supervisory responsibility such as CEO, Vice President, Director, Manager, Scientific Officer, Chief, etc., generally create real or perceived conflicts and are thereby not allowable as consulting relations. 

2. While appointments and service in Industry scientific or technical advisory boards or councils are different from managerial and supervisory roles and titles, these appointments can also create real or perceived conflicts of interests if they reasonably interfere or tend to interfere with or are inconsistent with the performance of the individual’s work or responsibilities for the College. 

3. Consulting arrangements providing for guaranteed compensation without specific, associated duties are considered “gifts” and are thus prohibited. 

4. To avoid the appearance of impropriety or gifts disguised as consulting arrangements, all consulting arrangements with Industry, including appointments on scientific or technical advisory boards or councils, must timely be disclosed to ensure that the consulting contract identifies specific tasks and deliverables and contains payment provisions that are at fair market value and consistent with the assigned tasks. 

F. Violations of This Policy

1. Any alleged violations are to be reported in a timely manner to the Dean of the School of Medicine, the individual’s department head, or to the NYMC Institutional Compliance Office.  Reports to the Dean or any department head must be promptly forwarded to the NYMC Institutional Compliance Office.

2. All reports of alleged violations shall be investigated as appropriate under the direction of NYMC’s Institutional Compliance Office, in consultation with the Dean of the School of Medicine or the individual’s department head.  All NYMC-sponsored programs are required to fully cooperate with such an investigation.

G.  Interpretation 

Questions concerning the interpretation or applicability of this policy should be directed to the Office of Graduate Medical Education.

VI.  EFFECTIVE DATE

This policy is effective immediately.

VII.  POLICY MANAGEMENT

Executive Stakeholder: Dean of the School of Medicine
Oversight Office: Office of Graduate Medical Education