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September 14, 2010

Yale Updates Conflict of Interest Reporting Requirements

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Last April, Yale University issued a press release regarding an improved conflict of interest (COI) reporting process in response to concerns from faculty and staff about the time and effort required to comply with federal regulations and University policy on the disclosure of potential COIs. The “two significant improvements in COI reporting” were a modification of the types of activities that require disclosure, and the redesign and automation of the disclosure process. 

In addition to these changes, Yale also recently adopted a new “Policy on Interactions between Clinical Personnel of the Yale Medical Group and Industry.” Under Yale’s current Policy on Conflict of Interest and Conflict of Commitment, the university encourages its faculty “to consult widely, and to engage in other activities that may benefit not only the participants but also the University itself, and the larger public.” This includes interactions with industry based on the highest ethical and professional standards, which are intended and designed to enhance patient care, to improve the practice of medicine, or to support medical education.

 

In order to ensure interactions are as such, Yale approved this policy in August “to increase the awareness of Yale Medical Group (YMG) clinicians about the potential for conflicts of interest arising from relationships with industry and to establish parameters for these relationships so that actual or potential conflicts may be avoided or properly managed.”

 

The Policy applies to all physicians, PAs, APRNs, RN’s, midwives (Clinical Personnel), or other clinicians who practice in the YMG, and acts as a supplement to the University’s policies on conflict of interest.

 

Gifts

 

Clinical Personnel cannot accept personal gifts from industry representatives under any circumstances.  The term gift applies to any item, product, or service, regardless of the nature, purpose, or value, and includes, but is not limited to:

 

-   Pens, pads, and other promotional items;

-   Cash;

-   Food and drink (except in the limited circumstances described below)

-   Entertainment such as tickets to events, golf, and other sports outings;

-   Hotels, transportation, and other travel expenses (except as described below)

-   Stock, equity, and other ownership interests;

-   Discounts on products or services

 

The policy does not consider the following as “personal gifts:”

 

-   Books, charts, or other materials used for patient care or for training purposes may be accepted if distributed through the relevant department;

-   Payments for contractual services if the engagement complies with this policy; and

-   Unrestricted educational funds provided to a School of Medicine department

 

Meals

 

Industry-supplied or supported food or drinks are considered personal gifts and may not be accepted by Clinical Personnel on-campus or off-campus. Industry-supplied food or drinks may only be accepted:

 

-   If provided in connection with attendance at programs compliant with the Accreditation Council on Continuing Medical Education (ACCME) Standards for Commercial Support;

-   As a reasonable and necessary travel expense associated with services rendered in accordance with this policy (i.e. consulting); or

-   If provided in connection with attendance at scientific or professional society meeting events open to all meeting attendees.

 

Consulting

 

The policy allows Clinical Personnel to consult with industry if:

 

-   There is a written agreement specifying the service(s) to be provided and the pay;

-   Payment is at fair market value and commensurate with the time and effort for the contractual services; and

-   Clinical Personnel consulting for industry disclose the engagement as required under this Policy.

 

Consulting engagements involving compensation without commensurate time and effort are considered personal gifts and are prohibited under this Policy.

 

Drug Samples

 

Clinical Personnel can accept free drug samples from industry for distribution to patients, particularly those who lack financial access to the medications, but:

 

-   Clinical Personnel should be cautious in distributing medications that are not on formulary because it may encourage use of costlier medications;

-   Free drug samples may never be sold; and

-   Free drug samples may never be used by Clinical Personnel for themselves or family members, except when prescribed and/or dispensed by a physician.

 

Site Access by Industry Representatives

 

Industry representatives are permitted in non-patient care areas by appointment only. Appointments will be permitted only on the invitation of Clinical Personnel. Industry representatives are strictly prohibited from entering patient care areas except:

 

-   To provide in-service training or assistance to Clinical Personnel on devices or equipment;

-   Clinical Personnel must be present at all times during patient care interaction; and

-   Disclosure must be provided to the patient (or to his/her family) that industry representative(s) may be present in the procedure area.

 

In-service training and interactions with industry to evaluate devices or equipment are not considered “educational programs” and are not subject to the requirements in the sections pertaining to education.

 

Industry Support of Continuing Medical Education

 

All industry-sponsored continuing medical education (CME) events on the Yale campus must be compliant with the ACCME Standards for Commercial Support in effect on September 1, 2010. In addition, industry-sponsored CME events on the YSM campus must also comply with the following provisions:

 

-   Gifts or compensation may not be provided solely for attendance at the meeting or lecture; and

-   Industry funds to support the specific educational activity must be given directly to the University in accordance with University policy and may not be provided directly to Clinical Personnel.

 

The YSM Center for Continuing Medical Education (Yale CME) is the exclusive provider of accredited continuing professional development for Clinical Personnel.

 

Industry-sponsored Educational Programs (off-campus)

 

The policy allows Clinical Personnel to actively participate (e.g., by giving a lecture, organizing the meeting) in industry-sponsored meetings or lectures only if nine requirements listed in the policy are met. Similarly, Clinical Personnel can attend off-campus industry-sponsored programs only if three requirements listed in the policy are met. Additionally, the policy recommends that Clinical Personnel should not attend or participate in industry-sponsored off-campus events for primarily promotional/marketing purposes.

 

Travel Expenses

 

Clinical Personnel cannot accept travel funds from industry, except for legitimate reimbursement of reasonable and necessary travel expenses such as:

 

-   To provide services rendered in accordance with the terms of a written agreement (e.g., approved consulting activity); or

-   For in-service training or on-site inspection and demonstration of capital equipment or devices.

 

Authorship

 

Clinical Personnel can only be listed as an author on an article, in which they make a substantive contribution to the content of the article. The policy requires Clinical Personnel to list and disclose industry representatives or others retained by industry that contribute to an article the faculty members name appears on. The policy also states that ghostwriting is unacceptable under all circumstances.

 

Scholarships/Fellowships/Other Educational Funds for Trainees

 

The policy requires that industry funds must be given directly to the School of Medicine Department or Section that support scholarships, fellowships, or other educational programs for trainees and may not be provided directly to the trainee. In addition:

 

-    The Department, Section, or Program must determine that the conference or training has educational merit;

-    The industry donor may not have any input or involvement in the selection of the individual(s) that will receive the funding; and

-    The recipient of the funds may not be subject to any implicit or explicit quid pro quo (i.e., “no strings are attached”).

 

In situations where a scholarship for participation in an educational program is administered by the industry sponsor, the application must be approved in advance by the Department Chair or Section Chief.

 

Disclosure of Industry Relationships

 

Clinical Personnel must disclose industry relationships in accordance with the University Policy on Conflict of Interest and Conflict of Commitment.

 

-   Publications: Clinical Personnel must adhere to the financial interest disclosure requirements of the journal or the ICMJE requirements if journal has none.

-   Presentations: Clinical Personnel must adhere to disclosure requirements of a professional society, ACCME Standards, and the presentation must include a slide with the disclosure information.

-   Patients/Students/Trainees: Clinical Personnel must disclose all relevant financial interests to patients. The timing, method, and content of the disclosure shall be determined by the individual program.

-   Public: The University will disclose to its patient communities information regarding the industry relationships of Clinical Personnel that relate their University responsibilities. The format and mechanism for such disclosures remain to be determined, but may include public websites, informational brochures, etc.

 

This is a thorough and comprehensive policy regarding interactions with industry. It is obvious from the highly structured nature of this policy that Yale intends to continue encouraging its faculty and staff to engage and work with industry to help clinicians promote the goals of the school, which include supporting medical education, training, and clinical research, while having a positive impact on patient care. The contents of the policy do not appear to be as restrictive as other recently passed policies such as Harvard or Michigan which ban commercial support of activities and prohibit certain participation in activities with commercial support.

 

This approach seems to be more centered on the importance of disclosure and following specifically articulated criteria to ensure relationships with industry are of the highest integrity.

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