Educational program agreement guidance

ORC does not process agreements for for Graduate Medical Educational fellowships that are subject to ACGME or ICGME accreditation (which are handled by the DUHS Clinical Contracts Office).

Educational program agreements are those agreements under which Duke either conducts an educational program for the benefit of researchers/physicians (Duke and/or outside parties) or where another entity provides an educational program for the benefit of Duke researchers. These agreements may be for programs related to disease state education or a technique/device demonstration, and may range from didactic presentations, case studies, Duke Human Fresh Tissue Lab programs, surgical observations in Duke facilities, or a combination of these.

Due to the possibility that certain educational activities may be construed as an unacceptable company reward for placing business with the company, or promotional in nature (Duke does not conduct promotional activities), Duke must ensure that any Duke educational program is a legitimate, objective, balanced educational program appropriate for presentation by a reputable university, rather than for a company’s sales or marketing purposes or as reward for purchase of a company’s products.  Duke’s facilities cannot be used for commercial purposes or in a manner that would imply promotion or endorsement by Duke of a company’s product or service.  If a program involves a company’s product, it must meet the requirements of the FDA’s Guidance on Industry-Supported Scientific and Educational Activities. All funds must be paid to Duke and not to any individual Duke employee. Any payments from Duke to an individual must be through the normal payroll system.

To help Duke staff determine what constitutes acceptable educational activities, the following guidance is provided:

  1. Duke educational programs are most often in the form of a program where the content and presentation is totally controlled by Duke, although review and comment by the funder can be acceptable and useful.  Duke will generally accept programs in which some content is provided by the company, but with approval rights from Duke, and the Duke program Director confirming that the content is objective, balanced, and not promotional.
  2. Strong preference is that the program be presented by Duke personnel, although some involvement by company personnel may be appropriate.  A presentation of a company-designed program by company personnel will generally not be appropriate, except in the case where Duke has requested a demonstration for the benefit of Duke personnel.
  3. Strong preference is that the audience be selected by Duke or by open registration.  An audience of Duke personnel is generally not of concern, while an audience of external physicians selected by the company requires consideration of whether or not Duke facilities constitute an implied endorsement of the company’s product or whether the opportunity to participate in the program is a “reward” to the participant.
  4. It is generally acceptable for a presentation to be focused on a company’s products so long as the Duke program director is free to address advantages and disadvantages, and to describe competing products and uses.  It is generally not acceptable to receive funding for a program on a company’s product when comparisons to other products are not allowed.  It is generally not acceptable for Duke to agree to discuss only on-label uses of a marketed product – Duke should have the opportunity to discuss off-label uses as long as Duke identifies the discussion as Duke’s or other researchers’ opinions.
  5. Duke must be unrestricted in its use of program material it develops.  Duke preparing materials for a program is not a work-for-hire exercise, but part of our normal educational mission. Assuming the program Director agrees, we will generally allow the company to use the materials for its own, internal educational purposes, but not for commercial purposes, such as sale or licensing to others, and not for use in connection with sales, marketing or promotion of its products or services.