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Indian Health Service The Federal Health Program for American Indians and Alaska Natives

Clinical Support Center (CSC) "Leading Indian Health Care Education"

Office of Continuing Education

DISCLOSURE OF COMMERCIAL SUPPORT
The Clinical Support Center generally does not sponsor activities for which there is commercial support from prohibited sources*. Prohibited sources include any person who (1) is seeking official action by the employee's agency, or (2) does business or seeks to do business with the employee's agency. Sometimes, however, faculty you have selected do have relationships with commercial entities; these might include, for example, acceptance of research grants or significant stock holdings. These are not necessarily a problem; it is however required practice to let the audience know about such relationships and resolve any conflicts of interest that may be disclosed. Therefore, all coordinators, planning committee members, and speakers (without exception) should complete a Disclosure of Commercial Support Form. This form should be filled out before the activity takes place. You may be surprised how many health care professionals have established ties with commercial entities. You will also find that most individuals involved with continuing education are familiar with the form and have no reluctance to fill it out.

In the past, only faculty members had to complete the disclosure process. New accreditation requirements state that “everyone who is in a position to control the content of an educational activity” must complete the disclosure process also. This means that all course coordinators and planning committee members must also complete the disclosure process by completing the Disclosure of Commercial Support Form. Those who are unable or unwilling to do so must be excluded from participating. An easy way to meet this requirement is to have all planning committee members complete and sign a CSC Disclosure Form at the beginning of the planning process.

The disclosure form gives two options: you can state that there are no such relationships, or you can identify the type of relationship that exists and list the name of the commercial entity with a brief description of the existing relationship. There is also a box for the speaker to check affirming that he or she will inform those attending of any “off-label” or investigational uses of medications, and will use generic names or multiple brand names when referring to medications.

If a conflict of interest is identified during the disclosure process, the new accreditation requirement standards requires that we 1) identify all relevant financial relationships with commercial interest; 2) have a mechanism to determine whether these relationships create a conflict of interest with the individual’s control of the content; and 3) have a mechanism to resolve all conflicts of interest before the activity occurs.

The following outlines what needs to be conducted during the disclosure process:

  1. If the person states that he/she has nothing to disclose, then nothing more needs to be done other than letting the audience know that the process has taken place and that there is nothing to disclose, using the prescribed disclosure statements on the pre-conference publicity and on the course materials distributed at the meeting. If however, there is something significant to disclose, then the new requirements state that not only must the audience be informed, but there must be “resolution of the conflict of interest”.
  2. There are various types of relationships that might constitute a conflict of interest, such as the receipt of an honorarium, service on a speaker’s bureau, acceptance of research funds, ownership or equity in the company, and so on. The Standards for Commercial Support have always required that these relationships be disclosed to the audience. However, now we have to examine those relationships in the context of the role that the person plays in the design and execution of activity, and the scope of the educational content of the activity. An easy way to do this is to contact the CSC whenever there is any potential conflict of interest and we will discuss the matter together and determine what needs to be done.
  3. Some examples on how to resolve a conflict of interest are as follows:
    1. Prior review of the content of a presentation with special attention to the best available evidence, and requirements for revision as need be.
    2. Asking a speaker or a planning committee member to recuse him/herself from the activity.
    3. Asking the person in question to divest themselves of the financial relationship.
    4. Assigning the speaker a different topic.
    There are many other ways to resolve a conflict of interest. However, simply monitoring the activity will no longer suffice. Concrete action must be taken before the educational activity takes place. Written documentation of what steps were taken to resolve the conflict of interest will need to be submitted and is a critical component of the continuing education file.
You, as the educational activity coordinator, should mark the appropriate box(es) at the bottom of the Disclosure of Commercial Support form showing how the information obtained from these forms was communicated to the participants.

All information obtained from the completed Disclosure of Commercial Support forms needs to be communicated to those attending. The best way to do this is to include it on the faculty list (see sample faculty list located in the following pages) and to make a brief announcement at the time each speaker is introduced.

If you want more information about this matter, please call and ask us to send the "Standards for Commercial Support" from the Accreditation Council for Continuing Medical Education.

Remember, the completed faculty Disclosure of Commercial Support Forms should be forwarded to CSC before the meeting and will be filed in the permanent continuing education activity record.

On the reverse side of the Disclosure Form, faculty can provide biographical information that will allow you to compile a faculty list and gives you information with which to introduce your speaker. You will also find out about audiovisual equipment needs and handout reproduction and distribution.

*CSC may jointly sponsor or cosponsor activities for which the other sponsors accept commercial support, so long as this is done in accordance with the accreditation bodies' standards for commercial support and applicable ethical guidelines for federal employees.

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