NFID Policies for Managing Commercial Support and Conflicts of Interest
The policies of the National Foundation for Infectious Diseases (NFID) are based on the ACCME Standards for Commercial Support. These policies are designed to ensure independence in CE activities. All individuals in a position to control the content of NFID educational activities are provided a copy of relevant policies.
Standard 1: Independence
NFID maintains a strict separation of its CE program from all commercial interests. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. Commercial support for NFID CE activities is in the form of unrestricted educational grants.
Employees of commercial interests will not be involved in the planning of educational activities and will have no control over the content. Employees of commercial interests will not be invited as speakers in plenary sessions or symposia.
Employees of commercial interests may submit abstracts to be considered for oral or poster presentation at NFID-sponsored activities. The members of the activity planning committee will review and validate the research process as well as the results and conclusions of each abstract. The selection of content for presentation will be based on its relevance and importance to activity attendees. If selected for oral presentation, potential conflicts of interest will be resolved using the process described in Standards 2.3.1 (alter control over content) and 2.3.2 (peer review of content) below.
Standard 2: Resolution of Personal Conflicts of Interest
2.1 All individuals in a position to influence or control content are required to disclose any relevant financial relationships, including CPE Committee members, members of Scientific Program Committees, activity chairs or co-chairs, presenters, content reviewers, editors, NFID staff, and staff of collaborating partners and/or joint sponsors. Signed disclosure forms are maintained on file for all NFID educational activities. NFID activity planners are solely responsible for needs assessment, educational objectives, content and its control, educational methods, and activity evaluation.
2.2 Anyone refusing to disclose relevant financial relationships is disqualified from any involvement in NFID CE activities.
2.3 NFID is committed to identifying and resolving all conflicts of interest prior to the educational activity being delivered to participants. As an added step (as part of the post-activity evaluation), participants and presenters are asked about whether disclosure procedures were followed and whether each presentation was evidence-based and free of commercial bias. In advance of the activity, conflicts of interest may be resolved by one of the following mechanisms:
2.3.1 Alter control over content – Individual and/or NFID staff can elect to alter the educational design, format, content, or individual responsibilities to maintain the scientific rigor, integrity, and balance of the CE activity. These options include:
•Select an alternative presenter/author for that portion of the content.
•Alter the focus of the activity to broaden the discussion and focus on issues rather than products or services.
•Alter the individual’s responsibilities in planning and implementation to areas not related to commercial interest’s products or services.
•Limit the content to a report on the “current state of the art” without recommendations
•Limit the source of recommendations to evidence-based sources that provide systematic and clearly defined parameters.
2.3.2 Peer review of content – Independent review and validation of content to verify the scientific basis and integrity of the content. Recommendations will be based on evidence currently accepted within the profession of medicine as acceptable justification for indications and contraindications for the care of patients. Scientific research referenced, utilized, and/or included in CE activities will conform to generally accepted standards of experimental design, data collection, and analysis.
Standard 3: Appropriate Use of Commercial Support
3.1 NFID makes all decisions regarding the disposition and disbursement of commercial support.
3.2 NFID maintains written documentation of letters of agreement, specifying that all support is in the form of unrestricted educational grants. The supporter agrees not to be involved in any aspect of the planning or implementation of the activity.
3.3 All commercial support is provided with the full knowledge and approval of NFID. Commercial support is disclosed in all promotional material and at the time of the educational activity.
3.4 Letters of agreement outline the terms, conditions, and purposes of the commercial support.
3.5 The name of the commercial supporter is clearly stated in each letter of agreement.
3.6 All letters of agreement are signed by both the supporter and NFID.
3.7 Written policies and procedures for honoraria and reimbursement of out-of-pocket expenses for planners, speakers, and authors are maintained.
3.8 All honoraria and expenses are disbursed directly by NFID.
3.9 No other payments are made to anyone involved in the educational activity.
3.10 Speakers are not provided any additional funds outside of honoraria and/or reimbursable expenses, as outlined in NFID’s policies and procedures.
3.11 Social events or meals at CE activities do not compete with the educational activity.
3.12 Commercial support is used only for expenses and honoraria of speakers, authors, employees, or volunteers. Funds are not provided to any other individuals participating in a CE activity.
3.13 Documentation of the receipt and expenditure of commercial support is maintained by NFID.
Standard 4: Appropriate Management of Associated Commercial Promotion
4.1 Commercial exhibits or advertisements do not influence the planning or interfere with the presentation of CE activities. Exhibit space is never exchanged for commercial support.
4.2 Promotional material or advertisement is never allowed during CE activities. NFID does not allow advertising in any printed CE materials. During live activities, advertisements and promotional materials are not displayed in the educational
space. Exhibits are physically separated from the educational activity.
4.3 All educational materials (including slides, abstracts, and handouts) are reviewed in advance to ensure that they do not contain any advertising, trade names, or product-group messages.
4.4 NFID does not advertise or promote commercial products in any of its materials.
4.5 NFID maintains a strict separation of the CE program from any commercial supporters. Commercial interests are never used to distribute CE activities to participants.
Standard 5: Content and Format without Commercial Bias
5.1 The content of all CE activities promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. Content validity is ensured in two ways:
5.1.1 Speakers are required to provide a copy of their presentation to NFID in advance of the activity for the purpose of peer review. Speakers are notified in writing of NFID’s requirements, and must sign and return an attestation form that they
will comply with the following requirements:
•Balance and scientific accuracy in the presentation, with content free of influence by industry or financial contributors.
•Provide evidence validating any clinical content (e.g., literature references) that is accepted within the profession of medicine as adequate justification and ensuring that all scientific research referred to, reported, or used in presentations regarding patient care recommendation conforms to the generally accepted standards of experimental design, data collection, and analysis.
5.1.2 NFID’s medical director, staff, and activity planning committees work closely with all speakers to ensure understanding and adherence to these requirements. An NFID representative attends each educational activity in order to monitor compliance.
5.2 All presentations provide a balanced view of therapeutic options. Speakers attest in writing that they will comply with the following requirements:
•Clinical recommendations presented in this activity are based on evidence that is accepted within the profession of medicine that adequately justifies the indications and contraindications in the care of patients.
•All scientific research referred to, reported, or used in support of justification of a patient care recommendation will conform to the generally accepted standards of experimental design, data collection, and analysis.
•If discussing specific healthcare products or services, use generic names to the extent possible. If trade names need to be used, use trade names from several companies when available, and not just trade names from any single company
Standard 6: Disclosures Relevant to Potential Commercial Bias
6.1 For all NFID educational activities, all relevant financial relationship(s) of any individual involved in the planning or implementation of the activity are disclosed to participants. These disclosures are published in written form in the activity materials (program or syllabus) and/or presented as a PowerPoint slide before presentations. Speakers are also encouraged to provide their disclosure information verbally before their presentation. Information provided includes the name of the individual, the name of the commercial interest, and the nature of the relationship.
6.2 For individuals with no relevant financial relationship(s), this information is provided to participants in advance of the activity via the activity materials, PowerPoint slides, and/or verbally.
6.3 The source and nature of commercial support is provided to participants in the activity materials.
6.4 Disclosures do not include the use of a trade name or product-group message.
6.5 All of the disclosure information is provided to participants prior to the beginning of the activity in the program materials and before each session.
These policies and procedures are reviewed annually by the CPE Committee.
Reviewed October 2012