Volume 5: Continuing Education
Chapter 3: Continuing Education Conflict of Interest Policy
Responsible Office: Continuing Education
Originally issued: 2001
Revised: August 2007, 3/17/09
The Division of Continuing Education at Georgia Health Sciences University must control the content and presentations of all Continuing Education activities. All educational activities must be free of commercial bias for or against any product, and the conference-related educational materials, including a speaker’s presentation, must not advance the proprietary interests of a financial supporter or proprietary company. This policy provides definitions and instances of potential conflicts of interest and describes the controls in place to prevent such conflicts of interest.
Reason For Policy
The Division of Continuing Education is required by its accrediting bodies to provide educational activities that are independent of commercial influence or bias.
Entities Affected By This Policy
All continuing education course directors, course planning committees, course faculty, commercial supporters (sponsors, grantors, and exhibitors), course participants, and university administrators are covered by these policies.
Who Should Read This Policy
Continuing Education course directors, course planning committees, course faculty, commercial supporters, and university administrators should read this policy.
|Director, Continuing Education||706-721-3967||http://www.georgiahealth.edu/ce/|
|Senior Conference Coordinator||706-721-3967||http://www.georgiahealth.edu/ce/medical|
|Assistant Conference Coordinator for Medicine||706-721-3967||http://www.georgiahealth.edu/ce/medical|
|Dental Conference Coordinator||706-721-3967||http://www.georgiahealth.edu/ce/dental.html|
|Assistant Conference Coordinator of Dentistry||706-721-3967||http://www.georgiahealth.edu/ce/dental.html|
|Nursing/Allied Health Conference Coordinator||706-721-3967||http://www.georgiahealth.edu/ce/|
Printable Version of This Policy
Accreditation Council for Continuing Medical Education (ACCME) Standards of Commercial Support: http://www.accme.org/dir_docs/doc_upload/700a1624-d6f0-46d8-a4bc-88e12a56eca2_uploaddocument.htm
Georgia Health Sciences University Conflict of Interest Policy: http://www.georgiahealth.edu/policies/documents/InstitutionalCOI.pdf
Food & Drug Administration Guidance for Industry-Supported Scientific & Educational Activities: http://www.fda.gov/Cder/guidance/isse.htm
Advanced Medical Technology Association Code of Ethics for Interaction with Health Care Professionals http://www.advamed.org/MemberPortal/About/code/default.htm
ADA CERP Recognition Standards and Procedures: http://www.ada.org/prof/ed/ce/cerp/standards.asp#standards
These definitions apply to these terms as they are used in this policy:
|Industry or Commercial Company||All proprietary, health-related entities that might create a conflict of interest (e.g., pharmaceutical, equipment, or biomedical companies).|
|Conflict of Interest||A situation in which a person (or spouse or partner) who is controlling the educational content of an activity has a relevant personal financial relationship with a commercial entity that benefits the individual and may bias the presentation of that content. For a conflict of interest to occur, there must be a financial relationship with a commercial interest occurring within the past 12 months and there must be the opportunity for that relationship to affect the content of the educational activity (definition based on the ACCME Standards of Commercial Support and ADA CERP Recognition Standards and Procedures).|
The Division of Continuing Education, in order to maintain accreditation by the respective governing bodies, must ensure that its Continuing Educational activities are free of commercial influence or bias. All planning committee members and presenters must submit disclosure statements, using a standardized form. The Director of Continuing Education will review each form. If a conflict of interest is found, the Director will ensure that the conflict is resolved or the individual will not be allowed to participate in the Continuing Educational activity. The Course Director will review all content and materials presented by speakers with conflicts to ensure that no commercial bias is presented.
Section 1. Defining a Conflict of Interest
A conflict of interest is present when individuals (or their spouses/partners) in a position to control the content of Continuing Education have a relevant personal financial relationship with a commercial entity that benefits the individual and may ultimately bias the presentation of that content to colleagues and participants. For a Conflict of Interest (COI) to be relevant, the presenter, the planner, or the author must have both of the following:
- A financial relationship (in any amount) with a commercial interest occurring within the past 12 months, AND
- The opportunity to affect the content of the Continuing Education about the products or services of that commercial interest.
For a COI to occur, there must be direct relationships between the proprietary entity and the individual. The nature of the relationship and its effect on the individual’s primary professional role, commitments, and responsibilities on the content of the Continuing Education activity must be considered during the planning phase of the Continuing Education activity and must be communicated to participants. Examples of direct relationships are:
- Employment or management positions
- Independent contractor (contracted research and clinical trials)
- Speaker’s Bureaus and teaching engagements
- Membership on advisory committees or review panels
- Other activities when remuneration is received or expected.
Section 2. Managing a Conflict of Interest
The Division of Continuing Education must control the content and presentations of all Continuing Education (CE) activities. All educational activities must be free of commercial bias for or against any product, and the conference-related educational materials, including a speaker’s presentation, must not advance the proprietary interests of a financial supporter or proprietary company.
An individual may receive financial benefits that can be described as salary (retainer), royalties, intellectual property rights, consulting fees, honoraria, or ownership interests (e.g., stocks or stock options, excluding diversified mutual/retirement funds not under the individual’s control). The Georgia Health Sciences University Division of Continuing Education, as a designated ACCME/ADA CERP/GNA provider, is responsible for creating a mechanism to identify, review, and resolve all conflicts of interest for all individuals involved in the planning and implementation of a Continuing Education activity. The Georgia Health Sciences University Division of Continuing Education incorporates the following strategies as part of the oversight of conflict management and resolution. The Division of Continuing Education will:
- Identify the presence or absence of any financial relationship that may constitute a potential conflict of interest for all individuals involved in the planning and implementation of the proposed CE activity (e.g., planning committee members, faculty presenters).
- Disqualify any individual from participation in the planning or implementation of the proposed CE activity who fails to provide disclosure.
- Implement educational planning and design strategies that work to ensure that content is scientifically rigorous, evidenced-based, balanced, and reflects the current standards of care or future directions of medicine, dentistry, nursing and other healthcare disciplines.
- Monitor and manage its CE activities in accordance with the current standards, regulations and guidelines outlined by the constituencies involved in the delivery of CE.
- Document the processes for needs assessment, content validation, and educational design that provide for fair and balanced discussion of the desired topics.
- Foster opportunities for interactivity, e.g., differences of opinion or dialogue that serve as the foundation for professional development and continuous improvement in approaches to patient care.
- Monitor the execution of CE activities to validate the presence or absence of commercial bias and the consistent application of the standards of quality education for physicians, dentists, nurses and other healthcare professionals.
Section 3. Disclosure of Conflicts of Interest
The Georgia Health Sciences University Division of Continuing Education will identify the presence or absence of relevant financial relationships for all planning committee members, course directors, invited faculty presenters/authors, and staff through the use of a standardized disclosure form. He/she will each receive a planner’s or speaker’s disclosure form to be completed, signed, and delivered to the CE office by the deadline determined by the CE staff. These deadlines ensure that COIs are resolved prior to planners or speakers being chosen.
If a COI is identified, one of the mechanisms listed below may be used to resolve it:
Alter financial relationships: Individuals may choose to discontinue or alter their relationship with a commercial entity and eliminate any bias associated with the proposed CE content.
Alter control over content: The individual or the Division of Continuing Education can elect to alter the educational design, format, or content or individual responsibilities to maintain the scientific rigor, integrity, and balance of the CE activity. These options include:
- Select someone else to control, present, or author that portion of the content.
- Alter the focus of the CE activity in a way that broadens the discussion and focuses on patient care issues rather than the characteristics or influence of products or services.
- Alter the individual’s responsibilities in planning and implementation to areas that are not related to products and services (e.g., limit discussion to pathophysiologic basis of specific conditions).
- Limit the content to a report on the “current state of the art” without recommendations.
- Limit the sources of recommendations to evidence-based sources that provide systematic and clearly defined parameters.
Peer-Review of Content: Independent review and validation of content can verify the scientific basis and integrity of the content as well as the consistency with overall educational design. Peer review will follow these two standards:
- Clinical medicine/dentistry recommendations will be based on evidence currently accepted within the profession of medicine, dentistry, nursing and other healthcare professions as acceptable justification for indications and contraindications for the care of patients.
- Scientific research referenced, utilized, or included in CE activities will conform to generally accepted standards of experimental design, data collection, and analysis.
If a faculty member refuses to disclose the existence of financial relationships, the faculty member will be prohibited from being a planning committee member, faculty member, author, or moderator for that activity.
Below are examples of situations where COI cannot be effectively resolved:
- Requests for CE credit by individuals or groups after the planning for CE activity has occurred with faculty or content selections already determined.
- Short planning timeframes that do not permit adequate planning and implementation of required ACCME/ADA CERP/GNA and GHSU Division of Continuing Education policies and procedures.
- Inappropriate processes in educational planning or financial management that are not consistent with ACCME, ADA CERP, GNA, State of Georgia, or GHSU Division of Continuing Education policies and procedures.
Section 4. Grand Rounds Disclosure
All Grand Rounds speakers must submit disclosure to the course planners. These disclosures must be reviewed for resolution of conflict of interest. Verbal disclosure must be announced to the attendees by the moderator of the activity. Written documentation ensuring that disclosure information was delivered to participants shall be signed and filed in the activity record.
Section 5. Presentation of Scientific Research
If scientific research conducted by a proprietary company is the basis for a presentation, the research must conform to generally accepted standards of experimental design, data collection, and analysis.
Section 6. Product Promotion
Product promotion must not interfere with the presentation of continuing educational activities and may not be a condition of support for any educational activity. Product promotion may not be offered to the learner while he/she in engaged in the educational activity.
Section 7. Content and Format
The content or format of a CE activity or its related materials must promote improvements or quality in healthcare and not a specific, proprietary business interest of a commercial interest.
To ensure that content and format of CE activities promote improvements or quality in healthcare and not a commercial interest, the following procedures should be followed in the development of the activity:
- Colors or other design elements that are part of a product—promotional campaign shall not be used in the promotion or educational material for a CE activity discussing that product.
- Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the CE educational material or content includes trade names, where available, trade names from several companies should be used, not just trade names from a single company.
- CE activity content and format shall comply with the Food and Drug Administration Final Guidance on Industry-Supported Scientific and Educational Activities.
- When unlabeled commercial products are addressed in the educational activity, the Division of Continuing Education requires the activity speaker to disclose to the participants that the product under discussion is not labeled for use or announce that the product is investigational.
The responsibilities each party has in connection with Academic, Research, and Student Affairs Policy 5.05, Continuing Education Conflict of Interest Policy, are:
|Director of Continuing Education||Provides oversight and ensures compliance in managing conflicts of interest occurring in Continuing Education to deliver bias-free healthcare education.|
|Conference Coordinator for Medicine||Ensures all planners and speakers involved in Continuing Education activities disclose conflicts of interest.|
|Assistant Conference Coordinator for Medicine||Ensures all planners and speakers involved in Continuing Education activities disclose conflicts of interest.|
|Conference Coordinator for Dentistry||Ensures all planners and speakers involved in Continuing Education activities disclose conflicts of interest.|
|Assistant Conference Coordinator for Dentistry|
|Conference Coordinator for Nursing/Allied Health|
Peer Review Form