Operating Principles for Extramural Support
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The Operating Principles for Extramural Support of American Academy of Child and Adolescent Psychiatry (AACAP) Meetings and Related Activities provide the framework in which members of AACAP, AACAP meeting attendees, and AACAP meeting supporters agree to maintain the integrity of professional judgments and behaviors independent of any influences by funding sources and other supporters.
The AACAP meetings are designed as rich opportunities for scientific exchange, educational opportunities, and collegial interaction. AACAP’s Annual Meeting is the key opportunity for professionals in child and adolescent psychiatry and allied disciplines to assemble from around the world to advance understanding of the many facets of child development, developmental biology and psychology, developmental psychopathology, assessment, treatment, prevention and public policy.
AACAP is committed to maintaining a professional atmosphere that encourages interactions at the highest intellectual and ethical levels. AACAP is committed to the free and prompt sharing of scientific, clinical and other information for the primary purpose of enhancing the best practices in child and adolescent psychiatry. This, in turn, promotes the very best treatment for children and their families experiencing psychiatric illness and developmental disorders.
AACAP must address critical issues of extramural financial and other support for its meetings to assure that interactions meet the highest ethical standards in both action and perception. The Operating Principles for Extramural Support of AACAP Meetings and Related Activities reflect AACAP’s dedication to the premise that treatment of patients should be based, and perceived as being based, solely on each patient’s needs as well as the physician’s knowledge and experience.
Extramural supporters of AACAP meetings are expected to join AACAP in enhancing the science and practice of child and adolescent psychiatry as well as the clinical care of our patients. Interactions should be focused on informing child and adolescent psychiatrists and allied health professionals, providing scientific and educational information, and supporting medical research and education.
Principles for Compliance
• By virtue of participation in AACAP meetings, all individuals and organizations agree to comply with these Operating Principles.
• It is the responsibility of individuals/organizations interacting with third party companies to ensure that these principles are understood and upheld.
• Participating organizations are responsible for communicating these principles to all employees, third party companies, and other associates.
• AACAP encourages extramural supporters to consult with AACAP in advance if there is uncertainty about whether an action/behavior on the part of the extramural agency might constitute a violation of the Principles.
• AACAP reserves the right to monitor and enforce the Principles.
• Failure to comply will be considered a breech of professional and collegial conduct that could lead to sanctions by AACAP.
• AACAP investigates all potential breaches to the Operating Principles.
• AACAP notifies in writing the individuals involved and their company officers of the violation. Dialogue is exchanged and the result of the investigation is made known to the individuals/company.
• Sanctions include, but are not limited to, probation for a period of time, suspension / banning the company from any interaction with AACAP for a period of time, and other sanctions deemed appropriate by the Program Committee.
In developing these principles, AACAP considered the following:
• Code of Ethics of the American Academy of Child and Adolescent Psychiatry
• Principles of Practice of Child and Adolescent Psychiatry (May 1982)
• AACAP’s Guidelines for Commercial Contributions (approved by Council in October 1998)
• Accreditation Council for Continuing Medical Education’s Standards for Commercial Support of Continuing Education (August 2007)
• Guidelines for U.S. Healthcare Conventions from Healthcare Convention and Exhibitors Association (September 2008)
• AACAP Guidelines on Conflict of Interest for Child and Adolescent Psychiatrists (approved by Council January 2009)
• AACAP Guidelines on Conflict of Interest for Child and Adolescent Psychiatry Researchers (approved by Council January 2009)
• PhRMA Code on Interactions with Healthcare Professionals (effective January 2009)
I. The Structure and Content of AACAP Meetings
A. AACAP is solely responsible for decisions concerning the content and format of AACAP meetings.
B. Editorial responsibility for the review, selection and presentation of the scientific and clinical content of meetings is delegated to the Program Committee.
C. The chairperson and members of the Program Committee are responsible for policy and procedures related to the content and format of meetings.
D. AACAP manages all portions of the meetings, including AACAP governance and business functions.
E. AACAP is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) credit for physicians and will be the sole source for approval and provision of CME credit for all AACAP meetings.
F. Any member of the professional community related to child and adolescent psychiatry is welcome to submit proposals for scientific presentations for the Annual Meeting within guidelines in the Call for Papers. Information regarding the submission process is available at www.aacap.org.
II. AACAP Meetings and Related Activities – Educational Functions
A. Basic Requirements for CME Activities
1. AACAP Program Committee is solely responsible for the content, quality and scientific integrity of the accredited Continuing Medical Education (CME) activities at AACAP meetings and related programs.
2. AACAP’s Program Committee, to the greatest extent possible, is committed to assuring that presentations and programs:
a. Are free from commercialism and bias;
b. Communicate all real or perceived conflicts of interest;
c. Are objective and based on scientific methods that are generally accepted in the medical community.
3. AACAP CME activities are for scientific and educational purposes only, and do not promote commercial supporters’ products, directly or indirectly.
B. Program Structure
1. AACAP, through the Program Committee, is responsible for the content, format, and selection of presenters and moderators for its CME programs.
2. The Chair and members of the Program Committee have the responsibility for topics and faculty. Commercial supporters agree that there will be no “scripting,” emphasis, or influence on content by the company or its agents.
3. All submissions for AACAP meetings must undergo the peer review process designated and managed by the Program Committee.
a. Such a review is independent of funding, sponsorship and other similar extrinsic factors.
b. All individuals submitting proposals for presentation are required to openly declare any real or perceived conflicts of interest.
C. Disclosure of Financial Relationships
1. All individuals presenting at AACAP meetings must disclose any real or perceived conflicts of interest.
a. This obligation is for all individuals who make public comment at any AACAP meeting, including presenters, officers, discussants, etc.
b. Written declaration of conflicts of interest is required, in advance, for all presentations at all AACAP sponsored scientific/educational meetings and presentations.
c. The Program Committee will resolve any conflicts that arise prior to, during, or after the presentation.
2. Types of conflict of interest may include but are not exclusive to the following:
a. Consulting relationships;
b. Membership in speakers bureaus;
c. Support for honoraria, travel, lodging or other expenses at AACAP meetings;
d. Research support;
e. Stock / equity;
f. The presenter’s or a close family member’s financial interest in the company or product being discussed.
3. An individual or group that fails to disclose conflicts of interest will have breached an agreement with AACAP and will be subject to corrective actions by the Program Committee.
D. Terms of Extramural Support
1. Funding in support of CME, other educational activities, or event sponsorship will be used by AACAP as specified in the letter of agreement between AACAP and the funder.
2. AACAP is accountable for and will disclose to the audience the nature of contributions to support AACAP’s meetings.
E. AACAP Acknowledgement of Commercial Support
1. AACAP publicly acknowledges all commercial support.
2. The use of the commercial supporter’s logo is not permissible in the acknowledgement of commercial support.
3. External supporter of AACAP and the extent of their support will be listed in AACAP’s Annual Report and other publications as specified in the Letter of Agreement.
F. Promotional Materials
1. No commercial materials, promotional materials or product advertisements may be displayed outside of the designated exhibit area.
2. No commercial or promotional materials, promotional activities, or product advertisements may be displayed or distributed in the same room or adjacent areas immediately before, during, or immediately after an educational activity certified for CME credit.
3. No commercial materials, promotional materials or product advertisements may be distributed to guest rooms or space otherwise shared with attendees at AACAP meeting, including meeting rooms and areas for social events.
4. Representatives of commercial supporters may register for and attend an educational activity, but may not engage in sales or marketing activities inside educational activities or adjoining areas.
G. Publicity and Promotion of AACAP Meetings and Related Activities
1. AACAP meeting supporter may not engage in publicity about sponsored events, without explicit, written permission from AACAP, including approval of the promotional materials.
2. The logo or trademark of any product may not appear in promotional or published materials or a mobile app associated with AACAP meetings except to the extent that it is clearly delineated as advertising or in commercial exhibit spaces.
3. Without explicit, written approval of AACAP, supporters of AACAP meetings may not:
a. Send additional mailings concerning the meeting,
b. Arrange door drops, or
c. Have representatives contact meeting attendees to promote attendance at sponsored events.
4. Neither for-profit nor not-for-profit entities are permitted to hold press conferences or briefings prior to or at AACAP meetings or represent AACAP meeting content.
5. All presentations of data, research, or other information presented at AACAP’s meetings are embargoed until the day they are presented unless the presenter and chair of the Program Committee agree to an earlier release in writing.
6. No press releases may be issued prior to the time of presentation unless the presenter and chair of the Program Committee agree to an earlier release in writing.
7. All individuals registered as Press must sign the following statement:
“I agree that neither I nor the media organization I represent will reproduce, distribute, summarize, adapt, publicly perform or publicly display any presentation or accompanying materials, in whole or in part, for sale or resale for continuing education purposes without the prior written authorization from AACAP and I will not use the AACAP logo in connection with any commercial use of such materials without written authorization.”
8. All participants in AACAP meetings are expected to protect the confidentiality of subjects (from clinical trials, clinical practice, etc.) during clinical presentations.
H. Food, Beverage and Entertainment
1. Food, beverage and entertainment at AACAP meetings should be modest and consistent with the context in which it is presented at the exhibit booth and the international reception and are subject to review and approval by AACAP’s Program Committee.
I. Non-AACAP Sponsored Social Events
1. Social events that are not onsite at the AACAP meetings are discouraged and should never conflict with the regular scientific and educational program (in time or content) of AACAP meetings.
2. Social events that are not onsite at AACAP’s meetings are subject to the review and approval of AACAP’s Program Committee under the guidance of AACAP’s Operating Principles.
3. If approved by AACAP, social events not onsite of AACAP’s meetings are expected to comply with AACAP’s Operating Principles.
J. Audiovisual and Print Materials for CME and Other Educational Activities
1. External funding or support for audiovisual or print materials must be disclosed at the relevant session and in the material.
2. Contractors and others may assist with form and technical elements of a presentation, but they must not play a role in the creation or interpretation of the content.
3. Audiovisual and print materials in support of AACAP meetings are subject to the review and approval of the Program Committee.
4. No commercial logos are allowed on any printed materials. See section M for more explanation.
K. Off-Label Use or Investigational Therapies
1. When an off-label, investigational or experimental use of a medication or other product is the subject of a presentation or discussion, disclosure of this status should be clear to the audience, both verbally and in writing.
2. Such disclosures should also be made at the time of submission of materials for review by the Program Committee.
3. It is the responsibility of each presenter to make sure that the status of a procedure or treatment is fully disclosed.
4. If off-label or investigational products are discussed in areas within an exhibit booth, all discussions must take place within a designated medical information section of the booth only, there must be clear verbal identification of the fact that these are investigational or off-label products and have the appropriate following warnings and caveats:
a. Contain only objective statements about the product;
b. Contain no claims of safety, effectiveness, or reliability;
c. Contain no comparative claims to other marketed products;
d. May take place for the purpose of obtaining investigators;
e. If research participation is the purpose of the discussion, be accompanied by directions for becoming an investigator and a list of investigator responsibilities.
1. The entirety of AACAP meetings, as presented, are copyrighted and the sole property of AACAP.
2. Presentations or enduring materials are the property of AACAP and may not be reproduced or distributed without the explicit, written permission of AACAP.
3. All registrants must sign the following statement:
“By registering for this meeting, registrant grants AACAP and its sublicensee(s) the right to record his/her presentation, remarks, appearance, or other participation, and to reproduce and distribute such recording by any means and for any purpose without payment to the registrant. Registrant also agrees that he/she will not reproduce, distribute, summarize, adapt, publicly perform, or publicly display any presentation or accompanying materials, in whole or in part, for commercial purposes without prior written authorization from the copyright owner(s), nor will registrant use the AACAP name or logo in connection with any commercial use of such materials without written authorization from AACAP.”
M. Use of the AACAP Name and Logo
1. The AACAP name and logo and designs for AACAP meetings are the sole property of AACAP and protected by copyright.
2. The name, logo, designs or any representations of AACAP and its activities may not be used without the explicit, written permission of AACAP.
N. Educational and Scientific Programs, including Institutes, Symposia, etc.
1. It is not acceptable for AACAP members and presenters to participate in extramural meetings in the same city and time period of AACAP meetings (including satellite symposia). Participation in such presentations is subject to review and potential corrective actions by the Program Committee.
2. The “time period” of an AACAP meeting includes all days covered in the official program and the two days before and after the meeting.
3. AACAP recognizes that there is sometimes a need for specialized, small group meetings (investigator meetings, consultancies, etc.) during the time of AACAP meetings. These meetings are subject to review and approval by the Program Committee and should be scheduled through AACAP’s Department of Meetings and CME at firstname.lastname@example.org If a meeting room is available and can be released by AACAP, the group is responsible for any room rental, audio-visual, food and beverage, and other charges incurred (through direct billing with the hotel/convention center.)
4. During the time of AACAP meetings, off-site specialized, small group meetings are subject to AACAP review and approval.
In order to avoid conflict, individuals, groups or other entities wishing to hold meetings are encouraged to have early discussions with AACAP before scheduling such meetings.
O. Sponsorship of Educational and Scientific Programs
1. Sponsorship of educational activities at AACAP meetings is welcomed and encouraged.
2. Sponsorship is neither a prerequisite of submission of a Call for Papers nor a condition for acceptance.
3. The appropriateness of sponsorship is subject to the approval of AACAP’s Program Committee. To apply to sponsor a scientific event, please contact AACAP’s Development Department at email@example.com.
4. AACAP does not permit single commercial entities (as defined by the ACCME) to provide sole sponsorship of any educational and scientific programs.
P. Enduring Materials
1. AACAP develops online enduring materials from AACAP Annual Meetings and other programs.
2. Sponsorship of online enduring materials is welcomed and encouraged.
3. The appropriateness of sponsorship is subject to the approval of the AACAP. To apply to sponsor online enduring materials, please contact AACAP’s Development Department at firstname.lastname@example.org.
4. AACAP reserves all rights regarding production, licensing, and distribution of enduring materials.
5. No external company may reproduce, license, or distribute enduring materials originating from AACAP programs without the explicit, written approval of AACAP.
6. All inquiries regarding AACAP online enduring materials are directed to AACAP’s Meetings and Continuing Medical Education Department at email@example.com.
III. AACAP Meetings and Related Activities - Commercial
A. Advertising associated with AACAP Meetings
1. Both for-profit and not-for-profit entities may advertise in publications, exhibits and through other official mechanisms associated with AACAP meetings.
2. All advertising should be clearly designated and recognizable as such.
3. Advertising copy, exhibit material, handouts, other advertising and promotional materials associated with AACAP meetings is subject to the review and approval of the Program Committee.
4. The use of commercial logos and trademarks is specifically controlled by the Program Committee.
a. All logos and trademarks are considered to be advertising, designed to attract attention, to create a business relationship with or to market a product, entity or message.
b. The use of any logo or trademark to convey a real or implied endorsement by AACAP or association between AACAP and any other entity is prohibited unless it has the explicit, written approval of AACAP.
c. Except when delineated as advertising, exhibits or related activities, the display of logos or trademarks at AACAP meetings and in related publications, activities, and a mobile app, is prohibited without the explicit, written permission of AACAP.
d. Acknowledgement of general or specific support of AACAP meetings and its components is never to be accompanied by the placement of logos and trademarks.
B. Scholarships, Educational Support and Educational Outreach Grants
1. Scholarships, individual educational support and outreach grants for attendance and participation in AACAP meetings are welcomed.
2. It is recommended that such activities be conducted in collaboration and under the auspices of AACAP.
3. Scholarships, educational support and outreach grants administered through the auspices of AACAP will be subject to AACAP guidelines.
a. The support will be disclosed to the recipients prior to their acceptance.
b. The support will be publicly disclosed at the time of AACAP’s meeting.
c. AACAP reserves the sole right to select the recipients of the scholarships, educational support and outreach grants.
1. Exhibits are commercial enterprises conducted under the principles of AACAP and for the benefit of the professional registrants attending AACAP meetings.
2. Exhibits at AACAP meetings are permitted to provide information and support to the practice of child and adolescent psychiatry.
3. AACAP reserves the right to make the decision to reject or accept a specific exhibitor or exhibit for any AACAP meeting.
4. The acceptance of an exhibit for participation in an AACAP meeting never implies the endorsement or support of the exhibitor or its product or services.
5. All exhibits are subject to the rules and guidelines of the FDA and other applicable local, state and federal rules, laws and guidelines.
6. Exhibitors are expected to comply with relevant ethical standards and practices.
7. Exhibits and exhibitor activity are to be confined to AACAP’s exhibit area and hours.
8. No filming or photography of meeting attendees, whether to be used internally or externally, is permitted without prior written approval by AACAP.
9. AACAP designates the location and scheduling of the meeting exhibits.
10. AACAP reserves the right to review meeting exhibits and exhibitor activities for appropriateness in regards to the context and atmosphere of the meeting.
11. All demonstrations, sales activities and distribution of circulars and promotional materials are subject to prior written approval by AACAP, and confined to the limits of the exhibitor’s booth.
12. Materials deemed to be unacceptable (at the sole discretion of AACAP) must be immediately removed from the exhibit area.
13. Any advertising premium or novelty giveaway must be modest, appropriate and generally useable in professional practice. In addition, giveaways valued at or above $10.00 per item must be pre-approved by AACAP. However, it is advisable to obtain prior written permission from AACAP for all giveaways, regardless of value.
14. Modest food and beverages is permitted in exhibit booths with prior approval of both AACAP and hotel/convention center.
15. Exhibitors must only display goods or services that are part of their regular course of business, unless otherwise approved in writing by AACAP.
16. Display of Investigational or Off-Label Products
a. If off-label or investigational products are discussed in areas within an exhibit booth, all discussions must take place within a designated medical information section of the booth only, there must be clear verbal identification of the fact that these are investigational or off-label products and have the appropriate following warnings and caveats:
1. Contain only objective statements about the product;
2. Contain no claims of safety, effectiveness, or reliability;
3. Contain no comparative claims to other marketed products;
4. May take place for the purpose of obtaining investigators;
5. If research participation is the purpose of the discussion, be accompanied by directions for becoming an investigator and a list of investigator responsibilities.
17. Sales at AACAP meetings and in AACAP meeting exhibit space are subject to prior approval of AACAP.
a. Sales in AACAP meeting exhibit space are to be conducted solely as a service to AACAP members and AACAP meeting attendees.
b. When sales take place in an AACAP meeting exhibit space, it must be clear that this is a transaction between the vendor and the purchaser and that AACAP has no role in the transaction.
c. It is the responsibility of vendors making sales in AACAP’s exhibit space to comply with state, local and federal regulations and to pay appropriate taxes, including local sales taxes.
18. Medical-to-Medical Information Sharing (example physician to physician)
a. Pharmaceutical companies may not solicit medical-to-medical information sharing, but may respond to queries from practitioners visiting their exhibit.
b. Lecture rooms are not permitted in the Exhibit Hall. Interview rooms holding no more than 4 people must be preapproved by AACAP.