Purpose
IAS–USA endeavors to provide independent, expert certified continuing medical education (CME), information, and guidelines for health care practitioners involved in the management of people with HIV, HCV, or other viral infections. As part of this commitment, individuals who participate in direct commercial activities in which an ineligible company* or its agent** controls key elements of the activity are not eligible to participate in IAS–USA educational and informational programs, and particularly on Guidelines panels. This policy establishes the separation between individuals who participate in direct commercial activities for ineligible companies and those who participate in IAS–USA educational activities.
Definition of Direct Commercial Activity
A direct commercial activity is any educational, informational, marketing, or promotional activity in which an ineligible company or its agent controls any key elements of the activity. Key elements include, but are not limited to:
- Direct payment of honoraria, travel, or other expenses.
- Selection or invitation of speakers or authors.
- Selection of the audience.
- Determination of educational content or topics.
- Review or approval of presentation materials.
- Communication with faculty on behalf of the company.
Activities meeting any of these criteria, as well as formal speaker’s bureaus, are considered direct commercial activities regardless of who prepares the slides and regardless of whether specific products are mentioned or whether payment is made to them directly or to their institution.
Eligibility
Individuals who participate in direct commercial activities for an ineligible company are not eligible to participate in IAS–USA educational activities for 12 months following their last direct commercial activity and must agree not to engage in such activities during the period of their IAS-USA activity.
Examples of Direct Commercial Activities
- Company lectures or appearances coordinated by commercial companies, including those for which a commercial firm pays honoraria directly to the speaker/faculty member (regardless of who prepares the slides, whether specific products are mentioned, or whether payment is made to the speaker or their institution)
- Participation in industry-sponsored speakers’ bureaus or similar company-directed activities, including those for which a commercial firm pays honoraria directly to the faculty
- Satellite events that are organized and sponsored by industry member advertising, promotional, and marketing campaigns, or public relations agency, including “advertorials”
- Appearances or presentations at company-sponsored exhibit booths during professional events
Activities Generally Not Restricted
The following activities generally do not preclude participation in IAS–USA educational activities, provided they are not direct commercial activities as defined above:
- Scientific advisory board meetings intended to provide scientific guidance to the company regarding research or product development.
- Scientific or clinical research.
- Certified continuing medical education activities or an international equivalent. That are supported by industry, but not controlled or directed by them
- Independent educational activities in which the commercial company does not control the key elements described above. Examples
Faculty should evaluate whether the primary purpose of the advisory board is to obtain scientific guidance rather than to support commercial marketing objectives.
Questions to Ask Before Accepting an Invitation
What is the role of the person inviting you. Is it an employee of the commercial company or its agent?
- Who determined the agenda
- Who determined the topic or objectives?
- Who selected and invited the speakers?
- Who is communicating with the faculty?
- Who selected the audience?
- Who is paying the honorarium or expenses?
- Who is funding the activity?
- Is the activity independently organized or directed by a commercial company or its agent?
Scope of This Policy
This policy applies to speakers, moderators, course chairs and cochairs, authors, members of the Board of Directors or Scientific Leadership Board, advisory boards, program development committees, Guidelines panel members, and other eligible faculty participating in IAS–USA educational activities.
IAS–USA Independence Standards
IAS–USA policies are designed to ensure CME programming that is objective, balanced, scientifically rigorous, and free of commercial control. The IAS–USA independence policy also requires that:
- Any IAS–USA program that receives support from ineligible companies must have support from several companies with competing products. No single-company commercial support is permitted for any IAS–USA activity.
- These grants are pooled and used to support the specific national efforts as designated and controlled by the IAS–USA.
- Individuals who participate in direct commercial activities in which an ineligible company or its agent controls key elements of the activity may not participate in IAS–USA general educational and informational activities.
- Before medical professionals can create or present content for IAS–USA programs, they must disclose all relationships, financial or otherwise, with all ineligible companies and other outside entities.
- IAS–USA will identify and mitigate ahead of time any possible conflicts of interest that may influence CME activities with regard to exposition or conclusion. The content and recommendations of all IAS–USA activities are subject to independent peer review.
- When enduring materials are considered for renewal, their need for additional peer review is based on the nature of the changes required. As well, staff monitor participant comments about bias in the activity evaluations. If bias is noted in participant evaluations, IAS–USA staff follow-up with the peer review prior to the activity renewal.
- IAS–USA does not invite or accept any advertising revenue (eg, in any venue, including the journal and the website) or commercial exhibit revenue (eg, at CME courses or Conference on Retroviruses and Opportunistic Infections) nor participate in any product or company promotion.
Through its policies, the IAS–USA reinforces its commitment to standards that meet or exceed those set by others in the field, including the American Medical Association and the ACCME. The IAS–USA will continue to reevaluate its policies and programs to ensure that they uphold the organization’s mission.
Frequently Asked Questions
*The ACCME defines ineligible companies (previously defined as “commercial interests”) as “those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.” Examples of such organizations include:
- Pharmaceutical companies or distributors
- Advertising, marketing, or communication firms whose clients are ineligible companies**
- Bio-medical startups that have begun a governmental regulatory approval process
- Compounding pharmacies that manufacture proprietary compounds
- Device manufacturers or distributors
- Diagnostic labs that sell proprietary products
- Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
- Manufacturers of health-related wearable products
- Pharmacy benefit managers
- Reagent manufacturers or sellers