ASRS and ACCME Conflict of Interest Policies
Financial Disclosure FAQs
Because the ASRS is accredited by the Accreditation Council for Continuing Medical Education (ACCME), we require your assistance to comply with accreditation guidelines and help us create high-quality education that is independent of industry influence. In accordance with ACCME requirements, failure to provide disclosure information in a timely manner will result in disqualification of the potential planner, presenter, or content reviewer from this activity.
WHO NEEDS TO DISCLOSE?
Presenters/speakers, planners (i.e., Program and Education Committee members), and content reviewers who affect the content of this CME activity are required to disclose financial relationships they have with ineligible companies (e.g., any entity whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients).
The most common types of companies that fit the Accreditation Council for Continuing Medical Education (ACCME) definition of an ineligible company are pharmaceutical and medical device manufacturers, and compounding pharmacies. See full list in next question below.
The ASRS considers the Lead Authors, not co-authors, to be in control of the educational content. Though they are acknowledged, co-authors do not have control of content and their disclosures are not published or resolved.
WHAT TYPES OF COMPANIES ARE CONSIDERED BY THE ACCME TO BE INELIGBLE?
• Pharmaceutical companies and distributers
• Medical device manufacturers and distributors, including health-related wearable products
• Reagent manufacturers and sellers.
• Compounding pharmacies that manufacture proprietary compounds.
• Diagnostic labs that sell proprietary products.
• Pharmacy benefit managers.
• Biomedical start-ups that have begun a governmental regulated approval process. The ACCME describes these kinds of companies as:
- Prescription drugs and biologics: Before a compound can be made available for clinical trials it must be approved by the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) through an Investigational New Drug (IND) application. A startup is eligible until the company submits an IND application.
- Medical devices, including in-vitro diagnostics: A startup is eligible until it submits a request for FDA clearance under 510(k) protocol of the Food, Drug, and Cosmetic Act or under the Pre-market Approval (PMA) process.
- Over the counter (OTC) drugs: A startup is eligible until it submits an application or Over-the-Counter (OTC) Drug Review (OTC drug monograph) to the FDA.
ARE THERE INSTITUTIONS THAT DO NOT REQUIRE DISCLOSURE?
Because the ACCME specifically excludes certain types of companies from the definition of an ineligible company, please do not include these types of companies in your disclosures:
• 501 C non-profit organizations
• Government organizations (NEI, etc.)
• Non-health care related companies (e.g., publishing industry)
• Health insurance providers
• Group medical practices
• For-profit hospitals
• Diagnostic laboratories that do not sell proprietary products
WHAT RELATIONSHIPS NEED TO BE DISCLOSED?
In order to participate as a person who will be able to control the educational content of an accredited CE activity, we ask that you disclose ALL financial relationships with any ineligible companies that you have had over the past 24 months. There is no minimum financial threshold; you must disclose all financial relationships, regardless of the amount, with ineligible companies. We ask you to disclose regardless of whether you view the financial relationships as relevant to education. For more information on the Standards for Integrity and Independence in Accredited Continuing Education, please visit accme.org/standards. Types of financial relationships include:
• Advisory Board Member: paid advisory boards or fees for attending a meeting
• Board of Directors: paid member of an executive committee that jointly supervises the activities of an organization.
• Consultant: consultant fee received for providing expert advice professionally.
• Employee: full- or part-time employee receiving a W2 form from a company.
• Executive Role: hired to work in a role with fiduciary and/or management responsibilities; carries a named title in the organization such as Chief Officer.
• Owner: sole proprietor or controlling interest in a company, other than stock.
• Independent Contractor: contracted work, including contracted research.
• Principal or Named Investigator: grant support or other financial support from all sources, including research support from government agencies (e.g., NIH), foundations, device manufacturers, and/or pharmaceutical companies. Research funding should be disclosed by the principal or named investigator even if your institution receives the grant and manages the funds.
• Royalties or Patent Beneficiary: beneficiary of patents and/or royalties for intellectual property.
• Speakers Bureau: lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
• Stock Options: stock options in a private or public company.
• Stock, Private (not listed on the stock exchange): equity ownership or stock in privately owned firms, excluding mutual funds. NOTE: the ACCME considers stock ownership in a private company as ownership interest.
• Stock, Public (listed on the stock exchange): equity ownership or stock in publicly traded firms, excluding mutual funds.
ARE THERE TYPES OF RELATIONSHIPS THAT DO NOT REQUIRE DISCLOSURE?
- Mutual fund ownership should NOT be included in disclosure.
- Spouse’s financial relationships should NOT be included in disclosure.
- Non-financial/volunteer relationships should NOT be included in disclosures.
WHO IS EXCLUDED FROM PARTICIPATING IN CME ACTIVITIES?
Owners and employees of ineligible companies (either part-time or full-time) have a legal duty to act in their company’s best interests. They are considered to have unresolvable financial relationships and must not be allowed to influence or control planning, delivery, or evaluation of accredited continuing education. In addition to the traditional titles/roles of owner and employee, ACCME considers the following relationships to be “ownership interest”:
• Stock ownership in a private company
• Executive roles such as Chief Officer or other top-level management positions
ASRS staff and the Education Chair reiew all financial disclosures in order to determine which presenters are ACCME-defined owners or employees.
WHAT CRITERIA OR GUIDELINES ARE USED TO DETERMINE IF AN INDIVIDUAL IS AN EMPLOYEE OR OWNER OF AN INELIGIBLE COMPANY?
The questions below, based on the IRS common law test, will be asked in order to help ASRS determine whether or not you are an employee or owner of an ineligible company as defined by ACCME.
• What is your title?
• What are your roles and responsibilities?
• Are you paid hourly?
• Is your relationship long-term?
• Do you (or will you) supervise other employees?
• Is your relationship exclusive or are you able to assume the same role at a different company simultaneously?
• Are you a decision-maker or an advisor?
• Is the success or continuation of the business somewhat dependent on the type of service you provide to the company?
• What type of industry is this company involved in? E.g. pharmaceuticals, biomedical, medical device (including wearables), compounding pharmacy, diagnostic lab, grower/distributor/manufacturer or seller of medical foods or dietary supplements, other (describe).
• If the company is a biomedical start-up, have they started the governmental regulatory process?
ARE THERE EXCEPTIONS TO THE RULE ABOUT WHO CANNOT PARTICIPATE?
Presenters who are employed by a company, own a company or own stock in a private company may be permitted to present under limited circumstances:
• When the content is not related to the business lines or products of their employer/company.
• When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research, and they do not make care recommendations. This usually pertains to a company that has not yet submitted an investigational new drug application.
• As technicians in Skills Transfer Labs limited to demonstrating the safe and proper use of medical devices and do not recommend whether or when a device is used.
WHY DOES THE ACCME REQUIRE AND ASRS COLLECT THIS INFORMATION?
Since healthcare professionals serve as the trusted authorities when advising patients, they must protect their learning environment from industry influence to ensure they remain true to their ethical commitments. Many healthcare professionals have financial relationships with ineligible companies. By identifying and mitigating relevant financial relationships, we work together to create a protected space to learn, teach, and engage in scientific discourse free from influence from organizations that may have an incentive to insert commercial bias into education.
WHAT ARE THE NEXT STEPS IN THIS PROCESS?
After we receive your disclosure information, we will review it to determine whether your financial relationships are relevant to the content you are controlling. Please note: the identification of relevant financial relationships does not necessarily mean that you are unable to participate in the planning and implementation of an ASRS educational activity. Rather, the accreditation standards require that relevant financial relationships are mitigated before you assume your role in this activity.