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ASAM CME Education Disclosure of Relevant Financial Relationships Form

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ASAM CME Education Disclosure of Relevant Financial Relationships Form

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ASAM CME Education Disclosure of Relevant Financial Relationships Form

ASAM, as the accredited Continuing Medical Education (CME) provider, must ensure that this activity and the presentations are in full compliance with the Accreditation Council for Continuing Medical Education (ACCME) guidelines and Standards for Integrity and Independence in Accredited Continuing Education (ACE).

All content developers and presenters must complete the following financial disclosure form prior to the planning, development or presenting of an educational activity to ensure adequate review time by the ASAM CME Committee. Please click here to view a letter from the ASAM CME Committee.


Glossary of Terms

Ineligible Companies
Companies that are ineligible to be accredited in the ACCME System (ineligible companies) are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such organizations include:

  • 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
  • Pharmaceutical companies or distributors
  • Pharmacy benefit managers
  • Reagent manufacturers or sellers

The ACCME does not consider providers of clinical service directly to patients to be an ineligible company. Ineligible companies are prohibited from engaging in joint providership with accredited providers. Joint providership enables accredited providers to work with nonaccredited eligible organizations to deliver accredited education.

Exceptions to Ineligible Companies
The owners and employees of ineligible companies are considered to have unresolvable financial relationships and must be excluded from participating as planners or faculty and must not be allowed to influence or control any aspect of the planning, delivery, or evaluation of accredited continuing education. Individuals must be excluded from controlling content or participating as planners or faculty in accredited education. There are three exceptions to this exclusion—employees of ineligible companies can participate as planners or faculty in these specific situations:

  • When the content of the activity 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.
  • When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.

Eligible Organizations
Organizations eligible to be accredited in the ACCME System (eligible organizations) are those whose mission and function are: (1) providing clinical services directly to patients; or (2) the education of healthcare professionals; or (3) serving as fiduciary to patients, the public, or population health; and other organizations that are not otherwise ineligible. Examples of such organizations include:

  • Ambulatory procedure centers
  • Blood banks
  • Device manufacturers or distributors
  • Diagnostic labs that do not sell proprietary products
  • Electronic health records companies
  • Government or military agencies
  • Group medical practices
  • Health law firms
  • Health profession membership organizations
  • Hospitals or healthcare delivery systems
  • Infusion centers
  • Insurance or managed care companies
  • Nursing homes
  • Pharmacies that do not manufacture proprietary compounds
  • Publishing or education companies
  • Rehabilitation centers
  • Schools of medicine or health science universities
  • Software or game developers

Financial Relationships
Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected.

Relevant Financial Relationships
The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 24 months with an ineligible company. Circumstances create a relevant financial relationship when an individual has an opportunity to affect CME content about products or services of an ineligible company with which he/she has a financial relationship. ACCME focuses on financial relationships with ineligible companies in the 24‐month period preceding the time that the individual is being asked to assume a role controlling content of the CME activity. ACCME has not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

Clinical Condition
This is the disease state, clinical condition, or clinical area that a financial relationship relates to or impacts.


Instructions

  • List the names of proprietary entities (see the ACCME definition of an ineligible company listed above) with which you have had a relevant financial relationship within the past 24 months.
  • Describe what you received (ex: salary, honorarium etc).
  • Describe your role.
  • Describe the clinical condition or clinical area that this financial relationship was in (eg, addiction medicine, psychiatry, dermatology).


1. Information Needed

Select one of the following statements:

 

 

2. Financial Relationships

Ineligible Company #1

For example: Substance Use Disorder, Infectious Disease, Pain Management

Type of financial relationship. (Select all that apply.)

Ineligible Company #2

For example: Substance Use Disorder, Infectious Disease, Pain Management

Type of financial relationship. (Select all that apply.)

Ineligible Company #3

For example: Substance Use Disorder, Infectious Disease, Pain Management

Type of financial relationship. (Select all that apply.)

Ineligible Company #4

For example: Substance Use Disorder, Infectious Disease, Pain Management

Type of financial relationship. (Select all that apply.)

Ineligible Company #5

For example: Substance Use Disorder, Infectious Disease, Pain Management

Type of financial relationship. (Select all that apply.)

 

 

3. Off-Label Uses

Select one of the following statements:

 

 

4. Agreement

I certify that the information I have provided is complete to the best of my knowledge and I accept responsibility for the accuracy of the information in response to the aforementioned questions. By signing this box with my electronic signature, I attest that all information above is true and correct. I attest that the CME content for which I am responsible will be evidence-based, fair and balanced, unbiased, and free from any ineligible companies control. No promotional activities may occur during educational events. This includes distribution of product brochures or product information in conjunction with the educational activity or handouts. No slides or handouts developed by an ineligible company may be used during presentations. I agree to not promote any specific proprietary or commercial business interest in my role as planner or faculty/speaker. I understand that an employee of an ineligible company may NOT serve as a faculty or planner if the educational content that the employee controls relates to the products and/or services of the ineligible company’s employer. If the content DOES NOT relate to the products and/or services of the ineligible company’s employer, the employee may be eligible to serve as speaker or planner, but the educational content must be reviewed (must be sent with the application) before approval of CME credit will be considered. I understand that if I serve on a Speakers’ Bureau for the same clinical area as the education activity I plan to provide, and for which accreditation is being requested, my educational activity material(s) must be submitted for a full independent review at the time of the application submission before approval for CME credit will be considered. I understand that if I engage in a financial relationship with an ineligible company after the program has been granted accreditation, but before the educational activity has been implemented/delivered, I must alert ASAM and provide a new disclosure form. A second review for approval will become necessary before the activity can be delivered. I understand that if changes are made to my educational presentation/material(s) after the program has been granted accreditation, but before the educational activity has been implemented/delivered, I must alert ASAM and provide information/documentation on the changes. A second review for approval will become necessary before the activity can be delivered. If I have indicated a relevant financial relationship, I understand that this information will be reviewed to determine whether a relevant financial relationship may exist, and I may be asked to provide additional information. I understand that failure to disclose, false disclosure, or inability to mitigate any relevant financial relationships of interest will require the ASAM to identify a replacement or not offer CME credit for this activity.


If you have more then 5 sources of relevant financial relationships with ineligible companies to disclose, email CME@asam.org.