ELEVATE PX Speaker Disclosure Form

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS

Information You Need to Know to Disclose Your Financial Relationships with Companies Related to Healthcare Products or Services

Why We Ask:

As an accredited provider, we require your assistance to comply with accreditation guidelines and help us create high-quality Accredited Continuing Education (ACE) that is independent of industry influence. To participate in this educational activity, all individuals who have the ability to influence and/or control the content of this ACE activity must disclose all financial relationships with all companies - whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients - over the past 24 months.

What to Disclose:

  • There is no minimum financial threshold; you must disclose all financial relationships, regardless of the amount, with companies as described above; only disclose your own financial relationships, not those of your spouse or life partner.
  • We ask you to disclose all financial relationships regardless of whether or not you view the relationships as relevant to the ACE activity. Staff will determine if the information that you provide is relevant to the topics of the ACE activity in which you will participate.
  • Since healthcare professionals serve as the trusted authorities when advising patients, they must protect the learning environment from industry influence to ensure they remain true to their ethical commitments.
  • If the staff determine that the financial relationships create a conflict of interest, the staff will determine the appropriate method of mitigation. Mitigation may involve but is not limited to an independent review of the content you develop (or if you are a planner, other methods will be utilized, including peer review of content by non-conflicted planners, etc.).
  • Many healthcare professionals have financial relationships with companies as defined above. By identifying and mitigating relevant financial relationships, we will work together to create a protected space to learn, teach, and engage in scientific discourse free from the influence from organizations that may have an incentive to insert commercial bias into education.

EXAMPLE TERMINOLOGY:

Nature of the Financial Relationship: Examples of financial relationships include employee or executive role or an owner (of a pharmaceutical or medical device manufacturer), researcher, consultant, advisor, speaker, independent contractor (including contracted research), royalties or patent beneficiary, individual stocks, and stock options should be disclosed, but diversified mutual funds do not need to be disclosed. Research funding from companies should be disclosed by the principal or named investigator even if that individual’s institution receives the research grant and manages the funds.

Name of the Ineligible Company: A company is any entity whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Types of organizations for which you must disclose your financial relationships are as follows: (1) biomedical startups that have begun a governmental regulatory approval process; (2) compounding pharmacies that manufacture proprietary compounds; (3) device manufacturers or distributors; (4) diagnostic labs that sell proprietary products; (5) growers, distributors, manufacturers or sellers of medical foods and dietary supplements; (6) manufacturers of health-related wearable products; (7) pharmaceutical companies or distributors; pharmacy benefit managers; and (8) reagent manufacturers or sellers.

Relationship Ended: If the financial relationship existed during the last 24 months but has now ended, please check Yes; otherwise, check No. Staff will use this information to determine if any mitigation steps need to be taken.

 

ELEVATE PX Speaker Disclosure Form

DISCLOSURE FORM REQUIRED BY THE STANDARDS FOR INTEGRITY AND INDEPENDENCE

This section is to be completed by the Planner, Faculty, Author, Content Reviewer or Others who may control educational content.

Please review and complete the information below. Forms will not be accepted until signed and filled in its entirety.

Indicate your role in this activity:

#1. DISCLOSURE OF FINANCIAL RELATIONSHIPS

Please disclose all financial relationships that you have had in the past 24 months with ineligible companies. For each financial relationship, enter the name of the ineligible company and the nature of the financial relationship(s). There is no minimum financial threshold. We ask that you disclose all financial relationships, regardless of the amount, with ineligible companies.

Within the past 24 months, have you received financial support (in any amount) from an ineligible company (including employment, consulting, research grant support, honoraria, etc.)?
Relationships(Required)
Relationship Ended
Relationship Ended
Relationship Ended

#2. DISCLOSURE OF OFF-LABEL AND/OR INVESTIGATIVE USES

If, at any time during my educational activity I discuss an off-label/investigative (unapproved) use of a commercial product/device, I understand that I must provide disclosure of that intent.

With respect to this presentation/demonstration (check one):(Required)

#3. CONTENT VALIDATION *

Accredited providers are responsible for ensuring that their education is fair and balanced and that any clinical content presented supports safe, effective patient care. Please review the below:

1. All recommendations for patient care in accredited continuing education must be based on current science, evidence, and clinical reasoning, while giving a fair and balanced view of diagnostic and therapeutic options.

2. All scientific research referred to, reported, or used in accredited education in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation.

3. Although accredited continuing education is an appropriate place to discuss, debate, and explore new and evolving topics, these areas need to be clearly identified as such within the program and individual presentations. It is the responsibility of accredited providers to facilitate engagement with these topics without advocating for, or promoting, practices that are not, or not yet, adequately based on current science, evidence, and clinical reasoning.

4. Organizations cannot be accredited if they advocate for unscientific approaches to diagnosis or therapy, or if their education promotes recommendations, treatment, or manners of practicing healthcare that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.

*Per ACCME Standard 1: Ensure Content is Valid

#4. ATTESTATION
I have disclosed all relevant financial relationships and I will disclose this information to learners.(Required)
The content and/or presentation of the information with which I am involved will promote quality or improvements in health care and will not promote a specific proprietary business interest of a commercial interest. Content for this activity, including any presentation of therapeutic options, will be balanced, evidence-based and commercially unbiased.(Required)
I understand that my presentation/content may need to be reviewed prior to this activity, and I will provide educational content and resources in advance as requested.(Required)
If I am providing recommendations involving clinical medicine, they will be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to will conform to the generally accepted standard of experimental design, data collection and analysis.(Required)
To comply with Health Insurance Portability and Accountability Act (HIPAA), we ask that all program planners and instructional personnel insure the privacy of their patients/clients by refraining from using names, photographs, or other patient/client identifiers in course materials without the patient's/client's knowledge and written authorization. I agree that my presentations will be in compliance.

#5. DECLARATION

I understand that continuing education accreditation guidelines prohibit me from accepting any reimbursement (financial, gifts, or in-kind exchange) for this presentation from any source other than the accredited CME provider or its educational partner (or fiscal agent).

I attest that the above information is correct as of this date of submission (sign below):

By typing my name above, I acknowledge that this electronic signature has the same legal force and effect as a handwritten signature. I affirm that all information provided is true and accurate to the best of my knowledge
* Per ACCME requirements, persons who fail to sign and return this form are not eligible to be involved with this activity.