RWI Policy

Updated:Feb 22,2013

MOC Policies and Procedures Regarding Relationships With Industry for Writing Group Members

I.  Definitions

Relevancy:
Each author is required to identify all relationships within the last 12 months that are relevant to the topic of the manuscript.  A person has a relevant relationship with a company or other entity IF:

  • The relationship or interest relates to the same or similar subject matter, intellectual property or asset,topic, or issue addressed in the document.
  • The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document.
  • The person or a member of the person’s household, has/have a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.

Levels of Support:

  • No financial relationshippertains torelationships for which you receive no monetary reimbursement; Modest  < $10,000;  Significant  > $10,000.  
  • A person is deemed to have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, OR ownership of $10,000 or more of the fair market value of the business entity, or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. 

Nature of Support:

1.   Personal Ownership/Investments*

Includes any stock, stock option, partnership, membership or other equity position in an entity regardless of the form of the entity, or any option or right to acquire such position, and any rights in any patent or other intellectual property rights.           * Exception:  mutual diversified funds

2.   Personal Income

Includes consulting fees, speaker’s bureau, honoraria, expert witness, gifts, “in kind” compensation

3.   Programmatic Support

  • Research grants and/or “in-kind” support from industry
  • Fellowship support
  • Funding of salary or position or “in-kind” support of program

4.   DSMB

  • ALL DSMB participation (industry, government-sponsored, and university-managed) must be disclosed

5.   “No Financial Benefit” (RWI For Which No Monies Received)

  • “No financial benefit” category added:  Donated honoraria to charity must be disclosed unless they fall under the ACCME noted exception.
  • Disclosure of travel expenses (e.g., hotel, airfare, meals) is required if subsidized by an industry or device company.

6.   Honoraria That Do NOT Have to Be Disclosed

  • Honoraria received from work on ACCME-accredited programs do NOT have to be disclosed due to the ACCME firewall restrictions between industry and program content.

7.   Institutional COI/RWI

  • includes any institutional relationship for which you have direct decision-making responsibility (e.g., industry grant to the Division of Cardiology and you are Division Chief) and any organizational relationship.  “Organizational relationships” include any leadership or governance responsibilities or roles in another professional or other nonprofit organization with interests potentially adverse to or competitive with those of the ACCF/AHA.

II. Policy:

A.  Writing Group Members (see rules below for Chair):

  • SIGNIFICANT relationships in category of personal ownership/investments (equity interest, royalty income, ownership) DO NOT automatically disqualify service on writing group (except chair and co-chair). 
  • Modest or significant relationships in categories of speaker’s bureau, honoraria, expert witness, consultant/advisory board, or relevant research support from industry allowed if in a minority of members. 
  • Research funded by federal sources or not-for-profits must be declared but is not automatically counted as a relevant relationship.
  • The majority (50% + 1) of the writing group must be free of ANY (modest or significant) relationships.  RWI balance will be maintained by including at least 50% of the writing committee (not counting the chair) without relevant RWI at the onset of a writing activity.  The writing group chair must also have NO relevant relationships; therefore this makes the total writing group be at least 50% + 1.
  • Participation on a government-sponsored or university managed DSMBs must be disclosed but are not considered relevant relationships for the purpose of identifying writing committee members.

B.  Writing Group Chair:

The writing group chairperson is selected primarily for the competency of effectively managing the writing group.  A general working knowledge and competency in the writing topic is also necessary, but the chairperson does not have to be a leading expert in that topic.  The chairperson must be selected to avoid relationships that could taint or undermine the credibility of the writing group or its work product.  Therefore:

  • Chair cannot have ANY relevant relationships (modest or significant) in the categories of ownership interest, equity interest, royalty income, stock, stock options speakers bureau, honoraria, expert witness, consultant/advisory board, or relevant research support from industry.  Research funded by federal sources or not-for-profits is allowed on a case by case basis.  The appropriate oversight committee (e.g., Guideline Task Force or Manuscript Oversight Committee) will review and evaluate the relationship.
  • Participation on government-sponsored or university managed DSMBs must be disclosed but are not considered relevant relationships for the purpose of identifying a Chair or Co-Chair.
  • Volunteers will NOT be automatically disqualified from chairing a writing committee because of an institutional RWI or an organizational relationship (e.g., leadership, decision-making roles in an organization who may have a stance potentially competitive with ACCF/AHA).  The appropriate oversight committee (e.g., Guideline Task Force or Manuscript Oversight Committee) will review and evaluate the relationship to determine if the individual may serve as Chair.

C.  Writing Group Co-Chair:

  • Co-Chair can have modest or significant RWI in the categories of speakers’ bureau, honoraria, consultant/advisory board, expert witness, or relevant research support from industry.
  • SIGNIFICANT relationships in category of personal investments (equity interest, royalty income, ownership, stock, stock options) are not allowed; modest RWI in this category is allowed. 
  • Participation on government-sponsored or university managed DSMBs must be disclosed but are not considered relevant relationships for the purpose of identifying a Chair or Co-Chair.
  • Research funded by federal sources or not-for-profits must be declared but is not automatically counted as a relevant relationship.