Conflict of Interest Policy

PURPOSE

University of Medicine & Dentistry of New Jersey (UMDNJ) is committed to planning, developing and implementing continuing medical education (CME) activities of the highest quality and scientific rigor. The desired outcome is the conduct of CME activities that are free of the appearance of or actual conflicts of interest (COI) and the introduction/demonstration of bias in favor or against a commercial product/service/device in return for known or unknown personal and professional gain. **

REFERENCES

2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of CME Activities.

POLICY

  • UMDNJ CME activities will adhere to the 2004 Updated Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support: Standards to Ensure the Independence of CME Activities
  • Persons in a position to influence or control CME content (i.e., Activity Director, activity planning committee members, faculty, authors) are required to complete a Full Disclosure Statement to determine potential or actual conflicts of interests
  • Failure to complete a disclosure statement will disqualify a faculty member from participating in the CME activity
  • Actions taken to resolve COIs are to be documented on the standard disclosure statement
  • The CME application requires complete documentation, including completion of all standard disclosure statements from the incipient stages of the educational process, indicating no COI or COIs that have been resolved
  • If the CME staff has a question concerning the resolution and/or manageability of any conflict of interest, even if it has been designated as resolved, the Associate Vice President/CEO or Assistant Vice Presidents of CCOE will have the option to implement an additional peer review. This peer review, when necessary, will be the final authority over whether or not a conflict of interest is manageable within the scope of the activity.

** Activities for which UMDNJ awards AMA Category I credit or organizations in kind (e.g., AAFP Prescribed or Elective) credit(s) by the American Academy of Family Physicians)

DEFINITION OF TERMS

  • Conflict of interest: Conflict of interest exists when:
    • Person(s) involved in CME program planning and implementation has/have personal, professional and/or financial considerations that in
    • Specific situation(s) could potentially influence the person’s ability to be objective and unbiased in performance of program-related duties.

Undesirable outcome of conflict of interest is typically the introduction/demonstration of a bias in favor or against a commercial product in return for a personal/professional gain

  • Financial Relationships: The ACCME defines financial relationships as
    • Those relationships in which the individual receives a salary, royalty, intellectual property rights, consulting fee(s), honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit
    • Financial benefits that are 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, or in which the individual has fiduciary interests

ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. (added March 2005) When a person divests himself or herself of a relationship it is immediately not relevant to conflicts of interest but it must be disclosed to participants for 12 months. (added November 2004)

  • CME Peer Review :
    • A group of subject matter experts who are not part of the CME project under review
    • By training and clinical experience, these experts can determine accuracy, balance and validity of the COI in question

Note: Groups of people working together to conduct reviews of activity content prior to publication can resolve conflicts of interest by ensuring the content is valid and aligned with efforts likely to improve public health.

PROCEDURE: Mechanism to Resolve Conflict of Interest

I. Didactic conference, regularly scheduled conferences, symposia, enduring materials

  1. Activity Director (AD)
  • Proposed Activity Director is required to complete “Standard Disclosure form”
  • Disclosure form reviewed by CME staff:
    • if no COI identified, AD to proceed with program planning
    • if COI identified and resolved with CME staff, Associate VP& CEO to review and approve resolution

Or

    • if COI identified and no immediate resolution, Associate VP & CEO Continuing Education to initiate peer review process
      • Peer review conducted and deems resolution, then AD to proceed with program planning

Or

      • No resolution identified, AD not approved to proceed with activity

3) If COI arises at any time during the planning process, resolution is revisited

Planning Committee

  • Proposed Planning Committee member is required to complete “Standard Disclosure form”
  • Disclosure form reviewed by AD and CME staff:
    • if no COI identified, then Planning Committee member approved
    • if COI identified and resolved with AD and CME staff, Associate VP& CEO/Assistant VPs resolution and Planning Committee member approval

Or

    • if COI identified and no immediate resolution, AD to initiate peer review process

1. Peer review conducted and resolution identified, then Planning Committee member approved

Or

2. No resolution identified, proposed planning committee member not approved to proceed with activity

Faculty

  • Proposed Faculty are required to complete “Standard Disclosure form”
  • Disclosure form reviewed by AD and Planning Committee:
    • if no COI identified, faculty member approved
    • if COI identified and resolved with AD/Planning Committee, faculty member approved to proceed

Or

c. if COI identified and no immediate resolution, AD/Planning Committee to initiate peer review process (AD/Planning Committee has the ability to invite content experts to assist COI resolution if needed.)

d. no resolution identified, faculty member not approved to proceed with activity

Continuing Education Staff

1) CME Staff will be required to complete a ‘Standard Disclosure Form’ with each activity
initiated.

a. if COI identified, Associate VP/CEO/Assistant Vice President, CCOE will designate appropriate measures for resolution, including but not limited to reassignment of responsibilities or additional staffing as required.

II. Multidisciplinary conferences and Tumor Boards

a. faculty disclosures will be conducted on an annual basis for recurring conferences such as these.

Recommended by

New Jersey Medical School :

Jacob J. Lindenthal, Ph.D.
Chair, NJMS CME Advisory Committee

Anthony Boccabella, MD
Member, of NJMS CME Advisory Committee

Robert Wood Johnson Medical School

David E. Swee, MD
Acting Senior Associate Dean of Education

Ray Rosen, Ph.D.
Professor of Psychiatry & Medicine

School of Osteopathic Medicine

Frank Filipetto, DO
Academic Vice Chair, Dept. of Family Medicine

Stanley Schiff, DO
CME Director, Dept. of Medicine

Center for Continuing Outreach Education

Robert Moutrie, PhD
Associate Vice President & CEO