EDUCATION > Guidelines & Policies > COI Disclosure > AUA Disclosure Policy

AUA Disclosure Policy

PRINCIPLES, POLICIES AND PROCEDURES FOR MANAGING CONFLICTS OF INTEREST

(Approved – Board of Directors – October 2008)
(Revised – Board of Directors – February 2009, May 2011, October 2012)
(Reaffirmed – Board of Directors – October 2013)

AUA Disclosure Policy [pdf]

This document supersedes the Disclosure and Resolution of Conflict of Interest Policy approved by the Board of Directors in May 2005, and incorporates the Level 1, Level 2 and Level 3 concepts and specific rules that were approved by the Board throughout discussions in 2007. Also retained is significant procedural language relating to the Office of Education and ACCME compliance.

Principles

Definition of Conflicting Interests

Levels of Involvement

The AUA Board of Directors has adopted a "Matrix" that identifies groups of individuals who serve the AUA at various levels of activity juxtaposed to different activities or relationships which may or may not be permitted, or may require specific review for potential COIs. While all individuals assuming decisionmaking authority or responsibility within or on behalf of AUA must disclose their actual or apparent COIs, those with the highest level of responsibility must divest themselves of financial relationships giving rise to COIs. The levels of such responsibility have been defined:

Consultants. The COI Level I and Level II requirements of disclosure and disqualification apply equally to all AUA consultants whose roles, duties, or relationships relative to AUA activities are significant in education, research, or formulation of guidelines or treatment options, or who may otherwise be (or assumed by others to be) in a position to affect or influence medical care, product selection or use, health policy, coding or reimbursement. Included also are temporary or incidental consultants to workgroups reporting to standing committees and councils.

For all purposes under this COI Policy, these requirements apply to all individuals whose role entails consideration, analysis, discussion, drafting, or recommendations a) with respect to scientific or technological applications or strategies for use in the education or practice of urology; or b) with respect to modalities or products intended for urological research or training, or c) for patient care or treatment.

Any such consultant employed by or closely affiliated with an institution, medical practice, agency, company, or similar entity, must disclose not only his or her own real or potential conflicts, but also known conflicts of the employer and fellow employees, or of the affiliated entity – but only to the extent that the consultant possesses actual knowledge of the existence of such potential COI relationships during the period of consultancy.

Note: Any individual who participates in activities at more than one level is required to comply with the COI Guidelines of the higher level.

Specific issues arising with in a committee, or otherwise within AUA structures, or disclosure questions facing one or more individuals and involving potential COIs, may be referred to the AUA Judicial and Ethics Committee for consideration and decision or recommendation. Those questions and answers may be posted – without identifying information – on the J&E portion of the AUA website or otherwise made available to guide others under similar circumstances.

Procedures for Disclosure

Educational Activities: Mechanism to Prevent, Identify and Resolve Conflicts of Interest

All educational content for published, live, and Internet educational activities are reviewed by anonymous, independent urologists with written instruction from the Office of Education to ensure that it is based on scientific principles that are generally accepted as valid by the medical profession, and free from bias of any kind.

Prevention of Conflict of Interest

  1. All programs shall be designed to be fair, balanced, and free of bias.
  2. Review of the scientific program by appointed Education Council CME content peer reviewers will ensure a fair and balanced presentation of all scientific evidence.
  3. AUA will maintain strict adherence to the signed statement by all faculty to present peerreviewed content for all CME activity materials that is based on the highest level of evidence available including expert opinion and customary and generally accepted medical practice.
  4. Unbiased moderators will be appointed to panel discussions to challenge the panelists on salient points of potential bias and/or conflicts of interest.
  5. AUA will use generic brand names and medical equipment citation and/or use three or more brand or equipment names when specifics are presented.
  6. Statements of individual preferences and use will be limited to scientific evidence including both pro and con statements and discussions of how different uses and/or local settings may influence diagnostic and treatment choices.
  7. In hands-on training laboratory settings, no commercial supporter or manufacturer in that field of interest shall be excluded. Faculty and participants will use all equipment on a rotation basis to eliminate appearance of bias or favoritism.

Identification of Conflict of Interest

All disclosures will be reviewed by the program directors or editors for identification of conflicts of interest. The peer reviewers, working with the program directors and/or editors, will document the mechanism(s) for management and resolution of the conflict of interest. Final approval of the activity will be documented prior to implementation.

Resolution of Conflicts of Interest

Recommended methods for resolving conflicts of interest, which may be recommended by the Educational Council or Office of Education staff, include:

  1. Introduce a debate format with an unbiased moderator (count-counterpoint)
  2. Peer review for evidence-based content
  3. Provide faculty with alternate topic
  4. Select alternate faculty for specific topics
  5. Divestiture of the relationship by faculty
  6. Inclusion of a moderated panel discussion
  7. Limit content to evidence with no recommendations.
  8. Review of all materials associated with a CME activity by the author, program director, content reviewer, and/or assigned Office of Education staff.
  9. Limit equipment representatives to providing logistics and operation support only in procedural demonstrations.
  10. Publish a parallel or rebuttal article for an article that is felt to be biased.
  11. Communicate to participants/learners that they can expect balanced, bias-free, independent CME content, preferably in written form.
  12. Appoint a compliance officer is to oversee possible conflicts of interest.

The final mechanism for resolution of conflict of interest will be the decision of the Education Council members.

Enforcement and Sanctions

Procedures to Enforce. The Judicial & Ethics Committee is charged with responsibility to consider alleged violations of the disclosure requirements and other provisions of these Guidelines, to investigate complaints of such violations, and to recommend appropriate sanctions to the AUA Board of Directors.

Penalties. Unexcused failure by any individual to comply with the requirements of these COI rules and procedures will disqualify such individual from participation in AUA committee, educational or similar activities until rectified. Repeated or egregious violations including willful failure to disclose relevant information may lead to harsher sanctions, including expulsion from membership in the Association, or disqualification from participation in any of its activities.


Appendix 1 - Program Specific Requirements

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