Policy Title

AUA Disclosure/Conflicts of Interest

The American Urological Association recognizes that competent professionals - especially those involved in policy-making, research, education, fund-raising or outreach for a professional organization - are frequently subject to potential conflicts of interest. To ensure proper balance, independence, objectivity, and scientific rigor in both individually and jointly sponsored educational and professional activities, to inspire confidence and to avoid even the appearance of bias in sensitive matters, AUA policy requires that certain direct and significant conflicts not be permitted.

However, AUA considers it unwise to embrace a policy, which would prevent participation in Association affairs by all individuals having relationships with industry. To address unavoidable conflicts, the AUA requires that prior to participating in AUA programs, these individuals make full and effective disclosure of their private financial or institutional interests related to health care or to AUA activities, business transactions, presentations or publications. The disclosure should be made under circumstances permitting others to make an informed decision about the existence and impact of such conflict — including the necessity for the individual to recuse him or herself, or to withdraw completely from one or the other responsibility or activity.

A. Duality of Representation Prohibited.

No AUA officer nor other individual vested with authority to speak or take a formal position on behalf of AUA in any public forum, or before any public or quasi-public body — including medical committees, regulatory or funding agencies, legislative committees or similar forums — shall represent private industry, or any institution or enterprise unaffiliated with AUA, before the same or any related body. Nor shall such individuals make public statements contrary to any position or policy of the AUA.

B. No Commercial Endorsements.

Neither the American Urological Association, Inc., nor the American Urological Association Education and Research, Inc. (collectively "AUA"), nor any official, representative or employee identified with either organization, may endorse any commercial product related to the specialty of urology. However, this policy shall not prevent acceptance of industry advertisements in AUA publications, with an express disclaimer of endorsement, or acceptance of sponsorship support for AUA activities.

C. Funding of Research Activities.

No funding shall be solicited or accepted by AUA from any private industry or related source, under express conditions or attendant circumstances whereby the source of funds retains undue control over use of the funds. An AUA funding source may impose no restrictions on content of research, and specifically may not dictate a) the procedures, protocols or identity of individual researchers or institutions by whom or where the research will be conducted, b) conditions of confidentiality or prepublication review, or c) ownership of intellectual property or patentable results of the research. Donor-restricted grants will be accepted only after careful scrutiny to avoid imbalance between competing interests, or the appearance of such bias.

D. Universal Disclosure Policy.

1. Persons Required to Disclose.
   

   The following requirements of disclosure of competing interests are imposed on all of the following:

   1. AUA officers, board members, committee members/consultants, editorial board members, and senior staff employees;
   2. authors whose articles are submitted for publication in the Journal of Urology, in AUA News, or The AUA Update Series, CME and other instructional course directors and faculty, Guidelines authors and reviewers, and both members and nonmembers whose papers and abstracts are accepted for presentation at AUA's annual meeting or other scientific sessions, and reviewers of such abstracts and papers of any kind.

2. Definition of Competing Interest.
   

   The private or institutional interests of individuals which may compete or conflict with their primary duties owed to their professional organization include:

   1. their personal financial interests;
   2. those of their spouse, children, or professional colleagues; and
   3. the myriad professional or business interests of an institution or project with which they are in any way associated or allied.

   The relevant duality of interest may derive, by way of example, from employment, membership on the Board of Directors, or existence of any fiduciary relationship with such entity, membership on a scientific advisory panel or other scientific/medical committee, ownership of stock, receipt of honoraria or consulting fees, or receipt of financial support or grants for research or for significant travel on behalf of the other entity.

   The AUA does not view the existence of these interests or commitments as necessarily implying bias or decreasing the value of participation in Association activities, but merely as providing the basis for potential conflict - therefore requiring full disclosure.

3. Information to Be Disclosed by Individuals.
   

   Disclosure of possibly conflicting material interests or commitments should include, for both the individual and for defined family members and professional associates, and business and institutional interests, the following relationships:

   1. Affiliation. Membership on the board of directors, officership, editorial position, or status as a paid employee or paid or non-paid consultant in any health-related or business concern, including any health publishing, internet or e-commerce entity.
   2. Ownership. Significant personal holdings in any commercial entity, including any publishing, internet, e-commerce or other business interest that provides products or services related to health care or to AUA activities. For purposes of this policy, "significant" means an ownership interest of five percent (5%) or more of stock or assets of a single commercial entity; or an equity interest of $25,000 or more in any one commercial entity.
   3. Compensation. Support from commercial or other sources, including any publishing, internet or e-commerce organizations, related to health care or to AUA activities. Significant income includes stock options in, royalty arrangements with, or dividends from the commercial entity, anticipated to produce more than $2,500 in annual income from a single source, or payment for speaking engagements (exclusive of reimbursable travel costs) in excess of $2,500 from one source in any twelve-month period.

E. Mechanism for Disclosure to Third Parties.

1. In General. An interactive program on AUA's primary website (AUANet.org) permits each individual to establish a disclosure record, and to update the record to reflect changes either in one's role at AUA, or in one's disclosable outside interests or commitments. This disclosure should include both the nature and also the extent of the financial involvement, and should be made before undertaking any AUA activity. The online program may be edited from time to time, both by the persons making disclosure, and by AUA personnel, to eliminate outdated information.

2. Input versus Output. System input is universal and uniform; however, output will be limited or varied by one's role, audience, activity or program with AUA. Personal information and financial data entered by individuals on the website will not be publicly disclosed beyond the necessities of the AUA role or activity in question. An internal review policy will seek to limit the output to relevant program requirements.

3. CME Requirements. AUA is currently required to present its educational activities - including annual meeting and other courses for CME credits -- in compliance with ACCME policies for disclosure of commercial support, specifically representing that:
   1. AUA's educational activities are free of commercial bias for or against any product,
   2. commercial supporters of such activities have no control over the planning, content or execution of the activity,
   3. AUA's payment of honoraria and its reimbursement of out-of-pocket expenses for faculty is reasonable, customary and proper,
   4. commercial support is acknowledged in printed announcements and brochures,
   5. commercial support of CME faculty or providers is disclosed to participants at the time of the educational activities in the conference materials,
   6. no funds originating from commercial sources are used to pay travel, lodging, registration fees, honoraria, or personal expenses for non-faculty attendees, and only modest meals or social events held as part of the activity are subsidized.

   In conformity with this policy imposed by ACCME, all CME participants must disclose their financial interests and relationships with manufacturers of products or providers of services, including alternative treatment technologies. AUA must provide this information contemporaneously to the public and verify that it is accessible to the audience.

4. The Journal of Urology. To comply with current standards for scientific journals, when relevant, authors submitting manuscripts to the Journal of Urology and external peer reviewers of manuscripts are responsible for recognizing and disclosing conflicts relevant to their work or review.
   1. Authors must describe all sources of financial support for their research, and this information should be published with the manuscript.
   2. Authors must affirm that no funding agreement limits their ability fairly to complete and publish their research, and that they had full control of primary data.
   3. External peer reviewers must disqualify themselves from any manuscript for which a conflict might arise.
   4. Reviewers may not use pre-publication knowledge of the work to advance their own interests.

5. AUA Guidelines. To assure that AUA Guidelines are not developed with undue influence, disclosure by both panel members and by peer reviewers is required. However, the disclosure needs to be only relevant to the specific project subject.
   1. Panel members/authors must report private or institutional interests which may compete or conflict with their objectivity in guideline development on the relevant topic. Depending on the conflict, the panel members may need to recuse themselves from certain recommendation decisions.
   2. Peer reviewers must report private or institutional interests which may impact on their review of the guideline. However, there is no need for reviewers to recuse themselves from the peer review process due to conflict of interest.
   3. Panel members and peer reviewers may not use pre-publication knowledge of the work to advance their own interests.

F. Sanctions for Failure to Disclose.

Criticism is reserved for those who a) subordinate the interests of the Association to their private interests, b) fail to make appropriate disclosure of their competing interests, or c) in some circumstances, fail to avoid unnecessary and unjustified appearance of conflict of interest. Failure to comply with the disclosure policy shall be considered cause for sanctions, which may include:

1. removal of an AUA member from office or appointment,
2. recusal from review of abstracts or materials regarding which a conflict exists;
3. exclusion from participation in the affected AUA activity, or authorship of submitted materials;
4. when known or deliberate, disqualification for two years from participation in similar AUA educational or related activities, and
5. where egregious, expulsion from AUA or other sanctions prescribed by Article X of the AUA Bylaws.

AUA members shall be encouraged to report, in confidence, apparent violations of the disclosure policy by others. Sanctions shall be applied, following appropriate investigation, by recommendation of the AUA Judicial & Ethics Council to the AUA Board of Directors.

Board of Directors - April 2003