AUA Conflict of Interest/Disclosure Policy

American Urological Association
Office of Education Policy and Procedure

Subject: Disclosure and Resolution of Conflict of Interest Policy and Procedure

Effective Date:		Approved by Board of Directors April 2003
Revised Date:		Approved by Board of Directors May 20, 2005

1. PURPOSE
The Policy on Disclosure and Resolution of Conflict of Interest exists to ensure proper balance, independence, objectivity and scientific rigor in educational activities sponsored by the American Urological Association, to inspire confidence, and to avoid the appearance of bias. All decisions regarding disclosure and conflict of interest involving continuing medical education (CME) will be based upon that which is in the best interest of the public rather than any economic interests of the American Urological Association or commercial supporters.

2. POLICY
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 educational and professional activities, to inspire confidence and to avoid the appearance of bias in sensitive matters, AUA policy requires that relevant financial relationships constituting unresolved conflicts of interest 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/commercial support. The AUA requires that prior to participating in AUA programs, all individuals make full and effective disclosure of all relevant financial relationships 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 conflict—including the necessity for the individual to recuse him or herself, or to withdraw completely from one or the other responsibility or activity. All disclosures will be evaluated for identification of any conflicts of interest. If a conflict of interest has been identified, it will be resolved according to the procedure contained in this policy.

2.1. 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.

2.2. 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 financial or in-kind support for AUA activities.

2.3. Funding of Research Activities
No funding shall be solicited or accepted by AUA from any private industry/commercial support 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.

2.4. Universal Disclosure Policy

2.4.1. Persons Required to Disclose
The following requirements of disclosure of competing interests are imposed on all of the following:

2.4.1.1. Any individual in a position to control the content of an educational activity including AUA officers, board members, committee members/consultants, editorial committee members, and staff employees;

2.4.1.2. Authors whose articles are submitted for publication in The Journal of Urology^®, in AUANews, or The AUA Update Series; CME and other instructional course directors and faculty; Guidelines authors and reviewers; both members and non-members 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.

2.4.2. 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:

2.4.2.1. their personal financial interests;

2.4.2.2. 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.

2.4.3. Information to be Disclosed by Individuals
Disclosure of possibly conflicting material interests or commitments should include, for both the individual and business and institutional interests the following relationships created or existing at any time during the 12 months immediately prior to disclosure: ("The ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner," as stated in An Educational Resource for Implementing the 2004 ACCME Standards for Commercial Support.)

2.4.3.1. Affiliation. Membership on the Board of Directors, officership, editorial position, or status as a paid employee or paid or non-paid consultant in any proprietary interest producing health goods or services, including any health publishing, internet or e-commerce entity.

2.4.3.2. Ownership. 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.

2.4.3.3. Compensation. Support from commercial or other sources, including any publishing, internet or e-commerce organizations, related to health care or to AUA activities. Income includes stock options in, royalty arrangements with, dividends from the commercial entity, payment for speaking engagements (exclusive of reimbursable travel costs), or in-kind payments within the past twelve months.

2.5. Mechanism for Disclosure to Third Parties

2.5.1. In General. An interactive program on AUA's primary web site (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 the nature of the involvement, and should be made before undertaking any AUA activity. The on-line program may be edited from time to time, both by the persons making disclosure, and by AUA personnel, to eliminate outdated information.

2.5.2. 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 entered by individuals on the web site 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.

2.5.3. 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:

2.5.3.1. AUA's educational activities are free of commercial bias for or against any product

2.5.3.2. commercial supporters of such activities have no control over the planning, content or execution of the activity

2.5.3.3. AUA's payment of honoraria and its reimbursement of out-of-pocket expenses for faculty is reasonable, customary and proper

2.5.3.4. commercial support is acknowledged in printed announcements and brochures

2.5.3.5. commercial support of CME faculty or providers is disclosed to participants at the time of the educational activities in the conference materials

2.5.3.6. 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 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.

2.5.4. The Journal of Urology^®. To comply with current standards for scientific journals, when relevant, authors submitting manuscripts to the The Journal of Urology^® and external peer reviewers of manuscripts are responsible for recognizing and disclosing conflicts relevant to their work or review:

2.5.4.1. authors must describe all sources of financial support for their research, and this information should be published with the manuscript

2.5.4.2. 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

2.5.4.3. external peer reviewers must disqualify themselves from any manuscript for which a conflict might arise

2.5.4.4. reviewers may not use pre-publication knowledge of the work to advance their own interests

2.5.5. 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.

2.5.5.1. 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.

2.5.5.2. 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.

2.5.5.3. Panel members and peer reviewers may not use pre-publication knowledge of the work to advance their own interests.

2.6. 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:

2.6.1. removal of an AUA member from office or appointment

2.6.2. recusal from review of abstracts or materials regarding which a conflict exists

2.6.3. exclusion from participation in the affected AUA activity, or authorship of submitted materials

2.6.4. when known or deliberate, disqualification for two years from participation in similar AUA educational or related activities

2.6.5. 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.

3. PROCEDURE

In accordance with the Accreditation Council on Continuing Medical Education Essential Areas, Policies and Standards for Commercial Support, the American Urological Association will adhere to the following procedure to secure required disclosures, and subsequently prevent, identify, manage and resolve any conflicts of interest.

3.1 Online Submission Process and Management of Disclosure Records
The following guidelines and procedures are provided to give those participating in AUA activities a full and complete understanding of the methodology for disclosure reporting. Full disclosure reflects positively on the AUA, the membership, and other affiliated organizations. As per the AUA Disclosure Policy, disclosure of relevant relationships does not preclude involvement in the AUA, but allows a more informed audience to evaluate the information provided and facilitates identification, management and resolution of conflicts of interest.

Pursuant to Accreditation Council for Continuing Medical Education (ACCME) requirements, AUA requires disclosures for Annual Meeting abstracts, OE courses and products, JU articles (disclosure specific to manuscript), JU (specific to Home Study Course), and Annual Meeting speakers and moderators. Above and beyond these CME activities, the AUA also requires disclosure for Board and committee participation.

The following tools/programs and instructions are provided for capturing and presenting disclosure information.

3.1.1 Board of Directors/Committees/Staff

3.1.1.1 Submission Process

3.1.1.1.1 To begin each association year (June-May), Board and Committee Members are sent appointment/reappointment letters notifying them of their participation on specific committees and councils.

3.1.1.1.2 Each participant is provided his/her Membership Identification Number (needed to update their disclosure information on line) and the URL Link to the area on the AUA web site where they can review, update, edit or expire their disclosure information. If a committee member does not have a Membership Identification Number, one will be issued for this process (e.g., non-member consultants). Log-in information and instructions are provided with the notification letters.

3.1.1.1.3 Each participant is expected to fully disclose all commercial/other relationships as defined in the AUA Disclosure Policy.

3.1.1.1.4 CA staff will monitor on-line activity for all committee participants and assist as needed to help members establish their on-line records. CA staff will work with other committee staff liaisons in tracking these member records.

3.1.1.1.5 After the third reminder has been sent, a notification letter over the signature of the President will be sent to any individual who has failed to comply with the disclosure policy, informing them that they will be excluded from participation on the committee. The chair and staff liaison of each committee will be copied on the letter and any subsequent correspondence, as will the section administrator (where applicable to those Bylaws committees requiring sectional representation).

3.1.1.1.6 If a committee is convened or a committee member added out of this normal cycle period, then the above process will be utilized with an amended timeline.

3.1.1.2 Staff Access and Management of Disclosure Records
Access to Disclosure Records is limited to the individual who is disclosing and the staff liaison(s) for the committee(s) on which the individual serves.

3.1.1.2.1 Board of Directors
At least one week prior to each meeting of the Board of Directors, committee affairs staff will provide the Board Disclosure Compliance Committee with all disclosure information on record for members of the Board. The committee reviews these records in context of the planned Board agenda, to assess where any potential conflicts of interest may require a Board member to recuse himself/herself from discussion and/or vote. A report of this review is then presented orally by the chair of the committee at the commencement of the Board meeting.

3.1.1.2.2 Committees
The responsibility of reviewing Disclosure records for each committee is the responsibility of the committee chair, along with two members of the committee. The AUA staff liaison should work with the chair to choose two members who will serve in this role for the year. This mirrors the Board model of utilizing a small group to monitor all committee member disclosures, including that of the chair. This group will review all disclosures and report relevant financial relationships to the chair. The chair will report the committee's findings to the entire committee at the beginning of each committee meeting, and this disclosure process will be documented in the meeting minutes.

3.1.2 Abstracts for Annual Meeting

3.1.2.1 Submission Process
To submit an abstract to the AUA, the author must complete disclosure information relevant to that abstract only. Disclosure information is collected by DBPub (AUA's third-party vendor) at the time of the abstract submission. Abstracts cannot be submitted without completing the disclosure form on the DBPub site. The author can either access the DBPub database using the link provided at the AUA Disclosure page, or go directly to the DBPub site. The annual call for abstracts via AUANews, etc. includes notice of deadlines and links where specific instructions are included. Disclosure Information stored in DBPub is relevant to the abstract only and is not linked to other activity that individual may perform for AUA.

3.1.2.2 Staff Access and Management of Disclosure Records
Access to disclosure records is limited to the individual author who is disclosing and the AUA staff responsible for coordinating the AUA Annual Meeting program.
Disclosure information related to abstracts is indexed and published along with the abstract in the Annual Meeting scientific program publications.

3.1.3 The Journal of Urology^® Manuscripts

3.1.3.1 Submission Process
To submit a manuscript to The Journal, authors are required to complete disclosure information relevant to the manuscript only. Disclosure information is collected by On-line Editorial Manager (AUA's third-party vendor) at the time of the manuscript submission. Manuscripts cannot be submitted without completing the disclosure form on the Editorial Manager site. The author can either access the On-line Editorial Manager database using the link provided at the AUA Disclosure page, or go directly to the On-line Editorial Manager site per instructions provided by AUA publications staff. Information stored in the On-line Editorial Manager is relevant to the Journal of Urology^® Manuscript only and is not linked to other activity that individual may perform for AUA.

3.1.3.2 Staff Access and Management of Disclosure Records
Access to Disclosure Records is limited to the individual author who is disclosing and the AUA publications department staff.
This disclosure information is published along with the manuscript.

3.1.4 Office of Education Faculty/Annual Meeting Participant and OE Product Editors and Authors

3.1.4.1 Submission Process
To participate as OE Course faculty, an Annual Meeting participant, editor or author, individuals must disclose fully all relevant financial relationships per the AUA Disclosure Policy.

3.1.4.1.1 Individuals are notified of their roles/assignments by Office of Education staff throughout the year based on those activities. Each participant is provided his/her Membership Identification Number (needed to update their disclosure information on line) and the URL Link to the area on the AUA web site where they can review, update, edit or expire their disclosure information. Log-in information and instructions are provided with the notification letters.

3.1.4.1.2 OE staff will monitor on-line activity for individual participants and assist as needed to help members establish/update their on-line records.

3.1.4.1.3 A notification letter over the signature of the Education Council chair will be sent to any individual who fails to comply with the disclosure policy, informing them that they will be excluded from participation in the activity. The education staff will coordinate the processing of these letters for documenting the enforcement of the policy and cross checking against potential involvement the individual may have with other AUA activities.

3.1.4.2 Staff Access and Management of Disclosure Records
Access to Disclosure Records is limited to the individual who is disclosing and AUA education and committee affairs (or other appropriate department) staff until the disclosure is made public in connection with the related function or activity.
This disclosure information is included in relevant Annual Meeting and course materials and products.

3.2 Mechanism to Prevent, Identify, and Resolve Conflicts of Interest

All educational content for enduring, 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.

3.2.1 Prevention of Conflict of Interest

• All programs shall be designed to be fair, balanced, and free of bias.
• Review of the scientific program by appointed Education Council CME Program peer reviewers to ensure a fair and balanced presentation of all scientific evidence
• Strict adherence to the signed statement by all faculty to present peer-reviewed 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.
• Appointment of unbiased moderators to panel discussions to challenge the panelists on salient points of potential bias and/or conflicts of interest
• Use of generic brand names and medical equipment citation and/or use of three or more brand or equipment names when specifics are presented
• Statement of preferences and use by individuals limited to scientific evidence; both pro and con and how different uses and/or local settings may influence choices
• In hands-on training laboratory settings, every effort will be made to achieve balance and to eliminate appearance of bias by including the products of a variety of manufacturers or suppliers. Faculty and participants will use all equipment on a rotation basis to eliminate appearance of bias or favoritism.

3.2.2 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.

3.2.3 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:

• Introduce a debate format with an unbiased moderator (count-counterpoint)
• Peer review for evidence-based content
• Divestiture of the relationship by faculty
• Inclusion of a moderated panel discussion
• Limit content to evidence with no recommendations.
• Review of all materials associated with a CME activity by the author and/or program director and assigned Office of Education staff.
• Limit equipment representatives to providing logistics and operation support only in procedural demonstrations.
• Publish a parallel or rebuttal article for an article that is felt to be biased.
• Communicate to participants/learners that they can expect balanced, bias-free, independent CME content, preferably in written form.
• 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.