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)
(Revised – Board of Directors – February 2016)
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.
- Conflicts of Interest (COIs) are relationships or associations with organizations, persons, corporations or enterprises that may affect or be perceived to affect one's judgment or decision-making.
- The American Urological Association and its affiliated entities (collectively "AUA") hereby adopts a policy of universal disclosure of COIs, and where appropriate, divestiture or other resolution of COIs on the part of its officers, active members, consultants, senior staff and participants in AUA activities.
- AUA recognizes that professionals – especially those involved in policy-making, research, education, standard-setting, fund-raising or outreach for a professional organization – are subject to COIs. Therefore, AUA considers it unwise to embrace a general policy which would prevent participation in Association affairs by individuals having relationships which may represent COIs. The existence of an actual or apparent COI does not imply fault or wrongdoing on the part of an individual.
- The AUA policy requires disclosure of financial or intellectual relationships which may be regarded as possibly influencing actions taken or statements made under the aegis of the organization, by any of AUA's committees, or in AUA's publications or presentations. Relevant relationships that may create a conflict of interest must be disclosed regardless of whether or not compensation was received. Specific dollar amounts are not used as a threshold for disclosures because the potential for a conflict arises from the existence of the relationship not the monetary value.
- The AUA recognizes that need to have a policy that ensures proper balance, independence, objectivity and scientific rigor in governance and in educational, research, health policy, and all other activities sponsored by the AUA. Careful compliance will inspire confidence, will avoid both actual bias and the appearance of bias, and will comply with legal and regulatory standards.
- All actions, statements and decisions regarding management and operation of the organization, and in particular, those involving research or continuing medical education, or involving recommendations for patient safety, coding, reimbursement, health policy or related matters, must serve the best interests of the public and our patients rather than serve the economic interests of AUA's leadership, individual members, employees, consultants or commercial supporters.
- The AUA requires that prior to participating in AUA programs, all individuals without exception make full and effective disclosure of their relationships related in any way to health care or to their AUA activities, business transactions, presentations or publications.
- The AUA requires that all such disclosures should be made and disclosed in a manner that will allow others to make an informed decision about the existence and impact of COIs – including bias in opinions or recommendations, or the necessity for the individual to recuse him or herself, or to withdraw completely from an AUA responsibility or activity. If a COI has been identified, it will be resolved according to the procedures contained in this document.
- Duality of Representation. No AUA officer or other individual vested with authority to speak or take a formal position on behalf of AUA 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.
- Conflicting Entities or Organizations. Individuals who are part-time or full-time employees of Industry (pharmaceutical and device manufacturers) may not serve on AUA standing committees unless permitted by the AUA Bylaws. No AUA officer or committee chair shall assume a role with any competing or unaffiliated organization or entity which may be regarded as in competition with AUA, without knowledge and express consent of the AUA Board of Directors.
- Commercial Endorsements. No AUA official, representative, employees or those holding themselves out as representing the AUA 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.
- Funding of Research or Educational Activities. No funding shall be solicited or accepted by AUA from any private industry, commercial supporter or related source, under express conditions or attendant circumstances whereby the source of funds retains an inappropriate control over use of the funds. More specifically, no AUA funding source may impose restrictions on content or publication of research, nor dictate
- the procedures, protocols or identity of individual researchers or institutions by whom or where the research will be conducted,
- conditions of confidentiality or prepublication review, or
- ownership of intellectual property or patentable results of the research.
No individual making a presentation using materials prepared by industry shall do so without disclosing the nature and origin of such materials. Donor-restricted grants will be accepted only after careful scrutiny to avoid imbalance between competing interests, and to avoid the fact or appearance of bias.
Definition of Conflicting Interests
Non-AUA-Interests are defined as follows:
Disclosure Period for Conflicts of Interest:
- Types of Conflicts of Interests
COIs may be either financial or intellectual.
Financial COIs exist when an individual is in or may reasonably be perceived to be in a position to gain or suffer financial loss as a result of an action, deliberation or recommendation of the society.
Intellectual COIs exist or may exist as a result of competing scientific beliefs, competing academic institutions, societies or publications. Such COIs may be self-declared (e.g. competing beliefs) or be evident upon appropriately executed disclosures (academic affiliation or editorial responsibility).
- All financial and intellectual COIs must be disclosed in accordance with AUA policy.
Conflicting Interests – which must in all instances be disclosed (and which may in some instances constitute grounds for disqualification) are the private or institutional interests of individuals, which may under some circumstances compete or conflict with their primary duties owed to the AUA. These COIs include:
- Personal or family financial interests;
- Professional or business interests of a non-AUA institution or;
- Duality of interest from employment, membership on the board of directors, or existence of any fiduciary relationship with a non-AUA-sponsored entity. Such interest may include membership on a scientific advisory panel or other scientific or medical committee, ownership of stock, receipt of honoraria or consulting fees, or receipt of financial support or grants for research or for travel on behalf of the other entity, or ownership of a patent or other intellectual property rights in any drug, device or product related to urology or to medicine in general.
- Affiliation – Membership on the board of directors, holding an office, editorial position, or status as a paid employee or paid or non-paid consultant in any proprietary interest producing health goods or services, including health publishing, internet or e-commerce.
- Ownership – Personal or family holdings in any commercial entity, including any publishing, internet, e-commerce or other business enterprise that provides healthcare products or services related to AUA activities.
- Compensation – Support from commercial or other sources, including any publishing, internet or e-commerce enterprises, 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.
- With respect to any such interests existing within 12 months prior to assuming a role with AUA, or involving a substantial earlier relationship, or created following assumption of that role, disclosure should include, for both the individual, his or her family, and related business and institutional interests.
Examples of the Assorted Activities AUA Members Participation and Potential Conflicts
Intellectual Conflicts Pharma – IRB approved research, supervised by institution Pharma/Medical Device Company – Paid Lecturer or Paid Attendee Private Ownership Interest in ancillary services (e.g., lithotripsy, ambulatory surgery centers, radiology/pathology services, patents) Officer or Board Member of other affiliated Society Editorial Positions with non-AUA publications Program oversight of non-AUA meetings (e.g., Program Organizer or Guidelines Publications) Financial Conflicts Commercial Interest – Ownership (e.g. investments, stocks, patents) Pharma/Medical Device Company – Governance Role Pharma/Medical Device Company – Consultant or Advisor Pharma/Medical Device Company – Investigator (paid Individually)
- Intellectual or financial COIs may be judged as grounds for recusal from participation within a committee or other AUA structure. Upon appropriate disclosure by the individual, the committee or task force chair or president of the board, shall present the potential COI to the other members of an AUA Board, Council, Committee or Task Force and , in conjunction with the committee member, shall determine whether such COI warrants recusal or exclusion from participation, under all of the attendant circumstances.
- While disclosure must be uniform, resolution of COIs is dependent on and defined by the activities of the individual relative to AUA.
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:
- Level I – Officers, & Board Consultants
This Level applies to the following AUA offices or roles–
- The major elected officers including President, President-elect, Immediate Past President, Secretary, Treasurer, Secretary-elect and Treasurer-elect
- The eight Section representatives to the Board of Directors
- The Chair of Education
- The Chair of Global Initiatives
- The Chair of Public Policy
- The Chair of Research
- The Chair of Science & Quality Council
- The Editor of The Journal of Urology®
- The Editor of Urology Practice
- The Chair of the Coding and Reimbursement Committee
- The Chair of the Practice Guidelines Committee
- The Chair of the Data Committee
- The Chair of the Quality Improvement and Patient Safety Committee
- The Chair of the Judicial & Ethics Committee
The disclosure record of these individuals must be updated and reviewed by the appointing authority, or new disclosure record established, prior to the appointment of these positions. Prior to assuming Level I responsibilities, these individuals must promptly disclose and divest themselves of significant relationships, for the term of their position or office, with the pharmaceutical and device industries (collectively, Pharma), including:
- Any governance role with a Pharma company
- Any role as consultant or advisor to Pharma
- Any role as paid lecturer or paid attendee at a Pharma event.
Upon appropriate disclosure and review, these individuals may be permitted to maintain current investments in Pharma stocks, or may participate in institutional or individual Pharma research. They may also maintain private ownership as an individual or part of a group in ancillary services, or may serve as an officer or board member of an affiliated society, unless deemed by the Board of Directors to be a substantial conflict to the AUA. Members of the Board of Directors are not allowed to serve as expert witnesses (for either plaintiff or defendant) in medical liability cases. This applies to new cases (after term of service of board commences), and does not apply to providing medical testimony for a member's own patients.
- Level IA – Guidelines Panel Chairs and Members
Chairs – All Guideline Panel Chairs are prohibited against participation in a governance role, as a consultant or paid lecture or attendee for any Pharma company for which there is specific subject-matter or material overlap for the duration of the Guideline development. This prohibition extends for a period of one-year after the on-line publication of the guideline. In addition, guidelines panel chairs must refrain from giving industry sponsored talks about the recently published guideline (for a period of one year from time of publication). The Guidelines Chair otherwise is encouraged to talk about the Guideline in other forums to benefit the AUA and increase the dissemination of the Guideline material.
Consistent with Level 1 COI, and after appropriate disclosure and review, panel chairs may be permitted to maintain current arms-length investments and current research; however the panel chair shall not enter into wholly funded Pharma-sponsored research regarding the topic during the Guidelines development and the 12-month period of time as determined above. They may maintain private ownership as an individual or part of a group in ancillary services, or may serve as an officer or board member of an affiliated society.
Members – A majority of new guidelines panel members (greater than 50%) should be free of Level 1A conflicts which includes the prohibiting of participation in a governance role, as a consultant or paid lecture or attendee for any Pharma company for which there is specific subject-matter or material overlap for the duration of the Guideline development and extends for a period of one-year after the on-line publication.
Panel members, regardless of their industry relationships, must NOT present themselves as spokespersons for the Guidelines when giving industry talks. Panel members giving industry sponsored talks are required during guideline development, and for the period of one year subsequent to publication, to publicly disclaim that they "are not an official spokesperson for the AUA Guideline panel" if speaking about any material related to the Guideline product. This allows the audience to understand that the panel members, while participants in the Guideline development, are not AUA spokespersons, and AUA copyrighted material is protected.
- Level II – Committee Members
All other committee chairs and members, guideline panel members, editors of and contributors to AUA publications or scientific and/or educational activities, consultants and review team members or abstractors, must make full disclosure of their relevant financial relationships.
The Chair of the committee should review these COI one month prior to the constitution of a committee and before each scheduled meeting. The chair is responsible to make report to the committee prior to each meeting. Each AUA committee or entity has the responsibility, prior to its meetings or efforts, to review the financial and intellectual COIs of its members and consultants, and to mandate disqualification or recusal of individuals whose COIs may have the appearance of affecting the exercise of their duties.
Following disclosure of potential COIs, it shall be the responsibility of each council or committee on which the individual serves, to determine whether such potential conflict warrants i) exclusion from discussion of the subject, or ii) recusal from any vote, or iii) dismissal from the committee. The goal of committee deliberations is to allow transparency of member interests and relationships in context of the planned agenda for those meetings. Such rules for committees should be openly discussed and it should be made clear that members may participate in the discussions, at the direction of the Chair and with agreement of the committee. However if a COI exists, as determined by the committee chair and the committee, the individual with this COI will be required to be excused from the deliberations during development of recommendations or any vote which may be affected by said conflict. Failure of a committee member to adhere to the disclosure policy and process, or serious breach of confidentiality, may result in a committee member being removed from the committee.
These rules and principles will apply as adapted to the variety of circumstances encountered by AUA participants at this level.
- All individuals participating in AUA activities at this level shall make the general disclosures required by this document, and shall renew and update those disclosures directly relevant to all activities in which the individual is engaged.
- No council or committee member shall serve as a paid or unpaid consultant to a company or interest which may profit from information obtained while serving on that entity; nor may such individual disclose such information to any person or interest which (to his knowledge) may profit from that information.
- No council or committee member shall accept compensation in any form from a company or interest seeking the approval or support of AUA for its product, service or technology.
- Any such issue unresolved within the processes of the council or committee in question may be referred to the AUA Judicial & Ethics (J&E) Committee for resolution by notifying the AUA staff or Chair of the committee.
- AUA councils or committees whose members are subject to these Level II requirements shall be at liberty to impose additional disclosure or other requirements on their members, if warranted due to the nature of the activities of each (Refer to Appendix 1).
- Level III – Other Members/Staff
All other individuals, AUA members and senior staff are responsible to make timely disclosure of all relationships giving rise to potential COIs indicated in the computerized AUA Disclosure Record, as it may be revised from time to time.
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
- General Procedures. 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 the nature of the involvement and should be made before undertaking any AUA activity. An individual's online disclosure must be kept current and updated at least annually. It is the responsibility of the member to update his or her disclosure record whenever relationships change related to relevant AUA activity. When an individual edits his/her disclosures to expire an item in his or her disclosure record, the information is nevertheless retained on the website for an additional period of 12 months.
Although system input is universal and uniform, 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.
- Process for Submission and Review of Disclosures. Submissions will be made in accordance with the following procedures:
- Appointments to Committees
- To begin each association year (June-May), individuals serving on the Board of Directors and each of its Councils and committees are sent appointment or reappointment notification emails.
- Participants are provided their Membership Identification Number (needed to update their disclosure information on line) and the URL link to the AUA web site where they can review and update 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 emails.
- Each participant is expected to fully disclose all commercial/other relationships as defined above, and to update that information whenever there is a change in any such relationship.
- AUA staff monitors the online compliance for all committee participants and assist as needed to help members establish their online records.
- After the third reminder has been sent, a notification letter over the signature of the President will be sent to individuals failing to comply with the disclosure policy, informing them that they will be excluded from participation on the committee as of a specified date. 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).
- 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. Disclosure records will be considered current if dated as of (or after) April 1 of the current AUA year.
- Board of Directors Meetings. 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.
- Committee Meetings. Review of disclosure records for each committee is the responsibility of the committee chair, along with at least one other committee member. 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 subset of the committee to monitor all committee member disclosures, including that of 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.
- Annual Meeting – Abstract Submissions
To submit an abstract to the AUA, the author must complete disclosure information relevant to that abstract only. Disclosure information is collected by AUA's third-party vendor at the time of the abstract submission. Abstracts cannot be submitted without completing the disclosure form on the submission site. The author can either access the vendor database using the link provided at the AUA Disclosure page, or go directly to the vendor site. The annual call for abstracts via AUANews, etc. includes notice of deadlines and links where specific instructions are included. Disclosure Information stored in this abstract database is relevant to the abstract only and is not linked to other activity that individual may perform for AUA.
Disclosure information related to abstracts is indexed and published along with the abstract in the Annual Meeting scientific program publications.
- The Journal of Urology® Manuscripts
To submit a manuscript to The Journal, authors are required to complete disclosure information relevant to the manuscript only. Disclosure information is collected by Online 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 Online Editorial Manager database using the link provided at the AUA Disclosure page, or go directly to the Online Editorial Manager site per instructions provided by AUA publications staff. Information stored in the Online Editorial Manager is relevant to the Journal of Urology® Manuscript only and is not linked to other activity that individual may perform for AUA.
This disclosure information is published along with the manuscript.
- Office of Education Faculty/Annual Meeting Participant and OE Product Editors and Authors
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.
- 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 and update their disclosure information. Log-in information and instructions are provided with the notification letters.
- OE staff will monitor online activity for individual participants and assist as needed to help members establish/update their online records.
- 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. 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.
- Staff Access and Management of Disclosure Records
Access to Disclosure Records is limited to the individual who is disclosing and AUA staff in the departmental areas responsible for the activity.
- Appointments to Committees
- COI Review Process. Committee Chairs are required to review all COI disclosures of committee members prior to each meeting. This review must address each COI identified and document the resolution in the minutes.
Review of proposed members or chairs should also occur prior to the formation of or appointment to any new council, committee, editorial board, guidelines panel or task force. This initial review shall be performed by the AUA officer or chair proposing such an appointment. This review will be formally presented to the J&E Committee. The chair of the J&E Committee will annually report to the AUA Board of Directors.
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
- All programs shall be designed to be fair, balanced, and free of bias.
- Review of the scientific program by appointed Education Council CME content peer reviewers will ensure a fair and balanced presentation of all scientific evidence.
- 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.
- Unbiased moderators will be appointed to panel discussions to challenge the panelists on salient points of potential bias and/or conflicts of interest.
- AUA will use generic brand names and medical equipment citation and/or use three or more brand or equipment names when specifics are presented.
- 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.
- 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:
- Introduce a debate format with an unbiased moderator (count-counterpoint)
- Peer review for evidence-based content
- Provide faculty with alternate topic
- Select alternate faculty for specific topics
- 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, program director, content reviewer, and/or 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.
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
- ACCME-regulated activities. CME participants must comply strictly with the following policies for disclosure of commercial support, and AUA must represent that:
- All of its educational activities are free of commercial bias for or against any product;
- The commercial supporters of such activities have no control over or input into the planning, content, execution, or evaluation of the activity;
- Payment of honoraria and reimbursement of out-of-pocket expenses for faculty is reasonable, customary and proper, and in accordance with the AUA Stipend and Honoraria Policy;
- Any and all commercial support, including any "in-kind" support, is acknowledged to the learners prior to any activity;
- All relevant financial relationships of everyone who has any control over educational content, including planners, faculty, authors, content reviewers, and staff will be disclosed to the learners and will include:
- The name of the individual
- The name of the commercial interest(s) (Disclosure must never include the use of a trade name or a product-group message);
- The nature of the relationship the person has with each commercial interest
- For an individual with no relevant financial relationship, the learners must be informed that no relevant financial relationship exists
- An individual who refuses to disclose relevant financial relationships or fraudulently discloses such relationships will be disqualified from being a planning committee member, a teacher, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CME activity
- 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.
All participants in activities sponsored by AUA's Office of Education must comply also with the requirements of the Educational Content Review process of that Office.
- 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:
- Authors must describe all sources of financial support for their research, and this information should be published with the manuscript;
- Authors must disclose whether any portion of their research findings were written by persons employed by affected industry;
- Authors must affirm that no funding agreement limits their ability to fairly complete and publish their research, and that they had full control of primary data;
- External peer reviewers must disqualify themselves from any manuscript for which a conflict might arise. Peer reviewers must indicate in "Comments for Editor" if they have reviewed this paper previously for another publication. If previous or present connections with the author(s) and the author(s)' institution (intellectual conflicts), or personal financial interests might be construed as creating a conflict of interest, these issues must be disclosed. If reviewers feel they might have any difficulty writing an objective review, they should not review the paper and report this immediately.
- Reviewers may not use pre-publication knowledge of the work to advance their own interests.
- AUA Guidelines. To assure that AUA Guidelines are not developed with undue influence, disclosure by panel members, consultants and peer reviewers is required. However, the disclosure needs to be only relevant to the specific Guidelines topic.
The breadth of such "topic" shall include any and all products or modalities used in, useful for or undergoing any form of research development or assessment for the care, diagnosis or treatment of the specific disease, stage or condition as will be discussed in the Guideline in question, whether or not the product or modality is itself specifically approved for, used in, promoted for or referred to in the text of the Guideline. The requirement of recusal or disclosure shall continue for the duration of the Guideline development and for one year after on-line publication of the Guideline.
- Panel members, consultants or authors must report private or institutional interests which may compete or conflict with their objectivity in guidelines development on the relevant topic. Such COIs may warrant recusal of such individuals from discussion or voting on such topic, or on a complete Guidelines document.
- Peer reviewers must report private or institutional interests which may impact on their review of the guideline and should follow the same procedures outlined for Journal of Urology peer reviewers above.
- Panel members and peer reviewers may not use pre-publication knowledge of the work to advance their own interests.
- Non-Disclosure Agreement. Members who serve on AUA Guidelines Panels must also complete and comply with a Non-Disclosure Agreement. As a panel member/peer reviewer and/or writer of documents produced by the relevant panel, these members are routinely exposed to certain confidential and/or proprietary information, materials or data related to the panel's work and final documentation. It is important to the integrity of the writing process and final work that this information should be kept strictly confidential and not disclosed at any time under any circumstances.
Panel members therefore agree:
- To not disclose or cause to be disclosed to anyone or any entity outside of the Guideline panel or the appropriate AUA staff and AUA contractor any confidential and/or proprietary information, materials or data related to the Guideline Panel's work.
- To not speak publicly about a guideline or the deliberations regarding the development of the guideline until the embargo is officially lifted from any guidelines report(s).
- To keep all such confidential information in their possession or control in a safe and secure place and take all reasonable steps to protect against inadvertent disclosure or theft of the information.
- To promptly report to AUA any potential breach of this strict confidentiality of which they are aware, by themselves or others, from whatever cause, and assist to the extent possible in avoiding further disclosure and all possible consequences of such breach.
- Upon request from the Guideline Panel Chair or appropriate AUA staff, to promptly destroy all confidential information that they have been sent or acquired relating to the Guideline Panel. Notwithstanding the return or destruction of any confidential information, they will continue to be bound by this obligation.
Penalties/Sanctions. Panel members acknowledge that any violation or breach of this Agreement on their part shall constitute grounds for termination of access to such information and the penalties described as follows:
- A letter of warning from the Practice Guidelines Committee
- Removal from the panel
- Possible censure by the AUA including possible expulsion